FDA · structured requirements

🇺🇸 United States IVD regulatory data

Explore the IVD requirements currently available for United States, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in United States. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

United States approvals and evidence in other markets (173 records)

AlbaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence. ABPM publishes no reduced period and no separate recognition route for US clearances.
Timeline Savings: None published

Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AlgeriaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only, with no published reduction.
Timeline Savings: None published

Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34)Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9)Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15)Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Declaration of Conformity

Official Timeline

Min: 15
Max: 15
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA 510(k)
EU CE Mark

Notes

Art. 5: the INPM has 15 administrative working days to assess the dossier and rule
Since 16 Feb 2026 an imported Class II device authorised in a Decreto 892/2025 Annex I country can instead use the prior-notification route, which takes effect on filing

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 110
Max: 110
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 18
Max: 24
Unit: months

With Prior Approval

Min: 12
Max: 16
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

Art. 6: Class IV runs on the same 110 administrative working days as Class III
Extensive clinical evidence and an on-site audit are possible, and art. 7 suspends the period during the deficiency response

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration with clinical data

Official Timeline

Min: 110
Max: 110
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 12
Max: 18
Unit: months

With Prior Approval

Min: 8
Max: 12
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
EU CE Mark

Notes

Art. 6: ANMAT has 110 administrative working days to assess the dossier and issue the administrative act
Art. 7 suspends that period while the applicant answers the single consolidated deficiency notice, which is why the realistic range is far longer

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Facilitates approval process
Timeline Savings: 2-4 months

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks Disposición ANMAT 236/2026 — prior-notification route for imported Class I/II devices and Class A/B IVDs under Decreto 892/2025

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · Türkiye conformity assessment

Prior approval / evidence record

Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country

reliance.origin-country-or-imdrf-authorisation-evidence-for-unregistered-import

Fact-level verified

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

Fact-level verified

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.

ArmeniaUS FDA

Prior approval / evidence record

US FDA 510(k)/PMA

Authority: US FDA 510(k)/PMA
Accepted: Yes
Benefit: Registration in the United States opens the simplified Armenian national route, because Article 46(4) of the Law on Medical Care and Services to the Population admits devices registered in a member country of the International Medical Device Regulators Forum; it does not replace the Armenian registration decision or the import (conformity) certificate.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21 Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4 EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

AustraliaUS FDA · EU conformity assessment · MDSAP

Prior approval / evidence record

Class III — ARTG inclusion

class-iii

Class Name

Class III — ARTG inclusion

Risk Level

highest

Pathway

Inclusion in the ARTG on overseas or TGA conformity assessment evidence

Official Timeline

Min: 20
Max: 20
Unit: working-days

Realistic Timeline

Min: 6
Max: 9
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

EU CE Mark (30-50% faster)
FDA 510(k)
MDSAP

Notes

The inclusion decision itself still carries the 20-working-day statutory clock. What makes Class III slow is what sits either side of it: an application audit, which has no legislated timeframe, and where TGA conformity assessment is required, a separate certificate that must be obtained first
Non-IVD Level 2 application audits: TGA expects the first round of specialist assessment within 100 working days, and will explain a revised timeframe if it cannot meet that
Sponsor responses to a s41JA notice or a Proposal to Refuse are due within 20-40 business days depending on complexity, and that time does not count against TGA targets
The published targets replaced an older blanket 60-working-day audit target that TGA says was arbitrary and not consistently met

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

Verification Status

official-verified

Official Source

Title: TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
Url: https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Accessed Date: 2026-08-30

TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AustraliaUS FDA · EU conformity assessment · MDSAP

Prior approval / evidence record

Class IIb — ARTG inclusion

class-iib

Class Name

Class IIb — ARTG inclusion

Risk Level

high

Pathway

Inclusion in the ARTG on overseas or TGA conformity assessment evidence

Official Timeline

Min: 20
Max: 20
Unit: working-days

Realistic Timeline

Min: 1.5
Max: 2
Unit: months

With Prior Approval

Min: 1
Max: 1.5
Unit: months

Prior Approval Benefits

EU CE Mark
FDA 510(k)
MDSAP

Notes

Same 20-working-day statutory inclusion clock; audit selection is more likely at this class and suspends any published limit
Level 1 compulsory audits ran to a median of 14 and a mean of 27 TGA days in the published snapshot, and Level 2 compulsory audits to a median of 161 and a mean of 174

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

Verification Status

official-verified

Official Source

Title: TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
Url: https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Accessed Date: 2026-08-30

TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AustraliaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Accepted for Class IIa/IIb
Timeline Savings: 20-30%

TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification TGA — understanding the medical device application audit process: statutory 20-working-day preliminary assessment, non-IVD Level 2 first-round specialist assessment expected in 100 working days, sponsor responses due in 20-40 business days TGA — understanding processing timeframes for medical device applications: published half-yearly snapshot of actual processing times by application and audit type TGA — varying your medical device or IVD ARTG entry: software transition variations carry a 3-5 business day target, and section 41JA or section 31 notices allow not less than 10 working days to respond

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AustraliaUS FDA · EU conformity assessment · MDSAP

Prior approval / evidence record

Class IIa — ARTG inclusion

class-iia

Class Name

Class IIa — ARTG inclusion

Risk Level

medium

Pathway

Inclusion in the ARTG on overseas or TGA conformity assessment evidence

Official Timeline

Min: 20
Max: 20
Unit: working-days

Realistic Timeline

Min: 1
Max: 1.5
Unit: months

With Prior Approval

Min: 0.75
Max: 1
Unit: months

Prior Approval Benefits

EU CE Mark
FDA 510(k)
MDSAP

Notes

The 20-working-day statutory clock runs to the inclusion decision, not to the end of an audit: if the application is selected for audit there is no legislated limit on what follows
Non-Class I applications completed without audit took a median of 9 and a mean of 10 TGA days in the published snapshot
Australia is unusual in splitting conformity assessment from market authorisation, which is what allows overseas certification to be used in place of a TGA assessment at this class

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

Verification Status

official-verified

Official Source

Title: TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
Url: https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
Accessed Date: 2026-08-30

TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AustriaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

AzerbaijanUS FDA

Prior approval / evidence record

US FDA 510(k)/PMA

Authority: US FDA 510(k)/PMA
Accepted: No
Benefit: No recognition route exists for devices: the foreign-registration recognition mechanism in the registration Rules is confined to medicinal products, so an FDA clearance neither opens an abridged procedure nor substitutes for the Ministry of Health certificate. It may serve as supporting technical documentation in the expertise file.

Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1 Cabinet Resolution No. 345 of 18 July 2024 as registered on the legal portal — citation 345, adopted 18.07.2024, in force 19.07.2024, register code 14202407180345, status Qüvvədədir

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

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)
Accepted: Yes
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.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) — general rules, process of submission, variation and renewal NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) — important rules, classification review time NHRA Medical Device Registration SLA 2025 — service completion time

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

Fact-level verified

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."

BahrainEU conformity assessment · US FDA

Prior approval / evidence record

CE certificate under the medical-device directives/regulations or FDA Certificate to Foreign Government required as quality assurance certificate

reliance.ce-or-fda-quality-assurance-certificate

Fact-level verified

Statement: Registration of a medical device in Bahrain requires a Quality Assurance Certificate for the legal manufacturer, which is accepted in the form of a CE certificate under Directive 93/42/EEC, Regulation 2017/745, Directive 98/79/EC or Regulation 2017/746, or an FDA Certificate to Foreign Government (CFG), verified on the issuing body's website. The foreign approval is mandatory supporting paperwork for a local review that still runs in full, not a route that shortens it.
Source Approval: EU CE marking under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746; US FDA Certificate to Foreign Government (CFG)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Not applicable for class I non-sterile devices and Class A / other IVDs, for which a Declaration of Conformity may be accepted instead
The certificate must be verified on the issuing body's website (Quality Assurance Certificates and Verification Process Guideline)
The address on the certificate must match the artwork
Applies to the legal manufacturer; a separate ISO 13485 certificate is required for the physical manufacturer

Verbatim source passage: "Quality Assurance Certificate (QAC) - CE directives 93/42/EEC, 2017/745, 98/79/EC, 2017/746 or FDA Certificate to Foreign Government (CFG) for the Legal manufacturer with the address matching the artwork along with verification evidence ... Not applicable for class I non-sterile and Class A/others IVD."

BahrainEU conformity assessment · US FDA

Prior approval / evidence record

EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government

Authority: EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government
Accepted: Yes
Benefit: Mandatory supporting documentation for a local review that still runs in full, not a route that shortens it: the CE certificate or CFG is the Quality Assurance Certificate required for the legal manufacturer, and for class III and class D IVDs the EC Design Examination certificate or CFG is an additional class-specific dossier item.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

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

Fact-level verified

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

Fact-level verified

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.)."

BahrainEU conformity assessment · US FDA

Prior approval / evidence record

Class III / Class D IVD requires an EC Design Examination certificate or FDA Certificate to Foreign Government

reliance.class-iii-ec-design-examination-or-fda-cfg

Fact-level verified

Statement: For class III medical devices and class D IVDs, Bahrain requires an EC Design Examination certificate or an FDA Certificate to Foreign Government for the legal manufacturer; the same document must be supplied for class IIb devices if available. The named foreign instrument is a mandatory class-specific dossier item, not a shortened review.
Source Approval: EC Design Examination certificate (EU notified body); US FDA Certificate to Foreign Government (CFG)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Also required for class IIb medical devices 'if available'
Verification evidence for the EC Design Examination certificate must be provided
Class mapping: Bahrain classes I, IIa, IIb, III for general devices; classes A-D for IVDs

Verbatim source passage: "For class III medical devices as well as class D IVD's, an EC Design examination certificate or an FDA Certificate to Foreign Government (CFG) for the legal manufacturer is required along with verification evidence ... This document needs to be submitted for class IIB medical devices if available."

BangladeshUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Usable as supporting technical evidence alongside the free sale certificate. The Citizen Charter sets one period per service and it does not vary with the origin of the device.
Timeline Savings: None published

ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BelarusUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only, with no recognition route and no published reduction.
Timeline Savings: None published

Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

BelgiumUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

BoliviaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No Bolivian instrument names the FDA or any individual foreign regulator as a basis for a shortened device registration; an FDA clearance is neither market access nor a substitute for the Registro Sanitario, and it is used only as evidence in the dossier.

Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro Sanitario Manual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 Rechazo Circular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicos Resolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de reliance Circular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Bosnia and HerzegovinaUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority: US FDA 510(k) clearance or PMA approval
Accepted: No
Benefit: Not recognised by Law čl. 102 or by the Agency's Instruction; useful only as supporting technical documentation.

Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 65(5)-(9)Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08 od 21.07.2008, čl. 118 Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10, čl. 70 i 71 ALMBIH — Dopuna i izmjena upisa u Registar medicinskih sredstava, spisak dokumentacije, 30.10.2025

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway

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)
Accepted: No
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

BrazilUS FDA · MDSAP

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Registration

Official Timeline

Min: 250
Max: 320
Unit: days

Verification Status

official-verified

Official Source

Title: ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date: 2026-08-25

Realistic Timeline

Min: 1
Max: 11
Unit: months

With Prior Approval

Min: 10
Max: 14
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP

Notes

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
Clinical evidence mandatory
10 year validity

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilUS FDA · MDSAP

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline

Min: 250
Max: 320
Unit: days

Verification Status

official-verified

Official Source

Title: ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date: 2026-08-25

Realistic Timeline

Min: 1
Max: 11
Unit: months

With Prior Approval

Min: 8
Max: 12
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP

Notes

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
B-GMP certificate mandatory
10 year validity

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilUS FDA

Prior approval / evidence record

FDA 510(k)/PMA/De Novo

Authority: FDA 510(k)/PMA/De Novo
Accepted: Yes
Benefit: Recognised AREE for IN 290/2024 optimized analysis of Class III and IV registrations
Timeline Savings: None published — Art. 10 preserves queue position

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)ANVISA IN 290/2024 — optimized analysis of Class III and IV device registration petitions using an equivalent foreign regulator (AREE)ANVISA RDC 687/2022 — criteria for granting and renewing the Brazilian GMP certificate for medical devices ANVISA RDC 850/2024 — amends RDC 497/2021 Art. 8 to give MDSAP-based device GMP certificates four years of validity

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

BulgariaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

CanadaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: eSTAR pilot closed, no formal recognition
Timeline Savings: None

Health Canada service standards — medical device submission evaluations (first-review calendar-day table, published for fiscal year 2020 to 2021 and still the current edition)Health Canada MDEL FAQs — 120 calendar-day performance standard, 1 April annual licence review, 25% fee credit when the standard is missed Medical Devices Regulations (SOR/98-282) — s. 43 annual licence statement before 1 November

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ChileUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.
Timeline Savings: None published

ISP Chile ficha 9100003 v03 (25-09-2025) — registro sanitario de dispositivos médicos: 60 días hábiles en promedio, vigencia 3 años ISP Chile ficha 9100019 v08 (01-07-2026) — registro sanitario de DMDIV: 60 días hábiles en promedio desde el inicio de la evaluación ISP Chile ficha 9100016 v02 (28-08-2024) — inscripción de empresa: 25 días hábiles en promedio, vigencia indefinida ISP Chile ficha 9200007 v2 (21-07-2025) — autorización de bodega: 45 días hábiles Región Metropolitana, 60 días hábiles regiones ISP Chile ANDIM — registro sanitario de DM y DMDIV: lista de categorías bajo registro obligatorio por decreto

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ChinaNMPA · US FDA · EU conformity assessment

Prior approval / evidence record

Hainan Boao Pilot Zone

Name: Hainan Boao Pilot Zone
Description: Fast-track initial use with real-world data collection
Timeline Reduction: 4 months vs 3-5 years standard
Eligibility: Approved overseas (FDA, CE)
Not yet registered in China nationally

医疗器械监督管理条例 (Regulations on the Supervision and Administration of Medical Devices, State Council Order No. 739). Art. 13 puts Class I on filing and Classes II and III on registration; art. 15 completes the filing on submission of conforming materials; art. 18 gives the registering authority 20 working days from receipt of the review opinion to decide NMPA service item — 进口第一类医疗器械备案 (imported Class I device filing): 办件类型即办件, filed 当场 once the materials are complete and in the required form, no fee, and Regulation No. 739 art. 15 obliges publication within 5 working days of receipt NMPA licensing service item — promised acceptance 5 working days, statutory approval clock NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ChinaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Required as home country approval
Timeline Savings: Required documentation

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ColombiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Reference-country origin under Decreto 3275/2009, homologating technical studies, sterilisation method and disposal method for Class I/IIa and additionally clinical studies for Class IIb
Timeline Savings: None published

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

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

class-iia

Class Name

Class IIa

Risk Level

medium

Pathway

Registration (NSO)

Official Timeline

Min: 2
Max: 2
Unit: working-days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 1
Max: 2
Unit: months

With Prior Approval

Min: 2
Max: 3
Unit: months

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

Local Testing Required

Gmp Required

Yes

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

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

class-iib

Class Name

Class IIb

Risk Level

high

Pathway

Registration (RSO)

Official Timeline

Min: 90
Max: 90
Unit: working-days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 6
Unit: months

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

Local Testing Required

Gmp Required

Yes

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)

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

Costa RicaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction in the decision deadline.
Timeline Savings: None published

Costa Rica Decreto 38409-S (La Gaceta 94, 19-05-2014) — art. 34.2 decision deadlines

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

Fact-level verified

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.
Source Approval: none
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).

CroatiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima (NN 100/2018) — Article 9(2) register-of-distributors decision and Article 11(3)-(4) classification-dispute decision

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

CubaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Same route: recognised origin-country registration evidence rather than a separate reliance pathway

Resolución Ministerial No. 184/2008, Reglamento para la Evaluación y el Control Estatal de Equipos Médicos (Gaceta Oficial Ordinaria No. 64 de 22/12/2008) — Art. 52 ten-working-day documentary review, Art. 56 thirty-working-day applicant response, Art. 57 ninety/sixty-working-day technical report, Art. 59 five-year certificate, Art. 63 clinical investigation, Art. 97 importer inscription, Art. 113 appeal CECMED Regulación E 86-16, Evaluación Estatal de Equipos y Dispositivos Médicos (in force 29/07/2016) — procederes A to D by risk class, §4.2 outcomes, §4.3 registration validity CECMED Regulación E 129-25, inscripción de fabricantes, suministradores e importadores de dispositivos médicos (Resolución No. 43) — §3.8 audit scheduling, §6.1 130-natural-day inscription decision, §6.2 120-natural-day applicant window

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

CyprusUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)MDR Annex IX — conformity assessment based on a quality management system and on assessment of technical documentation (§5.1 expert-panel consultations, §5.2(d) medicinal-products authority opinion)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)CYMDA notice of 6 November 2025 on recording the importer's details and other distributor and importer duties — restates Decree No. 7 published in the Third Supplement of the Official Gazette of 5 January 2012 CYMDA announcement of 24 March 2026 on language requirements — Decree No. 6 under article 59(1)(ζ) of the Basic Requirements Laws 2002 to 2011 CYMDA notice of 8 January 2026 — compulsory use of the first four EUDAMED modules (actor registration, UDI/devices registration, notified bodies and certificates) from 28 May 2026 under Commission Decision (EU) 2025/2371 CYMDA — commencement of a clinical investigation or performance study in Cyprus: MDR Articles 62 and 63 to 80 with Annex XV; IVDR Articles 56 to 57 and 59 to 77 with Annexes XII and XIV; CYMDA authorisation granted where the Cyprus National Bioethics Committee has not issued a negative opinion

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

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

Fact-level verified

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.
Source Approval: none
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.

Czech RepublicUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

DenmarkUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

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
Accepted: Yes
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.

DIGEMAPS — Registro sanitario de productos sanitarios: tiempo de respuesta (90 días laborables)DIGEMAPS — Renovación de registro sanitario de productos sanitarios: tiempo de respuesta MSP — Procedimiento simplificado: costo del servicio y tiempo de respuesta (Inmediatamente / según los requisitos)Decreto núm. 45-23 que modifica el Decreto núm. 117-18 — renovación automática de registros sanitarios, Artículos 2, 3 y 4 Resolución No. 000004 del 27 de enero de 2016 — criterios para la aplicación del registro sanitario, venta libre y buenas prácticas de establecimientos

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

EcuadorUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Serves the same role as any other reference-country registration for the homologation route.
Timeline Savings: None published

ARCSA response times by trámite — device registration 1,216 working hours, recognition route 760 working hours Resolución ARCSA-DE-2026-003-DASP — substitute device regulation, art. 33 recognition-route clock, in force 2027-01-28

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

EgyptUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: A 510(k) clearance plus an FDA CDRH export certificate satisfies the free-sale evidence for a reference country

EDA Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates (EDREX: GL.CAMD.002, version 2, effective 09/2025) — §4.1.1 intake response, §4.1.2 evaluation, §9 ten-year licence EDA Regulatory Guideline of Registration of Locally Manufactured Medical Devices not holding International Quality Certificates (EDREX: GL.CAMD.009, version 2, effective 01/09/2025) — §6 pre-registration inspection and §6.1-6.3 registration clocks EDA Regulatory Guideline of Issuance of Import Approvals of All Types Medical Devices (EDREX: GL.CAMD.007, version 2, effective 01/09/2025) — §4.1 two-working-day intake reply, three-working-day evaluation and one-year import permit EDA Regulatory Guideline for the Procedures and Rules Organizing the changes done to a Registration License Data of a Medical Device (EDREX: GL.CAMD.003, version 03, effective 01/09/2025) — 8/5 working-day intake and 25/10 working-day evaluation for normal and fast track

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

EstoniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23 — § 26(3)-(4) notifications, § 27(1) incident registration, § 29(2) and (5) the medical devices and aids database Riigilõivuseadus (State Fees Act) § 28⁵⁴ — free-sale certificate issued within 45 days, or within five working days at the applicant's request

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

EstoniaUS FDA

Prior approval / evidence record

US FDA clearance: no recognition route into Estonia

reliance.us-fda-no-recognition-route

Fact-level verified

Statement: A US FDA 510(k), De Novo or PMA clearance gives no market-access route in Estonia. Estonia applies Regulation (EU) 2017/745 directly and a device may be placed on the Estonian market only if it complies with that Regulation; the Regulation provides for conformity assessment under Annexes IX to XI and contains no reliance or abridged procedure based on a third-country marketing authorisation. An FDA-only holder must obtain CE marking under MDR (or IVDR for IVDs) and designate an EU authorised representative.
Source Jurisdiction Id: usa
Source Authority Id: fda
Source Approval: US FDA 510(k) clearance, De Novo grant or PMA approval
Target Jurisdiction Id: estonia
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

No Estonian or Union instrument recognises an FDA clearance as a substitute for CE marking; the Medical Devices Act contains no third-country approval provision.
A non-EU manufacturer must designate a sole authorised representative in the Union (MDR Art. 11).
The same answer applies to a PMDA-, MFDS- or NMPA-only holder: none of those approvals opens a route; only the Union conformity-assessment route exists.

Effective from 2021-05-26

English source. Verbatim text: "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 Estonian national act expressly disapplies itself where the Union regulations apply (MSS § 1(2), separately evidenced in this file).

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

Fact-level verified

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.

European UnionUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: Clinical data can be leveraged
Timeline Savings: 2-4 months prep time

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

FinlandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

FranceUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

GeorgiaUS FDA

Prior approval / evidence record

US FDA 510(k)/PMA

Authority: US FDA 510(k)/PMA
Accepted: No
Benefit: No recognition or abridged route for medical goods: the Law on Medicines recognition regime is written for pharmaceutical products and the only state-registration rule for medical technical items was repealed in 2012 without a successor. An FDA clearance is not a route onto the Georgian market; where a device is registered under the Law on Medicines it can serve as origin-country documentation alongside the ISO/EC certificate or free-sale certificate the dossier accepts in place of a certificate of pharmaceutical product.

Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10)Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GermanyUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

GhanaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Serves the same role as a CE certificate in a reliance submission.
Timeline Savings: None published

FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

GreeceUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

GuatemalaUS FDA · ISO

Prior approval / evidence record

A US FDA, DGKC or IFCC credential can satisfy the manufacturing-guarantee dossier item

reliance.foreign-authority-manufacturing-guarantee

Fact-level verified

Statement: For the addition of an alternative manufacturing plant, NT-37 requires a manufacturing-guarantee certificate issued by a health authority and names as acceptable sources Good Manufacturing Practices, Standards Approval, an ISO certificate, the US FDA, the DGKC or the IFCC. A US FDA or comparable foreign credential can therefore satisfy this dossier item — as evidence, not as an approval that replaces the inscription.
Source Approval: US FDA; DGKC (German Society for Clinical Chemistry); IFCC (International Federation of Clinical Chemistry and Laboratory Medicine); ISO certificate; GMP or standards-approval certificate from a health authority
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

This wording sits in the modification chapter (Art. 6.12, addition of an alternative manufacturing plant); the general inscription dossier requirement for a GMP certificate or equivalent sanitary norm is Art. 5.1.6.
The same wording is reproduced as requirement 6 of the national trámites record 3361.
Evidence-only: the named foreign credentials satisfy a dossier item and do not open an abridged route or substitute for the local decision.

Spanish source (Guatemala). Translation: "6.12.6 Manufacturing guarantee certificate issued by the health authority (Good Manufacturing Practices, Standards Approval, ISO certificate, FDA, DGKC or IFCC: International Federation of Clinical Chemistry and Laboratory Medicine)." Reproduced verbatim on the national trámites record 3361 as requirement 6: 'Certificado original de garantía de manufactura emitido por la autoridad sanitaria (BPM, Aprobación de normas, certificado ISO 9001, FDA, DGKC ó IFCC).' NT-40 Art. 4.1.5 applies the same idea to IVDs: 'Certificado original de garantía de manufactura emitido por la autoridad sanitaria (BPM, Certificado ISO 9001, FDA, DGKC ó IFCC).'

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

Fact-level verified

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)
Accepted: No
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.

Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuesta Norma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Arts. 5, 8, 9 y Anexo 1 Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Arts. 3 y 4.3 Norma Técnica 77 versión 8-2023 — homologation on a WHO-listed authority registration, Art. 2 (scope: chemical-synthesis medicines and vaccines only)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Hong KongUS FDA

Prior approval / evidence record

FDA 510(k)/PMA/De Novo

Authority: FDA 510(k)/PMA/De Novo
Accepted: Yes
Benefit: Satisfies D002 in place of an MDACS Conformity Assessment Certificate; a Certificate to Foreign Government may be requested

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongNMPA · US FDA

Prior approval / evidence record

"Novo Lane" innovative device priority (GN-02 item E001)

Name: "Novo Lane" innovative device priority (GN-02 item E001)
Description: Prioritised processing for first-of-its-kind devices, devices approved through another regulator’s innovation channel (NMPA 創新器械名錄, FDA De Novo) within 5 years, devices with AI features approved within 5 years, or devices whose core technology was patented within 5 years
Timeline Reduction: Priority in the processing queue; MDD publishes no shorter target period, and the device still needs the same D001 or D002 evidence
Eligibility: At least one of the four E001 innovation criteria
Conformity Assessment Certificate or reference marketing approval still required

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

HungaryUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

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

Fact-level verified

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.
Source Approval: none
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.

IcelandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for the MDR conformity assessment and no shortcut to the Icelandic market, because Iceland grants no national approval to shortcut: useful as predicate documentation in the technical file and as supporting evidence in the manufacturer's own clinical evaluation.

Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devices Lög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561 have the force of law in Iceland as they are taken up in the EEA Agreement; with reglugerð nr. 907/2022 listing each instrument and its EEA Joint Committee decision Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity-assessment timelines (30 days for the application review, 120 or 90 days for the assessment phase, 20 days for the final review)Lög um lækningatæki nr. 132/2020 — 28. gr. (registration of distributors with Lyfjastofnun), 36. gr. b (six-month notice before an interruption or discontinuation of supply, inserted by lög nr. 69/2025), 38. gr. (temporary prohibition of sale or supply, at most four weeks at a time), 39. gr. (the fee power)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

IndiaUS FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · GHTF

Prior approval / evidence record

Class A

class-a

Class Name

Class A

Risk Level

low

Pathway

Registration

Official Timeline

Min: 45
Max: 45
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 9
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

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

Local Testing Required

Yes

Gmp Required

Yes

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: A free sale certificate from the United States triggers Rule 36(3): the import licence is granted without clinical investigation. Rule 63(1) fourth proviso additionally waives clinical investigation results for a device without a predicate if it has been US-approved and marketed there for at least two years. Neither provision shortens the nine-month Rule 36(1) decision period.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
Timeline Savings: None published

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Full Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 6
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8)
Clinical data may be required

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 45
Max: 45
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 5
Max: 7
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8)
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 6
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8)
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IraqUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Origin-market evidence expected in practice; no published period reduction

بوابة أور — تقديم طلب إلكتروني لتقييم الاجهزة والمواد والمستلزمات المختبرية (Iraq UR national services portal, service 51503, Ministry of Health Technical Affairs Directorate): "وقت إنجاز الخدمة (10) ايام عمل كحد اقصى"بوابة أور — إجازة الاستيراد (Iraq UR national services portal, service 51307): medical equipment and supplies require an import licence, valid one year from issue, with no completion time published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IrelandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

IsraelUS FDA

Prior approval / evidence record

FDA 510(k)/De Novo/PMA

Authority: FDA 510(k)/De Novo/PMA
Accepted: Yes
Benefit: Israel does not run an independent assessment: a recognized-state approval is what makes a device registrable at all, and which one you hold decides which track you land in. A US clearance plus four months of US marketing puts a Class II device on fast track 1, and a US clearance paired with an approval from a second independent authority puts an EU Class IIb device on fast track 2 without needing actual marketing in the US.
Timeline Savings: Fast track 1 is up to 45 working days and fast track 2 up to 60, against the 120-day regular-track target

AMAR REG-2023/04 — declaration-route registration (certificate within 48 hours)AMAR REG-2024/06 — fast-track registration handling times by channel AMAR Q&A — registration and import of medical equipment (regular-track handling target of 120 days)

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

Recognized-state registration route

reliance.recognized-country-route

Fact-level verified

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.

ItalyUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

JapanUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: STED documentation can be adapted; no abridged Japanese period
Timeline Savings: 2-4 months prep

PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)PMDA — Class I pre-marketing notification procedure (製造販売届に関する手続き)PMDA — registered certification body scheme (登録認証機関制度), MHLW notice 医薬機審発0306第1号 PMDA standard review process timeline — new medical devices (新医療機器に係る承認審査の標準的プロセスにおけるタイムライン)PMDA standard review process timeline — improved devices with clinical data (改良医療機器（臨床あり）)PMDA standard review process timeline — improved devices without clinical data and follower devices (改良医療機器（臨床なし）及び後発医療機器)PMDA submission to the 21st MHLW periodic exchange — mid-term-plan total review period targets and tile values by application category

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

JordanUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Accepted as origin-market evidence in the registration annexes

أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 (Official Gazette no. 5570, p. 1722; JFDA board session No. 54 of 20/2/2019) — Art. 3(b)(3) 45-working-day committee decision, Art. 5 registration scope, Art. 7 ten-year renewal, Art. 13 thirty-day appeal

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

KazakhstanUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only. There is no recognition route and no published reduction.
Timeline Savings: None published

Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

KenyaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Recognised reference-authority decision for the same reliance route

PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

KuwaitUS FDA · EU conformity assessment

Prior approval / evidence record

US FDA approval and the EU route — a CE certificate from an EU-authorized notified body

Authority: US FDA approval and the EU route — a CE certificate from an EU-authorized notified body
Accepted: Yes
Benefit: Two of the recognised reference authorities for the Abridged Review Pathway and the first two entries in the class B/C/D dossier's product verification and validation list; an accelerated assessment that still runs under Kuwaiti requirements and post-market obligations, with the acceptance decision reserved to the Administration.

CITRA — Service Details: New Type Approval (SrvcID=44), service fee and duration CITRA — Service Details: Renew Type Approval (SrvcID=66), service fee and duration CITRA — Service Details: Issuing a permit to import communications equipment (SrvcID=82), duration and fee

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

LatviaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reports Zāļu valsts aģentūra — Pirms laišanas apgrozībā: Brīvās tirdzniecības sertifikāta saņemšana — 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.'

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

LebanonIMDRF member authorities

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)
Accepted: Yes
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)
Accepted: Yes
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.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

LiechtensteinUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

LithuaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

LuxembourgUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

MacauUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction.
Timeline Savings: None published

Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
Timeline Savings: None published

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

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

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

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

class-c

Class Name

Class C

Risk Level

high

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

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

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

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

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

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

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

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

Fact-level verified

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.
Source Approval: none
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.

MaltaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

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

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)COFEPRIS ARR equivalence Lineamientos (DOF 18-07-2025) — 30 working days COFEPRIS reliance briefing — abbreviated pathway in force 30 working days after the 18-07-2025 DOF publication, ARR list, 30-working-day resolution, device homoclaves Acuerdo Anexo Uno (July 2025) — low-risk registration 20 working days

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

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration or Equivalency

Official Timeline

Min: 35
Max: 35
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

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

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

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

class-iii

Class Name

Class III

Risk Level

highest

Pathway

Registration or Equivalency

Official Timeline

Min: 60
Max: 60
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

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

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
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

MoldovaUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority: US FDA 510(k) clearance or PMA approval
Accepted: No
Benefit: Not recognised by AMDM as a route to the State Register; useful only as supporting technical documentation in the dossier.

AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctul 6 (termen de pînă la 30 de zile din momentul efectuării plății)AMDM — AMDM simplifică procedura de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, anunț privind Ordinul nr. Rg04-264 din 08.09.2026 (statutul „Suspendat”: 10 zile lucrătoare)Ordinul AMDM nr. Rg04-264 din 08.09.2026, Anexa 1 — Procedura administrativă de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, pct 8, 13, 17, 19-20, 33-34 și 40-42 AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctele 4, 5 și 8 (28 de zile lucrătoare, valabilitate 5 ani, obligația de notificare a modificărilor)AMDM — Descrierea procedurii de notificare și înregistrare a dispozitivelor medicale care dețin marcaj CE

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MongoliaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval

Authority: FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
Accepted: No
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.

Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing Эм, эмнэлгийн хэрэгслийн тухай хууль (Law on Medicines and Medical Devices) — Arts. 33 (registration and exemptions), 44 (import declaration), 51 (Medical Devices Council), 58.2 (fees)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MontenegroUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority: US FDA 510(k) clearance or PMA approval
Accepted: No
Benefit: No substitute for the conformity documents recognised by CInMED; useful only as supporting technical documentation in the file.

Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40 Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67 Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101 Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44 CInMED — Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoroccoUS FDA

Prior approval / evidence record

US FDA attestation

Authority: US FDA attestation
Accepted: No
Benefit: Accepted as an alternative to the CE certificate for dossier item 4. Dossier evidence only — no abridged or recognition route for devices exists.

Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossier Décret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an update Décision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete application Loi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossier Arrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MyanmarUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence on the same terms as a CE certificate, with no recognition route behind it.
Timeline Savings: None published

DFDA Myanmar Medical Device Section awareness deck — four-step import route (online booking, dossier and sample submission, review averaging 30-90 working days, certificate) and the division of device services between local manufacture and importation DFDA Myanmar Exemption List for Medical Devices — 106 listed items plus 20 additional items that "do not need to apply for Import Recommendation for the time being"DFDA Myanmar notice on parallel imports of medical devices — extra documents for gray-market goods and a per-lot notification certificate ASEAN Medical Device Directive as published by DFDA Myanmar (October 2024) — supplies the A-D classification framework Myanmar applies, but prescribes no national decision period

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

NetherlandsUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

New ZealandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Same position as a CE certificate: useful evidence for the sponsor, irrelevant to the notification itself.
Timeline Savings: None — there is no review period to shorten

Medicines (Database of Medical Devices) Regulations 2003 — WAND notification duties Medsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500 Therapeutic Products Act Repeal Act 2024 (2024 No 55) — repealed the Therapeutic Products Act 2023 on 18 December 2024 before its 1 September 2026 commencement, leaving devices under the Medicines Act 1981 and the WAND regulations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

NigeriaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction outside the WHO-listed-authority route.
Timeline Savings: None published

NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

North MacedoniaUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority: US FDA 510(k) clearance or PMA approval
Accepted: No
Benefit: No substitute for the documents MALMED recognises and no reduction in the procedure or the fee. A US clearance is useful only as supporting technical documentation inside the чл. 8 dossier for a device that has no EC certificate.

Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134 Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days Правилник за содржината на образецот на барањето и потребната документација … за запишување на медицинските помагала во регистерот на медицински помагала, Сл. весник на РМ бр. 151 од 22.11.2010, чл. 7, 8, 17 and 22

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

North MacedoniaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

No route exists for non-EU approvals (FDA, PMDA, MFDS, NMPA and similar)

reliance.non-eu-approvals-no-route

Fact-level verified

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.
Source Approval: none
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.

NorwayUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

OmanUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Accepted for the same document slot as a CE certificate, with no published reduction.
Timeline Savings: None published

Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PanamaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Recognised free-sale evidence from a high-standard authority under Ley 92 Art. 9 validation

Decreto Ejecutivo N° 490 de 4 de octubre de 2019 (Gaceta Oficial 28875-A) — Art. 13 five-year licence, Art. 20 45-working-day licence decision, Art. 21 five-year certificate, Art. 24 30-working-day technical-criterion decision, Art. 30 risk classes Ley 92 de 12 de septiembre de 2019 (Gaceta Oficial 28859-B) — Art. 8 defers device sanitary registration to technical-criterion certificates, Art. 18 transitorio leaves the start date of device sanitary registration to the health authority

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

Fact-level verified

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.

ParaguayWHO · IMDRF member authorities

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
Accepted: Yes
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.

Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicos Resolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigencia Resolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguayUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: The US FDA is named in the Listado Anual Oficial (Resolución DINAVISA N° 182/2026), but every published entry of that list states an Alcance of medicamentos and/or vacunas, so the FDA authorisation does not by itself qualify a device for the simplified route; it remains useful as dossier evidence under Art. 6.

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

Fact-level verified

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.

ParaguayWHO · IMDRF member authorities

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 · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline

Min: 66
Max: 66
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
Technical file review required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · EU conformity assessment

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 66
Max: 66
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 8
Max: 15
Unit: months

With Prior Approval

Min: 5
Max: 8
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
All device procedures carry negative administrative silence (no deemed approval on lapse)
Clinical data may be required

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: The United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.
Timeline Savings: None published

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 44
Max: 44
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 8
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

FDA 510(k)
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
CAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden

Prior approval / evidence record

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

Authority: País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Accepted: Yes
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

PhilippinesUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
Timeline Savings: None published

FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times FDA Philippines AO 2018-0002 — statutory evaluation clocks ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 180
Max: 180
Unit: days

Verification Status

official-verified

Official Source

Title: FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date: 2026-08-25

Realistic Timeline

Min: 9
Max: 18
Unit: months

With Prior Approval

Min: 6
Max: 10
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

FDA Philippines AO 2018-0002 — statutory evaluation clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 80
Max: 80
Unit: working-days

Verification Status

official-verified

Official Source

Title: FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
Url: https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 9
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
ASEAN MRA

Notes

2025 Citizen's Charter: CMDR Class B initial registration decided in 80 total working days for complete applications
Abridged processing (ASEAN NRA-approved Class B/C/D): 30 working days from receipt of proof of payment (FDA Circular 2022-008)
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Registration

Official Timeline

Min: 180
Max: 180
Unit: days

Verification Status

official-verified

Official Source

Title: FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
ASEAN MRA

Notes

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical data may be required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

FDA Philippines AO 2018-0002 — statutory evaluation clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PolandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

PortugalUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

RomaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

RussiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only. There is no recognition route and no published reduction.
Timeline Savings: None published

Roszdravnadzor — registration timelines from 01.03.2025 (50/31 working days)

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

Fact-level verified

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
Accepted: Yes
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.

Guidelines for Registration of Medical Devices, DHT/GDL/024 Version 2, sections 1.10.1 and 1.10.2

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Saudi ArabiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: GHTF route canceled Jan 2022 - data helps but no expedited path
Timeline Savings: None

SFDA FAQ — MDMA issued within 35 business days SFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 years SFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing Authorization SFDA MDS-ExcE — clinical trial approval no later than 60 days (Art. 7.5(1))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

SerbiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence. ALIMS publishes no reduced period for US clearances.
Timeline Savings: None published

Serbia Law on Medical Devices — registration within 30 days (Art. 52)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

IBR/Expedited/Full Route

Official Timeline

Min: 0
Max: 220
Unit: working-days

Verification Status

official-verified

Official Source

Title: HSA fees and turnaround time for medical devices
Url: https://www.hsa.gov.sg/medical-devices/fees/
Effective Date: 2026-03-26
Accessed Date: 2026-08-13

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 0.03
Max: 0.03
Unit: months

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

Local Testing Required

Gmp Required

Yes

HSA fees and turnaround time for medical devices

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

class-b

Class Name

Class B

Risk Level

medium

Pathway

IBR/Expedited/Full Route

Official Timeline

Min: 0
Max: 160
Unit: working-days

Verification Status

official-verified

Official Source

Title: HSA fees and turnaround time for medical devices
Url: https://www.hsa.gov.sg/medical-devices/fees/
Effective Date: 2026-03-26
Accessed Date: 2026-08-13

Realistic Timeline

Min: 3
Max: 9
Unit: months

With Prior Approval

Min: 0.03
Max: 0.03
Unit: months

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

Local Testing Required

Gmp Required

Yes

HSA fees and turnaround time for medical devices

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)
Accepted: Yes
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

HSA medical device registration overview HSA fees and turnaround time for medical devices HSA Priority Review Scheme for medical devices

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

SingaporeUS FDA

Prior approval / evidence record

FDA 510(k)/De Novo/PMA

Authority: FDA 510(k)/De Novo/PMA
Accepted: Yes
Benefit: A single US clearance qualifies the device for the abridged route, and for IBR or ECR-1 if it has also been marketed in the US for three years.
Timeline Savings: Class B 100 working days against 160; Class C 160 against 220; Class D 220 against 310

HSA medical device registration overview HSA fees and turnaround time for medical devices HSA Priority Review Scheme for medical devices

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

class-d

Class Name

Class D

Risk Level

highest

Pathway

IBR/Expedited/Full Route

Official Timeline

Min: 180
Max: 310
Unit: working-days

Verification Status

official-verified

Official Source

Title: HSA fees and turnaround time for medical devices
Url: https://www.hsa.gov.sg/medical-devices/fees/
Effective Date: 2026-03-26
Accessed Date: 2026-08-13

Realistic Timeline

Min: 9
Max: 18
Unit: months

With Prior Approval

Min: 6
Max: 12
Unit: months

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

Local Testing Required

Gmp Required

Yes

HSA fees and turnaround time for medical devices

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

SlovakiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

SloveniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

South AfricaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: A US clearance or approval serves the same role as a recognised-authority approval on the reliance pathways.
Timeline Savings: None published

SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cycles SAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees apply SAHPRA Medical Devices Reliance Guideline (SAHPGL-MD-19 v1, effective 31 October 2025) — reliance pathways for establishment listing, Class B/C/D product registration, ISO 13485 audits and clinical trials; publishes no processing periods SAHPRA FAQs — medical device establishment licence processed in 6-8 weeks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

South KoreaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: No direct recognition
Timeline Savings: None

Government24 service record — medical device manufacture/import notification (의료기기 제조(수입)(변경) 신고), processing period 즉시 / within 3 working hours Government24 service record — medical device manufacture/import certification (의료기기 제조(수입)인증), processing period 5 days at the Korea Institute of Medical Device Safety Information Government24 service record — medical device manufacture/import approval (의료기기제조(수입)허가), processing period 10 / 65 / 80 days by review type Government24 service record — medical device manufacturer/importer establishment licence (의료기기 제조(수입)업 허가), processing period 25 days MFDS e-Medis — approval procedure flowcharts and processing periods (허가 절차)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

SpainUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

SwedenUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

SwitzerlandUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: Documentation can support Swiss application
Timeline Savings: Indirect

Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates Verordnung über klinische Versuche mit Medizinprodukten (KlinV-Mep, SR 810.306), Stand 20. Mai 2025 — Art. 12, 13 and 19 procedural deadlines

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TaiwanUS FDA · EU conformity assessment · Japan MHLW / PMDA

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 140
Max: 140
Unit: days

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
Effective Date: 2026-08-17
Accessed Date: 2026-08-29

Realistic Timeline

Min: 9
Max: 14
Unit: months

With Prior Approval

Min: 6
Max: 9
Unit: months

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

Local Testing Required

Yes

Gmp Required

Yes

TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TaiwanUS FDA · EU conformity assessment · Japan MHLW / PMDA

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

highest

Pathway

Registration with clinical data

Official Timeline

Min: 200
Max: 200
Unit: days

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
Effective Date: 2026-08-17
Accessed Date: 2026-08-29

Realistic Timeline

Min: 12
Max: 18
Unit: months

With Prior Approval

Min: 8
Max: 11
Unit: months

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

Gmp Required

Yes

TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TaiwanUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Fast-track pathway
Timeline Savings: 2-4 months

TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TanzaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction.
Timeline Savings: None published

TMDA Compendium of Guidelines (June 2024) — registration stage clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
Timeline Savings: None published

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO

Prior approval / evidence record

Class 3

class-3

Class Name

Class 3

Risk Level

high

Pathway

Registration

Official Timeline

Min: 250
Max: 250
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

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

Local Testing Required

Yes

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

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

class-2

Class Name

Class 2

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 250
Max: 250
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

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

Local Testing Required

Yes

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

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

class-4

Class Name

Class 4

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 300
Max: 300
Unit: days

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
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

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

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

TunisiaUS FDA

Prior approval / evidence record

US FDA 510(k) / PMA

Authority: US FDA 510(k) / PMA
Accepted: No
Benefit: Named in the ANMPS dossier guide as the conformity evidence for devices declaring conformity to United States legislation — a copy of the 510(k) for class I and class II, and a copy of the PMA for class III. Dossier evidence only, with no shortened review.

CERT — procédure d'obtention du certificat d'homologation: 48 hours for the sample-withdrawal authorisation, then 3, 7 or 21 working days depending on the route, from receipt of a complete dossier ANMPS — procédure de contrôle des dispositifs médicaux au CTI (P-OP2-001-FR), §2.1 à §2.4: AMC tracks, per-importation undertaking, disqualifying changes and the two-year evidentiary window ANMPS — guide d'élaboration d'un dossier technique de dispositifs médicaux (T-OP9-003-FR), §2.1 et §2.2: dossier items and the analyse add-ons

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

TurkeyUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only. Market entry runs on a CE or Turkish notified-body certificate, and a US clearance substitutes for neither.
Timeline Savings: None published

Tıbbi Cihaz Yönetmeliği (Resmî Gazete 2/6/2021 no. 31499 mükerrer, amended 2022, 2023 and 17/8/2024) — Art. 52 conformity assessment routes and Arts. 70, 75 and 78 clinical investigation deadlines

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

United Arab EmiratesUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Required, not optional. EDE lists a certificate of quality conformity or marketing authorisation such as EC, 510(k) or PMA, matched to the device class, among the documents that must accompany the application, alongside a free sale or registration certificate from the country of origin attested by the UAE Embassy. There is no separate recognition route and no second, shorter service.
Timeline Savings: None published — 45 working days is the only figure EDE publishes, and it is the same for every class

UAE EDE — medical device marketing authorization (45 working days)

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
Accepted: Yes
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.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

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
Accepted: Yes
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.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

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
Accepted: Yes
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.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

United KingdomUS FDA · EU conformity assessment · Australia TGA · Health Canada · UK MHRA

Prior approval / evidence record

International Reliance (draft legislation, not in force)

Name: International Reliance (draft legislation, not in force)
Description: Stand-alone route giving a Certificate of International Reliance to devices already authorised by the FDA, Health Canada or the TGA, without UKCA marking; the EU is deliberately excluded pending the separate CE-recognition decision
Timeline Reduction: Not quantified — the draft fixes no review period
Eligibility: Draft Medical Devices (Amendment) Regulations 2026, WTO-notified 8 May 2026
Route 1 lowest-risk: self-declaration and registration only
Routes 2 and 3: certificate from a UK approved body first
Anticipated in force mid-2028

The Medical Devices Regulations 2002 (SI 2002/618, as amended) — reg. 16(1) and 29(1) 60-day clinical investigation notice, and the 210-day Secretary of State opinion on ancillary medicinal substances MHRA — Register medical devices to place on the market (guidance states no processing time)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

United KingdomUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: No
Benefit: Under consultation for future reliance
Timeline Savings: Future TBD

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

UkraineUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only. There is no recognition route for a US clearance and no published period to reduce.
Timeline Savings: None published

Технічний регламент щодо медичних виробів, approved by CMU Resolution No. 753 of 2 October 2013 (current version 30 November 2022) — §18 Class I declaration of conformity, §33 60-day clinical investigation notice, and the 210-day State Expert Centre opinion CMU Resolution No. 759 of 10 June 2026 approving the new Технічний регламент щодо медичних виробів, which transposes EU MDR 2017/745 but is brought into effect only from 31 December 2030

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

UruguayUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.
Timeline Savings: None published

Uruguay Decreto 3/008 Art. 6, 11 y 13 — registro máximo 180 días, validez 5 años, renovación con 90 días para subsanar Uruguay Decreto 428/022 — RTM MERCOSUR GMC 25/21 Parte 3 §8: el plazo de evaluación queda remitido a la legislación de cada Estado Parte

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

UzbekistanUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the FDA dossier is reused but the Annex-1 periods are unchanged.
Timeline Savings: None published

Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

VietnamUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: A US clearance supplies the free sale certificate and the technical evidence the Vietnamese dossier is built on. Decree 98/2021 sets its periods per procedure and class, not by where the device was approved.
Timeline Savings: None published

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 Vietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

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 C

class-c

Class Name

Class C

Risk Level

high

Pathway

Circulation number registration (Ministry of Health)

Official Timeline

Min: 45
Max: 45
Unit: days

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
Effective Date: 2022-01-01
Accessed Date: 2026-08-29

Realistic Timeline

Min: 4
Max: 5
Unit: months

With Prior Approval

Min: 10
Max: 10
Unit: working-days

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

Local Testing Required

Gmp Required

Yes

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

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

class-d

Class Name

Class D

Risk Level

highest

Pathway

Circulation number registration (Ministry of Health)

Official Timeline

Min: 45
Max: 45
Unit: days

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
Effective Date: 2022-01-01
Accessed Date: 2026-08-29

Realistic Timeline

Min: 4
Max: 5
Unit: months

With Prior Approval

Min: 10
Max: 10
Unit: working-days

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

Local Testing Required

Gmp Required

Yes

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

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
Accepted: No
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.

ZAMRA, Guidelines on Application for Grant of Marketing Authorisation of Non In-Vitro Diagnostic Medical Devices for Human Use (version 2, implemented 21 June 2024) — section 1(h) and the definition of 'expedited evaluation'ZAMRA, Guidelines for Grant of Marketing Authorisation of In-Vitro Diagnostic Devices for Human Use (ZAMRA/MA/GUD/0003, version 1.0) — sections 1.9.3 and 1.10.1-1.10.2 Guidelines on the Application for Marketing Authorisation of Condoms — ZAMRA guidance for the preparation and submission of dossiers, §1.12.1-1.12.2 Time Frames (acknowledgement within 14 days; review of a new application within 365 days on a first-come basis)ZAMRA Notice to all Manufacturers, Wholesalers, Retailers and Importers of Non-IVD Medical Devices in Zambia, 10 September 2024 — non-IVD device registration in effect on a phased basis from Class A and Class B, with import controls only for Class C and Class D until further notice

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Prior approvals and evidence for United States (8 records)

United StatesEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: No
Benefit: Clinical data can be leveraged
Timeline Savings: Indirect

FDA 510(k) submission process FDA De Novo classification request FDA PMA review process eCFR 21 CFR 807.81 — 510(k) timing (90 days before introduction)eCFR 21 CFR 814.40 — PMA review time (180 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesUS FDA

Prior approval / evidence record

510(k)

510-k

Class Name

510(k)

Risk Level

medium

Pathway

Premarket Notification

Official Timeline

Min: 90
Max: 90
Unit: days

Verification Status

official-verified

Official Source

Title: FDA 510(k) submission process
Url: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
Accessed Date: 2026-08-13

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 6
Max: 8
Unit: months

Prior Approval Benefits

Prior 510(k) as predicate
Pre-Sub meeting

Notes

FDA MDUFA decision goal: 90 FDA days, excluding days on hold for an Additional Information request
The end-to-end planning range includes preparation and regulator questions

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

FDA 510(k) submission process

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesSource authority not specified

Prior approval / evidence record

Breakthrough Device Designation

Name: Breakthrough Device Designation
Description: Priority review for innovative devices addressing unmet needs
Timeline Reduction: 1-2 years faster than standard PMA
Eligibility: Life-threatening condition
Irreversibly debilitating disease
Breakthrough technology

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesUS FDA

Prior approval / evidence record

Prior 510(k)

Authority: Prior 510(k)
Accepted: Yes
Benefit: Use as predicate device
Timeline Savings: 3-6 months

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesUS FDA

Prior approval / evidence record

Pre-Submission (Q-Sub)

Name: Pre-Submission (Q-Sub)
Description: FDA meeting to align requirements before submission
Timeline Reduction: 2-3 months saved by avoiding rejections
Eligibility: All device classes
Recommended for complex devices

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesSource authority not specified

Prior approval / evidence record

PMA

pma

Class Name

PMA

Risk Level

highest

Pathway

Premarket Approval

Official Timeline

Min: 180
Max: 180
Unit: days

Verification Status

official-verified

Official Source

Title: eCFR 21 CFR 814.40 — PMA review time (180 days)
Url: https://www.ecfr.gov/current/title-21/part-814/subpart-C/section-814.40
Accessed Date: 2026-08-25

Realistic Timeline

Min: 48
Max: 96
Unit: months

With Prior Approval

Min: 48
Max: 72
Unit: months

Prior Approval Benefits

Breakthrough Device Designation

Notes

The statutory PMA review period is 180 days after filing (21 CFR 814.40(a))
The planning range includes clinical evidence development and submission preparation

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

eCFR 21 CFR 814.40 — PMA review time (180 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesMDSAP

Prior approval / evidence record

MDSAP

Authority: MDSAP
Accepted: Yes
Benefit: Substitutes routine FDA inspections
Timeline Savings: 1-2 months

Maintained reference · planning ranges remain estimates · reviewed 2026-08-25

United StatesNMPA

Regulatory reference

NMPA certificate does not replace applicable US import requirements

reliance.china-nmpa-no-recognition-route

Fact-level verified

Statement: FDA requires foreign manufacturers to meet applicable US requirements, including establishment registration, device listing, quality-system, labelling and reporting requirements, a US agent, and premarket notification or approval unless exempt. An NMPA certificate alone does not discharge these obligations. Determine the FDA class and submission/exemption separately.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: usa
China Classes In Scope: All NMPA classes -> all FDA classes
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: null
Target Decision Retained: null

Conditions

This is a bounded finding about ordinary import requirements, not a finding that foreign clinical/technical evidence has no possible use.
Premarket submission depends on the device and any applicable exemption.

Independent primary-page review 2026-09-15. The earlier purported quote about recognising no foreign authorisations was not on the cited page and has been removed.

Related structured datasets

Classification systems · 1 record

Open FDA Classes I, II, and III. →

usa:medical-device

Jurisdiction Id

usa

Domains

medical-device
ivd

Name

FDA Classes I, II, and III.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

FDA

Official Domains

fda.gov

Source Status

official-source-verified

Source Title

FDA — Classify Your Medical Device (classification and classification panels)

Source Url

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Verified On

2026-08-25

Source Supports

class-axis
classification-rules

Notes

Class I general controls, Class II general and special controls, Class III general controls plus premarket approval; determined by intended use and indications for use; approximately 1,700 generic device types across 16 medical specialty panels.
Approximately 572 generic types (about 74% of Class I devices) are exempt from 510(k); exemption limitations are stated in the classification regulations at 21 CFR parts 862-892, section .9 of each part.
Classification panels are codified in 21 CFR parts 862-892; a formal device classification determination can be requested from FDA under FD&C 513(g) (user fee applies; small business discount available).

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open United States registration →

Country

United States

Jurisdiction Id

usa

Country Code

Flag

🇺🇸

Regulator

Food and Drug Administration

Regulator Abbrev

FDA

Region

americas

Tier

Risk Classification

3-class with pathways (I, II, III)

Classes

Id
510-k
Class Name
510(k)
Risk Level
medium
Pathway
Premarket Notification
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
FDA 510(k) submission process
Url
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
Accessed Date
2026-08-13
Realistic Timeline
Min
6
Max
12
Unit
months
With Prior Approval
Min
6
Max
8
Unit
months
Prior Approval Benefits
Prior 510(k) as predicate
Pre-Sub meeting
Notes
FDA MDUFA decision goal: 90 FDA days, excluding days on hold for an Additional Information request
The end-to-end planning range includes preparation and regulator questions
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
de-novo
Class Name
De Novo
Risk Level
medium
Pathway
De Novo Classification
Official Timeline
Min
150
Max
150
Unit
days
Verification Status
official-verified
Official Source
Title
FDA De Novo classification request
Url
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
Accessed Date
2026-08-13
Realistic Timeline
Min
8
Max
15
Unit
months
Notes
For novel devices without a legally marketed predicate
FDA review clock: 150 review days per the MDUFA decision goal, excluding time on hold (review days run between FDA receipt and decision)
FDA pages still label the goal under MDUFA IV; MDUFA V is in force for FY2026
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
pma
Class Name
PMA
Risk Level
highest
Pathway
Premarket Approval
Official Timeline
Min
180
Max
180
Unit
days
Verification Status
official-verified
Official Source
Title
eCFR 21 CFR 814.40 — PMA review time (180 days)
Url
https://www.ecfr.gov/current/title-21/part-814/subpart-C/section-814.40
Accessed Date
2026-08-25
Realistic Timeline
Min
48
Max
96
Unit
months
With Prior Approval
Min
48
Max
72
Unit
months
Prior Approval Benefits
Breakthrough Device Designation
Notes
The statutory PMA review period is 180 days after filing (21 CFR 814.40(a))
The planning range includes clinical evidence development and submission preparation
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
Breakthrough Device Designation
Description
Priority review for innovative devices addressing unmet needs
Timeline Reduction
1-2 years faster than standard PMA
Eligibility
Life-threatening condition
Irreversibly debilitating disease
Breakthrough technology
Name
Pre-Submission (Q-Sub)
Description
FDA meeting to align requirements before submission
Timeline Reduction
2-3 months saved by avoiding rejections
Eligibility
All device classes
Recommended for complex devices

Prior Approvals

Authority
EU CE Mark
Accepted
No
Benefit
Clinical data can be leveraged
Timeline Savings
Indirect
Authority
Prior 510(k)
Accepted
Yes
Benefit
Use as predicate device
Timeline Savings
3-6 months
Authority
MDSAP
Accepted
Yes
Benefit
Substitutes routine FDA inspections
Timeline Savings
1-2 months

Key Requirements

US Agent (for foreign manufacturers)
Establishment Registration
Device Listing
QSR/21 CFR 820 compliance
eSTAR submission (mandatory Oct 2025)

Local Rep Required

Yes

Local Rep Name

US Agent

Mdsap Accepted

Yes

Mdsap Benefit

Substitutes routine FDA inspections

Registration Validity

Annual registration renewal

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
FDA 510(k) submission process
Url
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
Accessed Date
2026-08-13
Title
FDA De Novo classification request
Url
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
Accessed Date
2026-08-13
Title
FDA PMA review process
Url
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
Accessed Date
2026-08-13
Title
eCFR 21 CFR 807.81 — 510(k) timing (90 days before introduction)
Url
https://www.ecfr.gov/current/title-21/part-807/subpart-E/section-807.81
Accessed Date
2026-08-25
Title
eCFR 21 CFR 814.40 — PMA review time (180 days)
Url
https://www.ecfr.gov/current/title-21/part-814/subpart-C/section-814.40
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Process

Template Id

usa

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Device Classification
Description
Determine FDA device class (I, II, or III) and identify predicate device for 510(k) submissions.
Duration
2-4 weeks
Icon
🏷️
Step
2
Title
Pre-Submission Meeting
Description
Optional Q-Sub meeting with FDA to discuss testing strategy and submission requirements.
Duration
2-3 months
Icon
💬
Step
3
Title
Testing & Documentation
Description
Complete biocompatibility, EMC, performance testing. Prepare technical file and 510(k) summary.
Duration
3-6 months
Icon
🧪
Step
4
Title
510(k) Submission
Description
Submit 510(k) application to FDA via eCopy or eSTAR. Pay user fee (currently $22,381 for small business).
Duration
1 day
Icon
📤
Step
5
Title
FDA Review
Description
FDA conducts substantive review. Average 160-176 calendar days. May issue Additional Information requests.
Duration
90-180 days
Icon
⚙️
Step
6
Title
510(k) Clearance
Description
FDA issues clearance letter (SE = Substantially Equivalent). Device can be marketed in the USA.
Duration
1 day
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open United States fees →

Country

United States

Jurisdiction Id

usa

Country Code

Authority

FDA

Low Risk Local

Min: 13785
Max: 28653
Currency: USD
Per Product: No

High Risk Local

Min: 22286
Max: 636732
Currency: USD
Per Product: No

Details

Id
annual-establishment-registration
Item
Annual Establishment Registration
Currency
USD
Amount Local
13785
Amount Local Formatted
$13,785
Frequency
Annual per facility
Notes
FY2027 (October 1, 2026 – September 30, 2027)
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
510-k-review-standard
Item
510(k) Review - Standard
Currency
USD
Amount Local
28653
Amount Local Formatted
$28,653
Frequency
Per submission
Notes
FY2027; Class II typically
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
510-k-review-small-business
Item
510(k) Review - Small Business
Currency
USD
Amount Local
7163
Amount Local Formatted
$7,163
Frequency
Per submission
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
513-g-request-standard
Item
513(g) Request - Standard
Currency
USD
Amount Local
8596
Amount Local Formatted
$8,596
Frequency
Per request
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
513-g-request-small-business
Item
513(g) Request - Small Business
Currency
USD
Amount Local
4298
Amount Local Formatted
$4,298
Frequency
Per request
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
pma-pdp-pmr-bla-standard
Item
PMA/PDP/PMR/BLA - Standard
Currency
USD
Amount Local
636732
Amount Local Formatted
$636,732
Frequency
Per submission
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
pma-pdp-pmr-bla-small-business
Item
PMA/PDP/PMR/BLA - Small Business
Currency
USD
Amount Local
159183
Amount Local Formatted
$159,183
Frequency
Per submission
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
de-novo-review-standard
Item
De Novo Review - Standard
Currency
USD
Amount Local
191020
Amount Local Formatted
$191,020
Frequency
Per submission
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
de-novo-review-small-business
Item
De Novo Review - Small Business
Currency
USD
Amount Local
47755
Amount Local Formatted
$47,755
Frequency
Per submission
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
panel-track-supplement-standard
Item
Panel-track Supplement - Standard
Currency
USD
Amount Local
509386
Amount Local Formatted
$509,386
Frequency
Per supplement
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
panel-track-supplement-small-business
Item
Panel-track Supplement - Small Business
Currency
USD
Amount Local
127347
Amount Local Formatted
$127,347
Frequency
Per supplement
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
180-day-supplement-standard
Item
180-Day Supplement - Standard
Currency
USD
Amount Local
95510
Amount Local Formatted
$95,510
Frequency
Per supplement
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
180-day-supplement-small-business
Item
180-Day Supplement - Small Business
Currency
USD
Amount Local
23878
Amount Local Formatted
$23,878
Frequency
Per supplement
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
real-time-supplement-standard
Item
Real-Time Supplement - Standard
Currency
USD
Amount Local
44571
Amount Local Formatted
$44,571
Frequency
Per supplement
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
real-time-supplement-small-business
Item
Real-Time Supplement - Small Business
Currency
USD
Amount Local
11143
Amount Local Formatted
$11,143
Frequency
Per supplement
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
bla-efficacy-supplement-standard
Item
BLA Efficacy Supplement - Standard
Currency
USD
Amount Local
636732
Amount Local Formatted
$636,732
Frequency
Per supplement
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
bla-efficacy-supplement-small-business
Item
BLA Efficacy Supplement - Small Business
Currency
USD
Amount Local
159183
Amount Local Formatted
$159,183
Frequency
Per supplement
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
30-day-notice-standard
Item
30-Day Notice - Standard
Currency
USD
Amount Local
10188
Amount Local Formatted
$10,188
Frequency
Per notice
Notes
FY2027
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
30-day-notice-small-business
Item
30-Day Notice - Small Business
Currency
USD
Amount Local
5094
Amount Local Formatted
$5,094
Frequency
Per notice
Notes
FY2027; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
class-iii-periodic-reporting-standard
Item
Class III Periodic Reporting - Standard
Currency
USD
Amount Local
22286
Amount Local Formatted
$22,286
Frequency
Annual
Notes
FY2027; PMAs, PDPs, and PMRs
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current
Id
class-iii-periodic-reporting-small-business
Item
Class III Periodic Reporting - Small Business
Currency
USD
Amount Local
5572
Amount Local Formatted
$5,572
Frequency
Annual
Notes
FY2027; PMAs, PDPs, and PMRs; FDA-qualified small businesses
Verification Status
official-verified
Source Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Source Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Source Effective Date
2026-10-01
Verified On
2026-10-19
Amount Status
exact-current

Notes

FY2027 amounts apply from 1 October 2026 through 30 September 2027 (Federal Register 2026-15335).
Establishment registration is facility-level; submission fees are application-level.
510(k)s reviewed by an FDA-accredited third-party reviewer incur no FDA user fee.

Last Updated

2026-10-19

Verification Status

official-verified

Official Sources

Title
FDA FY2027 MDUFA fees (Federal Register 2026-15335, Table 5)
Url
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
Effective Date
2026-10-01
Accessed Date
2026-10-19

Reviewed On

2026-10-19

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open United States certifications →

Slug

usa

Market

United States

Confidence

high

Schemes

Id
fda-recognized-electrical-emc-standards-evidence
Name
FDA recognized electrical/EMC standards evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Source Binding
unresolved
Id
fcc-certification
Name
FCC Certification
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Intentional Radiator Or Certification Route Equipment
Source Urls
https://docs.fcc.gov/public/attachments/DA-24-415A1.pdf
Source Binding
candidate
Id
fcc-supplier-s-declaration-of-conformity
Name
FCC Supplier's Declaration of Conformity
Category
emc
Status
Mandatory If Feature
Object
Equipment On Sdoc Route
Source Urls
https://docs.fcc.gov/public/attachments/DA-24-415A1.pdf
Source Binding
candidate
Id
fda-electronic-product-radiation-control
Name
FDA Electronic Product Radiation Control
Category
Non Ionizing Radiation
Status
Mandatory If Feature
Object
Radiation Emitting Electronic Product
Source Urls
https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-questions
Source Binding
candidate
Id
state-radiation-installation-use-licensing
Name
State radiation installation/use licensing
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Facility Or Operator
Source Binding
unresolved
Id
nrtl-listing
Name
NRTL listing
Category
General Electrical Components
Status
Voluntary Or Procurement
Object
Workplace Or Ahj Equipment
Note
Not a generic federal medical-device premarket certificate.
Source Binding
unresolved
Id
legal-metrology-ntep
Name
Legal metrology/NTEP
Category
Legal Metrology
Status
Mandatory If Feature
Object
Regulated Commercial Measuring Instrument
Source Binding
unresolved

Official Sources

Authority
FDA
Topic
radiation-emitting medical device applicability
Url
https://www.fda.gov/medical-devices/classify-your-medical-device/does-product-emit-radiation
Authority
FDA
Topic
Electronic Product Radiation Control market FAQ
Url
https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-questions
Authority
FCC
Topic
equipment authorization program
Url
https://docs.fcc.gov/public/attachments/DA-24-415A1.pdf
Authority
FCC
Topic
equipment authorization knowledge database
Url
https://apps.fcc.gov/oetcf/kdb/index.cfm