🇨🇳 China IVD regulatory data

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

albania

NMPA Class II/III certificates and Class I filings; target all Albanian classes

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

algeria

All device classes (I-III) subject to ANPP homologation

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

argentina

NMPA Class I filings and Class II certificates for devices that are ANMAT Class I/II (and IVD A/B without cold chain)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

argentina

NMPA Class II/III certificates (and Class I filing proof) for ANMAT Class II, III and IV devices

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

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

Origin Country Evidence

Evidence Only

Import Control

Yes

Yes

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.

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

Abridged Or Recognition Route

facilitated

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

australia

All classes; ARTG inclusion applications and abridgement of TGA conformity assessment

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

austria

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

bangladesh

Bangladesh Class B (NMPA Class I/II equivalents); also the origin-FSC component for Class C/D

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

bangladesh

Bangladesh Class C and D (NMPA Class II/III equivalents)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

Chinese medical-device registration certificate and export certificate for the eligible China-produced device

belarus

China-produced, China-registered devices covered by the procurement notice; equivalence of a Class I filing to the required registration certificate is not established

Procurement Admission

facilitated

Public Procurement

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

belarus

All classes under the national registration route (Minhealth Resolution 55, Appendix 1, item 2.3) and the EAEU route (Decision 46 dossier item 10)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

belgium

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

brazil

NMPA Class II/III certificates and Class I filings; target: ANVISA Class III/IV registration (optimized procedure)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

brazil

All device classes (framework MoU; no product-level effect)

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

bulgaria

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

canada

NMPA Class II/III -> Canada Class II-IV licences

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

chile

NMPA Class I/II/III (all ISP classes I–IV, since Class I requirements apply cumulatively to higher classes)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

colombia

NMPA Class I filings and Class II/III certificates for all INVIMA classes of imported devices

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

colombia

NMPA Class I/II/III; target INVIMA classes I, IIa, IIb (Decreto 3275/2009 homologation) and reference-country CLV substitution under Art. 29 b)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

costa-rica

NMPA Class I filings and Class II/III certificates for EMB classes 2, 3 and 4 (class 1 exempt from registration)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

none

No Reliance Route

none

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

cuba

all regulatory functions incl. device registration (reliance practice)

Eligibility Unresolved

undetermined

Product Marketing

Yes

Yes

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.

none

No Reliance Route

none

Premarket Review

No

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

czech-republic

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

denmark

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China-issued Certificate of Free Sale or equivalent satisfying Article 25(a), not merely any NMPA certificate

ecuador

Imported devices within the regulation; qualifying free-sale documentation must be established for the particular product

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

ecuador

NMPA Class II/III certificates; target ARCSA simplified registration (Arts. 31–34) for classes I–IV

Eligibility Unresolved

undetermined

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

egypt

Non-sterile Class IIa only (initial registration file)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

egypt

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'

No Reliance Route

none

Product Marketing

Yes

Yes

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.

China NMPA medical device registration certificate (Class II/III) or Class I filing record

No Reliance Route

none

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

eu

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

finland

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

france

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

germany

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

ghana

all classes under the device registration guideline (full dossier review)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

greece

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable

hong-kong

NMPA-registered IVD; separately determine whether the product falls within Hong Kong Class B/C/D

Abridged Or Recognition Route

facilitated

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

hungary

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

none

No Reliance Route

none

Product Marketing

No

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

india

Not class-specific; regulatory-cooperation instrument only

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

india

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))

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

india

All NMPA classes; concerns Indian import licence (Form MD-15) for Class A-D devices

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

indonesia

Medical devices and PKRT within Pasal 58; local classification and application pathway require separate assessment

Eligibility Unresolved

undetermined

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

iran

NMPA Class II/III registration certificate (and Class I filing) as country-of-manufacture sales evidence for China-made devices

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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).

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

iran

NMPA Class I/II/III; all imported devices (IMED risk classes A-D)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

iraq

Equipment covered by these two 2023 dialysis tenders only

Eligibility Unresolved

undetermined

Public Procurement

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

ireland

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

israel

NMPA Class II/III certificates and Class I filings; AMAR regular track for imported devices of all risk classes

Eligibility Unresolved

undetermined

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

israel

All NMPA classes (Class I filing, Class II/III registration); relevant to all Israeli risk classes and tracks

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

israel

Drugs, medical devices and cosmetics (regulatory cooperation; no product-class scope)

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

italy

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

japan

All device and IVD marketing approvals (承認); NMPA approval carries no procedural benefit

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

jordan

All imported medical supplies/devices subject to JFDA registration (Class I sterile/measuring, IIa, IIb, III, active implants); NMPA Class I/II/III alike

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

jordan

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

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

kazakhstan

All classes (1, 2a, 2b, 3 and IVDs) under the national registration route

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

kazakhstan

All classes under the EAEU common registration route (Council Decision No. 46)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

kenya

NMPA Class II/III certificates and Class I filings; target Kenya Class B, C and D (abridged, expedited and immediate routes)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

kenya

all health products and technologies incl. medical devices and IVDs (reliance pathways)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

kenya

NMPA Class I filing (备案) or Class II/III certificate as country-of-origin evidence; target Kenya Class A listing

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

liechtenstein

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

lithuania

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

luxembourg

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

macau

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

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

No prior registration certificate in either China or Malaysia (eligibility prerequisite)

malaysia

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)

Bilateral Programme

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

malaysia

Class B/C/D devices and IVDs under the standard conformity-assessment-by-verification route; NMPA approvals not eligible

No Reliance Route

none

Product Marketing

Yes

Yes

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.

none

No Reliance Route

none

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

malta

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

mexico

Vaccines, medicines and medical devices/equipment (framework agreement)

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

Qualifying NMPA Class II/III medical-device registration certificate

mexico

NMPA Class II and Class III registration certificates (medical devices and IVDs); target COFEPRIS registro sanitario of any class via COFEPRIS-04-050

Abridged Or Recognition Route

facilitated

Product Marketing

Yes

Yes

Solicitud de Registro Sanitario de Dispositivos Médicos por Equivalencia de Autoridades Regulatorias de Referencia (COFEPRIS-04-050)

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

myanmar

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'

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

netherlands

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

new-zealand

All classes

No Reliance Route

none

Product Marketing

Yes

Yes

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).

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

nigeria

NMPA Class I filing or Class II/III certificate and Chinese manufacturing licence as documentary evidence; target all imported devices

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

nigeria

NMPA Class II/III certificates; target all NAFDAC-registered devices incl. IVDs (reliance procedure)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

none

No Reliance Route

none

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

norway

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

oman

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

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

pakistan

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

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

pakistan

All classes (enlistment Class A, registration Class B-D)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

panama

NMPA Class I filings and Class II/III certificates for all Panamanian device classes (registration under Ley 90/2017 and DE 490/2019)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

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

Abridged Or Recognition Route

facilitated

Premarket Review

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

peru

NMPA Class I filings and Class II/III certificates for DIGEMID device classes I, II, III and IV

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

peru

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)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

philippines

Class A imported devices (Certificate of Medical Device Notification); NMPA Class I filing or Class II/III certificate serves as country-of-origin evidence

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

philippines

Class B/C/D medical devices (abridged processing); NMPA approvals not eligible; IVDs and refurbished devices excluded from the circular altogether

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

poland

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

portugal

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

qatar

Implantable medical devices (IMD) of any NMPA class; MoPH IMD registration is the only product-registration route Qatar operates for devices

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

qatar

Implantable medical devices (any NMPA class)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

romania

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

russia

All classes under the national registration route (Government Decree No. 1684)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

russia

Not class-specific; cooperation instruments only

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

russia

All classes under the EAEU common registration route (Council Decision No. 46)

Origin Country Evidence

Evidence Only

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

saudi-arabia

Not class-specific; regulator-to-regulator cooperation covering drugs, medical devices and cosmetics

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

saudi-arabia

All NMPA classes (Class I filing, Class II, Class III); SFDA MDMA covers Saudi Classes A-D and IVDs

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

serbia

NMPA Class II/III certificates and Class I filings; target all Serbian classes (I, IIa, IIb, III, IVD)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

singapore

Framework MoU covering chemical drugs, APIs, biologics, TCM, medical devices, cosmetics and (new) cell, tissue and gene therapy products

Cooperation Mou

none

Product Marketing

Yes

Yes

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).

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

singapore

Class B/C/D devices and IVDs (abridged, expedited and immediate routes); NMPA Class II/III approvals do not qualify

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

slovakia

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

slovenia

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

south-africa

NMPA Class II/III certificates; target South Africa Class C and D devices and IVDs (licence listing and Certificate of Free Sale)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

south-africa

NMPA Class II/III certificates; target Class B, C and D product registration and licence listing (reliance pathways)

No Reliance Route

none

Product Marketing

Yes

Yes

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).

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

south-korea

All device classes (1-4) and IVDs; NMPA Class I-III certificates confer no review benefit

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

south-korea

Framework MoU covering drugs, medical devices and cosmetics; no product-class scope

Cooperation Mou

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

spain

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

sri-lanka

All device classes (general medical devices and IVDs)

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

sweden

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

No Reliance Route

none

Product Marketing

null

null

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

switzerland

All NMPA classes -> all Swiss classes

No Reliance Route

none

Product Marketing

Yes

Yes

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.

china

nmpa

China NMPA medical device registration certificate (Class II/III) or Class I filing record

taiwan

All imported devices whose place of manufacture is Mainland China (陸製醫療器材), all classes; NMPA registration confers no import right

Import Restriction

none

Filing Prerequisite

Yes

Yes