Reliance & recognition by country

Conformity of a device with the essential requirements is confirmed by issuance of the CE marking document or, equally, by an FDA certification document; for CE the manufacturer follows the conformity procedure set in the technical rules adopted by Council of Ministers decision.

statement: Albanian device registration with AKBPM rests on CE conformity: Law 21/2020 amending Law 89/2014 provides that conformity with the essential requirements is confirmed by a CE marking document or, equally, an FDA certification document (held fact), and the AKBPM registration dossier under Order 360/2016 as amended by Order 734/2018 requires a copy of the declaration of conformity and/or CE certificate issued under technical rules VKM 731/2015, 508/2015 and 189/2016. No provision refers to China, NMPA or certificates from the country of manufacture, so an NMPA registration has no documentary or procedural role. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: albania · chinaClassesInScope: NMPA Class II/III certificates and Class I filings; target all Albanian classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

A device conforming to all applicable Albanian harmonized standards (reference list published in the Official Gazette) is presumed to conform to the essential requirements; if it conforms only partially, the presumption covers only the requirements corresponding to the standards met.

statement: Algeria's device regime (Décret exécutif n° 20 324 of 22 November 2020 and its implementing arrêté of 10 May 2021) requires an imported device to be documented by the competent authority of the country of origin: a certificate of free sale or equivalent and the origin country marketing authorisation in the homologation dossier, and ongoing reporting of any prohibition or restriction imposed by the origin country health authority, while the homologation decision itself rests on ANPP's own commission evaluation. For a China manufactured device the NMPA registration certificate (or Class I filing) is the origin country authorisation this evidence rests on, but neither text names NMPA or any foreign authority whose approval abridges the Algerian review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: algeria · chinaClassesInScope: All device classes (I III) subject to ANPP homologation · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The homologation dossier must include a certificate of free sale (CLV) or equivalent document from the pharmaceutical regulatory authority (or other recognized authority) showing the device is registered and marketed in the country of origin, plus the origin country marketing authorization and CPP where applicable, and copies of marketing authorizations obtained in other countries.

The renewal dossier must include a CLV or equivalent proving that registration and commercialization of the device are maintained in the country of origin, a renewed origin country marketing authorization (and CPP where applicable), and a benefit/risk evaluation of the device in Algeria and in the country of origin.

ANPP may take into account evaluations performed by a 'strict' pharmaceutical regulatory authority or by an authority recognized by ANPP when approving device modification applications.

statement: Decreto 892/2025 (in force 60 days after 17 Dec 2025) and ANMAT Disposición 236/2026 create a notification based import route for Class I and II medical devices that are authorized for public consumption in at least one country of Anexo I of the decree, and exempt such products from local testing on presentation of a free sale certificate. Anexo I lists Australia, the EFTA countries, the EU countries, the United States, Israel, Japan and the United Kingdom; China is not included, so an NMPA certificate does not open this route. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: argentina · chinaClassesInScope: NMPA Class I filings and Class II certificates for devices that are ANMAT Class I/II (and IVD A/B without cold chain) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For imported Class II–IV devices, Disposición ANMAT 727/2013 Art. 3 g3) requires an authenticated copy of the registration proof issued by the competent authority of the country where the device is manufactured, issued within the previous 24 months and legalized/apostilled; for China made devices the NMPA registration certificate is therefore a mandatory dossier document but confers no abridged review. Separately, Art. 5 allows ANMAT, at its discretion, to treat a device authorized by a foreign health authority whose regulatory functions and legislation are 'in line with' Argentina's framework as meeting similar quality/safety/efficacy characteristics and to exempt it from certain dossier items; the disposición deliberately abolished the former country list (Anexo III of Disposición 5267/06), so no official list includes or excludes China. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: argentina · chinaClassesInScope: NMPA Class II/III certificates (and Class I filing proof) for ANMAT Class II, III and IV devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

At inscription of a product already authorized by a foreign health authority with an equivalent regulatory framework (with official free sale certificate), the applicant is exempt from certain dossier items: Art. 2 incisos f) and g) and Art. 3 incisos e), g2) and g3) of Disposición ANMAT 727/2013.

target: geo:arg · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · membership: affiliate member · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · note: FDA lists ANMAT among MDSAP Affiliate Members (not full members); MDSAP audit reports/certificates serve as evidence within ANMAT processes and do not create product authorization or a BPF waiver.

statement: Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate. · sourceApproval: Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin country free sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home country registration/free sale evidence (or an IMDRF country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides. · sourceApproval: Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free sale certificate or a Declaration of Conformity with register references · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: import control · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: TGA accepts market authorisation evidence only from its designated comparable overseas regulators and assessment bodies: EU notified bodies (MDD/AIMDD/IVDD, MDR, IVDR), US FDA (PMA and 510(k)), Health Canada, Japan MHLW/PMDA, Singapore HSA, and UK approved bodies designated by MHRA, with MDSAP certificates as manufacturer evidence. China's NMPA is not a comparable overseas regulator, so an NMPA registration certificate cannot be used as manufacturer evidence or product assessment evidence for ARTG inclusion or to abridge a TGA conformity assessment. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: australia · chinaClassesInScope: All classes; ARTG inclusion applications and abridgement of TGA conformity assessment · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: EU CE under MDR/IVDR · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marking · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: Health Canada medical device licence · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: Singapore HSA product registration · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: Great Britain UKCA · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:aus · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: austria · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:aut · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Azerbaijan operates no recognition, abridged or fast track route for medical devices. The foreign (international) registration recognition mechanism in the Cabinet's registration Rules is expressly confined to medicinal products ('dərman vasitəsi') under Article 6 2 of the Law on Medicinal Products, and paragraph 1.3 subjects only medicinal products and medicinal substances to the simplified expertise procedure of Resolution No. 502. A medical device is registered solely through the full national dossier and expertise in Part 4 of the Rules, whatever FDA, CE, PMDA or MFDS approval the device holds. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Every medical device registration dossier must contain, with a notarially certified translation into Azerbaijani, any one of: (a) a document confirming state registration of the device in the country where it is manufactured, or — where it is not registered there — a document (documents) confirming state registration in another country or countries; or (b) the device's free sale or export certificate, where one exists. The item is mandatory paperwork for the national expertise; it creates no shortened route and does not by itself establish a right to market. · sourceApproval: Any country's national device registration certificate; or a free sale / export certificate issued for the device · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Registration of a medical device in Bahrain requires a Quality Assurance Certificate for the legal manufacturer, which is accepted in the form of a CE certificate under Directive 93/42/EEC, Regulation 2017/745, Directive 98/79/EC or Regulation 2017/746, or an FDA Certificate to Foreign Government (CFG), verified on the issuing body's website. The foreign approval is mandatory supporting paperwork for a local review that still runs in full, not a route that shortens it. · sourceApproval: EU CE marking under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746; US FDA Certificate to Foreign Government (CFG) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For class III medical devices and class D IVDs, Bahrain requires an EC Design Examination certificate or an FDA Certificate to Foreign Government for the legal manufacturer; the same document must be supplied for class IIb devices if available. The named foreign instrument is a mandatory class specific dossier item, not a shortened review. · sourceApproval: EC Design Examination certificate (EU notified body); US FDA Certificate to Foreign Government (CFG) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin country free sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12). · sourceApproval: Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA. · sourceApproval: Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: classification · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment. · sourceApproval: US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For import purposes the Licensing Authority will not grant registration or a licence for a drug (including a device) for human or animal use unless the product is registered under the same brand name in the countries listed for this purpose; the Government publishes and updates that list of countries from time to time.

statement: For Class C and D devices the DGDA registration dossier must contain a free sale certificate from any one of the EU, USA, Canada, Australia and Japan in addition to the country of origin FSC. China/NMPA is not among the accepted reference countries, so a China made Class C/D device cannot rely on its NMPA certificate alone. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: bangladesh · chinaClassesInScope: Bangladesh Class C and D (NMPA Class II/III equivalents) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For Class B devices the dossier requires the free sale certificate from the country of origin, and for Class C/D the country of origin FSC is required alongside a reference country FSC. A China NMPA registration certificate or NMPA based FSC satisfies the country of origin requirement for China made devices; no abridged review follows. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: bangladesh · chinaClassesInScope: Bangladesh Class B (NMPA Class I/II equivalents); also the origin FSC component for Class C/D · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The Department (DGDA) may accept clinical trial information or approved data obtained from foreign drug regulatory authorities.

Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)

target: geo:bgd · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information

The Department (DGDA) may, where necessary for a decision it is to adopt, follow the decision of an authority listed by the World Health Organization.

statement: Since 7 July 2024, Ministry of Health Resolution No. 51 of 19 May 2021, as described in the Belarusian Embassy procurement notice, allows unregistered medical devices produced by residents of the People's Republic of China and in circulation in China to be offered in Belarusian public procurement procedures. The bidder must include copies of the Chinese export certificate and the Chinese device registration certificate, a valid contract with the Centre for Expertise and Testing in Health Care for pre registration technical work, and an undertaking to hold a Belarusian registration certificate by the delivery date. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: Chinese medical device registration certificate and export certificate for the eligible China produced device · targetJurisdictionId: belarus · chinaClassesInScope: China produced, China registered devices covered by the procurement notice; equivalence of a Class I filing to the required registration certificate is not established · edgeType: procurement admission · marketAccessStrength: facilitated · regulatoryLayer: public procurement · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For foreign made devices the national dossier must include a document on registration and/or authorisation to market the device in the country of manufacture (registration certificate, free sale certificate, declaration of conformity or a dated screenshot of the regulator's official website), legalised and translated; an NMPA registration certificate is that document for China made devices. Under the EAEU route the same evidence is an 'if available' item. Neither route abridges the Belarusian or EAEU expertise on the basis of NMPA approval. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: belarus · chinaClassesInScope: All classes under the national registration route (Minhealth Resolution 55, Appendix 1, item 2.3) and the EAEU route (Decision 46 dossier item 10) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

A device registered under the EAEU common registration procedure is admitted to production, sale and medical use in Belarus without a separate national registration; Belarus also acts as EAEU reference or recognition state through Минздрав (procedure 9.3.6: issue of the registration certificate for EAEU registered devices; procedure 9.3.7: EAEU dossier changes coordinated with recognition states).

For foreign made devices the national dossier must include a document on registration and/or authorization to market the device in the country of manufacture (registration certificate, free sale certificate, declaration of conformity, or a dated screenshot of the regulator's official website), with legalization/apostille and notarized Belarusian/Russian translation unless an international treaty provides otherwise.

The national production inspection requirement is triggered differently where the devices are already in circulation in the USA or EU member states; the inspection case list excludes foreign class 1 devices (non sterile) and treats sites previously declared only for US/EU circulating or EAEU registered devices separately.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: belgium · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:bel · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For imported medical devices the applicant must file a certificate of the medical device issued by the competent national health authority of the country of origin, stating that the product is duly authorised there, legalised by a Bolivian consulate, and where the origin country has no Bolivian consular representation, certified by Bolivia's Ministry of Foreign Affairs together with the original document. This is a mandatory element of the local dossier and does not shorten or replace the local evaluation. · sourceApproval: Registration/marketing authorisation of the device by the competent national health authority of the country of origin (any country of origin; no specific authority is named) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: AGEMED's Resolución Administrativa N° 42 of 18 September 2024 approved the 'Principios relativos para la utilización de decisiones regulatorias de otros países — Reliance (Confianza)' and its attached directive for inscription, renewal and rectification of marketing authorisations. The directive's scope clause names 'dispositivos médicos' and 'dispositivos de diagnóstico in vitro' among the products it applies to, so a foreign regulatory decision is an admissible input for a Bolivian device registration. Eligibility requires the device to hold a current registration/marketing authorisation from at least one reference authority, and the reference authority must be one recognised by law, a PAHO/OPS reference authority, or a WHO Listed Authority (WLA) for the regulatory function 'registration and marketing authorisation'. For devices the documentary proof of the reference decision is a sworn declaration of equivalence in which the importer or responsible party declares the device to be identical to the one authorised by the reference regulator. AGEMED states expressly that the procedure does not imply automatic acceptance of the reference authority's evaluation and that it retains its independence and sovereignty over the decision. · sourceApproval: Any authority on the WHO Listed Authorities (WLA) list or the PAHO/OPS reference authority list for the regulatory function 'registration and marketing authorisation' (the resolution names no authority individually; US FDA, EU/CE, Japan PMDA and Korea MFDS are not named) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Where the conformity of a medical device with the general and special requirements is determined by a conformity assessment body recognised in the European Union, the manufacturer marks the device with the CE marking, and that marking is recognised in Bosnia and Herzegovina in place of the national BiH conformity marking. The CE route therefore replaces the national conformity assessment and marking step, but the device must still be entered in the Register of medical devices kept by the Agency before it may be placed on the market. · sourceApproval: EU CE Marking — conformity assessment determined by a body recognised in the EU; in practice an MDR (EU) 2017/745 certificate, or during the transition a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate that remains valid under MDR Article 120 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For in vitro diagnostic medical devices the registration dossier must contain a certificate of conformity with the directives and regulations of the European Union (CE marking certificate, EC certificate) — except for in vitro diagnostic devices on List D — together with the manufacturer's declaration of conformity against the European directive stating the list to which the device belongs. Class I (other) non IVD devices are likewise exempt from the EC certificate limb. · sourceApproval: EU in vitro diagnostic certificate (CE marking certificate / EC certificate) under the EU IVD directives or IVDR · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: An EC certificate issued by an authorised body under Directives 90/385/EEC or 93/42/EEC from 25 May 2017, which was valid on 26 May 2021 and has not subsequently been withdrawn, remains in force beyond the end date printed on the certificate until 31 December 2027 for class III devices, implantable class IIb devices and AIMD devices, and until 31 December 2028 for the remaining class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. The Agency accepts such certificates only where the manufacturer holds a signed MDR Annex VII written agreement with a notified body and confirms no significant change in design or intended purpose and no unacceptable risk. · sourceApproval: Legacy EU EC certificate under MDD 93/42/EEC or AIMD 90/385/EEC extended by MDR (EU) 2017/745 Article 120 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Since 26 May 2021 a manufacturer's declaration of conformity issued against Directive 93/42/EEC can no longer be regarded as a valid document for a Class I risk device and will not be accepted; a declaration of conformity complying with Regulation (EU) 2017/745 must be submitted to the Agency for applications filed after that date. Any significant change in the design or intended purpose of the device requires a fresh conformity assessment and consequently a new declaration of conformity. · sourceApproval: EU MDR (EU) 2017/745 declaration of conformity; the legacy MDD 93/42/EEC declaration is no longer accepted · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A registration application for a class I, IIa, IIb or III medical device must include proof that the device is marketed in the country of the manufacturer or in one of the countries of the European Union — a 'Free Sale Certificate' or similar document. This is a mandatory documentary element of the dossier and is required alongside, not instead of, the EU conformity certificate. · sourceApproval: Evidence of marketing in the manufacturer's country or in an EU member state (Free Sale Certificate or similar document) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases. · sourceApproval: Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: China's National Medical Products Administration is named as an acceptable reference authority in the exemption pathway, but the recognition is expressly limited to Class A and Class B medical devices; the same limitation is applied to SAHPRA. China NMPA is not a Stringent Regulatory Authority under BoMRA's SRA definition and so cannot ground the Class C or Class D abridged criteria. · sourceApproval: China National Medical Products Administration (NMPA) marketing authorisation Class A and Class B medical devices only · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: As a regional concession, abridged assessment is available for contraceptive medical devices that have already been registered in any SADC country, without the SRA or RRA approval that the general abridged criteria otherwise require. · sourceApproval: Registration of the contraceptive device by any SADC national regulatory authority (e.g. SAHPRA, MCAZ, ZAMRA, TMDA) · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For devices that are not on the interim register/listing, BoMRA's exemption guideline makes a foreign marketing authorisation a required piece of evidence: a copy or proof of the marketing authorisation issued by a relevant Reference Regulatory Authority, Singapore HSA, China NMPA (Class A and B only) or SAHPRA (Class A and B only), and/or a CE certificate issued by a European notified body under MDD 93/42/EEC, IVDD 98/79/EC, MDR (EU) 2017/745 or IVDR (EU) 2017/746, and/or proof of a WHO EUL or Prequalification acceptance letter. Approval places the device on an exempted list with a six month validity. · sourceApproval: Reference Regulatory Authorities recognised by BoMRA; Singapore Health Sciences Authority; China NMPA (Class A and B only); South African Health Products Regulatory Authority (Class A and B only); CE certificate from a European notified body under MDD/IVDD/MDR/IVDR; WHO EUL or WHO Prequalification acceptance letter · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Separately from the product dossier, BoMRA recognises and relies on GMP inspection outcomes. Under the Guideline for Good Recognition and Reliance Practices it accepts desk assessment of inspection reports issued by WHO Listed Authorities, by SADC regulators (SAHPRA, MCAZ, ZAMRA and TMDA) including outcomes from the WHO Prequalification Programme and ZAZIBONA, and by other authorities such as Ghana FDA; it also recognises WHO Prequalification and regional initiatives such as ZAZIBONA and AMA. Facilities approved through those mechanisms may not require an on site inspection. This abridges the site inspection step, not the dossier review. · sourceApproval: WHO Listed Authorities; WHO Prequalification Programme; SADC national regulatory authorities (South Africa SAHPRA, Zimbabwe MCAZ, Zambia ZAMRA, Tanzania TMDA); ZAZIBONA; AMA; other authorities such as Ghana FDA · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: BoMRA operates a separate reliance/recognition guideline for regional and international bodies that names reference authorities, ZAZIBONA, WHO Listed Authorities and an AMA continental listing procedure but its scope is expressly limited to medicines, vaccines, blood and blood products. It creates no medical device route and must not be read as one. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: WHO prequalification functions as a reference approval for the abridged pathway (WHO approval with ISO 13485 satisfies the Class B abridged condition, and WHO with ISO 13485 satisfies Class C), and devices entering through the WHO Collaborative Registration Procedure have a published target assessment time of three months. · sourceApproval: WHO prequalification (including WHO Collaborative Registration Procedure listings) · edgeType: international listing · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Reliance does not bind ANVISA: ANVISA decides the Brazilian petition independently of the decision issued by the reference authority (AREE).

Australia Therapeutic Goods Administration (TGA) listing on the Australian Register of Therapeutic Goods (ARTG) is accepted under the optimized review procedure for class III/IV device registration.

Health Canada Medical Device Licence is accepted under the optimized review procedure for class III/IV device registration.

Japan Ministry of Health, Labour and Welfare (MHLW) pre market approval (Shonin) is the accepted Japanese reference authorization under the optimized review procedure.

US FDA marketing authorizations accepted under the optimized review procedure: 510(k) Clearance, Premarket Approval (PMA), or 513(f)(2) De Novo.

statement: NMPA Commissioner Jiao Hong and ANVISA Director President Antonio Barra Torres signed a Memorandum of Understanding on cooperation on 26 November 2020 covering information exchange in the regulation of drugs, medical devices and cosmetics. ANVISA's official cooperation page lists the 'Memorando de Entendimento entre Anvisa e NMPA' under China, and a separate BRICS regulators' MoU. Neither instrument creates recognition of NMPA registrations; they are information exchange frameworks. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: brazil · chinaClassesInScope: All device classes (framework MoU; no product level effect) · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: ANVISA's optimized (reliance) review for Class III/IV device registration under RDC 741/2022 is available only for devices previously authorized by an AREE listed exhaustively in IN 290/2024 Art. 6: TGA (ARTG), Health Canada (Medical Device Licence), US FDA (510(k)/PMA/De Novo) and Japan MHLW (Shonin). China's NMPA is not listed, so an NMPA registration certificate gives no access to the optimized procedure and the ordinary route (RDC 751/2022 / RDC 830/2023) applies. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: brazil · chinaClassesInScope: NMPA Class II/III certificates and Class I filings; target: ANVISA Class III/IV registration (optimized procedure) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

GMP reliance: a CBPF certificate based on an audit performed under the Medical Device Single Audit Program (MDSAP) is valid for 4 years, versus 2 years for the standard certificate.

statement: Brunei Darussalam signed the ASEAN Agreement on Medical Device Directive at Bangkok on 21 November 2014 but is not among the Member States that have deposited an instrument of ratification or acceptance. Under AMDD Art. 22(2) the Agreement 'shall be in force only among the Member States that have ratified and/or accepted it', so the AMDD — including its registration obligation, its four risk classes and its Common Submission Dossier Template — does not bind Brunei and creates no device route there. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: dossier format · localApplicationRequired: No · targetDecisionRetained: No

statement: Brunei grants no recognition, abridgement, fast track or documentary credit to any foreign medical device approval, because it operates no medical device market authorisation regime for such recognition to attach to. Medical devices are excluded by definition from the Medicines Act, Chapter 285 — the only Brunei statute requiring product registration — so a US FDA 510(k)/PMA clearance, EU CE Marking, Japan PMDA approval, Korea MFDS approval or China NMPA registration confers no market access benefit and triggers no local registration obligation in Brunei. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: No · targetDecisionRetained: No

statement: In at least one Ministry of Health procurement, equipment must comply with one of five named international safety standards — US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. This is a tender technical requirement for the supply of equipment, not a market authorisation recognition rule: it creates no registration pathway, shortens no review, and does not name Japan PMDA, Korea MFDS or China NMPA. · sourceApproval: US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval) · edgeType: procurement admission · marketAccessStrength: evidence only · regulatoryLayer: procurement · localApplicationRequired: No · targetDecisionRetained: No

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: bulgaria · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:bgr · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Cambodia's device submission follows the ASEAN Common Submission Dossier Template (CSDT): the AMDD, which Cambodia has accepted, requires Member States to undertake appropriate measures to adopt and implement Annex 4 (CSDT) as a common technical document, alongside the post marketing alert system (Annex 5) and the harmonised Declaration of Conformity elements (Annex 6). This is a harmonised dossier format only — it is not recognition of a foreign marketing approval, and the Cambodian authority's own review and decision are retained. · sourceApproval: ASEAN Common Submission Dossier Template (CSDT) · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Health Canada issues a Class II IV medical device licence only on its own review of the application prescribed by section 32 of the Medical Devices Regulations (SOR/98 282); the Regulations contain no reliance or abridged licence route based on a foreign marketing authorisation, so a China NMPA registration certificate does not shorten or replace the Canadian licence review. NMPA appears in Health Canada's List of Regulatory Agencies only for the sections 61.2/68.3 foreign risk notification duty. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: canada · chinaClassesInScope: NMPA Class II/III > Canada Class II IV licences · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72 hour foreign risk notification duty.

program: Medical Device Single Audit Program (MDSAP) · effect: A single audit by a recognized MDSAP Auditing Organisation provides the QMS evidence for Canadian device licensing; it does not by itself authorize the product · local application required: Yes · target decision retained: Yes

Under Art. segundo of Decreto Exento N°25/2026, the applicant (titular) may demonstrate conformity with the internationally recognized essential principles of safety and performance using alternative or complementary standards, national or international, in place of the specific standards listed in the decree; ISP will set criteria for recognizing updated standard versions by reasoned resolution (Art. tercero).

statement: Decreto Supremo 825/1998 Art. 21 a) 6 requires, for every imported device subject to control, a certificate for export purposes issued in the country of origin, authorized by the corresponding state authority and duly legalized; an NMPA issued export/free sale certificate therefore satisfies this documentary requirement for China made devices. Neither DS 825 nor Decreto Exento 25/2026 (which brought a further group of devices/IVDs under registration) names any foreign reference agency or provides an abridged review based on foreign approvals; conformity is verified by ISP against NCh ISO 16142, 13485 and 14971 and product standards. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: chile · chinaClassesInScope: NMPA Class I/II/III (all ISP classes I–IV, since Class I requirements apply cumulatively to higher classes) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For imported devices, D.S. N°825/1998 requires a certificate for export purposes issued in the country of origin, authorized by the corresponding state authority and duly legalized; the current ISP filing sheet equally requires an export or free sale certificate from the competent health authority, consularized or apostilled.

statement: China's National Medical Products Administration (NMPA) is a member of the IMDRF Management Committee, listed by IMDRF alongside Australia TGA, Brazil ANVISA, Health Canada, the European Commission, Japan PMDA/MHLW, the Russian Ministry of Health, Singapore HSA, South Korea MFDS, Swissmedic, UK MHRA and US FDA; China is scheduled to hold the IMDRF chair in 2030. Membership does not itself grant product market access; each destination rule must independently establish its legal effect. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: IMDRF Management Committee membership (not product approval) · targetJurisdictionId: china · chinaClassesInScope: NMPA as an authority (all device and IVD classes) · edgeType: international listing · marketAccessStrength: evidence only · regulatoryLayer: authority status · localApplicationRequired: Not published · targetDecisionRetained: Not published

statement: WHO's list of transitional WHO Listed Authorities for medical devices (tWLAs MD), as of 1 July 2026, names China's National Medical Products Administration (NMPA) with the scope 'Medical devices including in vitro diagnostics', alongside TGA, ANVISA, Health Canada, the European Medical Devices Regulatory Network, MFDS, MHLW/PMDA, the Russian Ministry of Health, Swissmedic, HSA, MHRA and US FDA. The list exists to support regulatory reliance on medical devices and is built from the WHO Prequalification recognized regulatory authorities plus IMDRF Management Committee membership as of 30 June 2026; whether a given importing regulator relies on it is that regulator's decision. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: WHO transitional medical device authority listing (not product approval) · targetJurisdictionId: china · chinaClassesInScope: NMPA as an authority (all device and IVD classes) · edgeType: international listing · marketAccessStrength: evidence only · regulatoryLayer: authority status · localApplicationRequired: Not published · targetDecisionRetained: Not published

For import Class II/III registration the designated China agent submits, together with the application dossier, the marketing approval certificate issued by the regulator of the registrant's home country/region. The certificate functions as an eligibility/documentary gate, not a reliance route: NMPA still performs its own full review.

Innovative medical devices not yet marketed outside China need not submit the home country/region marketing approval certificate in the import filing/registration.

statement: Decreto 4725/2005 Art. 29 b) names the 'países de referencia' exhaustively as the European Economic Community, the United States, Canada, Japan and Australia (plus countries with a mutual recognition agreement), and Decreto 3275/2009 (Art. 18 parágrafo 3) lets a free sale certificate from those reference countries stand in for technical studies, sterilization and clinical data for class I, IIa and IIb devices. China is not a reference country and Colombia has no mutual recognition agreement with it, so an NMPA certificate cannot replace technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: colombia · chinaClassesInScope: NMPA Class I/II/III; target INVIMA classes I, IIa, IIb (Decreto 3275/2009 homologation) and reference country CLV substitution under Art. 29 b) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For imported devices, Decreto 4725/2005 Art. 29 b) requires a certification from the competent authority of the country of origin stating that the product is authorized for production or marketing there; for China made devices the NMPA registration certificate or filing record fulfils this requirement. The full INVIMA dossier (technical studies, sterilization, clinical evidence) still applies because China is not a reference country. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: colombia · chinaClassesInScope: NMPA Class I filings and Class II/III certificates for all INVIMA classes of imported devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For imported devices, a certificate from the competent authority of the country of origin stating the product is authorized for production or marketing there is required; if the product is not used in the country of origin, a free sale certificate from a reference country (EU, United States, Canada, Japan, Australia) or a country with a mutual recognition agreement is required instead.

The Regístrelo regulation defines 'Reconocimiento' as the procedure by which a sanitary registration issued by a regulatory authority that is a member of the Unión Aduanera Centroamericana (Central American Customs Union) is recognized; Regístrelo supports trámites for registro, cambios post registro, renovación, uso de registro y reconocimiento of products of sanitary interest (which include EMB).

statement: RTCR 505:2022 (Decreto Ejecutivo 43902 S) requires, for imported equipo y material biomédico, a Certificate of Free Sale as defined in numeral 4.7 (as amended by Decreto Ejecutivo 44431 S of 11 April 2024): a document issued by the competent authority of the country or region of origin certifying that the products are authorized for sale, use or distribution there, legalized or apostilled with official translation (numeral 11.3). For China made devices an NMPA certificate is that document; it does not shorten the review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: costa rica · chinaClassesInScope: NMPA Class I filings and Class II/III certificates for EMB classes 2, 3 and 4 (class 1 exempt from registration) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Under WTO TBT Article 6.1 principles, the Ministry may accept conformity assessment results of registration systems of foreign governments that have completed the equivalence procedure in Anexo B of RTCR 505:2022 (government to government). For devices manufactured, registered and on sale in accepted countries, only a reduced dossier is required (form, technical/medical specifications, free sale certificate, radiation authorization where applicable, label, fee, manufacturing contract, power of attorney); the Ministry may still request any exempted document during or after registration.

statement: The administrative dossier must include a document attesting the first placing on the market in the country of origin. This is Côte d'Ivoire's functional equivalent of a free sale certificate requirement: it is separate from the conformity attestation, it is mandatory, and its purpose is to establish that the device is lawfully marketed where it comes from. It confers no shortened review — it is an exhibit in a full national evaluation. · sourceApproval: Origin country document evidencing first placing on the market — the origin country marketing authorisation, free sale certificate (certificat de libre vente) or equivalent first marketing proof; the AIRP does not prescribe the document's form · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The device marketing authorisation dossier must contain a certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP. This is the operative foreign approval document — a CE certificate or equivalent conformity attestation — and it is a mandatory attachment for every device to be homologated, not a fast track key. The AIRP does not publish which international procedures it recognises, and the dossier still requires full technical documentation, a risk management plan and an essential requirements checklist. · sourceApproval: EU CE marking / conformity attestation obtained under the international procedures recognised by the AIRP (the AIRP does not publish the list of recognised procedures) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The AIRP participates in the WHO collaborative registration procedure for WHO prequalified in vitro diagnostic medical devices (DMDIV): the applicant files a national registration application with the AIRP, the manufacturer consents to WHO sharing its prequalification assessment dossier, inspection and performance evaluation results, and the AIRP must take its national decision within 90 calendar days of the regulatory clock. The AIRP may accept or refuse to apply the procedure to any individual application. · sourceApproval: WHO prequalification (WHO Prequalification Programme) for in vitro diagnostic medical devices · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A device lawfully bearing CE marking under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may be placed on the Croatian market on the strength of that certificate. Croatia secures the implementation of the two Union regulations by the Zakon o provedbi Uredbe (EU) 2017/745 ... (NN 100/2018), which establishes the national competent authorities, the national procedural duties and the penalties, but creates no additional national product approval, no national certificate and no national re assessment of the notified body's technical assessment. · sourceApproval: EU CE Marking under MDR (EU) 2017/745 / IVDR (EU) 2017/746 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: No

statement: Croatia is an EU member state: a device may be placed on the Croatian market only if it complies with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration certificate is not recognised by HALMED and opens no abridged, documentary, fast track or reciprocal route; the holder must obtain CE marking through a notified body under MDR/IVDR before the device may lawfully be placed on the Croatian market. The only exception is a public health derogation under Article 59 MDR / Article 54 IVDR, which Croatia implements nationally in Article 14 of NN 100/2018 and which authorises a specific device for a limited purpose; it is not recognition of a foreign approval. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The cited 2023 policy refers to PAHO reference authorities, WHO listed authorities and authorities covered by CECMED agreements. WHO subsequently included NMPA on its transitional medical device list on 1 July 2026. Whether CECMED treats that transitional device listing as qualifying under its policy has not been established. Do not infer exclusion from the permanent medicines authority list or from an incomplete list of cooperation instruments. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: cuba · chinaClassesInScope: all regulatory functions incl. device registration (reliance practice) · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The retained official E 86 16 text, section 3.2.4, permits a current prior registration certificate from the origin country or a qualifying comparable regulatory programme (including IMDRF members) in place of specified software, biological, safety, raw material and stability evidence. This is evidence reduction, not automatic Cuban approval. Section 4.1.2 restricts ordinary Proceder B eligibility to specified devices; China Class III does not itself establish eligibility. The regulation expressly excludes in vitro diagnostics. Current applicability still requires confirmation because the live official PDF could not be retrieved in this review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: Current country of origin product registration certificate, including a qualifying NMPA Class II/III certificate for a China made device · targetJurisdictionId: cuba · chinaClassesInScope: General medical devices only; excludes IVDs; Cuban risk class, novelty and sensitive device rules must be checked separately · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre clinical evidence, safety/environmental/parametric test reports, raw material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.

statement: A CE mark under Regulation (EU) 2017/745 (or 2017/746 for in vitro diagnostic medical devices) is the domestic route into Cyprus and is valid throughout the EU/EEA; CYMDA states that it has so far imposed no additional requirement beyond those provided for by Union and national legislation. What a CE holder still owes Cyprus is local: notify each device to CYMDA under Decree No. 7, ensure the importer is identified on the device, its packaging or an accompanying document, supply the information needed for safe and proper use in English and/or Greek (Greek mandatory for use by non healthcare professionals), register in EUDAMED, and accept the market surveillance and penalty powers under Law 225(I)/2022. · sourceApproval: EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: No

statement: Cyprus, as an EU Member State, operates no abridged, fast track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or China NMPA approval cannot be placed on the Cypriot market: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are directly applicable and permit placing on the market only of a device that complies with them, and CYMDA's own description of how a manufacturer affixes the CE marking describes only the Union conformity assessment procedure, with no national pre market approval step and no reference to any third country approval. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: No · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: czech republic · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:cze · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

target: geo:cze · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: denmark · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:dnk · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

target: geo:dnk · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No

statement: For an imported device, the sanitary registration dossier must include a current original certificate of free sale for the product issued by the health authority of the country of origin, legalised or apostilled, and a current original good manufacturing practices certificate (or quality system certification) of the manufacturing laboratory, legalised or apostilled. These are mandatory supporting documents for the full local review; they do not by themselves shorten the review, which is only shortened where the issuing authority is one of the listed Strict Authorities or ARNr. · sourceApproval: Certificate of free sale from the health authority of the country of origin (any origin country; no specific reference authority required) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure. · sourceApproval: WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: From 28 January 2027, Articles 31 32 require both high vigilance authority status and IMDRF membership, plus the stated device marketing/class conditions. IMDRF membership alone is insufficient. NMPA appears on WHO's July 2026 transitional medical device authority list, but ARCSA's treatment of this listing under its high vigilance definition has not been established; the maintained evidence therefore does not resolve NMPA only eligibility. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: ecuador · chinaClassesInScope: NMPA Class II/III certificates; target ARCSA simplified registration (Arts. 31–34) for classes I–IV · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: From 28 January 2027, ARCSA DE 2026 003 Article 25(a) accepts a Certificate of Free Sale (CLV), or qualifying equivalent, from the country of manufacture/export, a high vigilance agency or an IMDRF member country. A China issued document must itself satisfy the required declaration of marketing and product/manufacturer/site particulars; an NMPA registration certificate or Class I filing is not automatically a compliant CLV. This is documentary evidence for registration, not an automatic simplified review benefit. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China issued Certificate of Free Sale or equivalent satisfying Article 25(a), not merely any NMPA certificate · targetJurisdictionId: ecuador · chinaClassesInScope: Imported devices within the regulation; qualifying free sale documentation must be established for the particular product · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high vigilance agency, or from an IMDRF member country; if the CLV or the product owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.

From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device scope authorisation and ARCSA risk classification I IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.

statement: EDA's device registration guideline GL.CAMD.002 v2 (September 2025) enumerates the reference countries exhaustively (the EU/EEA states plus Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the UK and the USA) and China is not among them, so an NMPA certificate confers no reference country status. A China made device must submit the full Appendix 1 file (declaration of conformity, CE certificate from an EU notified body, ISO 13485:2016 for the actual manufacturer, and a free sale certificate from a reference country because the country of origin is non reference) and is routed to the relevant specialised scientific committee before registration, which may require published clinical trials, a stamped summary of market history in reference countries, and ILAC accredited laboratory test reports depending on device type. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: egypt · chinaClassesInScope: All classes (I, IIa, IIb, III; sterile and non sterile); NMPA Class I/II/III devices are treated as 'imported from a non reference country' · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For non sterile imported Class IIa devices EDA accepts, in the initial registration file, a free sale certificate from the country of origin, and even one from a non reference country, provided a reference country free sale certificate is filed within a 6 month grace period. This is the only point in GL.CAMD.002 at which an origin country (e.g. Chinese, NMPA based) marketing document has any evidentiary role; it grants no abridged review and lapses unless replaced by reference country evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: egypt · chinaClassesInScope: Non sterile Class IIa only (initial registration file) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For the initial registration file, Class IIb and III devices need a free sale certificate from a reference country; Class IIa devices may use one from the country of origin (or even a non reference country, provided a reference country certificate follows within 6 months).

Japan is a reference country (Technical Committee decision of March 2011); the same registration procedures as EU classes I, IIa, IIb and III apply to Japanese classes I, II, III and IV respectively. Japanese documents and labelling must be translated into English (by the Japanese manufacturer or an accredited Egyptian translation office).

EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non reference countries need extra evidence.

A CFG certificate issued by USFDA replaces the free sale certificate and the CE certificate; the ISO 13485 certificate is also waived if the FDA certificate shows the plant complied with current GMP requirements. 510(k) clearance supports Class II and PMA supports Class III. CFG legalization is waived when EDA can verify device data via FDA CDRH export certificate validation and 510(k)/PMA databases.

statement: For Estonia the CE marking route is not a foreign approval but the domestic route: Regulations (EU) 2017/745 and (EU) 2017/746 apply directly in Estonia and the Estonian Medical Devices Act does not apply where those regulations apply, so a device holding a valid MDR/IVDR conformity assessment enters the Estonian market through the Union route. Only the national residual duties attach: notification of first distribution (MSS § 26(4)), Estonian language information (MSS § 16(3) (5)), data submission to the MSA register (MSS § 29) and the Union registration duties. · sourceApproval: EU CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes

statement: A US FDA 510(k), De Novo or PMA clearance gives no market access route in Estonia. Estonia applies Regulation (EU) 2017/745 directly and a device may be placed on the Estonian market only if it complies with that Regulation; the Regulation provides for conformity assessment under Annexes IX to XI and contains no reliance or abridged procedure based on a third country marketing authorisation. An FDA only holder must obtain CE marking under MDR (or IVDR for IVDs) and designate an EU authorised representative. · sourceJurisdictionId: usa · sourceAuthorityId: fda · sourceApproval: US FDA 510(k) clearance, De Novo grant or PMA approval · targetJurisdictionId: estonia · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: In the low risk device route (Class I non IVD and Class A IVD), EFDA states that if the applicant submits a CE certificate, the free sale certificate or marketing authorisation certificate is not mandatory. Otherwise the applicant must supply an original and valid free sale or marketing authorisation certificate from the responsible regulatory authority where the device is marketable. This is a documentation substitution for the lowest risk classes and does not shorten the substantive review. · sourceApproval: EU CE certificate (including CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives) · edgeType: abridged or recognition route · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: EFDA's SRA route enumerates exhaustively the foreign authorities whose marketing authorisation, registration certificate or free sale certificate makes a device eligible (US FDA, Japan MHLW, Australia TGA, Singapore HSA, the 27 EU Member State competent authorities, UK MHRA, Health Canada, South Korea MFDS), plus WHO and UNFPA prequalification. China NMPA is not among them, so a device holding only an NMPA registration certificate is not eligible for the §9.4 shortened route and must be filed for full assessment. The NMPA certificate still has a documentary role, because every application must include a free sale certificate or marketing authorisation certificate from the national regulatory authority where the device is marketable, which for a China made device is the NMPA certificate. · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Every registration file must contain a free sale certificate or marketing authorisation certificate issued by the national regulatory authority of a country where the device is marketable, attesting that the device may be marketed there without restriction; where the device is not freely sold in the country of origin the reasons must be stated and justified. The certificate must be original and valid. This is an evidence requirement that applies to all devices regardless of risk class, and it is separate from the SRA shortened route. · sourceApproval: none · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: EFDA/GDL/042 'Guidelines on Reliance for Medicine Marketing Authorization' (Version 003, approved 2 December 2024) states in its Scope that it covers reliance 'in the registration and marketing authorization of medicines approved or listed by reference regulatory authorities or institutions'. Its reference authority annex, verification review and abridged review pathways therefore do not apply to medical devices; device reliance is instead governed by the SRA route in GDL/046 §9.4 and by the ordinary device registration guidelines. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A medical device that already holds a marketing authorisation, registration certificate or free sale certificate from one of the authorities EFDA lists as a Stringent Regulatory Authority can be filed on the SRA route (EFDA/GDL/046 §9.4). The applicant still submits the complete administrative and technical dossier required by the ordinary registration guidelines, but EFDA reviews it as a verification exercise focused on the genuineness of the submitted information rather than a de novo assessment, so the application takes shorter processing time. EFDA keeps the right to conduct a full assessment and to request further information whenever it deems necessary. · sourceApproval: US FDA marketing authorisation / registration certificate / free sale certificate; Japan MHLW; Australia TGA; Singapore HSA; a competent authority of one of the 27 EU Member States (Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017); UK MHRA; Health Canada; South Korea MFDS · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Devices already prequalified by WHO and/or UNFPA are filed on the same §9.4 route as SRA approved devices. Because a prequalified device may hold no registration or marketing authorisation certificate, the prequalification claim must instead be evidenced by the confirmation letter of acceptance for prequalification, by the product's presence in the prequalified products list, or by the evaluation report(s) issued by the prequalifying organisation. · sourceApproval: WHO Prequalification (including IVD prequalification); UNFPA prequalification · edgeType: international listing · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: eu · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

MDCG 2020 14 'Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the MDR/IVDR' (Commission endorsed, non binding) permits notified bodies to use MDSAP audit reports when conducting surveillance audits; MDSAP informs EU surveillance auditing but is not a substitute for EU conformity assessment and creates no EU product authorisation.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: finland · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:fin · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: france · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:fra · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For the three device type categories that are registered under the Law on Medicines — dental material, invasive mechanical means of contraception, and means of diagnostics (test systems, allergens, reagents, sera) — the administrative dossier may carry, in place of a WHO format Certificate of Pharmaceutical Product and in place of the GMP document or manufacturing licence that substitutes for it, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate. This is origin country documentary evidence: it is required paperwork for the national registration dossier, and the Georgian registration decision is still taken locally. · sourceApproval: EU EC certificate of the product manufacturer; ISO certificate of the product manufacturer; or a free sale certificate — accepted in lieu of a WHO format Certificate of Pharmaceutical Product · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Under the medical device clinical investigation technical regulation, the requirement that a first time international clinical investigation on humans take place in a country recognised by Government Decree No. 188 of 22 October 2009 does not apply to a device clinical investigation that satisfies all of: (a) it is an analogue/replacement of a device of the same manufacturer that is already registered and has improved technical characteristics compared with that device; (b) the previous generation model of the investigating device is in circulation on the market of a country/countries recognised by Decree No. 188; and (c) the manufacturing country/countries of the investigating device are on the list in that Decree. Instead of the recognised country location, the applicant files an opinion of an authoritative sectoral professional association on the appropriateness (benefit/risk), a recommendation of the Georgian National Bioethics Council, and an informed consent form stating that the international device clinical investigation is being conducted in Georgia for the first time and has not been conducted or is not under way in another country. The decision is taken by the Minister or by a specialist group formed for that purpose. · sourceApproval: market circulation of the previous generation of the device in a country recognised by Government Decree No. 188 of 22 October 2009; manufacturing country/countries on the same list · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Georgia's state registration has two regimes: a recognition regime and a national regime. The recognition regime applies to a product that has been granted a marketing authorisation in the respective market by a state body regulating pharmaceutical products in a foreign country or internationally, from a list of such bodies compiled by the Government of Georgia. Georgia unilaterally recognises the foreign safety, efficacy and quality requirements and does not repeat the expertise to determine safety, quality and therapeutic efficacy; the Georgian authorisation period follows the foreign one but is capped at 5 years. · sourceApproval: a marketing authorisation for the respective market granted by a state body regulating pharmaceutical products in a foreign country or internationally, from the list compiled by the Government of Georgia under Art. 11^7(2); the Government list is Government Decree No. 188 of 22 October 2009 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: germany · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:deu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: FDA Ghana's Guidelines for the Registration of Medical Devices (FDA/MCH/MDD/GL RMD/2013/01, Version 02, issued 1 March 2016) prescribe a full technical dossier (device description, evidence of conformity to Essential Principles via the Annex II checklist, materials, specifications, verification and validation, biocompatibility, clinical evidence, labelling) with no abridged route, no list of reference regulatory agencies and no requirement for a certificate of free sale or country of origin approval. A prior NMPA approval is therefore neither required nor recognised in the standard registration procedure; any credit for foreign approval arises only through the separate reliance guideline. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: ghana · chinaClassesInScope: all classes under the device registration guideline (full dossier review) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

FDA Ghana grants market authorisation for medical devices using reliance on regulatory decisions of well resourced National Regulatory Authorities, exchanging scientific assessments, safety data and inspection reports.

Under the WHO Collaborative Registration Procedure, the aim is for participating NRAs to issue a regulatory decision within 90 working days; participation is voluntary for manufacturers and applicants must comply with both national and CRP requirements.

The Medical Devices Department grants market authorisation for medical devices through the WHO collaborative registration procedure (CRP) for accelerated registration of WHO pre qualified medical devices.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: greece · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:grc · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For the addition of an alternative manufacturing plant, NT 37 requires a manufacturing guarantee certificate issued by a health authority and names as acceptable sources Good Manufacturing Practices, Standards Approval, an ISO certificate, the US FDA, the DGKC or the IFCC. A US FDA or comparable foreign credential can therefore satisfy this dossier item — as evidence, not as an approval that replaces the inscription. · sourceApproval: US FDA; DGKC (German Society for Clinical Chemistry); IFCC (International Federation of Clinical Chemistry and Laboratory Medicine); ISO certificate; GMP or standards approval certificate from a health authority · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Guatemala does operate a reliance route: Norma Técnica 77 versión 8 2023 homologates a Guatemalan health registration on a registration already granted by a WHO listed authority of high maturity and performance (WLA/ACO, ML3+). Article 2 confines that route expressly to pharmaceutical specialities of chemical synthesis and to vaccines (biological and biotechnological). It does not reach medical devices or in vitro diagnostics. · sourceApproval: Approval by a WHO listed authority (WLA/ACO, maturity level 3 or above) — e.g. US FDA, EMA, Japan PMDA, Korea MFDS — for chemical synthesis medicines and vaccines only · edgeType: abridged or recognition route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Guatemala's national trámites catalogue records a mutual recognition registration procedure ('Registro Sanitario Nuevo Reconocimiento Mutuo', trámite 3502, Q 750, 10 working days). Its application form is expressly for the mutual recognition of the health registration of medicines for human use, to be filed before the Regulatory Authorities of the States Party. No device or IVD equivalent exists in the catalogue; the companion homologation procedure (trámite 3495) is likewise pharmaceutical only. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The Central American harmonisation instruments that Guatemala publishes under its COMIECO/RTCA index cover medicines, natural medicinal products, cosmetics, hygiene products and pesticides. None addresses medical devices or IVDs, and the COMIECO mutual recognition of health registrations is confined by its own annex to pharmaceutical products originating in the member countries of the customs union. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: regional harmonisation · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A Certificate of Free Sale issued by the competent health authority of the country of origin is a mandatory element of every device inscription dossier. It is evidence of the product's status abroad and is required paperwork, but it neither shortens nor replaces the Guatemalan evaluation; the full local review still runs. · sourceApproval: Marketing authorisation or free sale certificate from any competent health authority of the country of origin; no specific authority (FDA, CE, PMDA, MFDS) is privileged · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: GN 02:2026 D002 accepts an NMPA registration certificate, with associated Product Technical Requirements where applicable, as reference approval evidence for MDACS Class II/III/IV general device listing. A003 also allows specified Chinese QMS documentation when accompanied by valid NMPA approval. E001 provides priority for eligible innovative devices, while E002 has additional conditions for expedited approval. These provisions do not grant automatic listing. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable · targetJurisdictionId: hong kong · chinaClassesInScope: NMPA Class II/III registration certificate (医疗器械注册证) > MDACS Class II/III/IV general medical devices · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: GN 06:2026 permits an NMPA registration certificate, with associated Product Technical Requirements where applicable, as a reference marketing approval supporting MDACS listing of Hong Kong Class B/C/D IVDs under D002. The Hong Kong class must be assessed separately. D003 requires the signed MDIVD CCL; an EU ER/GSPR checklist is an alternative only with qualifying EU approval evidence. Local listing and remaining requirements still apply. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable · targetJurisdictionId: hong kong · chinaClassesInScope: NMPA registered IVD; separately determine whether the product falls within Hong Kong Class B/C/D · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For EU approvals, MDACS accepts EU MDR certificates with Declaration of Conformity, or EU MDD certificates accompanied by an MDD extension declaration letter signed as per Regulation (EU) 2023/607 plus the associated DoC.

Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: hungary · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:hun · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: A device that carries CE marking under MDR (EU) 2017/745 or IVDR (EU) 2017/746 and a valid EU declaration of conformity may be placed on the Icelandic market and put into service without any Icelandic pre market approval, registration of the device, or conformity assessment. Iceland applies the same MDR/IVDR text as the EU/EEA single market, so the notified body certificate is the market access decision; Iceland runs no parallel review and issues no national device approval of its own. · sourceApproval: EU CE under MDR/IVDR (notified body certificate plus EU declaration of conformity per MDR Annex IV) · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No

statement: Iceland is not an EU member state. The EU route exists in Iceland because the EEA Joint Committee took MDR (EU) 2017/745, IVDR (EU) 2017/746 and Regulation (EU) 2020/561 up into the EEA Agreement (Decisions No 288/2019 and 301/2019 of 13 December 2019, and No 90 of 18 June 2020) and the Icelandic parliament then gave them the force of law by Article 2 of Act No. 132/2020, with the EEA adaptations. The practical consequence is that a CE marked device lawfully placed on the EEA market may be placed on the Icelandic market and that the substantive obligations are the Union text as adapted, not a separate Icelandic regime. · sourceApproval: EEA incorporation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (EEA Joint Committee Decisions No 288/2019, No 301/2019, No 90/2020) · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: regional harmonisation · localApplicationRequired: No · targetDecisionRetained: No

statement: An approval from a non EEA regulator gives no market access route and no abridgement in Iceland. Act No. 132/2020 and the Regulations provide no reference country fast track, no abridged review based on a foreign approval, and no acceptance of a foreign registration certificate in place of CE marking. A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be carried in the technical documentation as supporting evidence but substitutes for nothing: without CE marking and an EU declaration of conformity the device may not lawfully be placed on the Icelandic market. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes

statement: CDSCO and China's NMPA are both parties to the BRICS regulators' Memorandum of Understanding (together with ANVISA, the Russian Ministry of Health, Ministry of Industry and Trade and Roszdravnadzor, and SAHPRA), listed by CDSCO as valid until 31 January 2029. The instrument is a cooperation MoU and creates no recognition of NMPA approvals in India. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: india · chinaClassesInScope: Not class specific; regulatory cooperation instrument only · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Rule 36(3) of the Medical Devices Rules, 2017 grants the import licence without an Indian clinical investigation only where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country or the United States (the United Kingdom was added by amendment in 2022). China/NMPA is not on the list, so an NMPA registration certificate does not trigger the clinical investigation waiver. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: india · chinaClassesInScope: All NMPA classes; concerns Indian import licence (Form MD 15) for Class A D devices · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For devices imported from countries outside the rule 36(3) list, Class C and D licences may be granted only after safety and effectiveness are established through clinical investigation in India, and Class A and B licences after published safety and performance data or a clinical investigation in the country of origin plus a free sale certificate from the country of origin. A China NMPA registration certificate or the NMPA based free sale certificate therefore serves only as the country of origin documentary evidence required with Form MD 14/MD 15; it gives no abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: india · chinaClassesInScope: NMPA Class II/III certificate or Class I filing used as country of origin evidence; Indian Class A/B (rule 36(5)) and Class C/D (rule 36(4)) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.

Import izin edar applications must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of manufacture; if that authority does not issue CFS, it may be issued by the health authority of another country regulating devices, or (if the product is not registered in the origin country) by another institution in the origin country. The CFS must state at least trade name/brand, product type, manufacturer name and address, and validity.

statement: PMK 5/2026 Pasal 58(4) requires the Indonesian izin edar before importing medical devices and PKRT, subject to the applicable exceptions. This establishes a local permit requirement. It does not determine whether reliance, evidence reuse or an abridged assessment may be available in obtaining that permit; the cited clause alone cannot support a country wide finding that NMPA evidence has no benefit. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: indonesia · chinaClassesInScope: Medical devices and PKRT within Pasal 58; local classification and application pathway require separate assessment · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

PMK 5/2026 Pasal 58(4) requires a Minister issued izin edar for importing medical devices and PKRT, subject to the specified exceptions. It does not establish whether an abridged or reliance assessment is available in obtaining that local permit.

statement: IMED's device registration directive requires imported devices to present valid international approvals from CE (notified bodies of IMED accepted rank), US FDA (510(k)/PMA plus registration) or Japan, together with a sales certificate in the country of manufacture. The country of manufacture scoring table places the USA, Germany and Japan in G1, listed European states, Canada and Australia in G2, South Korea and other European countries in G3, and 'all other countries' in G4 with zero points. China/NMPA is not among the accepted approval authorities or named country groups, so an NMPA certificate carries no reliance value, and devices made in G3/G4 countries face mandatory ISO 13485 evidence (classes A/B) and pre registration production line audits (classes C/D). · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: iran · chinaClassesInScope: NMPA Class I/II/III; all imported devices (IMED risk classes A D) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: IMED's import registration file requires a sales/free sale certificate in the country of manufacture in addition to CE/FDA/Japan approval. For a device manufactured in China this country of manufacture requirement can be met with the NMPA registration certificate or China free sale documentation, but this is purely documentary evidence and provides no abridged or reliance review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: iran · chinaClassesInScope: NMPA Class II/III registration certificate (and Class I filing) as country of manufacture sales evidence for China made devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

IFDA's Medical Equipment Directorate has signed cooperation MOUs on mutual recognition of the registration process for drugs and medical/laboratory equipment with Oman and Qatar, and a mutual registration cooperation MOU with Syria (announced by the directorate's Export Office).

statement: KIMADIA tenders 55/2023/84 and 55/2023/85 for the national hemodialysis project specify FDA/CE quality evidence for the covered equipment. This dated tender document does not establish the requirements of every Iraqi procurement or private sector registration. Its Arabic/English wording also differs at item 2, so the procurer should resolve the exact tender requirement. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: iraq · chinaClassesInScope: Equipment covered by these two 2023 dialysis tenders only · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: public procurement · localApplicationRequired: Yes · targetDecisionRetained: Yes

Under the MOP standard bidding document sample clause, bidders who are not primary manufacturers must evidence that their product conforms to the primary manufacturer's quality standards and that they can supply the required quantities; the bidder must furnish a certificate from the competent Regulatory Authority (RA) that the manufacturer is licensed to manufacture the medical appliances offered. A 'primary manufacturer' performs all manufacturing operations including processing, blending, formulating, filling, packing, labeling and quality testing.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: ireland · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:irl · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

Australian and Canadian registrations in principle have no expiry; when filing (fast track), a validity of 5 years from the submission date is entered in the approvals table. TGA approvals are accepted only of the REGISTRATION type (not ARTG listing types other than registration).

Where registration relies on European approvals extended under EU transition rules, the Israeli register validity is based on the extension granted under the European regulation; the expiry date entered in the application (per new EU rules, e.g. 31.12.2027 or 31.12.2028) must follow those conditions.

statement: On 8 December 2020 NMPA Commissioner Jiao Hong and Israel's Ambassador to China (on behalf of the Israeli Minister of Health) signed a Joint Declaration of Intent on cooperation in the regulation of drugs, medical devices and cosmetics between NMPA and the Israeli Ministry of Health. The instrument is a cooperation intent declaration only; it contains no mutual recognition or reliance on NMPA registrations, and Israel's recognized state list was not amended as a result. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: israel · chinaClassesInScope: Drugs, medical devices and cosmetics (regulatory cooperation; no product class scope) · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The cited AMAR procedure requests regulatory evidence from recognised states for its recognised state pathway. This does not establish that a China made device is legally barred from the ordinary assessment route without FDA/CE approval. Confirm the current ordinary route procedure and product scope before concluding whether NMPA only evidence is eligible. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: israel · chinaClassesInScope: NMPA Class II/III certificates and Class I filings; AMAR regular track for imported devices of all risk classes · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Israel's Medical Equipment Law 5772 2012 defines a 'recognized state' (מדינה מוכרת) as any state listed in the First Addendum, and section 6(b) grants the abridged recognized state registration only to devices registered or marketed in such a state. The First Addendum enumerates 21 states exhaustively and China is not among them, so an NMPA registration certificate does not qualify a device for the recognized state route. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: israel · chinaClassesInScope: All NMPA classes (Class I filing, Class II/III registration); relevant to all Israeli risk classes and tracks · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Health Canada medical device licences are among the accepted reference approvals for AMAR registration (listed in the official registration guidelines alongside FDA, CE and TGA); Canadian registrations in principle have no expiry, so a validity of 5 years from the submission date is entered in the approvals table when filing.

Pilot: for register registration, MDR CE certificates issued by notified bodies from non recognized states (accredited by the EU under MDR) are recognized; the pilot has been extended until 31.12.2026, after which ministry policy will be examined in light of its results.

A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).

US FDA marketing authorizations (e.g. 510(k)) are primary reference evidence; like other no expiry approvals, 510(k) clearances are assigned 5 year validity from the submission date in the approvals table. Where EU and US classifications differ, the FDA classification takes precedence, provided the product meets the conditions of the chosen track.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: italy · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:ita · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Japan's only foreign approval linked mechanism for devices is priority processing under PMD Act Art. 23 2 5(9) for devices already approved in a country designated by Cabinet Order as having an approval system of equivalent standard to Japan's. Enforcement Order Art. 37 26, as amended by Cabinet Order No. 362 of 2025 effective 1 May 2026, designates only the United States for medical devices and IVDs; China/NMPA is not designated. All devices still require Japanese approval, certification or notification following full review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: japan · chinaClassesInScope: All device and IVD marketing approvals (承認); NMPA approval carries no procedural benefit · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

PMDA accepts MDSAP audit results and, where appropriate, streamlines the survey procedures for QMS conformity survey applications (evidence reuse at the QMS audit layer only; a local QMS conformity decision and product authorization are still required).

Devices already approved in a country with an approval system of equivalent standard to Japan's qualify for priority add on processing (faster review and surveys ahead of other products, Art. 23 2 5(9)); the only designated country is the United States.

statement: JFDA's binding circulation rules (Annex 1, item 4) require the registration file to contain ONE of an exhaustively listed set of conformity credentials: an FDA Certificate to Foreign Government, an FDA 510(k), a CE certificate from an EU Notified Body, a Japanese MHLW free sale certificate, or a country of origin free sale certificate paired with a free sale certificate from Switzerland, Australia, Canada, Norway or the United Kingdom. China/NMPA is not among the listed authorities, so an NMPA registration certificate alone does not satisfy the requirement and confers no abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: jordan · chinaClassesInScope: All imported medical supplies/devices subject to JFDA registration (Class I sterile/measuring, IIa, IIb, III, active implants); NMPA Class I/II/III alike · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Where a device is made in a country outside the named list, JFDA accepts a free sale certificate from an official body in the country of origin as part of the file, but only when supplemented by a free sale certificate from Switzerland, Australia, Canada, Norway or the UK. An NMPA based Chinese FSC is thus admissible origin evidence but must state that the device is freely sold in China, carry a validity period, name the manufacturer/marketing rights holder and site, and be accompanied by one of the five listed countries' FSCs; no abridged review follows. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: jordan · chinaClassesInScope: All imported medical supplies/devices not holding FDA CFG/510(k), CE or Japanese FSC, i.e. the typical position of an NMPA only device · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Testing methods may follow the methods stated in the technical file, official pharmacopoeias, adopted Jordanian standards (Art. 5(a)), or methods established by validation/verification studies and recognized international references (Art. 5(b)).

statement: Under the national expertise rules, the registration dossier for any foreign made device must contain a document certifying registration in the country of the manufacturer or production site (registration certificate, free sale certificate or export certificate) with Kazakh and Russian translation. For a China made device the NMPA registration certificate or NMPA based export/free sale certificate is that document; it triggers no abridged expertise. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: kazakhstan · chinaClassesInScope: All classes (1, 2a, 2b, 3 and IVDs) under the national registration route · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The EAEU registration dossier includes, where available, a copy of the registration certificate (free sale certificate or export certificate) issued in the manufacturer's country, and information on registration in other countries. An NMPA certificate for a China made device is submitted under this item; it is optional ('при наличии') and does not shorten the EAEU expertise. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: kazakhstan · chinaClassesInScope: All classes under the EAEU common registration route (Council Decision No. 46) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The recognition state's authorized body (expert organization) reviews the reference state's expert conclusion within 30 working days; approval of the expert conclusion is the basis for the registration decision in the recognition state.

During registration and expertise the authorized bodies (expert organizations) mutually recognize results of tests (studies) conducted by authorized organizations of member states.

statement: PPB's abridged, expedited (EBR/ECR/EDR) and immediate (IBR) evaluation routes are available only to devices already approved by PPB's listed medical device reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVDD certificates), Japan MHLW, US FDA (510(k) or PMA; 510(k) exempt products excluded), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. China NMPA is not among the eight agencies, so an NMPA registration certificate does not qualify a device for any abridged route; a device with no reference agency approval goes to the full evaluation route. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: kenya · chinaClassesInScope: NMPA Class II/III certificates and Class I filings; target Kenya Class B, C and D (abridged, expedited and immediate routes) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: PPB's Guidelines on Reliance Mechanisms (HPT/PER/GUD/091 Rev 0, January 2025) enumerate the reference authorities and institutions PPB relies on: WHO PQ/CRP/EUL, SRAs, WHO Listed Authorities, WHO transitional WLAs (Category A ML3/ML4 NRAs for vaccines, B SRA, C highly performing NRA for vaccines), continental and regional harmonisation bodies, EMA Article 58/Swissmedic MAGHP, NRAs with a PPB MoU at WHO ML3 or above, and 'Member of the International Medical Devices Regulators Forum as a founding member country'. China NMPA is not an SRA, not a WLA, and not an IMDRF founding member, so its decisions are not within PPB's recognised reference set. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: kenya · chinaClassesInScope: all health products and technologies incl. medical devices and IVDs (reliance pathways) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For listing of Class A medical devices PPB requires, among the submission documents, 'Regulatory approval from the country of origin of the product' together with proof of a quality management system. For a device made in China this documentary requirement is met by the NMPA registration certificate or Class I filing record; the requirement is evidentiary only and confers no abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: kenya · chinaClassesInScope: NMPA Class I filing (备案) or Class II/III certificate as country of origin evidence; target Kenya Class A listing · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k) exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).

PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities while retaining authority for final approval. Eligible reference mechanisms listed include WHO Prequalification Programme / Collaborative Registration Procedure, Stringent Regulatory Authorities (US FDA, EMA, Health Canada, Swissmedic, PMDA Japan, TGA Australia) and the East African Community Medicines Regulatory Harmonization (EAC MRH).

Kenya (PPB) lists the World Health Organization Prequalification Programme, including the Collaborative Registration Procedure, among the reliance mechanisms recognized for marketing authorization of health products and technologies.

statement: The Gulf Health Council operates a central registration system for medical devices and issues a medical device central registration valid for five years from the date of issuance, renewable on company request submitted within six months prior to expiry (Article (7)). Article (29) of the Medical Device Central Registration Regulation states that compliance with the Regulation 'shall not replace any additional requirements in member state'. A GCC central registration therefore does not by itself give Kuwaiti market access; Kuwaiti registration under Ministerial Decree No. (387) of 2025 remains necessary. · sourceApproval: none · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A CE mark under Regulation (EU) 2017/745 (or 2017/746 for IVDs) is the domestic route into Latvia and is valid throughout the EU/EEA. Once the Latvian notification procedure is complete, the notifier is entitled to place the device on the Latvian market without any decision or approval of the State Agency of Medicines; the agency publishes the notification data and the procedure is then deemed complete. What remains are local obligations: a manufacturer without an EU establishment must designate a sole authorised representative, and a distributor established in Latvia must be entered in the LATMED database before making devices available. · sourceApproval: EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: No

statement: The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre 2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and class IIb implantable devices other than certain well established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit because it is not a Directive certificate. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: No · targetDecisionRetained: Yes

statement: Latvia operates no abridged, fast track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or China NMPA approval cannot be placed on the Latvian market: the Latvian pre market notification procedure (paziņošanas procedūra) requires a copy of the EU declaration of conformity and copies of valid notified body certificates issued under Regulation (EU) 2017/745, and no Latvian or Union instrument names a third country approval as a basis for market access. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: No · targetDecisionRetained: Yes

statement: A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality system certificate. A manufacturer's authorisation for the local distributor is required in all cases. · sourceApproval: US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The Lebanese assessment of an implantable device does not address the clinical evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re reviewed in Lebanon. · sourceApproval: Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA) · edgeType: assessment report reliance · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist. · sourceApproval: US FDA 510(k)/PMA; EU CE marking (notified body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.) · sourceApproval: Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A Korean MFDS, Chinese NMPA or other approval from outside the GHTF reference set is named in neither the closed five jurisdiction conformity list nor the GHTF conformity requirement, and it opens no abridged or recognition route. The procedure instead provides a distinct evaluation track for medical devices that have no approval obtained from one of the regulatory authorities of the GHTF countries, so such a device is assessed on its own dossier rather than through reliance. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For products whose countries of origin are other than the European Union, the USA, Canada, Australia and Japan, the accepted conformity document is a certificate of conformity of the manufacturer's quality management system to ISO 13485, in place of a reference authority approval certificate. This is the documentary channel through which a device carrying only a Korean MFDS or Chinese NMPA approval can be filed, together with the manufacturer's authorisation for the local distributor. · sourceApproval: Korea MFDS; China NMPA; any other authority outside the EU, USA, Canada, Australia and Japan · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: liechtenstein · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:lie · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

Exceptional authorisations (Ausnahmebewilligungen) for non compliant devices issued by Swissmedic under the Swiss side rules (Art. 22 Abs. 1 MepV, Art. 18 Abs. 1/61 Abs. 3 IvDV) are valid for the whole customs territory (Switzerland/Liechtenstein); Liechtenstein accepts Swissmedic acts for the customs union channel.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: lithuania · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:ltu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No · nationalVerification: HSL Art. 59 1(1) permits on the Lithuanian market only devices conforming to Regulation (EU) 2017/745 (or, for IVDs, the technical regulation later replaced by references to Regulation (EU) 2017/746); national law adds only registration/notification, language and vigilance duties — it creates no separate national approval.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: luxembourg · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:lux · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Law 12/2025 makes prior registration or marketing authorisation in the place of manufacture a legal precondition for registering (Class IIb/III) or filing (Class I/IIa) any foreign made device in Macau, unless the device is made in a region designated by Chief Executive dispatch (currently the Hengqin Cooperation Zone). An NMPA registration certificate or Class I filing therefore satisfies this documentary prerequisite for Mainland manufactured devices, but ISAF still conducts its own review of safety, efficacy and quality controllability and issues its own registration certificate; the law creates no Mainland specific abridged or recognition channel. Separately, Article 12 designates PRC mandatory national standards as an accepted quality standard. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: macau · chinaClassesInScope: All classes (I, IIa filing; IIb, III registration); NMPA Class I filing / Class II III registration certificates satisfy the origin authorisation prerequisite for Mainland made devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Devices manufactured in the Hengqin Guangdong Macao Intensive Cooperation Zone are exempt from submitting the registration or marketing authorization document issued by the origin authority when applying for Macau registration or filing.

Foreign manufactured devices must already be registered or hold marketing authorization in the country/region of origin or of first marketing in order to be registered or filed in Macau, unless manufactured in a region designated by CE dispatch.

statement: Following the 2025 IVD reliance pilot (Phase 1, held), MDA and NMPA launched Pilot Phase 2, the Malaysia China Joint Evaluation Pilot Programme, from 1 July to 30 September 2026 under the GHWP Common Evaluation Reliance Practice (CERP) framework. Phase 2 replaces one way reliance with simultaneous, collaborative assessment by both regulators of devices not yet registered in either country: Chinese manufacturers submit to NMPA under its Special Channel Pilot Programme and Malaysian manufacturers submit to MDA for full conformity assessment, with each authority evaluating and issuing its own certificate. This is not a pathway for a product that already holds a China NMPA registration certificate. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: No prior registration certificate in either China or Malaysia (eligibility prerequisite) · targetJurisdictionId: malaysia · chinaClassesInScope: China made NMPA Class II or III general medical devices and IVDs (via NMPA 'Special Channel Pilot Programme'); Malaysian made Class B/C/D GMD and IVDs (via MDA full conformity assessment) · edgeType: bilateral programme · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Outside the time limited bilateral pilots, MDA's verification route (abbreviated CAB conformity assessment) is available only for devices holding a qualifying approval from the authorities enumerated in MDA/GD/0070 Annex 1 Table 5: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, US FDA, UK MHRA, Singapore HSA and Thai FDA. China's NMPA is not in the table, so an NMPA only device must undergo full conformity assessment. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: malaysia · chinaClassesInScope: Class B/C/D devices and IVDs under the standard conformity assessment by verification route; NMPA approvals not eligible · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Pilot Phase 1 (30 July 30 September 2025) under the MDA NMPA MoU: Chinese made IVDs (Class II approved by Provincial MPA or Class III by NMPA, manufacturer owning its China facility) are eligible for Malaysia's verification pathway, and Malaysian made IVDs (Class B, C or D approved by MDA) are eligible for China's green channel; up to 6 applications per side, priority for rare disease and innovative devices.

ARTG Registration Certificate from Australia TGA qualifies a Class B/C/D device for CAB conformity assessment by way of verification.

Specified EC certificates issued by EU Notified Bodies (MDR Annex IX Ch. I & III / Annex XI Part A; IVDR Annex IX Ch. I & III / Annex X + XI; and legacy 93/42/EEC, 90/385/EEC, 98/79/EC certificates) qualify for the verification route, mapped to the corresponding Malaysian class.

Health Canada Licence qualifies for the verification route.

Pre market certification (Ninsho) from a Japanese registered certification body or pre market approval (Shonin) from MHLW qualifies for the verification route.

Registration in the Singapore Medical Device Register (SMDR) qualifies for the verification route.

Thai FDA Class 2 3 Certificate of Notified Medical Device or Class 4 Certificate of Licensed Medical Device qualifies for the verification route.

For Great Britain: UKCA marking; for Northern Ireland: EC certificates (and UKNI together with EC certificates) from recognised EU NB approval types qualify for the verification route.

US FDA 510(k) clearance or Premarket Approval (PMA) qualifies for the verification route.

Special access type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non commercial exemptions.

Devices holding at least one qualifying approval from MDA recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2 3 notified / Class 4 licensed device certificates).

statement: A China NMPA registration certificate or Class I filing gives no market access route in Malta. Regulation (EU) 2017/745 Art. 52(1) (and Regulation (EU) 2017/746 Art. 48(1) for IVDs) requires the manufacturer to complete the EU conformity assessment in Annexes IX to XI before placing the device on the market; the Regulation contains no reliance or abridged procedure based on a third country marketing authorisation, so the NMPA certificate is not assessed and the Chinese manufacturer needs a CE conformity route plus an EU authorised representative. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: malta · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) is not a foreign approval in Malta — it is the domestic route. A device that complies with the applicable Union Regulation may be placed on the Maltese market without any Maltese pre market review of the device, because Member States may not refuse, prohibit or restrict the making available of a compliant device on their territory. The device does not need to be re certified, re registered or re approved in Malta. Local obligations still attach to the entities and to the presentation of the device: the Maltese economic operator must register with the Malta Medicines Authority, appoint a registered Medical Device Registered Person, enter the devices in the national medical device database, and label in English or Maltese. · sourceApproval: EU CE Marking under MDR (Regulation (EU) 2017/745) / IVDR (Regulation (EU) 2017/746) · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No

statement: Malta gives no market access route, abridged review or recognition to a US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration. The only pre market route onto the Maltese market is the EU conformity assessment under Regulation (EU) 2017/745 (MDR) Annexes IX to XI — Regulation (EU) 2017/746 (IVDR) for IVDs — followed by CE marking; S.L. 458.59 defines a 'medical device' solely by reference to those two Union Regulations, so the national regime has no approval of its own that a third country clearance could feed. A holder of only a third country approval must obtain a CE certificate (or use the MDR Art. 59 / IVDR Art. 54 public health derogation) and appoint an EU authorised representative. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS 04 050.

statement: On 21–22 April 2021 COFEPRIS Commissioner Alejandro Svarch and NMPA Commissioner Jiao Hong signed, virtually, the 'Acuerdo entre la NMPA de la República Popular China y la Secretaría de Salud de los Estados Unidos Mexicanos sobre cooperación regulatoria de productos médicos'. Per Mexico's Foreign Ministry, both agencies undertake to take into account the registration information issued by the counterpart as a reference for registration in their own country, in line with applicable national law, to exchange information and to explore acceptance of GMP inspection results. It is a cooperation agreement; it does not itself create an abridged route, which now flows from the 2025 Lineamientos. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: mexico · chinaClassesInScope: Vaccines, medicines and medical devices/equipment (framework agreement) · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The 2025 Lineamientos Article 24(I) recognises decisions of IMDRF Management Committee authorities for medical devices. NMPA is a committee member, so its qualifying product registration can support the COFEPRIS 04 050 equivalence application under Article 26(II), subject to the dossier in Article 31 and the Mexican decision. Article 24(II) separately addresses GMP certificates from MDSAP full members; IMDRF membership does not establish that a particular Chinese GMP document satisfies the GMP requirement. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: Qualifying NMPA Class II/III medical device registration certificate · targetJurisdictionId: mexico · chinaClassesInScope: NMPA Class II and Class III registration certificates (medical devices and IVDs); target COFEPRIS registro sanitario of any class via COFEPRIS 04 050 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · targetRoute: Solicitud de Registro Sanitario de Dispositivos Médicos por Equivalencia de Autoridades Regulatorias de Referencia (COFEPRIS 04 050)

target: geo:mex · sourceApproval: Health Canada medical device licence · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · detail: Same COFEPRIS 04 050 mechanism as other ARR approvals under the Lineamientos.

target: geo:mex · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · detail: Same COFEPRIS 04 050 mechanism as other ARR approvals under the Lineamientos.

target: geo:mex · sourceApproval: GMP certificate issued under MDSAP full membership / recognized national regulatory agency · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes · detail: Lineamientos Art. 24 recognizes GMP certificates from MDSAP full members as ARR evidence; RIS Art. 190 Bis 4 requires for the first prórroga of foreign made devices a GMP certificate issued by a national regulatory agency recognized by the Secretaría.

If the applicant presents a favorable technical opinion (dictamen favorable) issued by a COFEPRIS authorized third party (Tercero Autorizado) confirming safety and efficacy, the Secretaría must authorize the device registration within no more than 15 days.

target: geo:mex · sourceApproval: US FDA marketing authorization (510(k)/De Novo/PMA) · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · detail: Available through COFEPRIS 04 050 where the approving regulator qualifies as an ARR (IMDRF Management Committee member country) under the Lineamientos.

statement: A device that holds CE marking reaches the Moldovan market through the notification and registration route and not through a national conformity assessment. AMDM's Administrative Procedure of 08.09.2026 states that devices may be placed on the market, made available, put into service and used only if they have been notified and registered by the manufacturer or its authorised representative in the State Register of Medical Devices (RSDM); the applicant notifies AMDM before placing the device on the market and files the dossier electronically in the authorised representative's personal cabinet. The CE certificate substitutes the conformity assessment step, but the national notification and registration step is still mandatory and is performed by AMDM as the competent authority. Because the instrument does not issue a market authorisation the registration of CE marked devices is expressly stated not to be the issuance of a permissive act the Agency retains only the power to reject a dossier, not to grant or refuse a marketing authorisation on conformity grounds. · sourceApproval: EU CE marking a valid CE/EU certificate of conformity issued under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), or a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Moldova is not a CE only market. Under art. 8 of Legea nr. 102/2017 a device that does not hold CE marking may be placed on the market or used only if it has been subjected to conformity assessment and has been registered, and the manufacturer or its authorised representative must register it with the Agency before placing it on the market. The procedures for that route were approved by Ministry of Health, Labour and Social Protection Order No 212 of 21.03.2018 and operate on paper, on a two copy form filed with the Agency's single window, not on the CE track electronic platform. The route is a national conformity assessment and registration route: it is not triggered by, and does not recognise, any named foreign marketing approval, and no instrument retrieved identifies which conformity assessment body performs the assessment or whether a third country approval is accepted as evidence for it. · sourceApproval: No CE marking a device without CE marking (national route under art. 8 of Legea nr. 102/2017 and Ordinul MSMPS nr. 212 din 21.03.2018); not recognition of any foreign marketing approval · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A US FDA 510(k) clearance, De Novo grant or PMA approval gives no market access route of its own in Moldova. Neither Law No 102/2017 nor AMDM's Administrative Procedure of 08.09.2026 names a US or other third country marketing approval: the documents the Procedure makes mandatory are the manufacturer's declaration of conformity, the valid CE/EU certificate for the risk classes for which a notified body is required, and the act designating the authorised representative, and the rejection grounds include the absence of the CE/EU certificate for classes where it is necessary. An FDA only holder therefore has two options only: obtain CE marking and use the CE route, or use the separate national route for devices without CE marking, which is a national conformity assessment and registration route and not recognition of the FDA clearance. The same answer applies to a Japan PMDA approval, a Korea MFDS approval and a China NMPA registration. · sourceJurisdictionId: usa · sourceAuthorityId: fda · sourceApproval: US FDA 510(k) clearance, De Novo grant or PMA approval · targetJurisdictionId: moldova · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Mongolia's accelerated foreign approval route is a medicines route and does not reach medical devices. Article 16.9 of the Law provides that medicines and pharmaceutical substances that have been prequalified by the World Health Organization, or manufactured and registered in a country that has a medicines regulatory authority recognised by WHO under the medicines regulatory assessment, shall be registered on an accelerated basis. It sits in the chapter on medicines registration; this article does not establish a device route. · sourceApproval: WHO prequalification or manufacture and registration in a country with a medicines regulatory authority recognised by WHO under the medicines regulatory assessment, as stated in Article 16.9. The article does not name individual national authorities. · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The Law empowers the Agency to conclude memoranda of understanding on trust with foreign bodies having the same function and with international organisations, to take part in memberships and to cooperate. This is an institutional cooperation power: it establishes no route by which a foreign device approval is recognised or a Mongolian registration facilitated, and no MoU operating as a device recognition route was located. · sourceApproval: none (no MoU creating a device recognition route was located) · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: institutional · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The ministerial procedure that implements the accelerated route places it in the medicines annex and gives the device annex nothing comparable. Paragraph 1 of Order A/206 allocates Annex One to medicines and pharmaceutical substances, Annex Two to medical devices, Annex Three to health supplementary products, Annex Four to the application form and Annex Five to the certificate template. The accelerated and conditional registration provisions appear in Annex One, and no equivalent provision appears in Annex Two. · sourceApproval: WHO listed medicines regulatory authority approval, and WHO Emergency Use Listing (EUL) / WHO listed conditional approval — medicines only · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Mongolia is not a member of the Eurasian Economic Union and therefore does not apply the EAEU's single market device circulation regime. The EAEU Member States are Armenia, Belarus, Kazakhstan, the Kyrgyz Republic and the Russian Federation; Mongolia is not among them, and no other regional mutual recognition arrangement for medical devices covering Mongolia was located. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: regional bloc · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Mongolia operates no recognition route for foreign medical device approvals. Under Art. 33.2 of the Law on Medicines and Medical Devices the Agency grants device registration taking into account the requirements of Arts. 15.3.1 and 15.3.7 and the fact that the device has been placed on the market in the country of manufacture (үйлдвэрлэгч улсад зах зээлд гаргасныг харгалзан үзэж), and on the basis of the Medical Devices Council's decision. The instrument names no foreign regulator, no foreign approval and no reference country list: the foreign element is evidence of origin country market placement, not a recognised authorisation. A full Mongolian application, dossier and Council review still run, and the Council retains the decision. · sourceApproval: none (no FDA, CE, PMDA, MFDS or NMPA approval is named or recognised; only evidence that the device is placed on the market in its country of manufacture is taken into account) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Annex 2 to Order A/206 requires an applicant seeking entry of medical equipment (and, identically, medical consumables) on the medical device list to file the product's marketing authorisation or free sales certificate — the provision is written in the bilingual form 'Marketing Authorization of the product/ free sales certification'. This is a documentary requirement evidencing that the product may be placed on the market in its origin country; it is not a recognised approval and confers no shortened route, and any origin country's certificate satisfies it since no country or authority is named. · sourceApproval: any origin country marketing authorisation or free sales certificate (no specific authority named; FDA, CE, PMDA, MFDS and NMPA are not mentioned) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Recognition of a conformity document and of the CE mark issued by a conformity assessment body that has no seat in Montenegro is carried out by the Institute within the medical device registration procedure; exceptionally, the Institute may issue a recognition decision on the request of the manufacturer or its authorised representative. · sourceApproval: EU CE Marking / EC certificate of conformity issued by a conformity assessment body established outside Montenegro (in practice an EU notified body) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A foreign document, or the CE mark, is directly recognised in Montenegro if it was issued by a notified body of the European Union, or if it was affixed to the device in accordance with the harmonised technical regulation of the European Union. Direct recognition is conditional on the foreign technical regulation providing at least the same level of protection of safety, health, environment and consumers as the corresponding Montenegrin technical regulation, and on the requirements the foreign conformity assessment body has to meet not being laxer than the Montenegrin ones. A recognition decision is valid until the foreign document expires, or at most three years from its issue if no expiry is stated. · sourceApproval: EU CE Marking issued by an EU notified body (prijavljeno tijelo) under the EU harmonised technical regulation · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For in vitro diagnostic devices that were "other IVD" under Directive 98/79/EC and are Class A under IVDR (EU) 2017/746 — i.e. needing no notified body — a declaration of conformity issued under Directive 98/79/EC is no longer a valid document after 26 May 2022 and will not be recognised by the Institute; the declaration of conformity must comply with IVDR (EU) 2017/746. Legacy IVDD certificates that were valid on 26 May 2022 and not withdrawn may keep devices on the market at the latest until 31 December 2027, subject to the IVDR Art. 110(3) conditions. · sourceApproval: EU CE Marking under IVDR (EU) 2017/746 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: An EC certificate of conformity issued under the former MDD/AIMD directives that was valid on 26 May 2021 and has not been withdrawn remains valid after the date printed on it only until 31 December 2027 for Class III, implantable Class IIb (with listed exceptions) and AIMD devices, and until 31 December 2028 for the remaining Class IIb, Class IIa and Class Is/Im devices. · sourceApproval: EU CE Marking — legacy MDD/AIMD EC certificates (MDR Art. 120 transition) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For a Class I device that keeps the same risk class under MDR (EU) 2017/745 and therefore needs no notified body, the Institute accepts placement on the Montenegrin market only if the device is compliant with MDR (EU) 2017/745. A declaration of conformity issued under Directives 93/42/EEC or 90/385/EEC is not considered a valid document, and such devices may not be distributed in Montenegro. · sourceApproval: EU CE Marking under MDR (EU) 2017/745 · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For manufacturers outside the European Union the registration dossier must, in addition to the standard documentation, contain a free sale certificate or a certificate issued by an authorised body under ISO 13485. The applicant guide states the same alternative as: an ISO 13485 quality management certificate, or proof that the device is marketed in the manufacturer's own country or in an EEA member state (free sale certificate). · sourceApproval: Free sale certificate from the manufacturer's own country or an EEA member state; or an ISO 13485 certificate — no named national approval is required · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For imported medical devices the registration dossier's technical part is lighter than for locally manufactured devices: under arrêté n° 2855 15 art. 2, 1) b) the technical pieces for an imported device of any class are the manufacturer's declaration of conformity to the essential requirements (or equivalent requirements), the draft labelling and, where applicable, draft instructions for use, and a sale model sample or prototype; the technical documentation with a conformity check list, the corresponding standards and the internal documents relied on — a mandatory item for locally manufactured devices under art. 2, 2) b) — is not a filing item but may be requested from the establishment during the evaluation of the device's clinical data. The AMMPS checklist (footnote 5 to item 10) restates this as 'la documentation technique n'est pas obligatoire' for imported devices and adds that clinical data must be supplied for class III. This documentary lightening is keyed to the device's imported status, not to a named reference authority; for classes Is, Im, IIA, IIB and III the imported device must in any event file the origin country competent authority certificate (CE, FDA, CVL or equivalent), so in practice that certificate plus the declaration of conformity and, for classes IIA–III, an ISO 13485 certificate stand in for the technical file. The 120 day review clock and the national decision are unchanged. · sourceApproval: EU CE marking certificate; US FDA attestation; or origin country marketing authorisation / certificat de vente libre (CVL) equivalent — the certificate that made the device registrable in its origin country · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A medical device registration application must include a certificate issued by the competent authority of the country of origin: an EU CE marking certificate, an 'FDA' attestation, a marketing authorisation / free sale certificate (CVL), or an equivalent. The item is mandatory for risk classes IIA, IIB and III and for sub classes Is and Im of class I. It does not shorten the Moroccan review: the device is still registered nationally and the certificate sits alongside the national dossier. · sourceApproval: EU CE marking certificate; US FDA attestation; or an origin country marketing authorisation / certificat de vente libre (CVL) or equivalent issued by the competent authority of the country of origin · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Myanmar FDA's import recommendation document list for Class B, C and D devices requires Evidence of Marketing Approval from abroad, such as an export certificate, free sale certificate or marketing history. An NMPA registration certificate or NMPA issued export sales certificate for a China made device meets this item; it is supporting evidence only and DFDA retains its own decision with no abridged pathway. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: myanmar · chinaClassesInScope: Class B, C and D import recommendation applications; NMPA Class II/III certificate or NMPA export/free sale certificate serves as 'Evidence of Marketing Approval from abroad' · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Class B, C and D import recommendation applications must include Evidence of Marketing Approval from abroad, such as an export certificate, free sale certificate, or marketing history.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: netherlands · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:nld · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: New Zealand has no pre market approval system for medical devices: there is no mandatory requirement for a device to be approved by any regulator before supply, and WAND notification does not imply any Medsafe assessment. A China NMPA certificate therefore has no regulatory role; the sponsor simply notifies the device to WAND and meets Medicines Act, labelling, advertising and post market obligations. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: new zealand · chinaClassesInScope: All classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

No foreign regulatory approval is required or assessed: there is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand, and WAND notification does not mean or imply that a device has been assessed by Medsafe (quality, safety, efficacy, or performance).

statement: NAFDAC's Reliance Procedure applies to drugs, vaccines and medical devices including IVDs whose quality, safety and efficacy/performance have been confirmed by a Stringent Regulatory Authority 'as per WHO definition/classification' or by an authority with which NAFDAC has a reliance agreement (WAHO, AMRH, Swissmedic MAGHP). The guideline's SRA definition is closed: ICH members before 23 October 2015 (US FDA, European Commission, Japan MHLW/PMDA), ICH observers before that date (EFTA/Swissmedic, Health Canada) and MRA associated authorities (Australia, Iceland, Liechtenstein, Norway). China NMPA is not an SRA, is not a WHO Listed Authority and has no reliance agreement with NAFDAC, so an NMPA certificate cannot open the reliance pathway. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: nigeria · chinaClassesInScope: NMPA Class II/III certificates; target all NAFDAC registered devices incl. IVDs (reliance procedure) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: NAFDAC's Guidelines for Registration of Medical Devices in Nigeria (VBM R&RA GDL 001 00, effective 4 November 2024) require, for imported devices, a Certificate of Manufacture and Free Sale issued by the relevant health/regulatory body in the country of manufacture and authenticated by the Nigerian Embassy, and the notarised declaration lists a 'Manufacturing license / Certificate for companies from India and China' authenticated by the Nigerian Mission. An NMPA registration certificate / export certificate therefore serves as country of origin evidence for China made devices, but NAFDAC still performs full documentation review, GMP inspection of the factory abroad, laboratory testing and FDRC approval (120 working days). · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: nigeria · chinaClassesInScope: NMPA Class I filing or Class II/III certificate and Chinese manufacturing licence as documentary evidence; target all imported devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

NAFDAC has mechanisms to rely on evaluation decisions of SRAs as per WHO definition/classification: it 'may rely on the assessment report of such SRAs but retains its Sovereignty in decision making', activating reliance case by case or at the explicit request of the applicant. The Reliance Procedure is limited to drugs, vaccines and devices (incl. IVDs) already assessed and inspected by SRAs.

Under the WHO Collaborative Registration Procedure for WHO prequalified medical devices (incl. IVDs), NAFDAC makes its national registration decision within 60 working days (approximately 90 calendar days) of regulatory time, and informs WHO/PQT and the applicant within 20 working days of the decision. This corrects the baseline '90 working days' reading.

statement: North Macedonia recognises conformity assessment performed through institutions recognised in the European Union. A device whose conformity is assessed by a notified body recognised in the European Union is marked with the EC mark, and the Agency accepts the resulting EC certificate or the manufacturer's EC declaration of conformity in place of full quality, safety and efficacy data. Where the device holds an EC certificate the registration dossier is the short documentary set in Article 7 of the 151/10 rulebook; where it does not, Article 8 requires the full administrative dossier plus quality, safety and efficacy data and an Agency opinion on efficacy, with risk analysis for class IIb, III, AIMD and List A/B IVDs. CE marking does not by itself confer market access: the device must still be entered in the national register of medical devices by decision of the Agency. · sourceApproval: EU CE marking — EC certificate of conformity issued by a notified body recognised in the European Union, or (for class I devices and general IVDs) the manufacturer's European EC declaration of conformity · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: An approval from a regulator outside the European Union gives no market access route and no abridgement in North Macedonia. The Law recognises conformity assessment only through institutions recognised in the European Union or bodies authorised by the Minister of Health, and the device registration rulebook distinguishes only between devices that hold an EC certificate and devices that do not. A US FDA 510(k) clearance or PMA approval, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be placed in the technical documentation as supporting material but substitutes for nothing: without the EC certificate or EC declaration of conformity the full quality, safety and efficacy dossier under Article 8 of the 151/10 rulebook applies, together with an Agency opinion on efficacy. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Proof that the device is placed on the market in the manufacturer's own country — a Free sale certificate — is a required document in the device registration dossier, both where the device holds an EC certificate of conformity and where it does not. It is verification paperwork: it does not shorten the national review or substitute for the EC certificate, and on the non EC route the full quality, safety and efficacy dossier and an Agency efficacy opinion still apply. · sourceApproval: Origin country marketing status evidence — Free sale certificate from the authority of the manufacturer's country (any country) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: North Macedonia operates a unilateral parallel import approval for medical devices. A registered wholesaler may import the identical device that is already entered in the national register and in circulation there from another country, on proof of the authorisation under which the device is entered with the competent authority of the source country, proof that it is in circulation there, a wholesale authorisation of the source supplier, the approved source country instructions for use, and the EC certificate or European EC declaration of conformity. The device itself is not re reviewed: what is checked is the source country authorisation and the differences from the nationally registered version. The Agency grants a temporary approval within eight working days, allowing participation in public procurement, and the full approval within three days of full payment of the fee, valid for two years. If the device is withdrawn from circulation in the source country the Agency revokes the approval. · sourceApproval: Marketing authorisation / registration of the identical device by the competent authority of the source (exporting) country, together with the EC certificate of conformity or the manufacturer's European EC declaration of conformity · edgeType: unilateral recognition · marketAccessStrength: facilitated · regulatoryLayer: import control · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: MALMED has signed memoranda of cooperation with the medicines agencies of Serbia (ALIMS), Bulgaria (BDA), Montenegro (CALIMS), Bosnia and Herzegovina (ALMBiH), Croatia (HALMED) and England (MHRA). The stated scope of these memoranda is the advancement of staff expertise, the exchange of information and experience, and the monitoring of health policies and European legislation. They create no abridged review, no acceptance of a foreign registration, and no market access route; a device approved only by one of these agencies still requires the full national registration with MALMED. · sourceApproval: Serbia ALIMS, Bulgaria BDA, Montenegro CALIMS, Bosnia and Herzegovina ALMBiH, Croatia HALMED, England MHRA — memoranda of cooperation · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: institutional · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: norway · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:nor · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Oman's Class C&D registration guideline lets the applicant declare the regulatory jurisdiction the device follows, with an open 'Others (specify)' option, and requires in Section 10 a free sale certificate from the competent authority in the country of origin. A Chinese manufacturer can therefore file under 'Others' with NMPA based origin evidence (NMPA registration certificate / China free sale certificate), but the guideline defines product certificate expectations only for the EU and US routes and offers no abridged review for NMPA approval. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: oman · chinaClassesInScope: Class C (IIb/III) and Class D (other III/IV/AIMD) medical devices, i.e. NMPA Class II/III devices falling in Oman's C/D bands · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Product verification/validation section accepts the origin jurisdiction certificate: for EU route devices CE/EC certificate, full quality assurance or design examination certificate (Class D adds TSE free certificate if biological); for US route devices 510(k) or PMA (Class D adds AATB certificate if from US and biological).

The registration dossier must include a free sale certificate from the competent authority in the origin country, or a Certificate of Foreign Government (CFG) if the product is from the USA, or CDNE (certificate for medical device not exported from the United States), plus a list of countries where the device is marketed.

The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.

Under rule 15(4), where a medical device's registration is cancelled or suspended by the exporting country, or its WHO prequalification is cancelled, the Pakistan registration holder is bound to inform the MDB.

statement: The Medical Devices Rules, 2017 reference country clause names the USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the United Kingdom, plus WHO prequalified devices and CE marked devices certified by NANDO listed bodies. China/NMPA is not among them, so an NMPA certificate confers none of the reliance or foreign inspection exemptions tied to that list. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: pakistan · chinaClassesInScope: All classes (enlistment Class A, registration Class B D) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The import application forms require a free sale certificate from the country of origin attested by the Embassy of Pakistan as a mandatory document, and separately ask whether the product is on free sale in a rule 67 reference country. For a China made device the NMPA based free sale/export certificate satisfies the country of origin item; it does not satisfy the reference country item and gives no abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: pakistan · chinaClassesInScope: NMPA Class I filing / Class II III certificate used as country of origin free sale evidence; Pakistan Class A enlistment (Form 6 A) and Class B D registration (Form 7 A) for import · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Under rules 15(2) and 15(3), devices registered by the authorities of the rule 67 countries are exempt from inspection of manufacturing units abroad irrespective of where the manufacturing unit is located, and devices pre qualified by the WHO or CE marked by NANDO notified conformity assessment bodies are likewise exempt from foreign inspection, subject to evidence and supporting documents.

Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.

statement: Decreto Ejecutivo 490 of 4 October 2019 (Gaceta Oficial 28875 A), which regulates Ley 90/2017, requires in Art. 36 numeral 11 a valid Certificate of Free Sale issued by the competent authority of the country of provenance (all such countries if more than one), and defines the CLV as the document from the competent authority of the country of provenance showing the device is registered and legally authorized for sale there. An NMPA certificate is therefore the required document for devices sourced from China; the decree names no reference agencies and provides no abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: panama · chinaClassesInScope: NMPA Class I filings and Class II/III certificates for all Panamanian device classes (registration under Ley 90/2017 and DE 490/2019) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

DNDM may issue the Registro Sanitario through expedited validation and acceptance of certifications issued by reference authorities recognized by the competent health authority, subject to regulation. The 2025 draft operationalizes this as a 'Proceso de Confianza Regulatoria en Autoridades Reguladoras de Referencia' and would allow registration based on a current registration from the country of origin or another reference authority (for products registered with a WHO/OPS prequalified high standard agency).

statement: The Listado Anual Oficial that Res. 226/2024 Art. 8(a) incorporates by reference does name US FDA, the European Commission (DG SANTE)/EMA, Japan MHLW/PMDA and Korea MFDS — but every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos médicos, so on the published instrument the simplified device route is not anchored to any device scoped reference authority. · sourceApproval: none · edgeType: international listing · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A class II, III or IV medical device already authorised by an authority of a country on the Listado Anual Oficial (emitted under Ley N° 7256/2024 Art. 3) or by an authority with a published bilateral recognition agreement enters the 'Proceso simplificado de Registro Sanitario' instead of full integral analysis. The applicant still files every Art. 6 requirement and still needs a Paraguayan registration, but DINAVISA re examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier. · sourceApproval: Any marketing authorisation issued by an authority of a country on the Listado Anual Oficial — the 2026 list (Resolución DINAVISA N° 182/2026) names US FDA, European Commission (DG SANTE)/EMA and EU national authorities, Japan MHLW/PMDA, Korea MFDS, Singapore HSA, Indonesia BPOM, ANMAT, ANVISA and ISP — each entry stated as scoped to medicamentos and/or vacunas · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Class I devices enter the Paraguayan market through a Notificación Sanitaria Obligatoria (NSO): the applicant files the Art. 6 requirements plus a sworn declaration that the device is class I, and DINAVISA issues the notification, which itself authorises manufacture or import. No foreign approval is required to obtain it and no foreign approval shortens or replaces it. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Combined medical devices are evaluated following the scientific technical decisions of reference regulatory authorities; applicants may nonetheless be subject to further technical and administrative requirements for registration. · sourceApproval: Reference regulatory authorities generally, as named by the instrument — no list is given in this article · edgeType: abridged or recognition route · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A device that has no Paraguayan sanitary registration may be imported for compassionate use where it has been authorised by a foreign reference regulatory agency included in the annual official list under Ley N° 7256/2024, and is required to treat a patient or group of patients urgently as determined by the treating specialist or the MSPBS. The route is an import authorisation, not a registration. · sourceApproval: Authorisation by a foreign reference regulatory agency included in the Listado Anual Oficial under Ley N° 7256/2024 (2026 list: US FDA, EU Commission/EMA, Japan MHLW/PMDA, Korea MFDS, ANMAT, ANVISA, ISP and others) · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free sale certificate), and within 120 business days for other imports. Annex I names high surveillance and adequate surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not. · sourceApproval: Sanitary registration and free sale certificate in force in an Annex I country — high surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Class II, III and IV in vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued. · sourceApproval: PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Paraguay internalised the MERCOSUR GMC health resolutions of Subgrupo de Trabajo N° 11 by Decreto N° 10403/2012, including GMC 20/11 (MERCOSUR technical regulation on good manufacturing practice for medical products and IVDs) and GMC 23/11 (exchange of information on serious adverse events caused by medical products). These are harmonised requirements, not recognition: the decree incorporates technical regulations and creates no route by which another MERCOSUR member's marketing authorisation is accepted in Paraguay. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Every imported device application must include a free sale certificate, or evidence of sanitary registration, or an equivalent document issued by the competent authority of the country where the device is manufactured and/or commercialised, describing the product and its models. This is a required document evaluated inside the local review, not a route that shortens it, and it is one of the items DINAVISA re examines even in the simplified process. · sourceApproval: A free sale certificate, sanitary registration certificate or equivalent issued by the competent authority of the country of manufacture and/or commercialisation (any country, not only a reference country) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: In post market risk management DINAVISA may base the regulatory measures it adopts to minimise risks associated with the use of medical devices on the decisions of reference regulatory agencies. This is a post market reliance mechanism: no application is filed and it confers no market access. · sourceApproval: Reference regulatory agencies generally, as named in Res. DINAVISA N° 361/2023 — no list is given in this article · edgeType: abridged or recognition route · marketAccessStrength: none · regulatoryLayer: postmarket review · localApplicationRequired: No · targetDecisionRetained: Yes

statement: D.S. 016 2011 SA Art. 9 fixes the closed list of 'países de alta vigilancia sanitaria' used throughout the regulation (for example acceptance of foreign GMP certificates in Arts. 22–23 and information sources for safety actions in Art. 13): France, Netherlands, United Kingdom, United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden. China is not on the list, so NMPA approvals or GMP certificates carry no high vigilance status before DIGEMID. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: peru · chinaClassesInScope: NMPA Class II/III certificates; target DIGEMID device classes I–IV (references to 'países de alta vigilancia sanitaria' for GMP acceptance and product evidence purposes) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For imported devices of every class, D.S. 016 2011 SA Arts. 124–127 numeral 2 require a copy of the free sale certificate issued by the competent authority of the country of origin or of the exporter; an NMPA certificate therefore satisfies this requirement for China made devices. Under Art. 21, a certificate issued by an authority that does not appear on DIGEMID's published list of competent authorities is valid only if legalized by the Peruvian consulate (or the exporting country's embassy in Peru) attesting that the issuer is the competent authority. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: peru · chinaClassesInScope: NMPA Class I filings and Class II/III certificates for DIGEMID device classes I, II, III and IV · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

A free sale certificate (or equivalent) issued by a competent authority not appearing on DIGEMID's published country list is accepted only if legalized by the Peruvian consulate in that place (or the exporting country's embassy in Peru) evidencing that the issuer is the competent authority.

For free sale certificate and related evidence purposes, the high vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.

Class B/C/D devices with product approval issued by the NRA of any ASEAN member country under AMDD CSDT requirements receive abridged processing: complete legal requirements plus the latest technical dossier submitted to the reference NRA; technical documents are not technically reviewed except labeling; the reference NRA CPR is verified; turnaround 30 working days from receipt of proof of payment.

For imported medical devices, the 2025 CMDN/CMDR checklists require one copy of the product approval issued by the National Regulatory Agency of any ASEAN member country under the AMDD CSDT requirements, valid and accompanied by a notarized declaration from the legal manufacturer or product owner.

Philippine registration requirements are aligned to the ASEAN Common Submission Dossier Template (CSDT) per the ASEAN Medical Device Directive; CSDT is a dossier format, not a mutual recognition of approvals each application is still filed and decided locally.

statement: FDA Circular No. 2022 008 limits abridged processing to Class B/C/D devices with product approval issued by the national regulatory authority of an ASEAN member country under the AMDD CSDT requirements, and expressly excludes devices whose CPR is based on abridged approval in countries outside ASEAN. China is not an ASEAN member, so an NMPA registration certificate does not qualify a device for abridged processing; such applications undergo standard CDRRHR technical review under AO 2018 0002. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: philippines · chinaClassesInScope: Class B/C/D medical devices (abridged processing); NMPA approvals not eligible; IVDs and refurbished devices excluded from the circular altogether · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For Class A notification of imported devices, the 2025 Citizen's Charter checklist requires evidence attesting to safety and effectiveness issued in the country of origin, which may be a product notification, certificate of product registration or equivalent document issued by the manufacturer (self declaration), the regulatory agency or an accredited notified body. An NMPA Class I filing record or a Class II/III registration certificate for a China made device satisfies this documentary requirement; there is no abridged review linked to it. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: philippines · chinaClassesInScope: Class A imported devices (Certificate of Medical Device Notification); NMPA Class I filing or Class II/III certificate serves as country of origin evidence · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Class A notification requires evidence attesting to safety and effectiveness issued in the country of origin: product notification, certificate of product registration, or equivalent document issued by the manufacturer (self declaration), regulatory agency or accredited notified body; must be valid, with notarized declaration; authenticated or apostilled documents accepted per checklist conditions.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: poland · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:pol · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: portugal · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:prt · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

IMD registration requires notarized CE or FDA certificates from the country of origin listing the reference numbers of the devices being registered.

statement: For implantable medical device registration, MoPH's application checklist requires notarized CE or FDA certificates covering the devices; it enumerates only CE and FDA and offers no 'other reference authority' option. A China NMPA registration certificate is therefore not an accepted conformity credential for IMD registration in Qatar. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: qatar · chinaClassesInScope: Implantable medical devices (IMD) of any NMPA class; MoPH IMD registration is the only product registration route Qatar operates for devices · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The IMD registration checklist separately requires a Free Sale Certificate for the device from the country of origin. For a China made implant this would be NMPA based free sale evidence, but it is a supplementary document that does not replace the CE/FDA certificate requirement or trigger any abridged review. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: qatar · chinaClassesInScope: Implantable medical devices (any NMPA class) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For MoPH technical evaluation of medical equipment in a healthcare facility, each device must be supported by an original FDA/CE certification or an equivalent approval.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: romania · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:rou · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Roszdravnadzor, the Russian Ministry of Health and the Ministry of Industry and Trade are parties with China's NMPA to the BRICS regulators' Memorandum of Understanding listed by CDSCO as valid until 31 January 2029. It is a cooperation MoU and gives NMPA registrations no legal effect in Russia; no Russia China mutual recognition arrangement for medical devices exists. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: russia · chinaClassesInScope: Not class specific; cooperation instruments only · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: National registration is conducted on the basis of technical tests, toxicological studies and clinical trials carried out as Russian conformity assessment forms, production inspection, analysis of the manufacturer's evidence materials and Roszdravnadzor's expertise of quality, effectiveness and safety. The Rules recognise no foreign approval and the dossier list contains no country of origin registration certificate item, so a China NMPA certificate has no legal effect in the national procedure. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: russia · chinaClassesInScope: All classes under the national registration route (Government Decree No. 1684) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: In the EAEU registration dossier filed with Roszdravnadzor, a copy of the registration certificate, free sale certificate or export certificate issued in the manufacturer's country is an 'if available' item, together with information on registration in other countries. A China NMPA certificate is submitted under this item and does not abridge the EAEU expertise. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: russia · chinaClassesInScope: All classes under the EAEU common registration route (Council Decision No. 46) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Roszdravnadzor publishes the unified EAEU register of medical devices registered under the EAEU common procedure; a device registered under EAEU rules circulates in Russia without separate national registration.

statement: Rwanda FDA operates an abridged assessment procedure for medical device registration. Abridged assessment is defined as a limited independent assessment of specific parts of the dossier, taking into account prior assessment (dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority the Authority deems competent. The cover letter template for an abridged application (Appendix 1 of DHT/GDL/024) requires the applicant to confirm that the product dossier submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC. The statutory basis is Article 16 of the device registration regulations, which allows the Authority to rely on regulatory decisions of regional, international and other stringent regulatory authorities for product market authorisation. For devices under abridged assessment, QMS compliance of the manufacturing site is confirmed by desk review rather than an on site inspection, although the Authority may still conduct an on site inspection if necessary. · sourceApproval: US FDA; EU CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives; Japan PMDA/MHLW; Korea MFDS; and any other authority the Rwanda FDA deems competent under the SRA concept, where the product is registered with that authority as an SRA; WHO Prequalification; EAC registration · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The same 'Expedited Review Documentation' section of the device registration guideline applies to devices registered in countries with which Rwanda FDA has signed a memorandum of understanding. The applicant must state whether the application falls under that case. The MoU is therefore a route trigger and not merely a cooperation statement, but the guideline does not name the countries covered, so the benefit is only available where a signed MoU exists. · sourceApproval: A marketing authorisation or registration held in a country with which Rwanda FDA has signed a memorandum of understanding · edgeType: cooperation mou · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The device registration guideline has a dedicated 'Expedited Review Documentation' section that applies to applications for WHO prequalified devices. The applicant must state in that section whether the submitted application falls under the WHO prequalified case. · sourceApproval: WHO Prequalification · edgeType: international listing · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The Rwanda FDA fee regulations set the registration and marketing authorisation fee for imported machinery, medical equipment and devices by origin: USD 100 for products imported from the East African Community, USD 400 for products imported from SRAs or WHO Listed Authorities, and USD 600 for products imported from other sources. The fee covers a five year registration and includes a GMP inspection. This is a fee preference tied to the origin/reference status of the approval, not a review shortcut. · sourceApproval: Devices imported from a Stringent Regulatory Authority or WHO Listed Authority jurisdiction (USD 400) versus other sources (USD 600); EAC origin devices (USD 100) · edgeType: abridged or recognition route · marketAccessStrength: evidence only · regulatoryLayer: fees · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Rwanda FDA's Guidelines on Reliance for Regulatory Decision Making (ODG/RAHC/GDL/001 Rev 3) apply to all types of medical products and to registration, marketing authorisation, GMP/GCP inspections, clinical trials, vigilance, post marketing surveillance and laboratory testing. For marketing authorisation the Authority may apply reliance where the product has been evaluated and listed as a WHO Prequalified Product (including the WHO PQ collaborative registration procedure), approved by stringent regulatory authorities, registered by WHO Listed Authorities (WLAs) or WHO transitional Listed Authorities (category B), recommended by continental or regional harmonisation initiatives such as EMA and the East African Community through joint dossier assessments, or registered by an ML3 functioning regulatory authority holding a memorandum of understanding with Rwanda FDA. The reliance pathway for marketing authorisation is stated to take 90 working days excluding clock stops. · sourceApproval: WHO Prequalification and the WHO PQ Collaborative Registration Procedure; Stringent Regulatory Authorities; WHO Listed Authorities and WHO transitional Listed Authorities (category B); EMA and EAC joint dossier assessments; ML3 authorities holding an MoU with Rwanda FDA · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Article 16 of the Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics (DFAR/HMDAR/TRG/002 Rev 2) provides that the Authority may rely on regulatory decisions from regional, international and other stringent regulatory authorities' decisions regarding product market authorization when deemed necessary. The article was introduced by Revision 1 of the regulations (8 June 2021). It is the legal basis on which the abridged assessment and expedited review procedures in the registration guidelines rest, and it leaves the decision on when to rely to the Authority. · sourceApproval: none · edgeType: abridged or recognition route · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: SFDA and China's NMPA signed a Memorandum of Understanding on regulatory cooperation in medicines, medical devices and cosmetics at NMPA headquarters in Beijing on 1 November 2024 (SFDA CEO Hisham Aljadhey and NMPA Commissioner Li Li). SFDA describes its scope as exchange of regulatory information on laws and regulations and sharing of regulatory experience and best practices; the Saudi Council of Ministers approved the MoU on 12 May 2025. No implementing measure giving NMPA certificates any reliance or recognition effect in the MDMA process has been published by SFDA as of the check date, so the MoU is a cooperation framework, not a recognition route. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: saudi arabia · chinaClassesInScope: Not class specific; regulator to regulator cooperation covering drugs, medical devices and cosmetics · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Under the Medical Devices Law (Royal Decree M/54) framework, the SFDA Medical Devices Marketing Authorization (MDMA) is a standalone technical file assessment: MDS REQ 1 v6.0 requires conformity with the Essential Principles (Annexes 1 2), technical documentation (Annexes 3 4) and an ISO 13485:2016 QMS, and neither lists reference regulators nor accepts any foreign marketing approval as a basis for authorization. The GHTF founding member basis (Australia, Canada, Japan, USA, EU/EFTA) of the pre 2021 Interim Regulation guidance MDS G5 no longer appears in the current requirement. A China NMPA registration certificate therefore confers no abridged, verification or recognition route, and China was never a listed reference jurisdiction. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: saudi arabia · chinaClassesInScope: All NMPA classes (Class I filing, Class II, Class III); SFDA MDMA covers Saudi Classes A D and IVDs · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The MDMA under the current Law is a standalone Saudi authorization: every device must be scientifically assessed by SFDA, and the current MDMA requirements (MDS REQ1 v6.0, 2021) contain no requirement to hold a foreign/reference country approval as a condition of application.

statement: The UEMOA device guidelines that Senegal is bound to implement require the marketing authorisation dossier to contain a certified copy of the conformity attestation obtained through the international procedures recognised by the competent authority, a copy of any good manufacturing practice certificate for medical devices in force, a document attesting first placing on the market, a batch conformity certificate, and an indicative price document. These are mandatory attachments inside a full national evaluation: the harmonised dossier has no abridged branch keyed to a foreign approval, and the foreign documents do not displace the essential requirements checklist, the technical documentation or the national decision. · sourceApproval: Conformity attestation obtained under the international procedures recognised by the competent authority (the guidelines do not name any scheme), plus a GMP certificate, a first marketing document and a batch conformity certificate · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Senegal's national vigilance system law gives the pharmaceutical regulatory structure an express power to recognise, under predefined conditions, vigilance decisions of other countries or regional or international bodies, and to adopt their vigilance reports and information. This is a genuine reliance mechanism in Senegalese law, but it is confined to the post market vigilance domain: it grants no premarket market access, no shortened review and no product authorisation. It is the sharpest statement of where foreign regulator reliance legally exists in Senegal for health products. · sourceApproval: Vigilance decisions, reports and information of other countries or of regional or international bodies — the source names no specific authority or scheme · edgeType: abridged or recognition route · marketAccessStrength: none · regulatoryLayer: postmarket surveillance · localApplicationRequired: No · targetDecisionRetained: No

statement: Registration with ALIMS under the Pravilnik o registraciji medicinskog sredstva (Sl. glasnik RS 84/2018, 58/2021, 6/2023) requires a Declaration of Conformity and, for all devices other than Class I and 'other' IVDs, an EC Certificate issued by a notified body; for Class I/other IVD manufacturers from states that are not EU members and have no MRA/PECA with the EU, an accredited ISO 13485 certificate or proof that the device is marketed in an EU/MRA state is required. The bylaw's recognition procedure (Član 3 5) tests whether the foreign technical regulation and conformity assessment body give at least the same protection as the Serbian technical regulation; it names no countries and provides no role for an NMPA registration certificate, so Chinese devices are registered on the basis of CE documentation. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: serbia · chinaClassesInScope: NMPA Class II/III certificates and Class I filings; target all Serbian classes (I, IIa, IIb, III, IVD) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

An ALIMS decision recognising a foreign document or CE mark is valid until the expiry of the validity term set in the foreign document; if the foreign document sets no expiry term, the recognition decision is valid at most three years from issuance. Recognition is refused if the foreign document does not meet the equivalence conditions of bylaw Art. 4.

statement: HSA and NMPA signed a renewed and expanded MoU in Beijing on 11 May 2026, replacing the 2021 agreement, to strengthen regulatory cooperation and 'explore building facilitative regulatory pathways, pilot innovative schemes, capacity building and staff exchanges'. The MoU does not itself create any reliance route or recognition of NMPA device approvals; HSA's reference agency list is unchanged. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: singapore · chinaClassesInScope: Framework MoU covering chemical drugs, APIs, biologics, TCM, medical devices, cosmetics and (new) cell, tissue and gene therapy products · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: HSA's abridged, expedited (ECR/EDR) and immediate (IBR) evaluation routes are available only for devices with prior approval from HSA's overseas reference regulatory agencies, which are exhaustively listed as Australia TGA, EU Notified Bodies, Health Canada, Japan MHLW and US FDA. China's NMPA is not a reference agency, so an NMPA registered device without one of those approvals undergoes full evaluation (optionally under the Priority Review Scheme). · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: singapore · chinaClassesInScope: Class B/C/D devices and IVDs (abridged, expedited and immediate routes); NMPA Class II/III approvals do not qualify · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

TGA (Australia) is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for Abridged, and with marketing history or a second approval for Expedited/Immediate registration routes.

EU notified body certificates qualify as reference approvals: MDR Annex IX/XI A, IVDR Annex IX, and legacy directive certificates (93/42/EEC, 98/79/EC) as specified on HSA's registration overview page.

Health Canada is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for the reliance based registration routes.

Japan MHLW/PMDA is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for the reliance based registration routes.

US FDA marketing authorizations are accepted as reference approvals; qualifying submissions are 510(k) clearance, De Novo and PMA. Class I and II exempt FDA clearances do not qualify.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: slovakia · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:svk · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: slovenia · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:svn · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: SAHPRA recognises six jurisdictions for premarket evidence: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification. Establishment licence applications must annex 'Evidence of premarket registration from one of the 6 jurisdictions recognised by SAHPRA', and Certificate of Free Sale applications for Class C and D devices must show pre market approval/registration or emergency use authorisation from at least one of the six or WHO PQ. China NMPA is not one of the six, so an NMPA only Chinese device cannot satisfy the Class C/D evidence requirement. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: south africa · chinaClassesInScope: NMPA Class II/III certificates; target South Africa Class C and D devices and IVDs (licence listing and Certificate of Free Sale) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: SAHPRA's Medical Devices Reliance Guideline (SAHPGL MD 22 v1, 25 February 2026; consulted as the November 2025 consultation text SAHPGL MD 19 v1) grants abridged review only to devices already approved by a Recognised Regulatory Authority with which SAHPRA aligns (list to be published on SAHPRA's agreements/MoUs page), by a WHO Listed Authority (WHO permanent WLA list), under WHO CRP/PQ/EUL, or under the AMA continental procedure; a device without prior approval from any listed recognised authority goes to the full evaluation route. China NMPA is neither on the WHO WLA list nor named as an RRA, and SAHPRA's agreements page currently lists no China arrangement. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: south africa · chinaClassesInScope: NMPA Class II/III certificates; target Class B, C and D product registration and licence listing (reliance pathways) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.

SAHPRA applies the WHO Collaborative Registration Procedure (CRP) for IVDs, covering new product registration and post registration amendments for IVDs, per the SAHPRA Medical Devices page.

statement: NMPA and MFDS signed a Memorandum of Understanding on regulatory cooperation for drugs, medical devices and cosmetics in Beijing on 26 February 2019. The MoU sets cooperation areas and channels (high level meetings, staff visits and training, information exchange) and does not establish any reliance, mutual recognition or abridged review of each other's device approvals. No subsequent Korea China device reliance pilot has been announced by either regulator as of the check date. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: south korea · chinaClassesInScope: Framework MoU covering drugs, medical devices and cosmetics; no product class scope · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Korea grants manufacturing/import approval only after MFDS (Class 3 4) or an MFDS designated technical document review body (Class 2) reviews the application and technical documents for safety and performance under Medical Devices Act Arts. 6 and 15 and the MFDS Notice on Approval, Notification and Review of Medical Devices. No provision recognises a foreign marketing approval as a basis for abridged or waived review; foreign data are accepted only as content of the technical file (e.g., clinical data), and MDSAP results are used only within the KGMP audit layer (already held). · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: south korea · chinaClassesInScope: All device classes (1 4) and IVDs; NMPA Class I III certificates confer no review benefit · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:kor · sourceApproval: Medical Device Single Audit Program (MDSAP) · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes · detail: MFDS guideline (민원인안내서 MDSAP 심사결과 활용 가이드라인, 안내서 1349 01, 2024 02 23) governs use of MDSAP audit results when MFDS performs device GMP reviews; it is evidence reuse and does not replace Korean authorisation.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: spain · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:esp · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: NMRA's reliance pathway considers registrations only from the USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member states (plus Singapore for IVDs). China/NMPA is not a recognized reliance country, so a China NMPA certificate does not open the reliance pathway and the device follows the standard consolidated dossier evaluation. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: sri lanka · chinaClassesInScope: All device classes (general medical devices and IVDs) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.

statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower risk devices may self declare, while other devices require notified body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: sweden · chinaClassesInScope: All NMPA classes (I filing, II, III) > all EU MDR/IVDR classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

target: geo:swe · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No

statement: Switzerland recognises only the EU CE conformity route (unilateral recognition of CE marked devices under the MedDO/IvDO); a China NMPA registration certificate gives no route to the Swiss market and is not assessed. A Chinese manufacturer needs CE conformity assessment plus a Swiss authorised representative and Swissmedic registration duties. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: switzerland · chinaClassesInScope: All NMPA classes > all Swiss classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Certificates issued by bodies designated under EU law and established in an EU or EEA state that are not recognised through an international agreement are treated as equivalent to certificates of Swiss designated bodies, provided it is credibly demonstrated that the applied conformity assessment procedures satisfy Swiss requirements and the body has qualifications equivalent to those required in Switzerland.

target: geo:che · sourceApproval: EU CE under MDR/IVDR · edgeType: unilateral recognition · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No · description: Switzerland unilaterally recognises the CE label: a device lawfully CE marked under the EU system may be placed on the Swiss market without a separate Swiss conformity assessment or authorisation step, subject to local obligations (CH REP, actor and device registration, languages, vigilance, market surveillance).

statement: TFDA import registration for Class II/III devices requires an original 出產國許可製售證明 (certificate that the device is approved for manufacture and free sale) issued by the highest health authority of the country of manufacture, stating device name/model, manufacturer name/address and approval for sale status. For a device made in Mainland China the NMPA registration certificate or an NMPA issued free sale/export certificate is the document that meets this definition; it is a dossier element only and TFDA performs full technical review. The certificate must be issued within 2 years and authenticated by a Taiwan overseas mission unless issued by a country with a device pre market technical cooperation agreement with Taiwan. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: taiwan · chinaClassesInScope: Imported Class II/III devices (Class I import registration also requires FSC per 附表一); NMPA Class II/III certificate serves as the country of manufacture free sale evidence for PRC made devices · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Taiwan does not recognise NMPA approval and additionally restricts PRC origin devices: 附表二 說明十三(三) provides that a device manufactured in China may only be submitted for TFDA registration after the applicant first obtains permission to import documentation from the Ministry of Economic Affairs (formerly Bureau of Foreign Trade, now International Trade Administration), reflecting the Mainland goods import controls under the restricted import list. Only tariff lines published as permitted Mainland goods may be imported freely; other items require a project based (專案) approval from the trade authority before TFDA will accept the registration application. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: taiwan · chinaClassesInScope: All imported devices whose place of manufacture is Mainland China (陸製醫療器材), all classes; NMPA registration confers no import right · edgeType: import restriction · marketAccessStrength: none · regulatoryLayer: filing prerequisite · localApplicationRequired: Yes · targetDecisionRetained: Yes

Imported device applications rely on a free sale certificate (出產國許可製售證明) defined as a document issued by the highest health authority of the country of manufacture certifying that the device may be manufactured and freely sold in that country; it is a required dossier element for import registration and for licence extension.

Imported device applications require a manufacturer's letter of authorization (國外原廠授權登記書), defined as a document issued by the foreign manufacturer of the imported device authorising an agent to act; it is required at registration and extension.

statement: TMDA's device registration framework (Control of Medical Devices Regulations 2015 and the June 2024 Compendium) subjects all Class A D devices and IVDs to independent dossier assessment with no reference authority list and no abridged pathway based on foreign approvals; TMDA's separate regulatory reliance guideline (17 April 2025) covers marketing authorisation of human medicinal products only, and the only device related reliance mechanism is the WHO Collaborative Registration Procedure for WHO prequalified IVDs. An NMPA registration therefore gives no procedural benefit beyond documentary marketing history evidence. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: tanzania · chinaClassesInScope: all device classes A (registrable), B, C, D and IVDs under standard registration · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: TMDA's Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment (TMDA/DMD/MDA/G/001 Rev 03, June 2024) requires applicants for specialised devices such as MRI, ultrasound, X ray and ECHO systems to submit a 'Certificate of market approval from any other country and market history', listing all countries where the device is marketed or withdrawn. An NMPA registration certificate satisfies this documentary requirement for a China made device; the compendium names no reference regulatory authorities and provides no abridged route. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: tanzania · chinaClassesInScope: NMPA Class II/III certificates as foreign market approval evidence; target Tanzania Class B, C and D specialised devices (MRI, ultrasound, X ray, ECHO and similar) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

WHO prequalified IVDs can be registered via the WHO collaborative registration procedure: applicant submits the same dossier to TMDA as the one approved by WHO for prequalification and authorizes WHO to share its assessment and inspection outcomes with TMDA; TMDA online submission and fees still apply.

statement: Thai FDA offers two submission channels: the full pathway and the abridged evaluation pathway, the latter reserved for devices with a registration history from the agencies Thai FDA recognises: Australia TGA, Health Canada, EU Notified Bodies, Japan MHLW, US FDA and WHO Prequalification for IVDs. China's NMPA is not a recognised reference agency, so NMPA registered devices are evaluated under the full pathway. The Singapore HSA reliance programme and the Malaysia MDA reliance programme (both held) are the only bilateral reliance channels and do not involve China. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: thailand · chinaClassesInScope: Class 2 4 devices and IVDs (detailed notification and licence routes); NMPA approvals do not qualify for the abridged pathway · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:tha · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:tha · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12

target: geo:tha · sourceApproval: EU CE under MDR/IVDR · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12

target: geo:tha · sourceApproval: Health Canada medical device licence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12

target: geo:tha · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12

target: geo:tha · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12

target: geo:tha · sourceApproval: Singapore HSA product registration · edgeType: assessment report reliance · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For a device conforming to European Union legislation, ANMPS accepts the EU conformity certificate as the conformity evidence in its device technical dossier: for class I devices a valid ISO 13485 certificate issued by a certification body, and for every other class a CE certificate of conformity issued under Regulation (EU) 2017/745 according to the device's risk class. Only CE certificates issued by notified bodies notified to the European Commission (listed on NANDO) are accepted. Where no valid MDR certificate exists, ANMPS accepts instead the written agreement with a notified body under Annex VII, section 4.3, second paragraph of Regulation (EU) 2017/745, or a notified body confirmation letter under Regulation (EU) 2023/607 — Tunisia expressly tracks the EU's own MDR transition extension. · sourceApproval: EU CE marking — CE certificate of conformity under Regulation (EU) 2017/745 issued by a NANDO listed notified body; or a valid ISO 13485 certificate for class I devices; or, where no valid MDR certificate exists, an Annex VII §4.3 written agreement with a notified body or a notified body letter under Regulation (EU) 2023/607 · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A certificat de vente libre (free sale certificate) issued by a competent authority of the country of origin is a mandatory item of the ANMPS device technical dossier, and it must be valid or dated less than five years ago. Where the products or product family are listed in an annex to the certificate, the annex must be present and the relevant articles identified. This is an origin country evidence requirement that sits on top of — and is separate from — the conformity certificate requirement. · sourceApproval: Certificate of free sale issued by the competent authority of the device's country of origin (or a certificate dated within the last five years) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: ANMPS's device technical dossier guide names two further conformity regimes and their proof documents. For devices conforming to United States legislation: a copy of the 510(k) premarket notification for class I and class II devices, and a copy of the PMA (Premarket Approval) for class III devices. For devices conforming to Canadian legislation: a copy of the medical device licence issued by Health Canada. As with the EU route, these are dossier items inside a Tunisian evaluation, not a substituted approval. · sourceApproval: US FDA 510(k) premarket notification (class I and class II) and US FDA PMA premarket approval (class III); Health Canada medical device licence · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Türkiye's Tıbbi Cihaz Yönetmeliği (national transposition of EU MDR 2017/745) allows a device to be placed on the Turkish market only if it meets the Regulation's requirements, demonstrated through the conformity assessment procedures of Annexes IX XI (notified body involvement for Class IIa and above) and evidenced by CE marking. The Regulation contains no clause recognising, abridging on the basis of, or otherwise giving effect to a non EU marketing authorisation; a China NMPA registration certificate or Class I filing has no regulatory status in Türkiye, and a Chinese manufacturer must obtain CE certification under the aligned regulation and register in ÜTS/EUDAMED through a Turkish authorised representative/importer. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: turkey · chinaClassesInScope: All NMPA classes (Class I filing, Class II/III registration) mapped to Türkiye Class I/IIa/IIb/III; IVDs under the parallel IVD regulation · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

TİTCK duyuru 2026/KKB 1 (04.05.2026, Medical Device Registration and Coordination Department) announces that use of the EUDAMED database system has become mandatory and sets out the effect on UTS certificate and device registration processes.

Devices conforming to harmonized standards (or relevant sections) whose reference numbers have been published in the Official Journal of the European Union are presumed to conform to the Regulation's requirements covered by those standards.

target: geo:tur · sourceApproval: EU CE under MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No

statement: Uganda's recognised country list is closed and does not include China. DAR/GDL/028 s. 4.11 enumerates the recognised countries as the United States, Canada, Japan and Europe; Table 2 names Australia, Canada, the European Union, Japan and the United States; and NDA's Medical Devices page names 'Australia, Canada, European Union countries, Japan, and the United States'. A China NMPA registration therefore does not by itself put a product into Track 1 and does not satisfy the s. 4.11 certification gate for classes B D. The applicable track depends on the device's qualifying approvals and evidence, not its manufacturing country alone. A Chinese manufactured device holding a qualifying recognised country approval may use Track 1. The separate country of origin approval document requirement remains applicable. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For surgical instruments or appliances classified or considered high risk, the applicant must submit a legalised approval issued by a health authority in the country of origin to market the product in the relevant country (a certificate of conformity, or any equivalent), together with all certificates or documents issued by an assessment body as evidence of regular approval or clearance. This is a mandatory dossier item and is distinct from the IMDRF reference country route: the country of origin need not be an IMDRF founding member, but its marketing approval must exist and must be legalised. · sourceApproval: Any marketing approval, certificate of conformity or equivalent issued by the health authority of the country of origin, legalised; plus certificates or documents issued by an assessment body as evidence of regular approval or clearance in the country of origin · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: A device already licensed in one of the IMDRF founding member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2. · sourceApproval: Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Uganda treats recognised country certification as an eligibility gate, not merely as evidence. DAR/GDL/028 s. 4.11 states that devices not certified by any of the recognised countries will be examined and may be exempted from recognised country certification only if they are class A; for other classes the recognised country or CE certification is a must. The recognised countries are the United States (FDA clearance/approval), Canada, Japan (MHLW clearance/approval) and Europe. For Europe the certificate required scales with class: full quality assurance / EC Type Examination Certificate for class B and C, and full quality assurance / EC Design Examination Certificate for class D, and the notified body must itself be approved by European health authorities. · sourceApproval: US FDA clearance/approval; Canada clearance/approval; Japan MHLW clearance/approval; Europe EC quality system certification with an EC Type Examination Certificate (class B and C) or EC Design Examination Certificate (class D) issued by a notified body approved by European health authorities · edgeType: eligibility gate · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Uganda deems registered, for the purposes of importation, sale or advertisement, all the reagents or articles of an in vitro diagnostic test kit that is licensed or registered outside Uganda, where those reagents or articles are manufactured by the manufacturer of the test kit. This is a statutory deemed registration rule in S.I. 2014 No. 29 reg. 28(2) and it is unilateral: the foreign licence or registration is not required to come from any named country or any reference list, and no Ugandan application is described for the deemed reagents and articles themselves. It sits alongside reg. 28(1), under which a surgical instrument or group that forms part of another registered instrument or group is likewise deemed registered. · sourceApproval: Any licence or registration of the test kit issued outside Uganda, by any jurisdiction; no reference country list is imposed · edgeType: unilateral recognition · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: No · targetDecisionRetained: No

statement: A product that is not licensed in an IMDRF founding member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'. · sourceApproval: WHO Prequalification, or ISO 13485/ISO 13488 (or the country equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding member country; more broadly, registration in a country NDA treats as a stringent regulatory authority · edgeType: qms audit reliance · marketAccessStrength: facilitated · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Ukraine requires conformity assessment to its technical regulations by Ukrainian designated bodies and recognises no foreign registration certificate. The martial law derogation (Resolution 389 of 29 March 2022) only lets a Ukrainian designated body recognise results of conformity assessment performed by foreign accredited conformity assessment bodies under Article 45(1) and (3) of Law 124 VIII, which requires an accreditation body MLA link and a recognition agreement between the Ukrainian designated body and the foreign body. An NMPA registration certificate is a regulator's approval, not an accredited body assessment result, and no arrangement with Chinese bodies is provided for or was found. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: ukraine · chinaClassesInScope: All classes (Technical Regulations 753, 754, 755) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

During martial law, devices that do not meet the technical regulation requirements may be placed on the market and/or put into use if a Ukrainian designated body recognizes the results of conformity assessment performed by foreign accredited bodies, in line with parts 1 and 3 of Article 45 of Law 124 VIII.

statement: Article 6(1)(c) provides for EDE assessment of reference country marketing approvals or research information demonstrating effectiveness, safety and quality. It does not name NMPA, automatically accept an NMPA certificate or Class I filing record, or create an NMPA specific abridged route. Any Chinese origin country evidence must meet the applicable EDE documentary requirements and remains subject to EDE assessment. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uae · chinaClassesInScope: No NMPA class or filing record is expressly accepted by the cited provision; product specific EDE requirements must be met. · edgeType: eligibility unresolved · marketAccessStrength: undetermined · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

target: geo:are · sourceApproval: Reference country marketing approval assessed by EDE, or research information proving effectiveness, safety and quality (Article 6(1)(c)) · edgeType: eligibility gate · marketAccessStrength: eligibility only · regulatoryLayer: filing prerequisite · localApplicationRequired: Yes · targetDecisionRetained: Yes

CE marked general medical devices certified under the MDD/AIMDD can be placed on the Great Britain market up until the sooner of certificate expiry or 30 June 2028; CE marked IVDs under the IVDD are accepted up until the sooner of certificate expiry or 30 June 2030, with MHRA registration and (for overseas manufacturers) a UK responsible person.

Devices CE marked under EU Regulation 2017/745 (MDR) or 2017/746 (IVDR) can be placed on the Great Britain market up until 30 June 2030, with MHRA registration and (for overseas manufacturers) a UK responsible person.

statement: Great Britain requires UKCA marking (or, within the statutory transition, CE marking) under the UK MDR 2002 before a device is placed on the market; MHRA guidance names no third country approval other than CE, so a China NMPA registration certificate is not recognised and creates no abridged route. Overseas manufacturers also need a UK Responsible Person and MHRA registration. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uk · chinaClassesInScope: All NMPA classes > all UK classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

The UKCA marking alone is not recognised in the EU, EEA or Northern Ireland markets; devices bearing only a UKCA mark cannot be placed on the Northern Ireland market unless accompanied by a CE mark.

EU MDR has applied in Northern Ireland since 26 May 2021 and EU IVDR since 26 May 2022; CE marking is required for the Northern Ireland market, with the UKNI indication additionally required where a UK notified body performed the mandatory conformity assessment. GB based manufacturers selling into Northern Ireland must appoint an EU or Northern Ireland based authorised representative, and NI devices must be registered with MHRA (custom made devices within 28 days of being made available on the NI market).

statement: FDA requires foreign manufacturers to meet applicable US requirements, including establishment registration, device listing, quality system, labelling and reporting requirements, a US agent, and premarket notification or approval unless exempt. An NMPA certificate alone does not discharge these obligations. Determine the FDA class and submission/exemption separately. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: usa · chinaClassesInScope: All NMPA classes > all FDA classes · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Not published · targetDecisionRetained: Not published

FDA establishment registration and listing confers no product authorization: the resulting entry in FDA's registration and listing database does not denote approval, clearance, or authorization of the facility or its devices; FDA does not issue device registration certificates, and presenting such certificates as evidence of FDA endorsement is misleading (misbranding).

FDA does not recognize regulatory authorizations from other countries (for example EU CE marking under MDR/IVDR): any device imported or marketed in the US must independently meet the applicable FDA requirements (registration, listing, 510(k)/PMA, QMS, labeling, US agent, MDR, inspections).

FDA (with TGA Australia, ANVISA Brazil, Health Canada, and MHLW/PMDA Japan) participates in the Medical Device Single Audit Program and may accept MDSAP audit reports as a substitute for routine Agency inspections; firms with Electronic Product Radiation Control (EPRC) activities remain subject to direct FDA inspection for those activities.

statement: Decreto 3/008 Art. 7 d) requires, for product registration before the Ministry of Public Health, a free sale certificate issued by the competent body of the country of origin; if the origin authorities do not issue one and MSP deems it pertinent, it may be replaced by a quality certificate from recognized bodies. An NMPA registration/free sale certificate is therefore the required origin document for China made devices. The decree contains no reference country list and no abridged review based on foreign approvals, and MSP evaluates safety and efficacy under Art. 8 f) with the option to require clinical investigation. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uruguay · chinaClassesInScope: NMPA Class I filings and Class II/III certificates for all MSP product categories (reactivos de diagnóstico, equipos médicos, dispositivos médicos) · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Registration requires a certificate of free sale (certificado de libre venta, CLV) issued by the competent authority of the country of origin; where the authorities of origin do not issue it and MSP deems it pertinent, it may be replaced by a quality certificate granted by recognised bodies.

statement: On 27 June 2025 NMPA Commissioner Li Li and Alisher Temirov, Director of the Pharmaceutical Safety Center of the Uzbekistan Ministry of Health, signed in Beijing the 'Memorandum of Understanding between the NMPA of the PRC and the Pharmaceutical Safety Center of the Ministry of Health of the Republic of Uzbekistan on regulatory cooperation for drugs and medical devices'. The MoU establishes cooperation and exchange; it does not add NMPA to Uzbekistan's recognition list. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uzbekistan · chinaClassesInScope: Not class specific; regulatory cooperation MoU (drugs and medical devices) · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Under Cabinet of Ministers Resolution No. 738, medical devices are registered by the recognition route only if registered by the US FDA, EU bodies authorised to issue CE certificates, the EMA, Japan's PMDA, Korea's MFDS or the UK MHRA. China's NMPA is not on the list, so a China NMPA certificate does not open the 15 working day recognition route and the device follows the general (full) registration procedure. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uzbekistan · chinaClassesInScope: All classes (recognition route) · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The general route dossier table requires, for every class, a certificate of registration of the device in the manufacturer's country or a document confirming registration (free sale certificate, export certificate with state language translation), or a copy of a document confirming registration in other countries. A China NMPA registration certificate or NMPA based export certificate satisfies this item; the device still undergoes full expertise (60 120 working days by class). · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: China NMPA medical device registration certificate (Class II/III) or Class I filing record · targetJurisdictionId: uzbekistan · chinaClassesInScope: All classes (I, IIa, IIb, III) under the general registration route · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Devices registered by the following are registered in Uzbekistan by the recognition route: US FDA; EU bodies authorized to issue CE conformity certificates; EMA (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (United Kingdom). Foreign certificates are verified against the issuing regulator's official registers/website; if not verifiable through open sources they must be apostilled or consularly legalized.

Vietnam's MOH issued Decision 2426/QĐ BYT (15/05/2021) adopting ASEAN guidance for preparing the common technical dossier for medical devices: harmonized dossier format only; national review and decision retained.

statement: Decree 98/2021/NĐ CP (consolidated text 08/VBHN BYT of 6 March 2026) names China's NMPA as one of the 'reference countries' (nước tham chiếu): a Class C/D device holding a Certificate of Free Sale or Market Authorization from a reference country qualifies for fast track issuance of a circulation number under Art. 29(2)(a). The fast track dossier (Art. 30(3)) consists of the application, legal documents, the reference country marketing document, a Vietnamese IVD quality certificate where applicable, and the CSDT; the Ministry of Health assesses only the legal documents and must issue the circulation number within 10 working days of a complete dossier (Art. 32(3)(a)). Other reference countries are US FDA, Australia TGA, Health Canada, Japan MHLW/PMDA, EU member states, UK, Switzerland and Korea MFDS. · sourceJurisdictionId: china · sourceAuthorityId: nmpa · sourceApproval: Valid Certificate of Free Sale or Market Authorization from China NMPA, as the named reference authority · targetJurisdictionId: vietnam · chinaClassesInScope: Products holding the qualifying reference authority document and independently classified as Vietnam Class C or D; do not assume Chinese risk classes map to Vietnam · edgeType: abridged or recognition route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

Decree 98 contains a dedicated provision (Art. 36) on handling medical devices with foreign elements involving organizations such as the EU and ASEAN; full provision text not extracted.

edgeType: origin country evidence · marketAccessStrength: evidence only · sourceApproval: Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state · statement: ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance. · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

edgeType: qms audit reliance · marketAccessStrength: evidence only · sourceApproval: A previous satisfactory GMP inspection report for the manufacturing site issued by ZAMRA or another recognised competent authority within the 24 months preceding receipt of the application · statement: Where ZAMRA cannot conduct a GMP inspection of a device manufacturing facility, it shall consider previous satisfactory inspection reports of that site conducted by ZAMRA or other recognised competent authorities, provided the inspection was conducted within twenty four months preceding receipt of the application. In the non IVD guideline the same mechanism is permissive: in determining whether to conduct a site audit for ISO 13485 compliance, the Authority may consider previous satisfactory site audit outcomes conducted by well resourced or regional regulatory agencies and that the audit was conducted within 24 months preceding receipt of the application. This is the one place where ZAMRA's device guidelines expressly rely on another regulator's work product, and it bears only on the manufacturing site inspection, not on the product evaluation. · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes

edgeType: origin country evidence · marketAccessStrength: evidence only · sourceApproval: An original Free Sale Certificate addressed to Zambia from the manufacturer home authority, plus the manufacturing licence and documentary proof of foreign registration · statement: A foreign manufacturer cannot file a Zambian device application without its home country paper: the applicant must provide an original Free Sale Certificate specifically addressed to Zambia (notarized copies are acceptable), the manufacturing licence of the device manufacturer, documentary proof of compliance with ISO 13485, and documentary proof of registration of the product in other countries, specifically those in the SADC region. The Annex II dossier checklist requires an original or notarized Free Sale Certificate, a notarized manufacturing licence, notarized registration certificates and an ISO 13485 certificate. The Free Sale Certificate / certificate of marketing authorisation is also a standing Administrative chapter item. This is a mandatory evidence requirement that runs alongside the full ZAMRA evaluation it does not replace it, and it does not by itself give the holder an abridged review. · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: For the only two regulated device classes the position is still not reliance. Approval of a type and brand of condom or a type of glove turns on whether the device meets Zimbabwe's own Second Schedule standards or standards the Authority specifies from time to time in guidelines; MCAZ's Medical Devices Laboratory performs the conformity assessment, testing condoms for bursting volume and pressure, freedom from holes and visible defects, package seal integrity, dimensions and total lubricant, and gloves for dimensions, watertightness and tensile strength before and after accelerated ageing. MCAZ states that the tests are performed 'in accordance with international standards and WHO guidelines and specifications'. An FDA, CE, PMDA, MFDS or NMPA approval is nowhere recognised or substituted; the foreign paperwork that appears in the process is descriptive the SR 03 Sample Receipt Form for medical devices records the manufacturer, the 'Country of Origin' and the 'Product license Number' of the sample submitted. Foreign approval is therefore evidence on the file, not a route. · sourceApproval: US FDA 510(k)/PMA clearance; EU CE Marking under MDR; Japan PMDA approval; Korea MFDS approval · edgeType: origin country evidence · marketAccessStrength: evidence only · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: An FDA, CE, PMDA, MFDS or NMPA approval holder has nowhere to file it in Zimbabwe. Zimbabwe does not operate a general medical device registration pathway: the Medicines and Allied Substances Control Act's registration machinery covers medicines, and devices enter control only through ministerial regulations made under section 38(1)(b). The only device classes ever brought under control are male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). For any other device an infusion pump, an orthopaedic implant, a CT scanner, an IVD there is no marketing authorisation to apply for, so no foreign approval can open, shorten or substitute for one. MCAZ's own Strategic Plan 2026 2030 records the Medical Devices Unit's entire regulatory function as the assessment of male condoms and medical gloves, and lists an 'expanded scope to medical devices and allied substances' as an effect of a Medical Products and Allied Substances Control Bill that is still only proposed. · sourceApproval: none · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes

statement: MCAZ does operate abridged and recognition routes, but they are medicines routes. The published reliance pathways are the WHO Collaborative Registration Procedure (3 months), the expedited registration pathway (3 months), the Zazibona SADC Centralised Procedure (3 months, country level approval) and the African Medicines Agency route (3 months, country level approval), against 'other products' at 9 months. MCAZ's Reliance Policy adds that an application supported by a replica dossier and the reference authority's full evaluation report can be expedited 'from 16 24 months to 3 months', and it names its functional agreements as the Egyptian Drug Authority (EDA) and the South African Health Products Authority (SAHPRA), with an agreement with the Islamic Republic of Iran Food and Drugs Authority under discussion. The EDA framework itself is titled 'Recognition Framework for Medicines Manufactured in Egypt and Approved by the Egyptian Drug Authority (EDA)' and is 'restricted to products manufactured in Egypt and are currently active on the Egyptian market'. None of these instruments mentions medical devices, and none creates a device route. · sourceApproval: Egyptian Drug Authority (EDA) approval; South African Health Products Authority (SAHPRA) approval; WHO Collaborative Registration Procedure; ZAZIBONA/SADC centralised procedure · edgeType: cooperation mou · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: MCAZ's Reliance Policy (QPM 09, Revision 3, September 2025) provides expressly for reliance on WHO Prequalification but its registration reliance section opens 'When MCAZ is conducting evaluation and registration of medicines it considers', and the devices item is written as a future contingency: 'WHO Prequalification for devices and Diagnostics (once the regulations are approved)'. The Authority therefore treats WHO Prequalification of a device or diagnostic as something it will be able to rely on only when Zimbabwe has device regulations to hang it on. It is a declared policy intention, not an operating reliance route, and it does not give a WHO prequalified device any Zimbabwean market access today. · sourceApproval: WHO Prequalification of medical devices and in vitro diagnostics · edgeType: international listing · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes