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.)."
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
UK MHRA
- Benefit
Named only in the Rule 63(1) proviso, which waives clinical investigation results for a no-predicate device marketed in the UK for at least two years. The UK is not in the Rule 36(3) list.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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.
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
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
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
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
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
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
