Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Law No. 89/2014 as amended is built on the EU framework, so the CE certificate and the technical documentation behind it are the substance of the ABPM dossier rather than an optional extra. ABPM publishes no shorter period for CE-marked devices.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
AlbaniaUS FDA · EU conformity assessment Regulatory reference
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.
Conditions
- CE marking is not required for clinical-investigation devices and custom-made devices (Art. 17(3)).
The original 2014 text accepted only CE marking; FDA certification was added by Law 21/2020 (in force 2020).
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Usable as technical and QMS evidence in the dossier. Algeria requires its own registration decision and publishes no recognition route or origin-based reduction.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class II
- Pathway
Declaration of Conformity
- Verification Status
official-verified
- Official Source
- Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
- Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
- Notes
- Art. 5: the INPM has 15 administrative working days to assess the dossier and rule
- Since 16 Feb 2026 an imported Class II device authorised in a Decreto 892/2025 Annex I country can instead use the prior-notification route, which takes effect on filing
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
- Benefit
Recognized for documentation
- Timeline Savings
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Class IV
- Verification Status
official-verified
- Official Source
- Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
- Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
- Prior Approval Benefits
- FDA PMA
- EU CE Mark Class III
- Notes
- Art. 6: Class IV runs on the same 110 administrative working days as Class III
- Extensive clinical evidence and an on-site audit are possible, and art. 7 suspends the period during the deficiency response
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Class III
- Pathway
Registration with clinical data
- Verification Status
official-verified
- Official Source
- Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
- Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
- Notes
- Art. 6: ANMAT has 110 administrative working days to assess the dossier and issue the administrative act
- Art. 7 suspends that period while the applicant answers the single consolidated deficiency notice, which is why the realistic range is far longer
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · Türkiye conformity assessment Prior approval / evidence record
Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country
reliance.origin-country-or-imdrf-authorisation-evidence-for-unregistered-import
- 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.
- Source Approval
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
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Import Control
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The obligation attaches to the import (conformity) certificate for devices without Armenian state registration; for devices that do have Armenian state registration the equivalent item is a copy of the Armenian registration certificate, and the origin-country evidence is not required.
- One of the ten statutory grounds for refusing the import certificate is that the imported device has no Armenian state registration, except in the cases the Law allows (Article 47.2(7)(8)). The origin/IMDRF evidence does not cure that ground where registration was required; it is the supporting document for the unregistered-device import cases the Law permits.
- The file also requires, for every batch, a quality conformity certificate or equivalent, and the instructions for use or a reference to their electronic version (Annex 2, para. 2(2)(b), (c)).
- The document list was extended by Government Decree No. 1731-Ն of 12.10.2023 and No. 1619-Ն of 17.10.2024.
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
Prior approval / evidence record
EU CE marking under MDR/IVDR
- Authority
EU CE marking under MDR/IVDR
- Benefit
An EU member state is an IMDRF member, so a CE-marked and EU-registered device meets the same simplified-route gate under Article 46(4); the CE certificate is not itself an Armenian marketing authorisation.
Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock) Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · IMDRF member authorities · WHO Prior approval / evidence record
Simplified national registration for a device registered in an IMDRF member country or prequalified by WHO
reliance.imdrf-member-or-who-prequalified-simplified-registration
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The provision is written as an annex to part 3 of the same article: 'under the procedure laid down by part 3 of this article' devices are registered under the general and simplified procedures. Part 3 is itself the Armenia-only route, and a footnote to Article 46 states that part 3 operates only until the end of the transitional period set by Article 11 of the EAEU Agreement of 23 December 2014 (footnote inserted by Article 3(2) of the Law of 5 December 2024 ՀՕ-502-Ն). The transitional period was extended by the Protocol signed in Moscow on 29 December 2025, which replaced '2025' with '2027' in the first paragraph of Article 11 of that Agreement and '2026' with '2028' in the third and fourth paragraphs.
- Bounded claim: the Law names IMDRF membership and WHO prequalification as the gate for the simplified procedure. It does not name the FDA, the CE mark, the PMDA or the MFDS; those follow from their countries' IMDRF membership, not from the text.
- The operational content of the 'simplified procedure' (dossier list, clocks, certificate form) sits in the Government procedure that Article 46(3) contemplates; that instrument was not located in this session (see unresolved: registration-pathways).
- Devices are registered by the Ministry of Health (the լիազոր մարմին / authorised body) with the examination carried out by the expert organisation designated by Government decision (Article 46(2), (5)).
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
AustraliaUS FDA · EU conformity assessment · MDSAP Prior approval / evidence record
Class III — ARTG inclusion
- Class Name
Class III — ARTG inclusion
- Pathway
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
- Prior Approval Benefits
- EU CE Mark (30-50% faster)
- FDA 510(k)
- MDSAP
- Notes
- The inclusion decision itself still carries the 20-working-day statutory clock. What makes Class III slow is what sits either side of it: an application audit, which has no legislated timeframe, and where TGA conformity assessment is required, a separate certificate that must be obtained first
- Non-IVD Level 2 application audits: TGA expects the first round of specialist assessment within 100 working days, and will explain a revised timeframe if it cannot meet that
- Sponsor responses to a s41JA notice or a Proposal to Refuse are due within 20-40 business days depending on complexity, and that time does not count against TGA targets
- The published targets replaced an older blanket 60-working-day audit target that TGA says was arbitrary and not consistently met
- Clinical Trial Required
No
- Verification Status
official-verified
- Official Source
- Title
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
- Url
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — evidence reuse
reliance.reliance-edge-reference-approvals-to-australia-approval-eu-ce-mdr-ivdr-australia
- Source Approval
EU CE under MDR/IVDR
- Market Access Strength
facilitated
- Regulatory Layer
Product Marking
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Evidence accepted for ARTG inclusion applications and as basis for abridged TGA conformity assessment
- Australian sponsor and Australian requirements remain
- MRA-issued certificates may no longer be acceptable for some higher-risk devices including Class III and AIMDs
AustraliaUS FDA · EU conformity assessment · MDSAP Prior approval / evidence record
Class IIb — ARTG inclusion
- Class Name
Class IIb — ARTG inclusion
- Pathway
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
- Prior Approval Benefits
- EU CE Mark
- FDA 510(k)
- MDSAP
- Notes
- Same 20-working-day statutory inclusion clock; audit selection is more likely at this class and suspends any published limit
- Level 1 compulsory audits ran to a median of 14 and a mean of 27 TGA days in the published snapshot, and Level 2 compulsory audits to a median of 161 and a mean of 174
- Clinical Trial Required
No
- Verification Status
official-verified
- Official Source
- Title
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
- Url
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
AustraliaUS FDA · EU conformity assessment · MDSAP Prior approval / evidence record
Class IIa — ARTG inclusion
- Class Name
Class IIa — ARTG inclusion
- Pathway
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
- Prior Approval Benefits
- EU CE Mark
- FDA 510(k)
- MDSAP
- Notes
- The 20-working-day statutory clock runs to the inclusion decision, not to the end of an audit: if the application is selected for audit there is no legislated limit on what follows
- Non-Class I applications completed without audit took a median of 9 and a mean of 10 TGA days in the published snapshot
- Australia is unusual in splitting conformity assessment from market authorisation, which is what allows overseas certification to be used in place of a TGA assessment at this class
- Clinical Trial Required
No
- Verification Status
official-verified
- Official Source
- Title
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
- Url
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
Abridged assessment route - major timeline reduction
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-austria
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language (German IFU under § 7 MPG 2021), EUDAMED actor registration, national register and national vigilance obligations still apply
EU baseline confirmed via the European Commission CE-marking page (supporting context for the single-market validity edge).
Prior approval / evidence record
EU CE marking under MDR/IVDR
- Authority
EU CE marking under MDR/IVDR
- Benefit
Same position: the recognition list approved by Cabinet Resolution No. 480 of 26 December 2023 is applied to medicinal products only, so a CE mark does not displace the national dossier and expertise.
Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1Cabinet Resolution No. 345 of 18 July 2024 as registered on the legal portal — citation 345, adopted 18.07.2024, in force 19.07.2024, register code 14202407180345, status Qüvvədədir Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
BahrainEU conformity assessment · US FDA Prior approval / evidence record
CE certificate under the medical-device directives/regulations or FDA Certificate to Foreign Government required as quality assurance certificate
reliance.ce-or-fda-quality-assurance-certificate
- 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.
- Source Approval
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)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Not applicable for class I non-sterile devices and Class A / other IVDs, for which a Declaration of Conformity may be accepted instead
- The certificate must be verified on the issuing body's website (Quality Assurance Certificates and Verification Process Guideline)
- The address on the certificate must match the artwork
- Applies to the legal manufacturer; a separate ISO 13485 certificate is required for the physical manufacturer
Verbatim source passage: "Quality Assurance Certificate (QAC) - CE directives 93/42/EEC, 2017/745, 98/79/EC, 2017/746 or FDA Certificate to Foreign Government (CFG) for the Legal manufacturer with the address matching the artwork along with verification evidence ... Not applicable for class I non-sterile and Class A/others IVD."
BahrainEU conformity assessment · US FDA Prior approval / evidence record
EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government
- Authority
EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government
- Benefit
Mandatory supporting documentation for a local review that still runs in full, not a route that shortens it: the CE certificate or CFG is the Quality Assurance Certificate required for the legal manufacturer, and for class III and class D IVDs the EC Design Examination certificate or CFG is an additional class-specific dossier item.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
BahrainEU conformity assessment · US FDA Prior approval / evidence record
Class III / Class D IVD requires an EC Design Examination certificate or FDA Certificate to Foreign Government
reliance.class-iii-ec-design-examination-or-fda-cfg
- 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.
- Source Approval
EC Design Examination certificate (EU notified body); US FDA Certificate to Foreign Government (CFG)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Also required for class IIb medical devices 'if available'
- Verification evidence for the EC Design Examination certificate must be provided
- Class mapping: Bahrain classes I, IIa, IIb, III for general devices; classes A-D for IVDs
Verbatim source passage: "For class III medical devices as well as class D IVD's, an EC Design examination certificate or an FDA Certificate to Foreign Government (CFG) for the legal manufacturer is required along with verification evidence ... This document needs to be submitted for class IIB medical devices if available."
Prior approval / evidence record
EU CE Mark
- Benefit
Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
BangladeshEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Regulatory reference
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.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
Regulatory reference
Inspection relief for devices already on US/EU markets
reliance.us-eu-circulation-inspection-relief
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.
Conditions
- National route; Minhealth Resolution 55 p. 6.1.
- Foreign class 1 devices (except sterile) from a first-declared site are exempt from inspection.
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Technical and QMS documentation can be reused, but Belarus runs its own state registration and publishes no recognition route for a CE certificate.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-belgium
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Belgian language regime for label and IFU, FAMHP distribution notification, EUDAMED actor registration and the FAMHP vigilance channel still apply
Loi du 22 décembre 2020 relative aux dispositifs médicaux is the Belgian implementing act; it sets the language regime, the FAMHP as competent authority, the distribution notification duty and the national vigilance channel, all of which sit on top of a valid CE certificate rather than replacing it.
Prior approval / evidence record
EU CE marking
- Benefit
No named-approval fast track exists. A CE certificate or ISO 13485 certificate is accepted as the quality-system evidence of numeral 2.3.1 of the device manual, not as an authorisation.
Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro SanitarioManual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 RechazoCircular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicosResolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de relianceCircular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Proof of marketing in the manufacturer's country or an EU member state is required for registration
reliance.origin-country-free-sale-certificate-required
- 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.
- Source Approval
Evidence of marketing in the manufacturer's country or in an EU member state (Free Sale Certificate or similar document)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The limb is satisfied by proof of marketing either in the manufacturer's own country or in an EU member state; a foreign (e.g. FDA) clearance is not recognised as such, but a free-sale certificate from the manufacturer's home market is acceptable evidence of marketing. The document is evidence of marketing, not a recognition of the approval.
Original (bs): as quoted. Translation: 'proof that the medical device is marketed in the country of the manufacturer or in one of the countries of the European Union'. The same requirement is repeated for in vitro diagnostic devices in Član 69. stav (1) tačka e), and restated by the Agency's current documentation list (30.10.2025) as '„Free Sale Certificate“ ili sličan dokument'.
Prior approval / evidence record
EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC
- Authority
EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC
- Benefit
Law čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out the conditions and documentation for recognising an EC certificate issued under Directive 90/385/EEC or 93/42/EEC that was valid on 26 May 2021 and not withdrawn, including the MDR Annex VII application-and-contract evidence. Recognition is an administrative act of the Agency under čl. 100 and 101 of the Law and čl. 68 of the Pravilnik; it does not replace entry in the Register, which under Pravilnik čl. 65(8) is what confers the right to place the device on the market.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU-recognised conformity assessment: CE marking is recognised in Bosnia and Herzegovina
reliance.ce-marking-recognised-in-place-of-national-conformity-marking
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The CE marking substitutes the conformity marking used in BiH; it does not remove the obligation to enter the device in the Register of medical devices kept by the Agency (Zakon 58/08, Član 108. stav (2); Pravilnik 71/12, Član 6. stav (2)).
- Under Zakon 58/08 Član 108. stav (2) (restated in Pravilnik 71/12 Član 6. stav (2)) it is prohibited to market devices that are not entered in the Register kept by the Agency. Pravilnik 4/10 Član 75. was repealed by Pravilnik 71/12 Član 18.
Original (bs): as quoted. Translation: 'By way of exception from paragraph (2) of this Article, a manufacturer of a medical device whose conformity with the general and special requirements is determined by a conformity-assessment body recognised in the EU must mark the medical device with the CE marking, which is recognised in BiH.' The same rule is repeated in the implementing Ordinance (Pravilnik, Član 38. stav (3)), which adds that the CE mark or certificate of conformity implies conformity with the requirements and directives of the European Union. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.
Prior approval / evidence record
Legacy MDD/AIMD EC certificates remain valid until 31 December 2027 or 2028 under MDR Article 120
reliance.legacy-mdd-aimd-ec-certificate-transition-deadlines
- 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.
- Source Approval
Legacy EU EC certificate under MDD 93/42/EEC or AIMD 90/385/EEC extended by MDR (EU) 2017/745 Article 120
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The Agency requires, together with the EC certificate, a notified-body document confirming the MDR Annex VII application and a manufacturer's document confirming no significant change in design or intended purpose and no unacceptable risk.
- MDR Article 120(3e) conditions include a quality management system compliant with MDR Article 10(9) from 26 May 2024.
- Any significant change in design or intended purpose requires a fresh conformity assessment and a new declaration of conformity.
Original (bs): as quoted. Translation: 'If an EC certificate was issued by an authorised body in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 and was valid on 26 May 2021 (the start of application of the EU MDR Regulation) and has not subsequently been withdrawn, it remains in force after the end of the period stated on the certificate, up to the following dates: (a) 31 December 2027 — for class III devices, implantable class IIb devices ... and AIMD devices; (b) 31 December 2028 — for class IIb devices not covered by point (a), class IIa devices and class I devices placed on the market in a sterile state or with a measuring function.' The guidance cites Article 120 of Regulation (EU) 2017/745 and Pravilnik Član 68.
Prior approval / evidence record
EU MDR (Regulation (EU) 2017/745) notified-body certificate
- Authority
EU MDR (Regulation (EU) 2017/745) notified-body certificate
- Benefit
The Agency's Instruction is expressly framed as the response to the EU's transition from the MDD/AIMD to the MDR and cites MDR Article 120, so an MDR certificate is recognised on the same basis as an EC certificate. Bosnia and Herzegovina is not an EU member and the MDR is not directly applicable; the certificate enters the national procedure as a conformity input.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
In vitro diagnostic devices: EC certificate required except List D, with declaration of conformity
reliance.ivd-ec-certificate-required-except-list-d
- 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.
- Source Approval
EU in vitro diagnostic certificate (CE marking certificate / EC certificate) under the EU IVD directives or IVDR
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- List D in vitro diagnostic devices are exempt from the EC-certificate limb of Član 69. stav (1) tačka c), but the manufacturer's declaration of conformity under tačka d) is still required.
- The device must still be entered in the Register of medical devices kept by the Agency.
Original (bs): as quoted. Translation: '(c) a certificate of conformity of the in vitro medical device with the directives and regulations of the European Union (CE marking certificate, EC certificate) or a certificate of conformity of the medical device, original or certified copy in the country of origin, except for in vitro medical devices on List D; (d) a manufacturer's declaration of conformity with the European directive for in vitro medical devices, stating exactly the list to which the device belongs (Declaration of conformity), original or certified copy in the country of origin'. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.
Prior approval / evidence record
Declaration of conformity must be issued against MDR after the 26 May 2021 transition
reliance.mdr-declaration-of-conformity-required-after-mdd-transition
- 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.
- Source Approval
EU MDR (EU) 2017/745 declaration of conformity; the legacy MDD 93/42/EEC declaration is no longer accepted
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The declaration of conformity is submitted as an original or a certified copy legalised in the country of origin (Pravilnik, Član 68. stav (1) tačka d)).
- For devices moving class under the MDR, the guidance requires a notification-body document confirming the MDR Annex VII application plus the manufacturer's statement of no significant change and no unacceptable risk.
- The guidance states it applies to applications not yet taken into processing.
Original (bs): as quoted. Translation: 'After 26 May 2021, a manufacturer's declaration of conformity with the requirements of Directive 93/42/EEC cannot be considered a valid document, i.e. it will not be accepted. In relation to the said medical devices, for applications submitted to the Agency after 26 May 2021, a manufacturer's declaration of conformity in accordance with the requirements of Regulation (EU) 2017/745 must be submitted.'
BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway Prior approval / evidence record
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
- Authority
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
- Benefit
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway · WHO Prior approval / evidence record
A prior approval from an SRA, an RRA, or WHO (with ISO 13485) opens the abridged assessment pathway
reliance.abridged-assessment-on-sra-rra-or-who-approval
- 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.
- Source Approval
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)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Each class has its own threshold: Class B - one RRA, SRA or WHO approval; Class C - one SRA or WHO approval plus 3 years marketed in an SRA jurisdiction; Class D - two RRAs including one SRA plus 3 years marketed.
- The three-year safety test is defined as no reported deaths, no reported serious deterioration in the state of health of any person, and no open field safety corrective actions including recalls at the point of submission.
- A prior rejection or withdrawal by a foreign jurisdiction for quality, performance/efficacy or safety reasons disqualifies the abridged route.
- The RRA list itself is not published in the guideline; it lives in BOMRA-ER-MED-Policy No.1, which BoMRA's site did not serve.
- Regulatory layer is premarket_review: the abridged route shortens the assessment, it does not dispense with BoMRA's registration.
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
BotswanaEU conformity assessment · NMPA · Singapore HSA · WHO Prior approval / evidence record
An exemption from registration can be granted on production of a marketing authorisation from an RRA or other named authority, a CE certificate from an EU notified body, or a WHO EUL/PQ acceptance letter
reliance.exemption-route-accepts-reference-authority-marketing-authorisation
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- s. 5.5.4 adds that for a public health emergency product a valid registration certificate/approval/emergency use authorisation issued by ICH member countries as defined prior to 23 October 2013, or by WHO, must be provided.
- s. 5.5.5 states that points 5.5.1 to 5.5.4 do not apply to a local manufacturer.
- The exemption is a limited-duration alternative to registration: s. 7.2 gives the approved product a validity period of six (6) months unless revoked by the Authority or terminated by the applicant.
- The exemption guideline applies to devices including IVDs that are not included in the interim register/listing.
Effective from 2023-04-01
Excerpt read from the OCR pass over BoMRA's scanned copy (download/98/exemptions/25635/...). In s. 5.5.1 the parenthetical '(Only for Class A & B medical devices)' is interleaved by the PDF's line order and applies to China NMPA and to SAHPRA; the wording has not been altered but the reading is flagged. BoMRA's own revision sheet records the addition of 'China National Medical Products Administration (Only for Class A & B medical devices)' at Issue 3.0 and 'by European notified bodies (Except Class A)' at Issue 2.0.
BrazilEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
Not an AREE under IN 290/2024 Art. 6
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
BruneiUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Foreign approvals appear in Brunei only as a government-procurement technical specification, not as a regulatory route
reliance.procurement-international-safety-standard
- 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.
- Source Approval
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
- Edge Type
Procurement Admission
- Market Access Strength
Evidence Only
- Regulatory Layer
procurement
- Local Application Required
No
- Target Decision Retained
No
Conditions
- The requirement is a specification in Tender Reference No. KK/179/2025/JPR/(TC), Annex 5A (Technical and Procurement Requirement), for the provision of automated peritoneal dialysis services to the Department of Renal Services.
- It is the only place found in any official Brunei document where foreign approvals are named; it must not be read as a registration or recognition mechanism.
- The accompanying requirement is that the equipment 'must also comply with relevant AAMI Standards such as UL2601 and IEC601-1'.
Verbatim from the tender document (44 pages, text layer, retrieved HTTP 200, 629,727 bytes): 'The equipment must comply to either one of the five international safety standards namely; US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. The equipment must also comply with relevant AAMI Standards such as UL2601 and IEC601-1.' Searches of the document for 'PMDA', 'MFDS', 'NMPA', 'Korea' and 'China' return no matches, which is why the sourceApproval string does not name those authorities. The bounded claim recorded in value is deliberately limited to what this one procurement states.
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-bulgaria
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
EU-level source confirms the single-market validity of CE marking; national Bulgarian layer (ЗМИ registration for class I route, Bulgarian IFU, wholesale permits, vigilance) still applies as conditions state.
CanadaEU conformity assessment Prior approval / evidence record
EU CE Mark
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ChileEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Chile requires ISP registration only for the controlled device families; for everything else the certificate supports importation rather than a registration decision. Where registration does apply, the ISP period does not vary with origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ChinaNMPA · US FDA · EU conformity assessment Prior approval / evidence record
Hainan Boao Pilot Zone
- Name
Hainan Boao Pilot Zone
- Description
Fast-track initial use with real-world data collection
- Timeline Reduction
4 months vs 3-5 years standard
- Eligibility
- Approved overseas (FDA, CE)
- Not yet registered in China nationally
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ChinaEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
Required as home country approval
- Timeline Savings
Required documentation
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ColombiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Class IIa
- Pathway
Registration (NSO)
- Verification Status
official-verified
- Official Source
- Title
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
- Url
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
- Prior Approval Benefits
- EU CE Mark
- FDA
- Health Canada
- Japan MHLW
- Australia TGA
- Notes
- Decreto 4725/2005 Arts. 21-22: automatic registro administrative act within 2 working days once documents are complete (Classes I and IIa)
- Reliance pathway available for recognized approvals
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ColombiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Class IIb
- Pathway
Registration (RSO)
- Verification Status
official-verified
- Official Source
- Title
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
- Url
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
- Prior Approval Benefits
- EU CE Mark
- FDA
- Health Canada
- Japan MHLW
- Australia TGA
- Notes
- Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)
- Incomplete dossiers are rejected at filing (not suspended)
- Technical documentation review required
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ColombiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Regulatory reference
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.
Conditions
- Applies to imported devices seeking registro sanitario or permiso de comercialización.
Prior approval / evidence record
EU CE Mark
- Benefit
Reference-country origin under Decreto 3275/2009
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Accepted as evidence of conformity alongside the certificate of free sale. Decreto 38409-S art. 34.2 sets the same decision deadline for every class, so origin does not move it.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Certified copy of a conformity attestation from internationally recognised procedures is a mandatory dossier item
reliance.origin-country-conformity-attestation
- 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.
- Source Approval
EU CE marking / conformity attestation obtained under the international procedures recognised by the AIRP (the AIRP does not publish the list of recognised procedures)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The source says 'obtenue suite aux procédures internationales reconnues par l'AIRP' — the claim is deliberately not upgraded to 'FDA is accepted', because the source never names FDA, CE or any other scheme.
- The same dossier section separately requires a copy of any good-manufacturing-practice certificate in force for medical devices, and a valid batch conformity certificate for the device lot.
- The obligation attaches to the device, not to the applicant: it is filed by the AIRP-agreed Ivorian import/commercialisation company acting for the manufacturer.
French original. Translation: 'A certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP.' The document is a scanned four-page AIRP procedure with no text layer; the passage was read by OCR of the official AIRP PDF at 200 dpi with Tesseract (fra). The identical dossier item appears in the UEMOA harmonised dossier annexes ('une copie certifiée de l'attestation de conformité obtenue suite aux procédures internationales reconnues par l'autorité compétente'), which corroborates the wording.
Prior approval / evidence record
EU CE marking / notified-body certificate
- Authority
EU CE marking / notified-body certificate
- Benefit
Not a substitute for the AIRP Autorisation de Commercialisation, but a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP is a required item of the Ivorian dossier, so the CE technical file is reusable evidence.
AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — declaration/listing, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list, and the persons authorised to applyDécision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39ARSN — Autorisastion: definition of an authorisation, licence and enregistrement scopes, downloadable forms; Agrément: the service activities subject to agrémentOrdonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI, arts. 88-93 (Journal officiel du 14 août 2012) and the ARTCI homologation procedure page Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU CE marking under MDR/IVDR — direct access to the Croatian market
reliance.eu-ce-marking-single-market-access
- 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.
- Source Approval
EU CE Marking under MDR (EU) 2017/745 / IVDR (EU) 2017/746
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
No
Conditions
- The CE certificate must be issued by a notified body designated under MDR/IVDR for the device class and, for Class I devices, the manufacturer's own EU declaration of conformity applies.
- Local duties still attach to the CE holder: registration of the manufacturer/authorised representative/importer with a unique registration number (Article 10 NN 100/2018), device registration in EUDAMED, the distributor register where the holder also distributes, Croatian-language information for patients and lay users (Article 30), market notification where the device is not in EUDAMED with Croatia listed, and vigilance reporting to HALMED.
- Croatia applies MDR and IVDR directly; the implementing act exists to designate authorities and add national procedure, not to re-approve the device.
- Applies equally to medical devices under the MDR and to in vitro diagnostic medical devices, which carry the CE marking under the IVDR.
Croatian (source language). Verbatim: "Ovim se Zakonom osigurava provedba sljedećih uredbi Europske unije: – Uredbe (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima ... – Uredbe (EU) 2017/746 Europskog parlamenta i Vijeća od 5. travnja 2017. o in vitro dijagnostičkim medicinskim proizvodima ...". Translation: "This Act secures the implementation of the following European Union regulations: Regulation (EU) 2017/745 ... Regulation (EU) 2017/746 ...".
CubaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Registration in a country with an essential-principles programme opens proceder B and waives some test reports
Resolución Ministerial No. 184/2008, Reglamento para la Evaluación y el Control Estatal de Equipos Médicos (Gaceta Oficial Ordinaria No. 64 de 22/12/2008) — Art. 52 ten-working-day documentary review, Art. 56 thirty-working-day applicant response, Art. 57 ninety/sixty-working-day technical report, Art. 59 five-year certificate, Art. 63 clinical investigation, Art. 97 importer inscription, Art. 113 appealCECMED Regulación E 86-16, Evaluación Estatal de Equipos y Dispositivos Médicos (in force 29/07/2016) — procederes A to D by risk class, §4.2 outcomes, §4.3 registration validityCECMED Regulación E 129-25, inscripción de fabricantes, suministradores e importadores de dispositivos médicos (Resolución No. 43) — §3.8 audit scheduling, §6.1 130-natural-day inscription decision, §6.2 120-natural-day applicant window Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
CyprusEU conformity assessment Prior approval / evidence record
CE marking under the Union regulations is the domestic route; Cyprus adds no requirement beyond Union and national law
reliance.eu-ce-marking-is-the-domestic-route
- 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.
- Source Approval
EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
No
Conditions
- The device notification under Decree No. 7 (Official Gazette No. 4462, 5 January 2012) must be made by each economic operator separately: CYMDA states that the notification of a device by one economic operator is independent of its notification of the same device by another economic operator.
- The importer's name, registered trade name or registered trade mark, registered place of business and address must appear on the device, its packaging or an accompanying document, in addition to the manufacturer's marking under MDR Annex I point 23.1 / IVDR Annex I point 20.2, and any additional labelling must not cover information provided by the manufacturer.
- Information required for the safe and proper use of the product must be provided in English and/or Greek; for products intended for use by non-healthcare professionals it must necessarily also be provided in Greek (Decree No. 6).
- Economic operators (manufacturers, authorised representatives and importers) must register in the EUDAMED Actor module and manufacturers must register their devices in the UDI/Devices module; as at 15 September 2026 the first four EUDAMED modules have been mandatory since 28 May 2026.
- A manufacturer without an establishment in a Member State may place the device on the Union market only by designating a sole authorised representative (Regulation (EU) 2017/745 Article 11(1)).
- CYMDA states that on physical inspections the absence of the importer's details where required, incomplete manufacturer labelling, and the absence of instructions for use in Greek where required for lay use, make the device non-compliant with the MDR/IVDR and make its import and/or movement an infringement of Article 5(1) that may lead to fines.
Effective from 2025-11-06
Greek source, notice of 6 November 2025. Translation of the excerpt: 'the Competent Authority, responsible for market surveillance and the safety of medical devices in the Republic of Cyprus, and for supervising the application of the relevant Regulations, has so far not imposed any additional requirement beyond those provided for by Union and national legislation.' The excerpt supports the bounded claim that Cyprus itself adds nothing to the Union route; the CE mark's EU/EEA-wide effect rests on Regulation (EU) 2017/745 (source res-cy-mdr-2017-745).
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-czechia
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
EU-level baseline confirming the edge; national obligations verified separately in this file.
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-denmark
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Danish-language duties under BEK 1731/2025 § 3 still apply to CE-marked devices sold in Denmark.
Dominican RepublicUS FDA · Health Canada · Japan MHLW / PMDA · Australia TGA · EU conformity assessment · Iceland · Norway Prior approval / evidence record
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
- Authority
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
- Benefit
Eligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.
- Timeline Savings
No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Dominican RepublicUS FDA · Health Canada · Japan MHLW / PMDA · Australia TGA · EU conformity assessment · Iceland · Norway · Brazil ANVISA Prior approval / evidence record
Simplified registration for imported products previously authorised by a WHO Strict Authority or a PAHO/PARF regional reference authority
reliance.strict-authority-prior-authorisation-simplified-procedure
- 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.
- Source Approval
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)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Eligibility runs to 'nuevos registros sanitarios y renovaciones' (new registrations and renewals of existing registrations) of imported products.
- The prior authorisation is evidenced by a Certificate of Free Sale plus a Certificate of Good Manufacturing Practices issued by the listed authority; the rest of the legally established requirements still apply.
- A product that one of the listed authorities has refused to authorise may not use the simplified procedure (CUARTO).
- Products identified as having quality failures in post-market monitoring or serious safety reports are excluded (PÁRRAFO of SEGUNDO).
- Resolution in force from 1 April 2016 (SEXTO).
- The resolution is drafted around the medicines framework; the MSP service listing for the simplified procedure expressly covers 'Productos Sanitarios' with its own fee, but the MSP listing shows Productos Sanitarios under the renewal modality only, while the fee table lists them under both new and renewal — the scoping for new device registrations is therefore stated by the MSP rather than by the resolution text itself.
Effective from 2016-04-01
Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
A device already registered in a reference country is what makes the ARCSA homologation route available, and the certificate of free sale plus that reference registration are the substance of the dossier. ARCSA publishes its periods per procedure, not per origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
EgyptUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · Norway · New Zealand · Ireland · Iceland Regulatory reference
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.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
EgyptEU conformity assessment · Japan MHLW / PMDA Regulatory reference
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).
Conditions
- Applies to devices circulated under Japanese regulation (MHLW/PMDA).
Effective from 2023-08-29
A parallel procedure exists for UKCA-marked devices (CAMD index, 07/2023 v02).
EgyptEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
A CE certificate and ISO 13485:2016 are the international quality certificates that open the GL.CAMD.002 route; Class I non-sterile devices are exempt from the CE requirement
EDA Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates (EDREX: GL.CAMD.002, version 2, effective 09/2025) — §4.1.1 intake response, §4.1.2 evaluation, §9 ten-year licenceEDA Regulatory Guideline of Registration of Locally Manufactured Medical Devices not holding International Quality Certificates (EDREX: GL.CAMD.009, version 2, effective 01/09/2025) — §6 pre-registration inspection and §6.1-6.3 registration clocksEDA Regulatory Guideline of Issuance of Import Approvals of All Types Medical Devices (EDREX: GL.CAMD.007, version 2, effective 01/09/2025) — §4.1 two-working-day intake reply, three-working-day evaluation and one-year import permitEDA Regulatory Guideline for the Procedures and Rules Organizing the changes done to a Registration License Data of a Medical Device (EDREX: GL.CAMD.003, version 03, effective 01/09/2025) — 8/5 working-day intake and 25/10 working-day evaluation for normal and fast track Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE marking under MDR/IVDR is the domestic route
reliance.eu-ce-marking-domestic-route
- 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.
- Source Approval
EU CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
Yes
Conditions
- Estonia is an EU member state, so the recognition runs through the Union single market rather than through a bilateral instrument.
- The Medical Devices Act's own market-placement conditions in § 16(1)-(2) were repealed with effect from 1 January 2023; the placement rule now rests on the directly applicable Union regulations.
- National residual duties listed in the statement are each evidenced by their own fact in this file.
Effective from 2023-01-01
Estonian source. Verbatim: "(2) Käesolevat seadust ei kohaldata juhtudel, kui kohaldub Euroopa Parlamendi ja nõukogu määrus (EL) 2017/745, milles käsitletakse meditsiiniseadmeid, ... või Euroopa Parlamendi ja nõukogu määrus (EL) 2017/746 in vitro diagnostikameditsiiniseadmete kohta ning millega tunnistatakse kehtetuks direktiiv 98/79/EÜ ja komisjoni otsus 2010/227/EL (ELT L 117, 05.05.2017, lk 176–332)." Consolidated text RT I, 12.07.2025, 23, in force 01.10.2025–30.09.2026.
Prior approval / evidence record
For low-risk devices a CE certificate replaces the free-sale / marketing authorisation certificate
reliance.ce-certificate-waives-free-sale-low-risk
- 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.
- Source Approval
EU CE certificate (including CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies only to devices within the published low-risk list (GDL/092 Annex I) — Class I non-IVD and Class A IVD that are not sterile and have no measuring function.
- The CE certificate does not replace the ISO 13485 quality management system certificate or the declaration of conformity.
- Devices not on the low-risk list are routed to the ordinary registration requirements (GDL/097 / GDL/087).
Effective from 2026-06-30
Verbatim: 'If the applicant submits a CE certificate, these certificates are not mandatory. Otherwise, the applicant should submit an original and valid free sale certificate or marketing authorization certificate issued by the responsible regulatory authority where the medical device is marketable, to attest that the device is marketable, without any restriction at their jurisdiction.'
EthiopiaUS FDA · Japan MHLW / PMDA · Australia TGA · Singapore HSA · EU conformity assessment · UK MHRA · Health Canada · South Korea MFDS Prior approval / evidence record
Registration route for devices approved by a listed Stringent Regulatory Authority (FDA, EU, Japan, Australia, Singapore, UK, Canada, Korea)
reliance.sra-verification-route
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The route is a shortened review, not a dossier waiver: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.'
- The claim must be supported by a marketing authorisation certificate or registration certificate or free-sale certificate issued by the listed authority (or by WHO/UNFPA prequalification evidence).
- EFDA determines eligibility for the SRA route after screening the eRIS submission; an application filed as SRA on misleading information is rejected at screening or evaluation.
- EFDA may still carry out a full assessment and request further information where a foreign approval does not provide the same assurance for use in Ethiopia.
- The SRA list is published in GDL/046 §9.4 and 'will be updated as deemed necessary'.
- The same list also appears (without Singapore HSA, UK MHRA and Korea MFDS) in the non-IVD and IVD registration requirement guidelines, which state that registration with those authorities is 'considered to be registered with Stringent Regulatory Authority approved devices registration procedures'.
Effective from 2026-06-25
Verbatim: 'At present, EFDA accepts the registration submissions as an SRA or prequalified products application if they're supported by one or more of the following document(s). 1. A Marketing Authorization certificate or registration certificate or free sale certificate issued by one of the following competent national regulatory authority: US Food and Drug Administration; Ministry of Health, Labour and Welfare, Japan; Trapeutic Goods Administration, Australia; Health Science Authority, Singapore; Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017.; Medicine and Healthcare Products Regulatory Agency, UK; Health Canada, Canada; Ministry of Food and Drug Safety, South Korea'. The passage also states: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.' Typographical errors are reproduced as they appear in the source.
Prior approval / evidence record
Legacy Device Transition
- Name
Legacy Device Transition
- Description
Extended deadlines for MDD-certified devices
- Timeline Reduction
Until Dec 2027 (Class III) or Dec 2028 (others)
- Eligibility
- Valid MDD certificate on Mar 20, 2023
- No significant changes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
MDD CE Mark
- Benefit
Extended market access during transition
- Timeline Savings
Until 2027-2028
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-finland
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Finnish and Swedish language duties under Laki 719/2021, Fimea notifications, EUDAMED actor registration and the Fimea vigilance channel still apply
Laki lääkinnällisistä laitteista 719/2021 is the Finnish act giving effect to MDR and IVDR. It names Fimea, sets the language duties and the national notification and vigilance obligations, none of which is a second conformity assessment.
FranceEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-france
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- French language duties, ANSM declarations, EUDAMED actor registration and the ANSM materiovigilance channel still apply
- reprocessed single-use devices are excluded outright under Art. L5211-3-2 CSP (MDR Art. 17 opt-out), whatever their CE status
Ordonnance n° 2022-582 adapted the Code de la santé publique to MDR, and Décret n° 2026-299 recast its regulatory part. One national restriction genuinely narrows the edge rather than merely adding paperwork: Art. L5211-3-2 CSP prohibits reprocessing single-use devices, France having exercised the MDR Art. 17 opt-out, so a lawfully CE-marked reprocessed single-use device cannot be placed on the French market.
GeorgiaEU conformity assessment · ISO Prior approval / evidence record
Dental material, invasive contraceptive mechanical devices and diagnostic products: an ISO certificate, an EC certificate or a free sale certificate stands in for the CPP
reliance.iso-ec-or-free-sale-certificate-in-lieu-of-cpp
- 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.
- Source Approval
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
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies only to the three categories named in Art. 11^11(19)(d): dental material, an invasive mechanic means of contraception, or means of diagnostics.
- These are also the only device-type categories given their own registration document list in Art. 11^11(20)(i)–(k) (contraceptive mechanical devices, dental product, diagnostic products).
- The alternative is offered in the same sub-paragraph that requires the CPP, so it displaces the CPP requirement rather than adding to it; the rest of the dossier under Art. 11^11(19)–(20) still applies.
Language of source: English consolidated text on matsne.gov.ge. Verbatim: "d) a (original) CPP in the form recommended by the World Health Organization, and if it is not available – a document certifying that the pharmaceutical product has been manufactured according to the GMP (Good Manufacturing Practices) standard, or a pharmaceutical product manufacturing licence issued by an authorised body of the manufacturing country. In the case of dental material, an invasive mechanic means of contraception, or means of diagnostics, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate may be submitted;"
Prior approval / evidence record
EU CE marking under MDR/IVDR
- Authority
EU CE marking under MDR/IVDR
- Benefit
No recognition route for devices. An EC certificate of the product manufacturer is, however, expressly accepted in the administrative dossier of the three device-type categories registered under the Law on Medicines in place of a certificate of pharmaceutical product (Article 11^11(19)(d)), which is documentary relief rather than an approval. Georgia separately recognises EU technical regulations as such under Article 56(11) of the Product Safety and Free Movement Code.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-germany
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- German language duties under the MPDG, § 4 MPDG notification into DMIDS, EUDAMED actor registration and the BfArM vigilance channel still apply
- a national classification ruling under § 6 MPDG or a special authorisation under § 7 MPDG can change what a given device may do in Germany
The Medizinprodukterecht-Durchführungsgesetz is the German implementing act: § 85 designates the authorities, § 4 sets the national notification duties fed into DMIDS, § 6 provides for national classification rulings and § 7 for a special national authorisation. None of these re-opens the conformity assessment behind the CE certificate.
GhanaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
GreeceEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-greece
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Greek language duties, EOF registration and notification forms, EUDAMED actor registration and the EOF vigilance channel still apply
- skin-applied camphor or menthol products with health claims are excluded by EOF borderline decision 91092/01-09-2023 regardless of CE status
EOF publishes the national harmonisation decisions that sit alongside the EU regulations. One of them narrows the edge in substance: EOF decision 91092/01-09-2023 bars skin-applied products containing camphor or menthol that carry health claims from the Greek market, so a CE certificate does not settle market access for that group.
GuatemalaWHO · US FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS Prior approval / evidence record
Homologation on a WHO-listed-authority approval exists but is scoped to medicines and vaccines, not devices
reliance.homologation-who-listed-authority-medicines-vaccines-only
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Scope limited to especialidades farmacéuticas de síntesis química and vacunas (biológicas y biotecnológicas).
- Not available for medical devices or IVDs; marketAccessStrength is 'none' for those domains because the route exists but gives them nothing.
- The WHO-listed authorities eligible are those published in the DRCPFA's own official lists.
Spanish source (Guatemala). Translation: "Article 2. Scope of application. This Technical Norm applies to pharmaceutical specialities of chemical synthesis and vaccines (biological and biotechnological) that hold a Health Registration granted by high-maturity-and-performance Regulatory Authorities as defined by the World Health Organization (WHO), published in the official lists of the Department of Regulation and Control of Pharmaceutical and Related Products, hereinafter THE DEPARTMENT." The norm's own title is 'HOMOLOGACIÓN DEL REGISTRO SANITARIO DE MEDICAMENTOS Y VACUNAS'. Art. 4.3 of the same norm defines the WLA/ACO concept and states that authorities reaching at least general maturity level 3 (ML3) qualify.
GuatemalaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS Prior approval / evidence record
WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)
- Authority
WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)
- Benefit
A foreign marketing approval is not among the NT-37 Art. 5.1 dossier items and opens no recognition route for devices. A Certificate of Free Sale from any competent origin-country authority is required paperwork, and a manufacturing-guarantee certificate from a named authority (FDA, DGKC, IFCC, ISO or a GMP certificate) satisfies one dossier item (NT-37 Arts. 5.1.5-5.1.6 and 6.12.6). The full local review still runs.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
EU MDD certificates accepted with extension declaration
reliance.eu-mdr-mdd-extension
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.
Conditions
- Applies to Pathway 2 applications relying on EU approvals.
Reflects the EU MDR transition extension in HK reliance practice.
Hong KongNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · South Korea MFDS · Singapore HSA Regulatory reference
Recognised jurisdictions for marketing approvals
reliance.recognised-jurisdictions
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.
Conditions
- Applies to Class II/III/IV GMD listings.
- The same eight jurisdictions apply to Class B/C/D IVD listings under GN-06.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
Prior approval / evidence record
EU CE Mark
- Benefit
MDR certificates, or MDD certificates with a Regulation (EU) 2023/607 extension letter, satisfy D002; an EU ER or GSPR checklist may then replace the MD-CCL
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-hungary
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Hungarian distributor notification with UDI-DI under 17. § (3) of 4/2009 EüM rendelet, national IVD notification under 7/A. § of 8/2003 ESzCsM rendelet, EUDAMED actor registration and the national vigilance channel still apply
Hungary states MDR direct applicability on its own regulatory page and names the two national implementing decrees, 4/2009 (III. 17.) EüM rendelet for devices and 8/2003 (III. 13.) ESzCsM rendelet for IVDs. Their content is notification and registration, not re-assessment.
Prior approval / evidence record
The CE route reaches Iceland through EEA Agreement incorporation, not EU membership
reliance.eea-agreement-incorporation-mechanism
- 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.
- Source Approval
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)
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Regional Harmonisation
- Local Application Required
No
- Target Decision Retained
No
Effective from 2021-05-26
Icelandic. edgeType reuses the established token single_market_validity because the effect is single-market validity; the distinct mechanism recorded here is the EEA treaty incorporation itself (regulatoryLayer regional_harmonisation), which matters to a filer because the citation to give a regulator is the EEA Joint Committee decision read with the national lögfesting, and because the same route extends to all EEA states rather than only to Iceland.
Prior approval / evidence record
Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State
- Authority
Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State
- Benefit
The certificate and the CE marking it supports are valid for the Icelandic market without any Icelandic recognition step, and no Icelandic authority re-examines the conformity assessment. This is the practical reliance route into Iceland, and the reason Lyfjastofnun operates no national approval of its own.
Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devicesLög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561 have the force of law in Iceland as they are taken up in the EEA Agreement; with reglugerð nr. 907/2022 listing each instrument and its EEA Joint Committee decisionCommission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity-assessment timelines (30 days for the application review, 120 or 90 days for the assessment phase, 20 days for the final review)Lög um lækningatæki nr. 132/2020 — 28. gr. (registration of distributors with Lyfjastofnun), 36. gr. b (six-month notice before an interruption or discontinuation of supply, inserted by lög nr. 69/2025), 38. gr. (temporary prohibition of sale or supply, at most four weeks at a time), 39. gr. (the fee power) Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU CE marking under MDR/IVDR is the Icelandic market-access route, with no separate local application
reliance.ce-marking-eea-single-market
- 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.
- Source Approval
EU CE under MDR/IVDR (notified-body certificate plus EU declaration of conformity per MDR Annex IV)
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Effective from 2021-05-26
Icelandic. 'Áður en lækningatæki er sett á markað, selt eða tekið í notkun er skylt að CE-merkja tækið í samræmi við nánari fyrirmæli reglugerðanna og það ferli sem sett er fram í IX.–XI. viðauka með reglugerðunum.' marketAccessStrength is written as 'direct' rather than the round's 'facilitated' because no local route exists at all: there is nothing for the CE mark to shorten, and the registry already uses 'direct' with single_market_validity for the other EEA/EFTA states (Norway, Liechtenstein) and the EU member states. 'facilitated' would understate the position and imply a residual Icelandic review.
IndiaUS FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · GHTF Prior approval / evidence record
Class A
- Verification Status
official-verified
- Official Source
- Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
- Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
- Prior Approval Benefits
- GHTF country approval (FDA, EU, Japan, Australia, UK)
- Notes
- Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii))
- GHTF approval provides significant advantage
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndiaEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
A free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA Regulatory reference
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.
Conditions
- United Kingdom added to the rule 36(3) list by G.S.R. 174(E) w.e.f. 04.03.2022.
- Devices from other countries: Class C/D need Indian clinical investigation (rule 36(4)); Class A/B need published safety/performance data or country-of-origin investigation plus FSC (rule 36(5)).
Effective from 2018-01-01
G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.
Prior approval / evidence record
EU CE Mark
- Benefit
Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Indonesian import authorisation remains required
reliance.no-foreign-approval-waiver
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.
Conditions
- Read with Pasal 58(5) and the special-access provisions of Pasal 62.
Effective from 2026-05-04
The former wording incorrectly inferred absence of reliance from a local permit requirement.
IndonesiaUS FDA · EU conformity assessment · ASEAN Prior approval / evidence record
Class C
- Verification Status
official-verified
- Official Source
- Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
- Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
- Prior Approval Benefits
- ASEAN MRA countries
- FDA
- EU CE Mark
- Notes
- Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8)
- Clinical data may be required
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndonesiaUS FDA · EU conformity assessment · ASEAN Prior approval / evidence record
Class D
- Verification Status
official-verified
- Official Source
- Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
- Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
- Prior Approval Benefits
- ASEAN MRA countries
- FDA
- EU CE Mark
- Notes
- Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8)
- Clinical evidence required
- Clinical Trial Required
Yes
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndonesiaUS FDA · EU conformity assessment · ASEAN Prior approval / evidence record
Class B
- Verification Status
official-verified
- Official Source
- Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
- Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
- Prior Approval Benefits
- ASEAN MRA countries
- FDA
- EU CE Mark
- Notes
- Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8)
- ASEAN harmonization applies
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IraqEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
Origin-market evidence expected in practice; no Iraqi instrument on a reachable source grants an abridged period for it
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-ireland
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Re-verified on the Commission CE-marking page; national operator registration and vigilance channels in Ireland are recorded as separate facts.
IsraelUS FDA · Australia TGA · Health Canada · EU conformity assessment Regulatory reference
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.
Conditions
- No-expiry approvals are assigned 5-year validity from submission.
Health Canada listed as accepted approval per the AMAR registration guidelines PDF.
IsraelEU conformity assessment Regulatory reference
MDDR CE from notified bodies in non-recognized states (pilot)
reliance.nb-nonrecognized-pilot
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.
Conditions
- Pilot only; notified body must be EU-accredited under MDR.
- Extended to 31.12.2026.
· Effective until 2026-12-31
IsraelEU conformity assessment Regulatory reference
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.
Conditions
- Applies to CE-based registrations with EU-granted extensions.
Confirms the baseline EU-CE reliance edge.
IsraelUS FDA · EU conformity assessment Regulatory reference
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.
Conditions
- FDA precedence applies when EU/US classifications differ.
Confirms the baseline US-FDA reliance edge.
IsraelEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
A recognized-state CE certificate puts a Class I device on the declaration track and an EU Class IIa device or IVDD Self Test / IVDR class B on fast track 1, in both cases with four months of marketing in the recognized state. EU Class IIb and IVDD LIST B / IVDR class C need the CE certificate plus a second independent authority for fast track 2.
- Timeline Savings
Declaration track is up to 48 hours and fast track 1 up to 45 working days, against the 120-day regular-track target
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ItalyEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-italy
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Italian language duties, registration in the Ministero della Salute national device database, EUDAMED actor registration and the national vigilance channel still apply
Decreto legislativo 5 agosto 2022, n. 137 is the Italian MDR adaptation, with D.Lgs. 138/2022 doing the same for IVDR. The national layer is registration in the Ministry of Health device database plus the Italian language duties, neither of which revisits the CE decision.
JapanEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
ISO 13485 applicable to Ordinance 169; no abridged Japanese period
- Timeline Savings
2-4 months prep
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
JordanEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
The أسس adopt the EU directives by reference for the class axis, and the annexes require the CE certificate and a free-sale certificate from the country of origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Technical and QMS documentation can be reused, but the EAEU route requires its own national expertise. The 70 and 110 working-day service periods in Order ҚР ДСМ-10 do not change with origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
KenyaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Opens the reliance route inside fast track, which replaces the 24-month FIFO review with a 90-day one
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
KenyaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Saudi Arabia Regulatory reference
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).
Conditions
- Used to qualify devices for abridged, expedited (EBR/ECR/EDR) and immediate (IBR) routes.
- Applies at the time of application.
KuwaitUS FDA · EU conformity assessment Prior approval / evidence record
US FDA approval and the EU route — a CE certificate from an EU-authorized notified body
- Authority
US FDA approval and the EU route — a CE certificate from an EU-authorized notified body
- Benefit
Two of the recognised reference authorities for the Abridged Review Pathway and the first two entries in the class B/C/D dossier's product verification and validation list; an accelerated assessment that still runs under Kuwaiti requirements and post-market obligations, with the acceptance decision reserved to the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
LatviaEU conformity assessment Prior approval / evidence record
CE marking under the Union regulations is the domestic route; no separate Latvian approval decision
reliance.eu-ce-marking-is-the-domestic-route
- 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.
- Source Approval
EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
No
Conditions
- The notification attaches to class IIa, IIb and III medical devices (MK noteikumi Nr. 461 paragraph 9) and to class B, C and D, A-list, B-list and self-test IVDs (MK noteikumi Nr. 582 paragraph 8).
- The agency checks the submitted declaration of conformity and notified-body certificates against the national regulation, Regulation (EU) 2017/745 and directly applicable EU acts, and may require corrections or translations (MK noteikumi Nr. 461 paragraphs 10 and 16).
- Manufacturers not established in a Member State may place a device on the Union market only if they designate a sole authorised representative (source res-lv-mdr, Article 11(1)).
- Distributors established in Latvia may make devices available on the Latvian market only if information about them is entered in the LATMED database (MK noteikumi Nr. 461 paragraph 41.1).
- Notification may be omitted once the manufacturer complies with MDR Article 29(4) EUDAMED registration, in the window from six to eighteen months after the Commission announces full EUDAMED functionality (MK noteikumi Nr. 461 paragraph 13).
Effective from 2023-08-23
Latvian source; translation: '12. The persons referred to in paragraph 9 of these Regulations, after completion of the notification procedure, are entitled to place the medical device on the market of the Republic of Latvia without a decision or approval of the agency.' The excerpt supports the bounded claim that Latvia issues no separate national approval for a CE-marked device; the EU/EEA-wide validity of the CE mark rests on Regulation (EU) 2017/745 itself (source res-lv-mdr).
LatviaEU conformity assessment · US FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
MDR transitional periods benefit only holders of Directive 90/385/EEC or 93/42/EEC certificates
reliance.mdr-transitional-periods-only-for-mdd-aimdd-certificates
- 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.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
No
- Target Decision Retained
Yes
Conditions
- Benefiting devices must continue to comply with the applicable Directive, have no significant changes in design and intended purpose, present no unacceptable risk, and the manufacturer must have put in place an MDR Article 10(9) quality management system by 26 May 2024 and lodged a notified-body application with a written agreement signed by 26 September 2024 (Article 120(3c) as inserted by Regulation (EU) 2023/607).
- Regulation (EU) 2023/607 also deleted the sell-off deadline, so devices lawfully placed on the market during the transitional period may continue to be made available.
- A Commission proposal of 16 December 2025 to revise the MDR and IVDR was pending when checked and is not reflected in the dates above.
Effective from 2023-03-20
English source. The excerpt is quoted from the amending act; the inserted text uses the defined terms of Regulation (EU) 2017/745 / 93/42/EEC / 90/385/EEC and names no third-country approval.
LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA Prior approval / evidence record
Clinical evaluation is not re-performed in Lebanon; the work of GHTF regulatory authorities is used
reliance.clinical-evaluation-uses-reference-authority-work
- 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.
- Source Approval
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
- Edge Type
Assessment Report Reliance
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Stated in Part 2 of the procedure as the assessment strategy for implantable medical devices; the same section records that the unit verifies quality data, document authenticity and coherence with the online database instead.
- The unit's effort is redirected to a sampling verification driven by the device's importance and criticality, its safety profile and the manufacturer's history.
- edgeType `assessment_report_reliance` is an existing registry token, used deliberately here because the mechanism is reliance on another authority's completed assessment work rather than a documentary evidence requirement (which is filed separately as `reliance.accepted-conformity-certificate-menu`).
Effective from 2013-11-01
Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."
LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA Prior approval / evidence record
Conformity to a GHTF reference-authority regulation is a precondition of Lebanese marketing authorisation
reliance.ghtf-reference-authority-conformity-prerequisite
- 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.
- Source Approval
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The list of jurisdictions is closed: Canada, Australia, Japan, the United States, EU member states. Korea, China and the United Kingdom are not named.
- Conformity to one of the five is a precondition for the Lebanese authorisation, not a substitute for it — the MOPH health technology unit still evaluates the file and the Minister of Health issues the final decision.
- Lebanese standards, where they exist, must be met in addition (LIBNOR standards, certification by the Industrial Research Institute).
- The same closed list is restated at statutory level by Decision No. 455/1 of 16 April 2013, Article One (European Union, United States, Canada, Japan, Australia).
- Instrument in force: the November 2013 national procedure read with Decisions 455/1 (2013) and 1506 (2014).
Effective from 2013-11-01
Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."
LebanonUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities Prior approval / evidence record
LebanonUS FDA · EU conformity assessment · Swissmedic · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
- Authority
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
- Benefit
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة, form MPH12-26: required documents, the Atomic Energy stamp condition, the LBP 1,000 fiscal stamp, submission on all official working days, and 'مدة انتهاء المعاملة: بين أسبوع وأسبوعين'Ministerial Decision No. 455/1 of 16 April 2013 — تنظيم إدخال واستعمال المواد الطبية المختلفة: the conformity certificate (Art. One), the Industrial Research Institute as the issuing body (Art. Three), entry permits, the statutory charge and customs stamping (Art. Four), and the pre-registration dossier for implantables with the Department of Programs and Projects (Art. Six)Ministerial Decision No. 1506/1 of 1 September 2014 — أحكام توضيحية لتطبيق القرار رقم 1/455: GMDN classification (Art. Two), the four risk levels and the reference-regulator class table (Art. Three), the GHTF/IMDRF free-sale certificate (Art. Four), and the import stop-date for implantables not recorded with the Department of Programs and Projects (Art. Six) Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
EU CE under MDR/IVDR - single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-liechtenstein
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Effective from 2021-05-26
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-lithuania
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
- National Verification
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.
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-luxembourg
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Confirmed on the Luxembourg CA website; national conditions (registration, language, vigilance) still apply.
MacauEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Usable as supporting technical evidence. Administrative Regulation 11/2026 sets the 5, 70 and 100 working-day periods by class, not by origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA Regulatory reference
Approvals excluded from the verification route
reliance.verification-excluded-schemes
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.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry) Prior approval / evidence record
Class B
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class B registration turn-around 30 working days from complete documents and cleared payment
- ASEAN harmonization applies
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MalaysiaEU conformity assessment · UK MHRA Regulatory reference
Great Britain UKCA — verification route
reliance.reliance-edge-reference-approvals-to-malaysia-approval-ukca-malaysia
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.
Conditions
- MHRA exceptional use authorisations excluded.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry) Prior approval / evidence record
Class C
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class C registration turn-around 30 working days from complete documents and cleared payment
- Clinical data may be required
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · Thailand Regulatory reference
Recognised foreign approvals for the verification route
reliance.verification-route-authorities
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).
Conditions
- Eligibility: device approved at least one year in the reference jurisdiction; same design and intended purpose as approved; no reported deaths, serious deteriorations or open field safety corrective actions in the last year; not rejected/withdrawn by a recognised authority; special/emergency access-type approvals excluded.
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry) Prior approval / evidence record
Class D
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class D registration turn-around 30 working days from complete documents and cleared payment
- Clinical evidence required
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
EU CE under MDR/IVDR — verification route
reliance.reliance-edge-reference-approvals-to-malaysia-approval-eu-ce-mdr-ivdr-malaysia
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.
Conditions
- Certificate types differ for Class B vs Class C/D devices and for IVD classes.
MaltaEU conformity assessment Prior approval / evidence record
EU/EEA CE marking under MDR/IVDR — the domestic route, free movement into Malta
reliance.eu-ce-marking-single-market-route
- 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.
- Source Approval
EU CE Marking under MDR (Regulation (EU) 2017/745) / IVDR (Regulation (EU) 2017/746)
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- This is the domestic conformity route, not a recognition of another jurisdiction's approval; a CE certificate issued by a notified body anywhere in the Union or EEA is valid for Malta.
- Operator-side duties remain: organisation registration, MDRP registration, device notification and the national database entry (S.L. 458.59 regs. 5(2)(f)-(g) and 6; MMA GL-MDF02 and GL-MDF05).
- Information supplied with the device must be in English, Maltese or both (MMA Factsheet for Importers & Distributors).
- IVDR equivalent of the free-movement clause: Article 21, Regulation (EU) 2017/746.
- Where the device relies on a Directive-era certificate, Regulation (EU) 2023/607 extended validity to 31 December 2027 (class III and class IIb implantable) or 31 December 2028 (other class IIb, class IIa, and class I sterile or with a measuring function).
Effective from 2021-05-26
The quoted free-movement clause is the Union rule that makes a CE-marked device directly placeable in Malta; the operator-side conditions listed here come from the Maltese instrument and the Authority's own guidance, and are recorded as separate facts.
MexicoNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA · IMDRF member authorities · MDSAP · WHO Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
- Name
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
- Description
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
- Timeline Reduction
Resolution within a maximum of 30 working days
- Eligibility
- Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States
- MDSAP full members are recognised for the good-manufacturing-practice certificate
- Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration
- Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
- Timeline Savings
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking opens the Moldovan notification-and-registration route
reliance.eu-ce-marking-notification-and-registration-route
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The CE route removes the conformity-assessment step only; the RSDM notification and registration before placing on the market is mandatory and separately evidenced in this file.
- Registration of CE-marked devices is not a permissive administrative act (punctul 35, quoting art. 7 alin. (10) of Legea nr. 102/2017), so no market authorisation is issued.
- A manufacturer seated outside Moldova must act through an authorised representative seated in Moldova (punctul 2.2 and the Annex on minimum requirements, punctul 1).
- Basic UDI-DI and UDI-DI are recommended and GMDN is optional at this stage (punctul 29).
Romanian source. Point 19 reads: 'Potrivit art. 7 alin. (2) din Legea nr. 102/2017 ... solicitantul notifică AMDM până la introducerea pe piață a dispozitivelor medicale care dețin marcajul CE'. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.
Prior approval / evidence record
EU CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
- Authority
EU CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
- Benefit
AMDM states that medical devices bearing the CE marking are placed on the market by way of the registration procedure, so the CE marking is the conformity input to the national route and there is a dedicated notification and registration procedure for it; the Agency describes the framework introduced by Ordinul nr. Rg04-264 din 08.09.2026 as aligned with the relevant European framework, including Regulations (EU) 2017/745 and (EU) 2017/746. Moldova is an EU candidate state and not a member, the MDR is not directly applicable, and the CE marking does not remove the entry in the State Register.
AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctul 6 (termen de pînă la 30 de zile din momentul efectuării plății)AMDM — AMDM simplifică procedura de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, anunț privind Ordinul nr. Rg04-264 din 08.09.2026 (statutul „Suspendat”: 10 zile lucrătoare)Ordinul AMDM nr. Rg04-264 din 08.09.2026, Anexa 1 — Procedura administrativă de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, pct 8, 13, 17, 19-20, 33-34 și 40-42AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctele 4, 5 și 8 (28 de zile lucrătoare, valabilitate 5 ani, obligația de notificare a modificărilor)AMDM — Descrierea procedurii de notificare și înregistrare a dispozitivelor medicale care dețin marcaj CE Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
MongoliaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
- Authority
FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
- Benefit
Mongolia recognises none of them and names none of them. Art. 33.2 requires the Agency to take into account that the device has been placed on the market in its country of manufacture, Order A/136 §3.6 permits the foreign risk grade to be considered, and Annex Two §§3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate — but no authority, country or reference list appears anywhere in the Law, in Order A/206 or in Annex Two, the foreign element is evidence of origin-country market placement rather than a recognised authorisation, no clock is shortened, and the Medical Devices Council still takes the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Direct recognition is limited to EU notified-body documents and CE marking
reliance.direct-recognition-limited-to-eu-notified-body-documents
- 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.
- Source Approval
EU CE Marking issued by an EU notified body (prijavljeno tijelo) under the EU harmonised technical regulation
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The recognition request must name the foreign document/CE mark, the foreign technical regulation under which it was issued, the conformity-assessment body that issued it, and the state that notified that body (Rulebook Art. 7).
- Validity: until the foreign document expires; at most three years if the foreign document states no expiry (Rulebook Art. 8(3)).
Effective from 2022-08-10
Verbatim Član 6: "Inostrana isprava, odnosno CE znak se direktno priznaje u Crnoj Gori ako je izdata od strane prijavljenog tijela Evropske unije, odnosno ako je postavljen na medicinsko sredstvo u skladu sa harmonizovanim tehničkim propisom u Evropskoj uniji." Član 5 st. 1 sets the two equivalence conditions; Član 8 st. 2-3 sets validity. Translation: a foreign document, i.e. the CE mark, is directly recognised in Montenegro if issued by an EU notified body or affixed in accordance with the EU harmonised technical regulation. Source language: Montenegrin.
Prior approval / evidence record
Recognition of a foreign conformity document and CE marking
reliance.ce-conformity-document-recognised-in-registration
- 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.
- Source Approval
EU CE Marking / EC certificate of conformity issued by a conformity-assessment body established outside Montenegro (in practice an EU notified body)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Recognition is a documentary act inside (or alongside) registration — it does not replace the Montenegrin registration decision.
- Detailed conditions and procedure are set by the Ministry (Rulebook, Sl. list CG 85/22, 126/22).
Effective from 2024-10-01
Verbatim: "Priznavanje isprave o usaglašenosti i CE znaka iz st. 2 i 3 ovog člana koje je izdalo tijelo za ocjenjivanje usaglašenosti koje nema sjedište u Crnoj Gori, vrši Agencija u postupku registracije medicinskog sredstva. Izuzetno od stava 4 ovog člana, Agencija može da izda rješenje o priznavanju inostrane isprave ili CE znaka i na zahtjev proizvođača, odnosno ovlašćenog predstavnika proizvođača." Translation: recognition of a conformity document and CE mark issued by a conformity-assessment body not seated in Montenegro is done by the Agency in the registration procedure; exceptionally the Agency may issue a recognition decision on the manufacturer's/authorised representative's request. Source language: Montenegrin.
Prior approval / evidence record
MDR-compliant declaration of conformity required; MDD declarations no longer valid
reliance.mdr-compliant-declaration-of-conformity-required
- 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.
- Source Approval
EU CE Marking under MDR (EU) 2017/745
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Class I devices that rise to a higher risk class under MDR and hold an MDD/AIMD declaration of conformity issued before 26 May 2021 may be placed on the market until 31 December 2028, subject to the MDR Art. 120 conditions (notified-body application by 26 May 2024, Annex VII agreement by 26 September 2024, ISO 13485 QMS certificate).
Effective from 2025-06-18
Verbatim: "Medicinska sredstva I klase rizika koja su klasifikovana kao medicinska sredstva I klase rizika i u skladu sa zahtjevima EU Regulative 2017/745 ... nakon 26.05.2021. godine mogu se staviti na tržište i u upotrebu na teritoriji Crne Gore samo ukoliko su usaglašena sa zahtjevima EU Regulative 2017/745. Ukoliko naprijed navedena medicinska sredstva ne posjeduju Deklaraciju o usaglašenosti koja je usklađena sa EU Regulativom 2017/745 neće moći da se distribuiraju u Crnoj Gori, a Institut Deklaracije o usaglašenosti koje su izdate u skladu sa Direktivama 93/42 EEC i 90/385 EEC ne može smatrati validnim dokumentom." Source language: Montenegrin. Notice is based on MDR Art. 120 and the Law on Medical Devices; updated 18.06.2025.
Prior approval / evidence record
IVDR-compliant declaration of conformity required for in vitro diagnostic devices
reliance.ivdr-compliant-declaration-of-conformity-required
- 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.
- Source Approval
EU CE Marking under IVDR (EU) 2017/746
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The Institute's notice relies on IVDR Art. 110(3) as amended by EU 2022/112, EU 2023/607 and EU 2024/1860, and on opinions of the Montenegrin Ministry of Health of 23.11.2022 and 14.12.2023.
Effective from 2025-06-18
Verbatim: "Nakon 26.05.2022. godine, Deklaracija o usaglašenosti izdata u skladu sa zahtjevima Direktive 98/79 EC ne može se smatrati validnim dokumentom, te takva Deklaracija neće biti priznata u postupcima koji se vode pred Institutom za ljekove i medicinska sredstva. Deklaracija o usaglašenosti mora biti u skladu sa zahtjevima Regulative EU 2017/746." and "... in vitro dijagnostičko sredstvo može biti u prometu najkasnije do 31.12.2027. godine". Source language: Montenegrin.
Prior approval / evidence record
EU CE marking under Regulation (EU) 2017/745 (MDR)
- Authority
EU CE marking under Regulation (EU) 2017/745 (MDR)
- Benefit
A declaration of conformity or EC certificate issued by an EU manufacturer or an EU-notified body is recognised as the conformity input in the CInMED registration procedure under the Pravilnik o priznavanju inostranih isprava i CE znaka, and it lowers the fee line for devices that would otherwise be registered without an EU conformity document. It does not remove the national registration, and CInMED no longer accepts declarations issued under the MDD/AIMD that are not aligned with Regulation (EU) 2017/745.
Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44CInMED — Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026 Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Legacy MDD/AIMD EC certificates recognised only to 2027/2028 deadlines
reliance.legacy-mdd-ec-certificate-transition-deadlines
- 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.
- Source Approval
EU CE Marking — legacy MDD/AIMD EC certificates (MDR Art. 120 transition)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The device must still comply with Directives 90/385/EEC and 93/42/EEC, have no significant changes in design or intended purpose and present no unacceptable risk.
- Manufacturer QMS to MDR Art. 10(9) by 26 May 2024; formal application to a notified body by 26 May 2024; Annex VII written agreement by 26 September 2024.
- The applicant must file the expired EC certificate, a manufacturer declaration and the notified-body documents with the Institute.
Effective from 2025-06-18
Verbatim: "Ukoliko je Sertifikat o usaglašenosti – EC sertifikat izdat od strane ovlašćenog tijela u skladu sa predhodno važećim direktivama važio na dan 26.05.2021. godine i nije naknadno povučen, ostaće na snazi i nakon datuma isteka navedenog na sertifikatu i to do sljedećih datuma: a. 31.12.2027. godine – za medicinska sredstva III klase rizika, IIb koja su implantabilna (izuzetak su šavovi, klipsevi, zubni ispuni, ortodontski aparati, zubne nadoknade, zavrtnji, klinovi, ploče, žice, igle, kopče i konektori), AIMD medicinska sredstva. b. 31.12.2028. godine – za medicinska sredstva IIb klase rizika koja nijesu obuhvaćena tačkom a., IIa klase rizika i I klase rizika koja se stavljaju na tržište u sterilnom stanju ili su sa mjernom funkcijom." Source language: Montenegrin.
MoroccoEU conformity assessment · US FDA Prior approval / evidence record
Full technical documentation waived for imported devices; only class III clinical data required
reliance.imported-device-technical-documentation-waiver
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The lightening is attached to the technical-documentation item only; the administrative pieces, declaration of conformity, ISO 13485 certificate (classes IIA/IIB/III), origin-country certificate (classes Is/Im/IIA/IIB/III), labelling and IFU drafts and sample are still required.
- For a class III imported device, clinical data must be filed (checklist footnote 5); the AMMPS may also call for the check-list documentation during clinical-data evaluation (arrêté art. 2, 1) b), last paragraph).
- Locally manufactured (FL) devices must file the technical documentation with check-list (arrêté art. 2, 2) b)); semi-finished imports (ISF) file the imported-device administrative pieces plus the local-manufacture technical pieces and a GMP certificate (art. 2, 3)).
- There is no recognition or abridged-review procedure behind this: the AMMPS recognition guidelines (LD RE-001, LD EA-013) cover medicines and vaccines only.
French original footnote (5) to dossier item 10. Translation: '(5) For imported DMs: the technical documentation is not mandatory, only the clinical data have to be supplied for class III DMs'. The waiver is an administrative-practice rule on the AMMPS's official dossier form, not a provision of loi 84-12 or décret 2-14-607; it is therefore bounded to the dossier item it annotates.
MoroccoEU conformity assessment · US FDA Prior approval / evidence record
Origin-country CE / FDA / free-sale certificate is a mandatory dossier item for classes Is, Im, IIA, IIB and III
reliance.origin-country-approval-certificate
- 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.
- Source Approval
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
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to classes Is, Im, IIA, IIB and III; plain class I devices are outside the list.
- The certificate must come from the competent authority of the country of origin, not from the manufacturer.
- Footnote 1 of the same checklist adds that a CE design-examination certificate is required in addition to the CE quality-system certificate for class III devices.
- The dossier is filed by the Moroccan establishment (declared manufacturing or importing establishment), not by the foreign manufacturer.
French original. Translation: '4- CE marking certificate or "FDA" attestation or marketing authorisation (CVL) or equivalent issued by the competent authorities in the country of origin (for DM belonging to risk classes IIA, IIB and III and sub-classes Is and Im of class I)'. Checklist Réf. DE ER DM/01, édition 9, date d'application 30/01/2025. The checklist is the AMMPS's own official dossier form; the same list is re-issued on each edition.
Prior approval / evidence record
EU CE marking certificate
- Authority
EU CE marking certificate
- Benefit
Mandatory dossier item 4 for classes Is, Im, II A, II B and III, with a CE design-examination certificate additionally required for class III. It does not shorten the review: the device is still registered nationally by the AMMPS, and the AMMPS recognition framework covers medicines and vaccines only.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Usable as technical and QMS evidence in the import dossier. Myanmar has no Medical Device Act and DFDA publishes no recognition route, so a CE certificate carries no defined standing beyond the documents it supplies.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-netherlands
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
EU baseline confirmed; national conditions (Dutch IFU language, notification duty, IGJ vigilance channel) apply on top.
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.
- Timeline Savings
None — there is no review period to shorten
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Usable as supporting technical evidence. The NAFDAC 2025 guidelines publish no reduced period for CE-marked devices; the only shortened route is the WHO-listed-authority one.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking — a certificate of EC conformity issued by a notified body
- Authority
EU CE marking — a certificate of EC conformity issued by a notified body
- Benefit
A device that holds a certificate of EC conformity follows the abridged documentation route in чл. 7 of the 151/2010 rulebook (declaration of conformity, EC certificate, EN ISO 13485 certificate, free-sale certificate, insurance policy and representation contract) instead of the full quality, safety and efficacy dossier required by чл. 8, and чл. 22 of the same rulebook ties the register entry's validity to the validity of the certificate. It does not remove the national register entry: чл. 131 of the Law still requires the device to be entered in MALMED's register, and чл. 119 ст. 3 governs the EC mark on the device. A declaration under the MDD or AIMD is not converted into a certificate under Regulation (EU) 2017/745 by this route, because North Macedonia is not an EU/EEA member state and does not apply that Regulation.
Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 daysПравилник за содржината на образецот на барањето и потребната документација … за запишување на медицинските помагала во регистерот на медицински помагала, Сл. весник на РМ бр. 151 од 22.11.2010, чл. 7, 8, 17 and 22 Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An EU-recognised notified body's EC certificate opens an abridged national dossier route, but the national registration decision is still taken
reliance.eu-notified-body-ec-certificate-abridged-route
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- A local application is always required: the device must be entered in MALMED's register of medical devices and the applicant must be a domestic manufacturer, a legal representative, a branch or a trade representation with a registered seat in the country and insurance covering its territory.
- The abridged dossier is documentary only — declaration of conformity, EC certificate (except class I and general IVDs), EN ISO 13485 certificate, free-sale certificate, insurance and representation contract — and the Agency may still require further data.
- A nationally authorised conformity-assessment body may be used instead; the Law provides for bodies authorised by the Minister of Health.
- The Law's conformity-assessment provisions are based on the pre-MDR MDD/AIMDD/IVDD certificate architecture; MDR (EU) 2017/745 and IVDR (EU) 2017/746 do not apply directly in North Macedonia.
Macedonian. Article 118(1) states the two permitted conformity-assessment routes: 'со оцена на сообразноста преку институции препознаени во Европската унија, односно соодветно тело за оцена на сообразноста или преку тела овластени од страна на министерот за здравство'. Article 119(3): 'медицинско средство, чија сообразност со општите и посебните услови е проценето од тело за оцена на сообразноста, односно од нотифицирано тело препознаено во Европската унија, е означено со ЕC ознака.' marketAccessStrength is 'facilitated' and not 'direct' because the recognised certificate opens a shortened documentary route only; the Agency retains and exercises its own registration decision.
NorwayEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-norway
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
CA treats Norway as part of the single EU/EEA market: registration (not approval) is the national act; MDR/IVDR are Norwegian law via the EEA Agreement (Lov om medisinsk utstyr § 1).
OmanUS FDA · EU conformity assessment Regulatory reference
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).
Conditions
- EU route: Class C (IIb/III) and Class D (other III/IV/AIMD).
- US route: Class C accepts PMA or 510(k); Class D accepts PMA.
GD5 mirrors this for IVDs (CE certificate, Full/Production Quality Assurance, Type Examination; US route PMA/510K).
OmanEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
A conformity certificate and a certificate of free sale from the country of origin are what the dossier is built on. The published service period does not change with origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
OmanEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Regulatory reference
Classification follows origin jurisdiction
reliance.origin-jurisdiction-classification
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.
Conditions
- Applies to all device and IVD registration applications.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
PakistanAustralia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · US FDA · Austria · Belgium · Denmark · France · Germany · Ireland · Italy · Netherlands · Norway · Spain · Sweden · WHO · EU conformity assessment Regulatory reference
Rule 67 lists reliance reference countries plus WHO prequalification and CE marking
reliance-reference-countries
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.
Conditions
- Reliance subject to evidence and supporting documents
Effective from 2018-01-16
Regulatory reference
Devices from reference authorities, WHO-prequalified or CE-marked devices are exempt from foreign manufacturing-site inspection
reliance-inspection-exemption
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.
Conditions
- Exemption applies irrespective of the manufacturing country of the site; subject to evidence and supporting documents
Effective from 2018-01-16
PanamaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA Prior approval / evidence record
Compassionate-use import where the device is authorised by a listed reference agency
reliance.compassionate-use-foreign-authorised-product
- 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.
- Source Approval
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)
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- No DINAVISA registration may exist for the product.
- Urgency determined by the treating specialist or by the MSPBS.
- Requires an import authorisation under the resolution's requirements (Art. 3 et seq.).
- Companion limb (Art. 2(a)) covers products in the investigational phase, where no foreign authorisation is required.
Effective from 2025-06-30
Source language: Spanish. Translation: 'Medicines or medical devices Registered by a Regulatory Authority: Medicines or medical devices that have been authorised by a foreign reference regulatory agency included in the official annual list pursuant to Law N° 7256/2024 or its updates, that do not have a sanitary registration issued by DINAVISA and that are required to treat a patient or group of patients urgently, determined by the treating specialist physician, or the Ministry of Public Health and Social Welfare.' Art. 12 (OCR renders it 'Artículo 129') sets the resolution in force from 30 June 2025.
ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA Prior approval / evidence record
Annual official list names FDA, EU, PMDA and MFDS but every entry is scoped to medicines or vaccines
reliance.annual-official-list-device-scope-gap
- 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.
- Edge Type
International Listing
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The 2026 list is emitted by Resolución DINAVISA N° 182/2026 in compliance with Art. 3 of Ley N° 7256/2024; it abrogates Resolución DINAVISA N° 148/2024 and Resolución DINAVISA N° 192/2025.
- The listed agencies' own names include medical devices (AEMPS, JAZMP, URPL), but their stated Alcance in this list is medicamentos y vacunas.
- This fact records the list's stated scope only; it is not evidence that DINAVISA refuses device reliance in practice, and no DINAVISA instrument was found that scopes the device route to a named device authority.
Effective from 2026-05-01
Source language: Spanish. Translation of the quoted entries: 'United States: US FDA. Scope: Medicines and vaccines.' / 'European Commission (DG SANTE); European Medicines Agency (EMA); National Regulatory Authorities. Scope: Medicines and vaccines.' / 'Republic of Korea: Ministry of Food and Drug Safety (MFDS). Scope: Medicines and vaccines.' / 'Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA). Scope: Medicines' and a second Japan entry 'Pharmaceuticals and Medical Devices Agency (PMDA). Scope: Vaccines'. The resolution is dated 'de mayo de 2026'; the day glyph is illegible in the scan and is not reproduced. effectiveFrom is the month of signature only.
ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA Prior approval / evidence record
Simplified registration route for class II-IV devices authorised by a listed reference authority
reliance.annual-official-list-simplified-route
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to applications for IMPORTED class II, III and IV medical devices and their accessories: Art. 8's chapeau reads 'las solicitudes de inscripción de Dispositivos Médicos importados deberán ajustarse y tramitarse según la Clase... (Clase II, III y IV)'.
- The foreign authorisation must come from an authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024, or from an authority with a bilateral recognition agreement that so provides, published on the DINAVISA website.
- The applicant still files all requirements of Art. 6; DINAVISA evaluates the technical information declared in DINAVISAPy and the documents filed for items b), c), d), g) and h).
- Only if the conditions do not differ from what the origin regulatory authority authorised.
- 45-business-day evaluation clock under Art. 9.
- Res. 226/2024 Art. 8(a) names the 2024 list (Resolución DINAVISA N° 148/2024); that list was replaced by Res. 192/2025 and then by Res. 182/2026, the text referring to the list 'y sus actualizaciones'.
Effective from 2024-09-16
Source language: Spanish. Translation: 'Applications for registration of products classified by DINAVISA as class II, III and IV medical devices that are authorised by authorities of the countries on the Annual Official List emitted in Resolución DINAVISA N° 148/2024 and its updates, as well as those Regulatory Authorities with which bilateral agreements for the recognition of authorisations exist, which so provide, published on the DINAVISA website, shall be subject to the simplified Sanitary Registration Process.' OCR of the two-column official PDF was normalised: 'Clase l' rendered as 'Clase II' and 'N*148/2024' as 'N°148/2024'.
Prior approval / evidence record
EU CE marking / EU notified body certificate
- Authority
EU CE marking / EU notified body certificate
- Benefit
The European Commission (DG SANTE), EMA and EU national authorities appear in the Listado Anual Oficial with an Alcance of medicamentos and vacunas; a CE certificate is accepted as quality-system evidence under Art. 6(a) but does not replace Paraguayan registration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
ParaguayBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · IMDRF member authorities · Portugal · Spain · South Korea MFDS · Japan MHLW / PMDA · UK MHRA · NMPA · Taiwan TFDA · Australia TGA · WHO Prior approval / evidence record
IVD simplified registration (PSR) for products authorised by PAHO/WHO, IMDRF or bilateral-partner authorities
reliance.ivd-psr-reference-authorities
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to class II, III and IV IVDs (Res. 44/2024 Art. 7: 'Clases II, III y IV'); class I IVDs are registered automatically under Res. 266/2022 Art. 14.
- The IVD must actually be commercialised in one of those countries and the foreign registration must correspond specifically to the same product being registered.
- 15 business days to validate; approval by positive silence.
- Objections may be answered only once (Art. 3), with 30 business days to rectify.
- Not applicable to the cases in Arts. 13 and 16 of Res. DINAVISA N° 266/2022 (Art. 11).
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
PeruUS FDA · EU conformity assessment · Brazil ANVISA Prior approval / evidence record
Class III
- Verification Status
official-verified
- Official Source
- Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
- Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
- Prior Approval Benefits
- FDA 510(k)/PMA
- EU CE Mark
- ANVISA
- Notes
- TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
- Technical file review required
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
PeruUS FDA · EU conformity assessment Prior approval / evidence record
Class IV
- Verification Status
official-verified
- Official Source
- Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
- Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
- Prior Approval Benefits
- FDA PMA
- EU CE Mark Class III
- Notes
- TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
- All device procedures carry negative administrative silence (no deemed approval on lapse)
- Clinical data may be required
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
PeruUS FDA · EU conformity assessment · Brazil ANVISA Prior approval / evidence record
Class II
- Verification Status
official-verified
- Official Source
- Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
- Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
- Prior Approval Benefits
- FDA 510(k)
- EU CE Mark
- ANVISA
- Notes
- TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
- CAN harmonization applies
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
PeruEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
Accepted where the certificate of free sale comes from one of the eleven EU or EFTA states on the high-surveillance list. A CE certificate from a notified body in a member state outside that list does not by itself carry the same standing.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class D
- Verification Status
official-verified
- Official Source
- Title
FDA Philippines AO 2018-0002 — statutory evaluation clocks
- Url
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
- Prior Approval Benefits
- FDA PMA
- EU CE Mark Class III
- Notes
- AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
- Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
- Clinical evidence required
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class B
- Verification Status
official-verified
- Official Source
- Title
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
- Url
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
- Notes
- 2025 Citizen's Charter: CMDR Class B initial registration decided in 80 total working days for complete applications
- Abridged processing (ASEAN NRA-approved Class B/C/D): 30 working days from receipt of proof of payment (FDA Circular 2022-008)
- ASEAN harmonization applies
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class C
- Verification Status
official-verified
- Official Source
- Title
FDA Philippines AO 2018-0002 — statutory evaluation clocks
- Url
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
- Notes
- AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
- Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
- Clinical data may be required
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-portugal
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Portuguese language duties, INFARMED notification, EUDAMED actor registration and the INFARMED vigilance channel still apply
- IVD distributors additionally communicate devices placed on the national market under art. 12 of Decreto-Lei n.º 189/2000
Decreto-Lei n.º 29/2024, as amended by Decreto-Lei n.º 118/2025, executes MDR in Portugal and gives INFARMED its mandate, the notification regimes and the language rules. Registration duties for IVDs additionally survive under the directive-era Decreto-Lei n.º 189/2000.
QatarUS FDA · EU conformity assessment Regulatory reference
CE or FDA certificates accepted for IMD registration
reliance.ce-fda-certificates
IMD registration requires notarized CE or FDA certificates from the country of origin listing the reference numbers of the devices being registered.
Conditions
- Applies to implantable medical device registration with MoPH.
QatarUS FDA · EU conformity assessment Regulatory reference
FDA/CE or equivalent approval accepted for equipment evaluation
reliance.fda-ce-equivalent-technical-evaluation
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.
Conditions
- Applies to medical equipment used within licensed healthcare facilities.
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-romania
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Romanian language duties under OUG 46/2021 for devices and OUG 137/2022 for IVDs, registration in the national database, EUDAMED actor registration and the ANMDMR vigilance channel still apply
Ordonanța de urgență nr. 46/2021 implements MDR and OUG nr. 137/2022 implements IVDR. Both designate the competent authority, set the Romanian language rules and require entry in the national database; neither creates a Romanian conformity decision.
RussiaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Technical and QMS documentation can be reused, but the EAEU route requires its own expertise at VNIIMT and its own Russian-language dossier. Roszdravnadzor publishes no reduced period for CE-marked devices.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
RwandaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · WHO Prior approval / evidence record
Abridged assessment route taking account of prior assessment and inspection outcomes from WHO prequalification or a competent NRA, on a sameness declaration with SRA / WHO PQ / EAC registration
reliance.abridged-assessment-sra-who-pq-eac
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The applicant must declare sameness of the dossier with the product registered with the relevant SRA, WHO PQ and EAC; the declaration is a tick-box on the Appendix 1 cover letter marked 'Only for Abridged Applications' (p. 67).
- The abridged procedure is assessed within 60 working days, against 180 working days for full assessment.
- QMS audit compliance for abridged devices is confirmed by desk review; the Authority may nevertheless conduct an on-site inspection where necessary.
- Neither DHT/GDL/024 nor the reliance guideline names US FDA, the EU, Japan or Korea as SRAs; the SRA concept is incorporated by reference and eligibility of a specific authority is determined by the Authority.
- Class C and Class D devices under the ordinary route must file a Rwanda FDA QMS audit certificate or proof of QMS audit application.
Effective from 2025-11-01
Verbatim (Glossary 2): "'Abridged assessment' a limited independent assessment of specific parts of the dossier, or regulatory submission of data for suitability of use under local conditions and regulatory requirements, taking into account prior assessment (including dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority (NRA) deemed by the Authority as competent to inform the latter in its decision." Verbatim (application form): 'I confirm that the Product Dossier information submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC (Only for Abridged Applications)'.
RwandaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS Prior approval / evidence record
FDA 510(k) / PMA, EU CE marking, Japan PMDA, Korea MFDS
- Authority
FDA 510(k) / PMA, EU CE marking, Japan PMDA, Korea MFDS
- Benefit
Handled through the SRA concept rather than by a substitute approval; the Rwandan registration and certificate are still issued by Rwanda FDA and the reliance decision is discretionary.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
RwandaWHO · EU conformity assessment Prior approval / evidence record
Reliance guideline recognises WHO PQ/CRP, SRAs, WHO Listed Authorities and transitional WLA category B, EMA/EAC joint assessments and ML3 authorities with an MoU
reliance.reference-authority-categories
- 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.
- Source Approval
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
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The guideline defines 'Reference Regulatory Authority' as a national, regional or international authority or trusted institution such as WHO prequalification and WHO transitional Listed Authorities whose decisions or work products are relied upon.
- Reliance is stated to be a sovereign decision: 'The Authority decides when and how to use reliance and in which circumstances.'
- The guideline does not publish an enumerated annex of named SRAs; it adopts the WHO categories.
- Reliance requires verification of sameness between the product submitted to Rwanda FDA and the product assessed by the reference authority.
Effective from 2024-02-14
Verbatim (5.1): 'The Authority may apply reliance procedures for granting Marketing Authorization in the following situations: a) The product should have been evaluated and listed as a WHO Prequalified Product including the WHO PQ collaborative registration procedure between WHO and the Authority. b) The product should have been approved by Stringent regulatory authorities. c) The product should have been registered by a WHO listed Authorities (WLAs) and WHO transitional Listed Authorities (B category). d) The product should have been recommended by Continental and Regional regulatory harmonization initiatives and networks such as EMA and EAC, through the Joint Dossier Assessments e) The product should have been registered by ML3 functioning regulatory Authorities having Memorandum of Understanding (MoU) with Rwanda FDA.' Verbatim (Scope): 'These Guidelines cover reliance activities regarding all types of medical products and regulatory activities using reliance approaches.'
Prior approval / evidence record
EU CE Mark
- Benefit
GHTF route canceled Jan 2022
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking / notified-body certificate
- Authority
EU CE marking / notified-body certificate
- Benefit
Not a substitute for ARP registration, but the technical file, the déclaration de conformité and the test reports behind a CE certificate are the same evidence the ARP requires for the enregistrement dossier.
Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux, Journal officiel n° 7704 du 24 février 2024, arts. 34, 36, 38, 39 and 40Arrêté du Ministre de la Santé et de l'Hygiène publique pris en application de l'article 28 du décret n° 2023-2419, fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux — arts. 15-21, 25 and 29 (registered 22 May 2026)ARTP procédure d'agrément d'équipement radioélectrique — requirements under art. 70 of loi n° 2018-028 du 12 décembre 2018 portant Code des Communications électroniquesARSN, « Combien de temps prend le traitement d'une demande ? » — published treatment time, validity and renewal of a radioprotection authorisation Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
SerbiaEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
ALIMS registration is EU-aligned and rests on the CE certificate, but the 30-day decision period in Art. 52 of the Law on Medical Devices is the same whatever the origin.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
SerbiaEU conformity assessment Regulatory reference
Effect and validity of recognition of foreign documents
reliance.recognition-validity
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.
Conditions
- Available both within registration and as a standalone procedure at manufacturer/AR request.
Consolidated bylaw text
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Class C
- Pathway
IBR/Expedited/Full Route
- Verification Status
official-verified
- Official Source
- Title
HSA fees and turnaround time for medical devices
- Url
https://www.hsa.gov.sg/medical-devices/fees/
- Prior Approval Benefits
- TGA
- Health Canada
- MHLW
- FDA
- EU NB
- Notes
- Five Class C routes: an immediate route confined to standalone medical mobile applications, expedited (ECR) at 120 working days, abridged at 160, full at 220, and full under the Priority Review Scheme at 143
- ECR-1 needs one reference approval plus three years of marketing there; ECR-2 needs two reference approvals. Both require no prior rejection or withdrawal by HSA or a reference agency
- Hip, knee and shoulder joint replacement non-bioactive implants are barred from ECR and must go full or abridged
- HSA turnaround times exclude applicant stop-clock time
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Class B
- Pathway
IBR/Expedited/Full Route
- Verification Status
official-verified
- Official Source
- Title
HSA fees and turnaround time for medical devices
- Url
https://www.hsa.gov.sg/medical-devices/fees/
- Prior Approval Benefits
- TGA
- Health Canada
- MHLW
- FDA
- EU NB
- Notes
- Four Class B routes, and which one applies is decided by how many reference approvals the device already holds rather than by choice: Immediate Class B Registration is granted on submission, abridged takes 100 working days, full takes 160, and full under the Priority Review Scheme takes 104
- IBR needs either one reference approval plus three years of marketing in that jurisdiction, or two reference approvals, and in both cases no global safety issue and no prior rejection or withdrawal. A standalone medical mobile application qualifies for an immediate route on one reference approval with no marketing history
- Abridged needs at least one reference approval; a device with none must go full route
- HSA turnaround times exclude applicant stop-clock time
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
- Authority
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
- Benefit
At Class B this is the IBR trigger and registration is granted on submission. At Class C and D it is the ECR-2 or EDR trigger.
- Timeline Savings
Class B immediate against 160 working days; Class C 120 against 220; Class D 180 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
Qualifies for the abridged route on the same terms, but only via the specific EC certificate routes HSA lists — a self-declared Class I CE mark does not count, and neither does a reference-agency Class I or Class II exempt classification.
- Timeline Savings
Class B 100 working days against 160; Class C 160 against 220; Class D 220 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
EU notified body certificates (MDR/IVDR and directives)
reliance.edge-eu-ce-mdr-ivdr
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.
Conditions
- same labelled use
- certificate type must be one of those specified by HSA
- one qualifying approval for the Abridged route
- two approvals can unlock expedited/immediate routes
Confirms baseline reliance edge; certificate annexes quoted from overview page.
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Class D
- Pathway
IBR/Expedited/Full Route
- Verification Status
official-verified
- Official Source
- Title
HSA fees and turnaround time for medical devices
- Url
https://www.hsa.gov.sg/medical-devices/fees/
- Prior Approval Benefits
- TGA
- Health Canada
- MHLW
- FDA
- EU NB
- Notes
- Four Class D routes: expedited (EDR) at 180 working days, abridged at 220, full at 310, and full under the Priority Review Scheme at 202. There is no immediate route at Class D
- EDR needs two reference approvals and no prior rejection or withdrawal. Active implantables, devices contacting the central circulatory or central nervous system, bioactive joint replacements, devices with a registrable drug in a secondary role, and HIV or donor-compatibility IVD assays are barred from EDR
- A Class D device with a registrable drug in a secondary role has only abridged at 220 and full at 310, and is excluded from the Priority Review Scheme
- HSA turnaround times exclude applicant stop-clock time
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-slovakia
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Slovak language duties, ŠÚKL notification under §§ 110 to 110b of Zákon č. 362/2011 Z. z., EUDAMED actor registration and the ŠÚKL vigilance channel still apply
Zákon č. 362/2011 Z. z. is the Slovak law of record, with §§ 110, 110a and 110b carrying the device provisions ŠÚKL applies. The national step is notification to ŠÚKL, not approval.
Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-slovenia
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Slovenian language duties, JAZMP registrations under ZMedPri-1, EUDAMED actor registration and the JAZMP vigilance channel still apply
The Zakon o medicinskih pripomočkih (ZMedPri-1), Uradni list RS 40/25, in force since 19 June 2025, is the Slovenian implementation act for MDR, IVDR and Regulation 2022/123. It sets competent authorities, language rules, registrations and supervision.
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
A CE certificate is the technical dossier and QMS evidence SAHPRA works from on the reliance pathways.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
No direct recognition
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
SpainEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-spain
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- Spanish language regime under RD 192/2023 for devices and RD 942/2025 for IVDs, entry in the Registro de comercialización (RECOPS), the establishment licence, EUDAMED actor registration and the AEMPS vigilance channel still apply
Real Decreto 192/2023 regulates devices and Real Decreto 942/2025 regulates IVDs. Spain layers two national duties on a CE-marked device that are easy to miss: entry in the Registro de comercialización (RECOPS) and a prior operating licence for the establishment placing the device on the market.
Sri LankaEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Singapore HSA · US FDA · UK MHRA · Norway Regulatory reference
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.
Conditions
- IVD list: 'USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries'.
- Reference NRA evidence: product registration certificate or free sale certificate issued by the reference authority.
SwedenEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-sweden
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Single Market Validity
- Market Access Strength
direct
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Confirmed with a national official source: approvals from other geographic regions cannot replace CE marking for Sweden.
Prior approval / evidence record
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Unilateral Recognition
- Market Access Strength
Direct With Local Obligations
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
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).
Conditions
- Medical devices and IVDs subject to route-specific scope
- Swiss representative, registration, language and surveillance obligations apply
Recognition is unilateral following the lapse of the mutual recognition agreement; Swissmedic states it 'follows what is specified for the European Union (EU) system of compliance assessment and certification'.
Prior approval / evidence record
EU CE Mark (MDR)
- Authority
EU CE Mark (MDR)
- Benefit
Full recognition - immediate Swiss market access
- Timeline Savings
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Unilateral recognition of EU/EEA certificates
- Name
Unilateral recognition of EU/EEA certificates
- Description
The device chapter of the EU-Switzerland MRA has not applied since 26 May 2021 and has not been restored; Switzerland instead recognises EU/EEA notified-body certificates one-way under MepV Art. 25(4), which is why a CH-REP and Swiss labelling are still required
- Timeline Reduction
No second conformity assessment
- Eligibility
- Certificate from a body designated under EU law and established in an EU or EEA state
- Procedures must meet Swiss requirements and the body must hold equivalent qualification
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Equal treatment of EU/EEA notified body certificates
reliance.eu-notified-body-certificates
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.
Conditions
- Equal-treatment rule of Art. 25(4) MedDO; certificates must satisfy both cumulative conditions.
Also underpins the legacy-transition option to apply to an EU/EEA notified body (Arts. 100-101 MedDO).
Prior approval / evidence record
Class I
- Pathway
Self-declaration (no conformity assessment body)
- Verification Status
official-verified
- Official Source
- Title
Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates
- Url
https://www.fedlex.admin.ch/eli/cc/2020/552/de
- Prior Approval Benefits
- EU CE Mark (recognised unilaterally by Switzerland)
- Notes
- MepV Art. 23 applies the EU MDR conformity assessment procedures, so a Class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared with no body involved and no review clock
- Swissmedic runs no product approval at all: the only Swiss step is swissdamed registration, which carries a filing deadline rather than a review period
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark (MDD)
- Authority
EU CE Mark (MDD)
- Benefit
Recognized until certificate expiry
- Timeline Savings
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark Recognition
- Name
EU CE Mark Recognition
- Description
Full recognition of EU CE marked devices until 2028
- Timeline Reduction
Immediate market access
- Eligibility
- Valid EU MDR CE Mark
- MDD CE Mark until expiry
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
TaiwanEU conformity assessment · Japan MHLW / PMDA Prior approval / evidence record
QSD Abbreviated Pathway
- Name
QSD Abbreviated Pathway
- Description
Abbreviated QMS review for USA/EU/Japan manufacturers
- Timeline Reduction
2-3 months faster
- Eligibility
- USA, EU, or Japan manufacturer
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
TaiwanUS FDA · EU conformity assessment · Japan MHLW / PMDA Prior approval / evidence record
Class II
- Verification Status
official-verified
- Official Source
- Title
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
- Url
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
- Prior Approval Benefits
- FDA 510(k)
- EU CE Mark
- Japan PMDA
- Notes
- Statutory handling period 140 calendar days (initial review 75 + post-supplement review 65)
- Class II in-vitro diagnostic reagents run on a separate 150-calendar-day clock (80 + 70)
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
TaiwanEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
Fast-track pathway
- Timeline Savings
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
TaiwanUS FDA · EU conformity assessment · Japan MHLW / PMDA Prior approval / evidence record
Class III
- Pathway
Registration with clinical data
- Verification Status
official-verified
- Official Source
- Title
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
- Url
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
- Prior Approval Benefits
- FDA 510(k)/PMA
- EU CE Mark
- Japan PMDA
- Notes
- Statutory handling period 200 calendar days (initial review 105 + post-supplement review 95)
- Class III in-vitro diagnostic reagents run on the same 200-calendar-day clock (105 + 95)
- Clinical Trial Required
Yes
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE under MDR/IVDR — abridged review
reliance.reliance-edge-big5-to-thailand-abridged-approval-eu-ce-mdr-ivdr-thailand
- Source Approval
EU CE under MDR/IVDR
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
- Marketing History Months
12
Conditions
- medical devices and IVDs subject to route-specific scope
- at least one year registration or approval history in a Big 5 reference jurisdiction
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
EU CE Mark
- Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO Prior approval / evidence record
Class 3
- Verification Status
official-verified
- Official Source
- Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
- Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
- Prior Approval Benefits
- FDA
- EU CE Mark
- Japan
- TGA
- Health Canada
- WHO (for IVD)
- Notes
- Statutory cap: class-3 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
- Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
- Clinical data may be required
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO Prior approval / evidence record
Class 2
- Verification Status
official-verified
- Official Source
- Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
- Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
- Prior Approval Benefits
- FDA
- EU CE Mark
- Japan
- TGA
- Health Canada
- WHO (for IVD)
- Notes
- Statutory cap: class-2 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
- Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
- ASEAN harmonization applies
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO Prior approval / evidence record
Class 4
- Verification Status
official-verified
- Official Source
- Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
- Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
- Prior Approval Benefits
- FDA
- EU CE Mark
- Japan
- TGA
- Health Canada
- WHO (for IVD)
- Notes
- Statutory cap: class-4 registration decided within 300 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
- Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
- Clinical evidence required
- Clinical Trial Required
Yes
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking accepted as the conformity evidence for the ANMPS device dossier
reliance.eu-ce-marking-conformity-evidence
- 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.
- Source Approval
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
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The certificate is a required dossier item, not a shortcut: ANMPS still evaluates the dossier ('avis technique') or analyses it ('analyse') and issues the Autorisation de Mise à la Consommation itself.
- ANMPS accepts the EU MDR-transition artefacts by reference, so a device operating under the EU's extended transition remains eligible.
- The requirement is expressed per conformity regime ('pour les DM conformes à la législation européenne'), so it applies to a device held out as EU-conforming — see also reliance.us-and-canada-approvals-conformity-evidence.
Effective from 2026-03-02
French original. Translation: 'f.1. The European Community conformity certificate (CE), for devices conforming to European legislation — For class I devices: a valid ISO 13485 certificate of conformity issued by a certification body. — For all other devices: a CE certificate of conformity according to the risk class of the device and the requirements of Regulation 2017/745. Note: only CE certificates issued by notified bodies notified to the European Commission (listed on the NANDO site) will be accepted.' and 'f.2. Case of absence of a valid CE certificate of conformity under MDR — A copy of the written agreement in accordance with Annex VII, section 4.3, second paragraph, of Regulation (EU) 745/2017 signed between the manufacturer and the notified body, or a letter from the notified body confirming the status of a formal application, the written agreement between the manufacturer and the notified body and the appropriate surveillance under Regulation (EU) 2023/607.' The document is dated 26.02.2026 with application from 02/03/2026. Retrieved as full raw text; portail.anmps.tn refuses direct TCP connections from this network (curl and WebFetch both return connection-refused / HTTP 000 on ports 80 and 443), so the document was read through a text-extraction fetch of the same URL.
Prior approval / evidence record
EU CE certificate of conformity (Regulation (EU) 2017/745, NANDO-listed notified body)
- Authority
EU CE certificate of conformity (Regulation (EU) 2017/745, NANDO-listed notified body)
- Benefit
Mandatory dossier evidence for every class except class I, and the regime the ANMPS guide names as the benchmark; where no valid MDR certificate exists the agency accepts an Annex VII §4.3 written agreement with a notified body or a notified-body letter under Regulation (EU) 2023/607. It does not replace the Tunisian AMC, which the ANMPS issues after its own avis technique or analyse.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
TurkeyEU conformity assessment Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
The Tıbbi Cihaz Yönetmeliği transposes EU MDR essentially verbatim, so a CE certificate from an EU notified body is directly usable for the ÜTS filing and there is no separate Turkish product approval to shorten. One divergence matters going forward: from 25 February 2027 the EU notified body issuing that certificate is capped at 170 days by Regulation (EU) 2026/977, while a Turkish-designated body issuing the same certificate stays uncapped because Turkey has not transposed it.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
TurkeyEU conformity assessment Prior approval / evidence record
EU CE under MDR/IVDR — customs union free circulation
reliance.reliance-edge-eu-ce-to-turkiye-approval-eu-ce-mdr-ivdr-turkiye
- Source Approval
EU CE under MDR/IVDR
- Edge Type
Customs Union Free Circulation
- Market Access Strength
Direct With Local Obligations
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- Turkish UTS, language, economic-operator, and surveillance obligations remain
Confirmed from the Turkish regulation itself: devices must bear the CE mark (Madde 20) and importers/distributors verify CE marking and the EU declaration of conformity (Madde 13(2)/14).
TurkeyEU conformity assessment Regulatory reference
EUDAMED use became mandatory — TİTCK duyuru 2026/KKB-1
reliance.eudamed-mandatory-2026-uts-effect
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.
Announcement verified on the official TİTCK activity-area page; the duyuru detail page itself was not reachable (404) from the research environment.
TurkeyEU conformity assessment Regulatory reference
Presumption of conformity via EU harmonized standards
reliance.harmonized-standards-presumption
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.
Prior approval / evidence record
EU CE Mark
- Benefit
An EC certificate is one of the accepted conformity certificates for the same mandatory document slot, with an EC declaration of conformity acknowledgement required in addition.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
UgandaUS FDA · Health Canada · Japan MHLW / PMDA · EU conformity assessment Prior approval / evidence record
For classes B, C and D, certification from a recognised country (or CE certification) is mandatory; only class A may be exempted
reliance.reference-country-or-ce-certification-mandatory-classes-b-d
- 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.
- Source Approval
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
- Edge Type
Eligibility Gate
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to appliances classified B, C or D; a class A appliance may be examined and exempted from recognised-country certification if appropriate.
- Evidence must be provided as original authenticated documents.
- For Europe the certificate type is class-dependent: EC Type Examination Certificate for class B and C, EC Design Examination Certificate for class D.
- The notified body must be approved officially by European health authorities and the committee will ask for documented evidence of the notified body's registration or licensing.
- This gate sits above the track structure: an uncertified class B/C/D product cannot fall back to Track 3, because Track 3 still requires a Manufacturer's Declaration of Conformity rather than third-party certification, and s. 4.11 makes recognised-country or CE certification a must for those classes.
Effective from 2020-08-14
Excerpt is a contiguous verbatim run from s. 4.11 with the class-by-class European detail joined by [...]. edgeType 'eligibility_gate' is reused from the existing vocabulary (1 prior use) rather than inventing a token: the mechanism is that recognised certification is a precondition for classes B-D, which is what that token means. marketAccessStrength is 'facilitated' rather than 'evidence_only' because holding the certificate changes which applications can be accepted at all, not just how much paperwork is filed. There is an internal tension in the source between s. 4.11 (certification is a must for classes B-D) and s. 4.12.3 (Track 3 for products with no certification to any listed quality system standard); both are recorded, and the tension is stated in conditions rather than resolved by assumption.
UgandaAustralia TGA · Health Canada · EU conformity assessment · Japan MHLW / PMDA · US FDA · IMDRF member authorities Prior approval / evidence record
Track 1: an IMDRF founding-member licence opens an abridged evaluation (Australia, Canada, EU, Japan, USA)
reliance.imdrf-reference-country-licence-track-1
- 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.
- Source Approval
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The recognised approval is country-specific: DAR/GDL/028 Table 2 names GMPALS licence or CE mark for Australia, an appliance licence for Canada, CE mark for the European Union, an appliance licence for Japan, and a 510K appliance letter for the United States.
- Track 1 still requires a national application on Form 7 and NDA retains the registration decision; the foreign licence abridges the evaluation, it does not replace the registration.
- Track 1 additionally requires a Certificate of Analysis confirming compliance to a quality system standard from DAR/GDL/028 Table 3 (ISO 13485 or ISO 13488 for Australia, Canada and the EU; GMP QS Standard for medical appliances #1128 for Japan; QS 21 CFR part 820 for the United States) and evidence of repeat sales in the country of manufacture.
- CE-marked products enter track 1 via the European Union founding-member entry; there is no separate CE-only track.
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
UgandaAustralia TGA · Health Canada · EU conformity assessment · Japan MHLW / PMDA · US FDA · IMDRF member authorities Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
- Authority
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
- Benefit
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
UgandaUS FDA · Health Canada · Japan MHLW / PMDA · EU conformity assessment Prior approval / evidence record
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
- Authority
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
- Benefit
DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
Northern Ireland: EU regime applies, CE plus UKNI
reliance.northern-ireland-ce-and-ukni
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).
Conditions
- Northern Ireland market only; GB market follows UK MDR 2002.
Effective from 2021-05-26
Regulatory reference
Legacy EU CE under MDD/AIMDD/IVDD - unilateral recognition
reliance.ce-legacy-directives-great-britain
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.
Conditions
- Valid CE route within the statutory transition; MHRA registration; UK Responsible Person for overseas manufacturers.
· Effective until 2030-06-30
Refines baseline '2028-06-30 or 2030-06-30 depending on CE route': MDD/AIMDD = 2028-06-30, IVDD = 2030-06-30.
United KingdomUS FDA · EU conformity assessment · Australia TGA · Health Canada · UK MHRA Prior approval / evidence record
International Reliance (draft legislation, not in force)
- Name
International Reliance (draft legislation, not in force)
- Description
Stand-alone route giving a Certificate of International Reliance to devices already authorised by the FDA, Health Canada or the TGA, without UKCA marking; the EU is deliberately excluded pending the separate CE-recognition decision
- Timeline Reduction
Not quantified — the draft fixes no review period
- Eligibility
- Draft Medical Devices (Amendment) Regulations 2026, WTO-notified 8 May 2026
- Route 1 lowest-risk: self-declaration and registration only
- Routes 2 and 3: certificate from a UK approved body first
- Anticipated in force mid-2028
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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.
Conditions
- Valid CE certificate under EU MDR/IVDR; MHRA registration; UK Responsible Person for overseas manufacturers.
· Effective until 2030-06-30
gov.uk consultation on indefinite recognition of CE-marked devices ran Feb/Mar 2026 (policy paper).
Prior approval / evidence record
CE Mark Recognition (Transition)
- Name
CE Mark Recognition (Transition)
- Description
EU CE marks accepted during transition period
- Timeline Reduction
Immediate market access
- Eligibility
- Class III & IIb implantable: until Dec 2027
- Other classes: until Jun 2028
- MDR/IVDR compliant: until Jun 2030
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Class I
- Pathway
Self-declaration (no approved body)
- Verification Status
official-verified
- Official Source
- Title
The Medical Devices Regulations 2002 (SI 2002/618, as amended) — reg. 16(1) and 29(1) 60-day clinical investigation notice, and the 210-day Secretary of State opinion on ancillary medicinal substances
- Url
https://www.legislation.gov.uk/uksi/2002/618
- Prior Approval Benefits
- EU CE Mark (accepted until 2028+)
- Notes
- UK MDR 2002 Part II: Class I devices that are not sterile and have no measuring function are self-declared, so no approved body or MHRA review of the file takes place and no review clock runs
- Class Is and Im still need a UK approved body for the sterile barrier or the metrological function, and no statutory or published period binds that assessment
- Registration with the MHRA under reg. 7A is a precondition for placing the device on the GB market, but the DORS service is self-declared and the MHRA guidance publishes no processing time
- CE mark provides immediate access during transition
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
- Benefit
Full recognition during transition (until 2027-2030)
- Timeline Savings
Months → Weeks
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Ukraine still runs the old EU directives rather than MDR, and Law No. 1207 as amended for martial law lets a CE-marked device onto the market on that basis, so the CE certificate is the route rather than an accelerant. No provision puts a period on the conformity assessment either way.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Uruguay works from the certificate of free sale and the technical dossier behind the CE certificate. The MSP period is set by the procedure, not by where the device was approved.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
- Benefit
Clinical data can be leveraged
Maintained reference · planning ranges remain estimates · reviewed 2026-08-25
Regulatory reference
Foreign authorizations not recognized
reliance.negative-reliance-foreign-approval-not-recognized-by-us
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).
UzbekistanUS FDA · EU conformity assessment · Japan MHLW / PMDA · UK MHRA · South Korea MFDS Regulatory reference
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.
Conditions
- Certificate authenticity checked via official registers; Centre may send an official request — no reply within 60 working days leads to refusal.
- Recognition route: 15 working-day review, no samples, no local laboratory tests, no clinical studies, no production inspection.
Effective from 2026-02-26
WHO-prequalified IVDs registered in cooperation with WHO get a separate 60-working-day route.
Prior approval / evidence record
CE Mark (EU MDR)
- Authority
CE Mark (EU MDR)
- Benefit
Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the CE dossier is reused but the Annex-1 periods are unchanged.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS Prior approval / evidence record
Class C
- Pathway
Circulation number registration (Ministry of Health)
- Verification Status
official-verified
- Official Source
- Title
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
- Url
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
- Prior Approval Benefits
- FDA
- TGA
- MHLW
- EU
- MHRA
- Swissmedic
- NMPA
- MFDS
- Notes
- Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
- Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
- Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
- Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
- The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
- Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
- Benefit
Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
VietnamEU conformity assessment · ASEAN Regulatory reference
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.
Conditions
- Applies to medical devices generally unless stated.
VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS Prior approval / evidence record
Class D
- Pathway
Circulation number registration (Ministry of Health)
- Verification Status
official-verified
- Official Source
- Title
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
- Url
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
- Prior Approval Benefits
- FDA
- TGA
- MHLW
- EU
- MHRA
- Swissmedic
- NMPA
- MFDS
- Notes
- Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
- Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
- Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
- Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
- The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
- Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
ZambiaWHO · US FDA · EU conformity assessment · IMDRF member authorities Prior approval / evidence record
Foreign approval (WHO PQ, US FDA, CE mark, IMDRF member state, SADC registration) is disclosed on the application form but opens no stated route
reliance.foreign-approval-disclosure-no-stated-route
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Source Approval
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.
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The approval information is a mandatory field on the Annex I application form, so withholding it is not an option; but the guidelines attach no procedural consequence to holding or not holding it.
- 'Expedited evaluation' is defined in the non-IVD guideline as 'the express evaluation of a product application within a 90 - day period'; the Authority authorises it and the guideline states no criteria, so reliance on a foreign approval as the trigger is aspirational rather than an operating rule.
- ZAMRA's published fee schedule carries a 'Fast track fees' head at 'Double the applicable MA applicable fee', confirming that a fast track exists commercially but again without stating a foreign-approval trigger.
- The same absence holds for IVDs: the IVD guideline (ZAMRA/MA/GUD/0003) has no recognition or abridged procedure based on a foreign marketing authorisation, although it defines a 'Fast Track process' as 'the authorised expedited evaluation or assessment of an application submitted for the purpose of grant of Marketing Authorisation'.
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
ZambiaIMDRF member authorities · WHO · US FDA · EU conformity assessment Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
- Authority
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
- Benefit
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
ZimbabweUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
No reliance route for medical devices: Zimbabwe operates no general device registration pathway at all
reliance.no-device-registration-route
- 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.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
Yes
Conditions
- sourceApproval is recorded as 'none' because there is no device registration route for a foreign approval to attach to. This is a structural no-route, not a policy of refusing foreign approvals.
- The absence is transitional rather than permanent: the Strategic Plan and the Reliance Policy both look forward to device regulation, but neither has been brought into force.
The claim rests on the Act's long title and structure (Part IV, 'REGISTRATION OF MEDICINES', ss.26-41, is the only registration regime in the Act) read together with the exhaustive MCAZ listing of device instruments (only the Condom Regulations, the Glove Regulations and their 2014 amendments) and the Strategic Plan 2026-2030 statement that the Medical Devices Unit's functions are 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005', 'Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006' and 'Factory inspections (cGMP) of condom and glove manufacturing facilities'. No device registration guideline, application form or device fee schedule exists in MCAZ's published document set.
