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".
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.
BahrainSaudi Arabia · US FDA · Australia TGA · Japan MHLW / PMDA · UK MHRA · Ireland · Swissmedic · France · Germany Prior approval / evidence record
Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
- Authority
Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
- Benefit
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
BahrainUS FDA · Japan MHLW / PMDA · Saudi Arabia · Australia TGA · UK MHRA · Ireland · Swissmedic · France · Germany Prior approval / evidence record
Registration certificate from a listed reference country is an alternative basis for Bahraini registration (Art. 7 bis)
reliance.reference-country-registration-certificate-route
- Statement
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.
- Source Approval
US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Only the nine authorities named in Article (7) bis are listed; Korea MFDS, Health Canada and China NMPA are not among them
- The EU CE mark as such is not listed; the Union route appears only through three named national authorities (HPRA, ANSM, BfArM)
- The application is still made by a Bahraini licensed Authorized Representative and the applicable fee must be paid
- In force from the day following publication in the Official Gazette (No. 3781, 21 November 2024)
- Resolution No. (69) of 2024 replaced Article (10) of Resolution No. (48) of 2020 so that marketing authorisation runs for three years
Effective from 2024-11-22
Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."
BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium Prior approval / evidence record
Free Sale Certificate may be issued by the country of origin or by a reference country
reliance.free-sale-certificate-origin-or-reference-country
- Statement
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
- Source Approval
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The classification guideline separately accepts a Free Sale Certificate OR Registration Certificate from one of the reference countries as a classification requirement
- The reference-country list in the registration guideline glossary includes Canada, Denmark, the Netherlands ('Holland') and New Zealand, which are not in the Article (7) bis list of Resolution No. (69) of 2024, and omits Germany
- Free Sale Certificate is also required on manufacturer acquisition (Section 12)
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium Prior approval / evidence record
Classification of a product as a medical device may be evidenced by a registration certificate from a reference country
reliance.reference-country-certificate-for-classification
- Statement
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
- Source Approval
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
classification
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- A classification letter is a separate, fee-bearing NHRA service that precedes importation and registration
- The reference-country list here is broader than the Article (7) bis list in Resolution No. (69) of 2024 and omits Germany and includes Canada, Denmark, the Netherlands and New Zealand
- For class I products without CE marking a manufacturer's Declaration of Conformity may be provided
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
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
Prior approval / evidence record
Japan MHLW
- Benefit
Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
BrazilUS FDA · Australia TGA · Health Canada · Japan MHLW / PMDA · Brazil ANVISA Prior approval / evidence record
Optimized analysis (procedimento otimizado, IN 290/2024)
- Name
Optimized analysis (procedimento otimizado, IN 290/2024)
- Description
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
- Timeline Reduction
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
- Eligibility
- Class III and IV primary registration petitions only, medical devices and IVDs (Art. 2)
- Prior authorisation by one of the four recognised AREE: TGA via the ARTG, Health Canada via a Medical Device Licence, US FDA via 510(k), PMA or De Novo, or Japan MHLW via Shonin (Art. 6)
- The device must be essentially identical to the one the AREE authorised, down to composition, indications, manufacturer and manufacturing process (Art. 5 II)
- Excluded if the AREE itself granted the authorisation through an abbreviated route similar to ANVISA optimized analysis (Art. 4)
- Filed as a secondary aditamento petition; omit it and the registration is analysed by the ordinary route (Art. 11)
- ANVISA keeps the right to revert to ordinary analysis with reasons (Art. 9) and to decide differently from the AREE (Art. 13)
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
Japan MHLW
- Benefit
Reference-country origin under Decreto 3275/2009
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
ColombiaUS FDA · Australia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Homologación for reference countries (Decreto 3275/2009)
- Name
Homologación for reference countries (Decreto 3275/2009)
- Description
Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.
- Timeline Reduction
None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly
- Eligibility
- Device originates from a reference country: the European Community, the United States, Canada, Japan, Australia, or a country with a mutual recognition agreement
- Risk class I, IIa or IIb — Class III devices file the complete Formato Único regardless of origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
CroatiaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
No recognition route for FDA, PMDA, MFDS or NMPA approvals
reliance.no-route-for-non-ce-approvals
- Statement
Croatia is an EU member state: a device may be placed on the Croatian market only if it complies with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration certificate is not recognised by HALMED and opens no abridged, documentary, fast-track or reciprocal route; the holder must obtain CE marking through a notified body under MDR/IVDR before the device may lawfully be placed on the Croatian market. The only exception is a public-health derogation under Article 59 MDR / Article 54 IVDR, which Croatia implements nationally in Article 14 of NN 100/2018 and which authorises a specific device for a limited purpose; it is not recognition of a foreign approval.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Croatia applies MDR and IVDR directly; the national implementing act (NN 100/2018) adds national duties and penalties but no separate product approval for CE-marked devices.
- A third-country approval can be used inside the technical documentation as supporting evidence, but no Croatian or Union provision examines or accepts it in place of conformity assessment.
- Derogation route (Article 14 NN 100/2018, MDR Article 59 / IVDR Article 54): Agency decision on a justified request with the health minister's consent, notified to the Commission and the other member states.
- Applies equally to medical devices and to in vitro diagnostic devices, which are not CE-marked but carry the CE marking under IVDR.
Source is the English consolidated MDR text on EUR-Lex. Verbatim: "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." The IVDR equivalent is Article 5(1) of Regulation (EU) 2017/746. The Croatian implementing act's only gateway for a non-conforming device is Article 14 (national derogation).
CyprusUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
No Cypriot market-access route on the basis of a US FDA, Japan PMDA, Korea MFDS or China NMPA approval
reliance.no-route-for-non-ce-approvals
- Statement
Cyprus, as an EU Member State, operates no abridged, fast-track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or China NMPA approval cannot be placed on the Cypriot market: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are directly applicable and permit placing on the market only of a device that complies with them, and CYMDA's own description of how a manufacturer affixes the CE marking describes only the Union conformity assessment procedure, with no national pre-market approval step and no reference to any third-country approval.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
No
- Target Decision Retained
Yes
Conditions
- Regulation (EU) 2017/745 has applied since 26 May 2021 and Regulation (EU) 2017/746 since 26 May 2022; both are binding in their entirety and directly applicable in Cyprus, so there is no Cypriot transposition act and no Cypriot approval decision for a CE-marked device.
- The only Union exception is the public-health derogation (Article 59 MDR / Article 54 IVDR), by which a Member State may authorise a device that has not undergone the applicable conformity assessment; that authorisation rests on a public-health or patient-safety ground, is not recognition of a third-country approval, and does not extend outside the authorising Member State.
- The extended transitional periods of Regulation (EU) 2023/607 benefit only devices covered by a Directive 90/385/EEC or 93/42/EEC certificate, or whose pre-26 May 2021 declaration of conformity did not require a notified body; an FDA, PMDA, MFDS or NMPA approval confers nothing under those provisions.
- Cyprus has no separate national device-approval instrument: the only national acts located are Decree No. 6 (language) and Decree No. 7 (notification), both made under article 59(1)(ζ) of the Basic Requirements laws, plus market-surveillance penalties under Law 225(I)/2022.
Effective from 2021-05-26
English source (Regulation (EU) 2017/745). The excerpt is the Union rule that governs placing on the Cypriot market. The Cypriot side of the same answer is CYMDA's conformity-assessment page (source res-cy-conformity-assessment), which describes only the Annex I essential-requirements plus notified-body route, and CYMDA's statement that it has imposed no additional requirement beyond Union and national law (source res-cy-importer-notice-2025). No Cypriot or Union instrument consulted names an FDA, PMDA, MFDS or NMPA approval as a basis for placing a device on the Cypriot market.
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
Japan PMDA and Korea MFDS
- Authority
Japan PMDA and Korea MFDS
- Benefit
Neither is named in the Resolución No. 000004 recognition list — Japan appears there only as NIHS — so a PMDA or MFDS marketing approval confers no simplified-procedure eligibility and the application is assessed under the ordinary route. DIGEMAPS' IMDRF affiliate membership creates no recognition route.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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.
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
Japan MHLW / registered certification body
- Authority
Japan MHLW / registered certification body
- Benefit
Approval or certification satisfies D002
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IcelandUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
No Icelandic route exists for non-CE approvals (FDA, PMDA, MFDS, NMPA and similar)
reliance.non-ce-approvals-no-route
- Statement
An approval from a non-EEA regulator gives no market-access route and no abridgement in Iceland. Act No. 132/2020 and the Regulations provide no reference-country fast track, no abridged review based on a foreign approval, and no acceptance of a foreign registration certificate in place of CE marking. A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be carried in the technical documentation as supporting evidence but substitutes for nothing: without CE marking and an EU declaration of conformity the device may not lawfully be placed on the Icelandic market.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
No
- Target Decision Retained
Yes
Effective from 2021-05-26
Verified negative. The Act states an exhaustive single condition for placing on the market (CE marking per Annexes IX–XI) and the Act and Regulations nowhere name a foreign regulator or a reference-country route; the agency's guidance likewise describes CE marking and the EU declaration of conformity as the route. The only non-CE access is the national exemption route in Article 9 and the Union derogations recorded under special-access-derogation, which are discretionary and are not recognition of a foreign approval.
Prior approval / evidence record
Japan PMDA
- Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndiaUS FDA · EU conformity assessment · Australia TGA · 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
KuwaitHealth Canada · Japan MHLW / PMDA · UK MHRA · Brazil ANVISA · Australia TGA Prior approval / evidence record
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
- Authority
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
- Benefit
Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
- Authority
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
- Benefit
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
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
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
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
MaltaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA Prior approval / evidence record
No route for a third-country approval (FDA, PMDA, MFDS, NMPA)
reliance.no-third-country-approval-route
- Statement
Malta gives no market-access route, abridged review or recognition to a US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration. The only pre-market route onto the Maltese market is the EU conformity assessment under Regulation (EU) 2017/745 (MDR) Annexes IX to XI — Regulation (EU) 2017/746 (IVDR) for IVDs — followed by CE marking; S.L. 458.59 defines a 'medical device' solely by reference to those two Union Regulations, so the national regime has no approval of its own that a third-country clearance could feed. A holder of only a third-country approval must obtain a CE certificate (or use the MDR Art. 59 / IVDR Art. 54 public-health derogation) and appoint an EU authorised representative.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to medical devices under the MDR and IVDs under the IVDR placed on the Maltese market.
- A manufacturer not established in a Member State may place a device on the Union market only if it designates a sole authorised representative (MDR Art. 11(1); IVDR Art. 11(1)).
- The national definition of a device is derivative: S.L. 458.59 reg. 2 refers to MDR Art. 2(1) and IVDR Art. 2(2).
- The only non-CE entry route is a derogation under MDR Art. 59 / Art. 97 or IVDR Art. 54 / Art. 92 (S.L. 458.46 Schedule 5, fee EUR 1,000), which is granted on public-health or patient-safety grounds and is not a recognition of a foreign approval.
Effective from 2021-05-26
Verbatim passage supports the mandatory-and-exclusive character of the EU conformity route. Regulation (EU) 2017/746 Art. 48(1) is identically worded for IVDs (source res-eu-ivdr-2017-746): 'Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.' Neither Regulation contains any provision recognising, or providing an abridged route on the basis of, a third-country marketing authorisation of the kind issued by FDA, PMDA, MFDS or NMPA; that absence is the basis of this fact rather than a quotable clause.
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
MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP Prior approval / evidence record
Class II
- Pathway
Registration or Equivalency
- Verification Status
official-verified
- Official Source
- Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
- Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
- Prior Approval Benefits
- FDA 510(k)
- Health Canada
- Japan PMDA
- IMDRF Committee Members
- MDSAP
- Notes
- RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen)
- ARR equivalence route (COFEPRIS-04-050, Lineamientos DOF 18-07-2025): maximum 30 working days
- Equivalency route much faster if FDA approved
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP Prior approval / evidence record
Class III
- Pathway
Registration or Equivalency
- Verification Status
official-verified
- Official Source
- Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
- Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
- Prior Approval Benefits
- FDA 510(k)/PMA
- Health Canada
- Japan PMDA
- IMDRF Committee Members
- MDSAP
- Notes
- RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen)
- ARR equivalence route (COFEPRIS-04-050): maximum 30 working days
- Equivalency pathway best option with FDA
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Japan PMDA
- Benefit
Reference Regulatory Authority for the abbreviated pathway
- Timeline Savings
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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
MoroccoJapan MHLW / PMDA · South Korea MFDS Prior approval / evidence record
Japan PMDA / Korea MFDS / other non-listed approvals
- Authority
Japan PMDA / Korea MFDS / other non-listed approvals
- Benefit
No Moroccan device instrument examined in this round names them, and the AMMPS reliance framework is scoped to medicines and vaccines, so they carry no listed documentary route for a device.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
No route exists for non-EU approvals (FDA, PMDA, MFDS, NMPA and similar)
reliance.non-eu-approvals-no-route
- Statement
An approval from a regulator outside the European Union gives no market-access route and no abridgement in North Macedonia. The Law recognises conformity assessment only through institutions recognised in the European Union or bodies authorised by the Minister of Health, and the device registration rulebook distinguishes only between devices that hold an EC certificate and devices that do not. A US FDA 510(k) clearance or PMA approval, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be placed in the technical documentation as supporting material but substitutes for nothing: without the EC certificate or EC declaration of conformity the full quality, safety and efficacy dossier under Article 8 of the 151/10 rulebook applies, together with an Agency opinion on efficacy.
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The negative is drawn from an exhaustive enumeration: Article 118(1) names two and only two conformity-assessment routes, and Article 119(3) names the EC mark as the marking that follows from a recognised notified body. No non-EU regulator is named anywhere in the Law's device chapter.
- The counter-check is Article 8 of the 151/10 rulebook, which applies the full dossier when the device does not hold an EC certificate — the rulebook contemplates no third category based on a non-EU approval.
- A device manufactured outside the EU is not shut out entirely: it reaches the market either through a notified body recognised in the EU, through a body authorised by the Minister of Health, or on the non-EC full dossier route.
Verified negative. Macedonian. Article 118(1) is exhaustive in form ('Постапката за оцена на сообразноста на медицинските средства се врши: … или …'). The same conclusion is reached on the origin-country side: the free-sale certificate is required from the manufacturer's own country whatever that country is, which shows the Law is not operating a reference-country recognition list. FDA, PMDA, MFDS and NMPA were searched for in the consolidated Law and in the device rulebooks and appear nowhere.
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
PAHO/WHO reference authority or IMDRF Management Committee member authority
- Authority
PAHO/WHO reference authority or IMDRF Management Committee member authority
- Benefit
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
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.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
- Name
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
- Description
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
- Timeline Reduction
From 30-120 business days down to 15 business days
- Eligibility
- Product classified as class II, III or IV under Resolución DINAVISA N° 266/2022 Art. 9
- Current authorisation and commercialisation in a country regulated by a PAHO/WHO reference regulatory authority, by an IMDRF Management Committee member authority, or by an authority with a bilateral agreement with DINAVISA
- The foreign registration must correspond specifically to the same product being registered in Paraguay
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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
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
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
SingaporeAustralia TGA · Health Canada · Japan MHLW / PMDA Prior approval / evidence record
Health Canada, Australia TGA, Japan MHLW
- Authority
Health Canada, Australia TGA, Japan MHLW
- Benefit
A Canadian or Australian device registration licence, or a Japanese Ninsho certification or Shonin approval, counts as a reference approval on the same terms as the US and EU.
- Timeline Savings
Same as the abridged route figures above; two of them together trigger IBR, ECR-2 or EDR
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
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
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
Japan PMDA
- Benefit
Fast-track pathway
- Timeline Savings
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
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
TunisiaJapan MHLW / PMDA · South Korea MFDS Prior approval / evidence record
Japan PMDA / Korea MFDS / other non-listed approvals
- Authority
Japan PMDA / Korea MFDS / other non-listed approvals
- Benefit
Not named anywhere in the ANMPS device dossier guide: a product holding only a PMDA or MFDS approval has no listed documentary route and must rely on the agency's reservation clause permitting it to request other documents.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
UgandaWHO · IMDRF member authorities · ISO Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
- Authority
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
- Benefit
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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
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
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
