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
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
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 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
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 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
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 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.
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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 · UK MHRA · Germany · France · Italy · Spain · Netherlands · Belgium · Ireland · Denmark · Sweden · Finland · Norway · Iceland · Greece · Portugal · Austria · Swissmedic · Australia TGA · Health Canada · New Zealand Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
Conditions
- Device must be registered or permitted for marketing and actually marketed in the recognized state.
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
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.
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
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
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).
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 · 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
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 · 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
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 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
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
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
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).
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
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
ParaguayBrazil ANVISA · US FDA · Health Canada · Austria · Belgium · Denmark · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · New Zealand · Norway · Spain · Sweden · Japan MHLW / PMDA · UK MHRA · Swissmedic · Australia TGA · WHO Prior approval / evidence record
IVD Annex I reference-country list drives the 30/45/120-business-day clocks
reliance.ivd-anexo-i-reference-country-list
- Statement
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
- Source Approval
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The Annex I list derives from Ley N° 3283/2007 Art. 11 (high and adequate sanitary surveillance).
- A product made outside Annex I is admitted on a 45-day clock only if it is registered and commercialised in an Annex I country.
- Korea (MFDS) does not appear in Annex I, so a Korean-only IVD authorisation does not by itself reach the 30/45-day clocks.
- A Paraguayan sanitary registration is still required in every case.
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
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
PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
- Authority
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
- Benefit
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
- Timeline Savings
None published — the TUPA period is set by class, not by origin
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
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
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
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
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
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
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
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 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 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
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
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
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
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
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
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
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
