A sponsor, investigator, or person acting for either may not promote or test market an investigational device before FDA approves it for commercial distribution, commercialize it beyond recovery of specified costs, or represent that it is safe or effective for the investigational purpose.
Conditions
This fact is limited to investigational devices governed by 21 CFR Part 812; it is not a complete statement of every U.S. advertising rule.
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
510(k) clearances, De Novo grants, and PMA approvals are not annually renewed product authorizations: continuing lawful marketing is maintained through annual establishment registration and listing (21 CFR 807.22) and, for PMA holders, periodic reports under 21 CFR 814.84 plus supplements under 21 CFR 814.39 when changes occur.
Baseline said 'annual reports'; the regulation (814.84) says 'periodic report', with the interval set at approval. FDA guidance confirms FDA issues no device registration certificates (see reliance fact).
There is no product-certificate expiry for clearances/approvals; what lapses is establishment registration - registration must be submitted each year between October 1 and December 31 (even with no changes) to remain active, and failure to maintain registration/listing or required PMA obligations disrupts lawful marketing.
Establishments subject to 21 CFR Part 807 renew registration and listing for each fiscal year during October 1 - December 31 (21 CFR 807.22); PMA holders additionally file periodic reports and supplements as applicable.
Authority & regime
Which authority and binding regime govern this product, task, and date?
The U.S. Food and Drug Administration (FDA), through the Center for Devices and Radiological Health (CDRH), is the competent authority regulating medical devices and radiation-emitting medical products marketed in the United States under the Federal Food, Drug, and Cosmetic Act.
Baseline cited an unidentified fda.gov document (media/157074); substance re-verified on the FDA importing guidance page.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
For changes to a 510(k)-cleared device there is no supplement mechanism: the outcomes are either internal documentation under the manufacturer's change-control procedures (when 21 CFR 807.81(a)(3) is not triggered) or submission of a new 510(k); PMA-side changes instead use the supplement regime of 21 CFR 814.39.
Corrected: baseline outcome list included 'prior_approval_amendment_or_variation', which does not exist for 510(k); the 510(k) outcomes are internal documentation or a new 510(k).
A new 510(k) is required for (i) a change or modification in the device that could significantly affect the safety or effectiveness and (ii) a major change or switch in the device's intended use (21 CFR 807.81(a)(3)(i)-(ii)); PMA changes are handled through the supplement regime of 21 CFR 814.39 or periodic reports where no supplement is required.
PMA changes follow 21 CFR 814.39: a supplement is required for changes affecting safety or effectiveness (indications, labeling, manufacturing facilities/methods, design, etc.); qualifying changes may use 30-day supplements or 'changes being effected' supplements; certain manufacturing changes may proceed on a 30-day notice (distribution 30 days after FDA receives the notice unless FDA objects, and inadequate notices become 135-day supplements); changes with no safety/effectiveness impact may be documented in periodic reports, and changes under an FDA-approved Predetermined Change Control Plan (FD&C 515C) require no supplement.
Clinical investigation & performance
Which clinical or IVD performance evidence or study is required and accepted?
Clinical data submitted in a 510(k) must meet 21 CFR 807.87(j); for clinical investigations conducted outside the United States, the submission must include the investigator and study-site information required by 21 CFR 812.28 (21 CFR 807.87(j)(2)).
PMA clinical investigations (21 CFR 814.20(b)(6)) must comply with 21 CFR parts 50 (informed consent), 56 (IRBs), and 812 (IDE); investigations conducted outside the United States must include the information required by 21 CFR 812.28, and financial interests of investigators must be disclosed under 21 CFR part 54.
Device definition & scope
Is the product a device, IVD, accessory, software, or borderline product locally?
FD&C Act 201(h)(1) defines a device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, that is intended for use in diagnosis of disease or other conditions, or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and that does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized.
In vitro reagents (IVDs) and radiation-emitting products with medical claims are devices; software functions (including mobile medical apps) that meet the 201(h) definition are devices; software functions excluded pursuant to FD&C Act section 520(o) are not devices.
Dossier requirements
Which evidence, local deltas, formats, and signatures are required?
A 510(k) must contain the items of 21 CFR 807.87(a)-(m), including device description, proposed labels and labeling, substantial equivalence discussion, a 510(k) summary or statement (807.87(h)), truthfulness and financial certifications, and clinical data meeting 807.87(j) - including for studies conducted outside the United States the investigator and study-site information required by 21 CFR 812.28 (807.87(j)(2)).
A PMA (21 CFR 814.20) must contain the items (a)-(h): full report of investigations, nonclinical laboratory studies, description of methods, facilities and controls, referenced information, samples or their location, proposed labeling, and environmental impact; applications from foreign applicants require the signature of a US resident representative; clinical investigations must comply with 21 CFR parts 50, 56, and 812, with 21 CFR 812.28 information for studies conducted outside the US and financial certification/disclosure under 21 CFR part 54; applicants must also submit status reports every 3 months while the PMA is pending.
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
A foreign establishment must designate a single U.S. agent (21 CFR 807.40) who must reside or maintain a place of business in the US (no PO boxes or answering services); the agent acts only as FDA's communication liaison - assisting communications, answering questions, and helping schedule inspections - and has no responsibility for adverse-event reporting under 21 CFR part 803 or for submitting 510(k)s under 21 CFR 807 subpart E. The initial importer (21 CFR 807.3(g)) is a distinct establishment role with its own registration, MDR, recall-reporting, and device-tracking duties.
Changes in the U.S. agent's name, address, or phone number must be reported to FDA within 10 business days of the change (21 CFR 807.40(b)(3)); when a new agent is designated, FDA sends an automated consent-confirmation email, and if the agent denies consent or does not respond within 10 business days the official correspondent/owner-operator must designate a new U.S. agent; no fresh establishment registration is required for an agent change.
Corrected: baseline described only a FURLS DRM update path; the binding deadline is the 10-business-day change-reporting rule of 807.40(b)(3), and the consent-email no-response window (also 10 business days) comes from FDA's U.S. Agents page.
Establishment, import & distribution
Which establishment licences, importer permissions, and distribution controls apply?
Devices offered for import are reviewed by FDA at entry (entry data transmitted via CBP's ACE system); foreign manufacturers must meet FDA registration and listing, 510(k)/PMA, QMS, US agent, labeling, MDR, and inspection requirements; the initial importer (21 CFR 807.3(g)) must register and comply with 21 CFR parts 803 (MDR), 806 (corrections and removals), and 821 (tracking); a finished device not legally marketed in the US generally may not be imported (exceptions include import-for-export and personal importation of up to a 90-day supply).
Initial registration and listing must be submitted within 30 days after an establishment enters into an operation requiring registration; annual registration is required for all establishments for each fiscal year during the period beginning October 1 and ending December 31, even if no changes occurred; foreign establishments must register before exporting devices to the US and must wait for 510(k)/PMA clearance or approval before listing such devices.
The fiscal year runs October 1 - September 30; FDA fiscal-year registration keeps the establishment active through the end of the calendar year (FDA When to Register and List page).
Label, IFU & language
Which label and IFU elements, languages, symbols, and translation controls apply?
Legal basis: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) - device definition in section 201(h), classification in section 513, PMA in section 515; implementing regulations codified in 21 CFR parts 800-898, including device classification panels in 21 CFR parts 862-892 and premarket pathways in 21 CFR part 807 (510(k)), part 860 (De Novo), and part 814 (PMA).
eCFR current as of 2026-08-21 was used for the CFR citations.
Manufacturer PMS
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
The holder of an approved PMA must comply with 21 CFR part 803 (MDR) and, unless FDA specifies otherwise, submit periodic reports that identify changes described in 21 CFR 814.39(a), include a summary and bibliography of new safety and effectiveness information, document changes made under exceptions (21 CFR 801.128, 809.11), and identify device identifiers in use and discontinued (21 CFR 814.84).
Official forms & portals
Which current form, portal, account, and submission package must be used?
Since October 1, 2025, all De Novo request submissions, unless exempted, must be submitted as electronic submissions using eSTAR (Electronic Submission Template and Resource).
Effective from 2025-10-01
The eSTAR mandates for 510(k) (since October 1, 2023) and small business requests via CDRH Portal (since November 1, 2024) were seen only in search snippets this cycle and are not asserted here.
QMS, audit & inspection
Which QMS, audit, inspection, and certificate scope is accepted or required?
FDA may accept MDSAP audit reports as a substitute for routine Agency inspections of medical device manufacturers; firms with activities under the Electronic Product Radiation Control (EPRC) provisions of the FD&C Act remain subject to FDA inspection for those EPRC activities.
Recall, FSCA & market surveillance
Which recall, FSCA, notice, and authority-coordination duties apply?
Manufacturers and importers must report to FDA a correction or removal of a device undertaken to reduce a health risk or to remedy a violation that may present a health risk, within 10 working days of initiating the correction or removal (21 CFR 806.10(a)-(b)); reports must include the UDI (806.10(c)(5)), and duplicate reporting is not required where another party has reported (806.10(f)).
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
The De Novo classification request (FD&C 513(f)(2), 21 U.S.C. 360c(f)(2)) is the route for novel devices of low-to-moderate risk without a valid predicate; it may be submitted after a 510(k) Not Substantially Equivalent decision or directly to FDA; content follows 21 CFR 860.220 and acceptance review 860.230; a grant (21 CFR 860.260) establishes a new classification, while a declined request leaves the device in Class III.
Market-access routes: (1) 510(k)-exempt Class I/II devices need only establishment registration and listing; (2) 510(k) premarket notification under 21 CFR 807 subpart E for most Class II and some Class I devices; (3) De Novo classification request under FD&C 513(f)(2) / 21 CFR part 860 for novel low-to-moderate-risk devices; (4) Class III PMA under 21 CFR part 814. Every route additionally requires establishment registration and listing under 21 CFR 807 subparts A and B.
Baseline source (fda.gov/media/157074, unidentified document) replaced with the FDA classification guidance page.
510(k) premarket notification timing and change trigger
A premarket notification must be submitted to FDA at least 90 days before the person introduces the device into commercial distribution; a new 510(k) is required for a change or modification that could significantly affect safety or effectiveness, or for a major change in intended use.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
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 (229 records)
Conformity of a device with the essential requirements is confirmed by issuance of the CE marking document or, equally, by an FDA certification document; for CE the manufacturer follows the conformity procedure set in the technical rules adopted by Council of Ministers decision.
Conditions
CE marking is not required for clinical-investigation devices and custom-made devices (Art. 17(3)).
The original 2014 text accepted only CE marking; FDA certification was added by Law 21/2020 (in force 2020).
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
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
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
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.
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.
AustraliaUS FDA · EU conformity assessment · MDSAP
Prior approval / evidence record
Class III — ARTG inclusion
Id
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
No
Local Testing Required
No
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
AustraliaUS FDA · EU conformity assessment · MDSAP
Prior approval / evidence record
Class IIb — ARTG inclusion
Id
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
No
Local Testing Required
No
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
AustraliaUS FDA · EU conformity assessment · MDSAP
Prior approval / evidence record
Class IIa — ARTG inclusion
Id
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
No
Local Testing Required
No
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
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.
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.
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."
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."
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.
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
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
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.)."
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."
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.
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.
The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today.
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 document is an unpublished draft: its cover reads '(Published on __________, 2026)' and the companion Fees Regulations read 'Made this ___ day of ___, 2026'.
BoMRA's press release of 31 August 2026 states the regulations are 'both still in draft form and open for stakeholder input'.
The 2025 Act on which the draft depends has its commencement 'ON NOTICE'.
Draft reg. 17(3) preserves BoMRA's power to request Botswana-specific information, impose local conditions, conduct independent assessment and take independent regulatory action.
Status is official-source-verified for the text of the draft; the conditions and the reliance-recognition value record that the instrument is not in force. This is the deliberate 'do not upgrade a policy aspiration into an operating route' fact for Botswana. The draft would also give registration a five-year term (draft reg. 20(1)).
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.
For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.
Source Approval
Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Each class has its own threshold: Class B - one RRA, SRA or WHO approval; Class C - one SRA or WHO approval plus 3 years marketed in an SRA jurisdiction; Class D - two RRAs including one SRA plus 3 years marketed.
The three-year safety test is defined as no reported deaths, no reported serious deterioration in the state of health of any person, and no open field safety corrective actions including recalls at the point of submission.
A prior rejection or withdrawal by a foreign jurisdiction for quality, performance/efficacy or safety reasons disqualifies the abridged route.
The RRA list itself is not published in the guideline; it lives in BOMRA-ER-MED-Policy No.1, which BoMRA's site did not serve.
Regulatory layer is premarket_review: the abridged route shortens the assessment, it does not dispense with BoMRA's registration.
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
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)
In at least one Ministry of Health procurement, equipment must comply with one of five named international safety standards — US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. This is a tender technical requirement for the supply of equipment, not a market-authorisation recognition rule: it creates no registration pathway, shortens no review, and does not name Japan PMDA, Korea MFDS or China NMPA.
Source Approval
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
Edge Type
Procurement Admission
Market Access Strength
Evidence Only
Regulatory Layer
procurement
Local Application Required
No
Target Decision Retained
No
Conditions
The requirement is a specification in Tender Reference No. KK/179/2025/JPR/(TC), Annex 5A (Technical and Procurement Requirement), for the provision of automated peritoneal dialysis services to the Department of Renal Services.
It is the only place found in any official Brunei document where foreign approvals are named; it must not be read as a registration or recognition mechanism.
The accompanying requirement is that the equipment 'must also comply with relevant AAMI Standards such as UL2601 and IEC601-1'.
Verbatim from the tender document (44 pages, text layer, retrieved HTTP 200, 629,727 bytes): 'The equipment must comply to either one of the five international safety standards namely; US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. The equipment must also comply with relevant AAMI Standards such as UL2601 and IEC601-1.' Searches of the document for 'PMDA', 'MFDS', 'NMPA', 'Korea' and 'China' return no matches, which is why the sourceApproval string does not name those authorities. The bounded claim recorded in value is deliberately limited to what this one procurement states.
Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72-hour foreign risk notification duty.
Conditions
Applies to Class II-IV licence holders and importing MDEL holders.
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
For imported devices, a certificate from the competent authority of the country of origin stating the product is authorized for production or marketing there is required; if the product is not used in the country of origin, a free-sale certificate from a reference country (EU, United States, Canada, Japan, Australia) or a country with a mutual recognition agreement is required instead.
Conditions
Applies to imported devices seeking registro sanitario or permiso de comercialización.
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
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).
Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.
Conditions
Foreign registration must be current at the time of the Cuban application (Proceder B requirement).
Effective from 2016-07-29
Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.
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.
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.
An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure.
Source Approval
WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico)
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Eligibility runs to 'nuevos registros sanitarios y renovaciones' (new registrations and renewals of existing registrations) of imported products.
The prior authorisation is evidenced by a Certificate of Free Sale plus a Certificate of Good Manufacturing Practices issued by the listed authority; the rest of the legally established requirements still apply.
A product that one of the listed authorities has refused to authorise may not use the simplified procedure (CUARTO).
Products identified as having quality failures in post-market monitoring or serious safety reports are excluded (PÁRRAFO of SEGUNDO).
Resolution in force from 1 April 2016 (SEXTO).
The resolution is drafted around the medicines framework; the MSP service listing for the simplified procedure expressly covers 'Productos Sanitarios' with its own fee, but the MSP listing shows Productos Sanitarios under the renewal modality only, while the fee table lists them under both new and renewal — the scoping for new device registrations is therefore stated by the MSP rather than by the resolution text itself.
Effective from 2016-04-01
Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.
From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high-vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device-scope authorisation and ARCSA risk classification I-IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.
Conditions
Apply both authority conditions together; the route is not in force before 2027-01-28.
Maximum 100 references for DMI/DMNI/DMA and 50 for IVD; the remaining requirements in Articles 33-34 still apply.
Effective from 2027-01-28
Recognition opens a simplified procedure; it is not a full reliance approval.
For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high-vigilance agency, or from an IMDRF member country; if the CLV or the product-owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.
Conditions
Applies to imported devices; CLV must state commercial name, product codes/references, manufacturer and manufacturing sites.
Effective from 2027-01-28
Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).
EgyptUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · Norway · New Zealand · Ireland · Iceland
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
A CFG certificate issued by USFDA replaces the free sale certificate and the CE certificate; the ISO 13485 certificate is also waived if the FDA certificate shows the plant complied with current GMP requirements. 510(k) clearance supports Class II and PMA supports Class III. CFG legalization is waived when EDA can verify device data via FDA CDRH export-certificate validation and 510(k)/PMA databases.
Conditions
Applies to devices holding valid USFDA certificates.
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)
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.
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.
FDA Ghana grants market authorisation for medical devices using reliance on regulatory decisions of well-resourced National Regulatory Authorities, exchanging scientific assessments, safety data and inspection reports.
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
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.
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
Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.
Conditions
Applies to Class II/III/IV GMD listings.
The same eight jurisdictions apply to Class B/C/D IVD listings under GN-06.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
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.
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.
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))
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
Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.
Conditions
United Kingdom added to the rule 36(3) list by G.S.R. 174(E) w.e.f. 04.03.2022.
Devices from other countries: Class C/D need Indian clinical investigation (rule 36(4)); Class A/B need published safety/performance data or country-of-origin investigation plus FSC (rule 36(5)).
Effective from 2018-01-01
G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.
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
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
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.
IsraelUS FDA · Australia TGA · Health Canada · EU conformity assessment
Health Canada medical device licences are among the accepted reference approvals for AMAR registration (listed in the official registration guidelines alongside FDA, CE and TGA); Canadian registrations in principle have no expiry, so a validity of 5 years from the submission date is entered in the approvals table when filing.
Conditions
No-expiry approvals are assigned 5-year validity from submission.
Health Canada listed as accepted approval per the AMAR registration guidelines PDF.
US FDA marketing authorizations (e.g. 510(k)) are primary reference evidence; like other no-expiry approvals, 510(k) clearances are assigned 5-year validity from the submission date in the approvals table. Where EU and US classifications differ, the FDA classification takes precedence, provided the product meets the conditions of the chosen track.
Conditions
FDA precedence applies when EU/US classifications differ.
Devices already approved in a country with an approval system of equivalent standard to Japan's qualify for priority add-on processing (faster review and surveys ahead of other products, Art. 23-2-5(9)); the only designated country is the United States.
Conditions
Identical device already approved in the US (non-veterinary use); emergency/conditional approvals excluded.
US-only reliance edge for expedited review; does not create automatic approval.
PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities while retaining authority for final approval. Eligible reference mechanisms listed include WHO Prequalification Programme / Collaborative Registration Procedure, Stringent Regulatory Authorities (US FDA, EMA, Health Canada, Swissmedic, PMDA Japan, TGA Australia) and the East African Community Medicines Regulatory Harmonization (EAC-MRH).
Conditions
Reliance approaches for devices are adapted to device class and public health impact.
Local application still required; national decision retained.
KenyaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Saudi Arabia
The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).
Conditions
Used to qualify devices for abridged, expedited (EBR/ECR/EDR) and immediate (IBR) routes.
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.
Latvia 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 Latvian market: the Latvian pre-market notification procedure (paziņošanas procedūra) requires a copy of the EU declaration of conformity and copies of valid notified-body certificates issued under Regulation (EU) 2017/745, and no Latvian or Union instrument names a third-country approval as a basis for market access.
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
The only non-CE pre-market route in Latvian law is the exceptional national authorisation under MK noteikumi Nr. 461 paragraphs 35-38 (public health or patient safety need, no conforming alternative), which is assessed against MDR Annex I essential requirements, harmonised standards and test results, not against any foreign approval.
Class I devices that are not placed on the market sterile and have no measuring function are not subject to the paragraph 9 notification at all, but still require conformity with Regulation (EU) 2017/745 (source res-lv-mdr, Article 5(1) and Article 52(1)).
The notification route for in vitro diagnostic devices is the parallel procedure in MK noteikumi Nr. 582 paragraph 8 (source res-lv-mk582).
Effective from 2023-08-23
Latvian source; translation: '9. Persons who in the territory of the Republic of Latvia start placing on the market class IIa, IIb and III medical devices shall submit to the agency a completed notification form (Annex 1) and attach a copy of the EC (EU) declaration of conformity, as well as copies of valid certificates issued by notified bodies (hereinafter - the notification procedure).' The excerpt shows that the only Latvian pre-market procedure is conditioned on EU documentation, i.e. on CE marking; the Union-side rule that a device may be placed on the market only if it complies with the Regulation is evidenced by the separately declared source res-lv-mdr (Article 5(1), Article 52(1)). No Latvian or EU instrument consulted names FDA, PMDA, MFDS or NMPA approval as a market-access basis.
The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre-2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and class IIb implantable devices other than certain well-established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit because it is not a Directive certificate.
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
Benefiting devices must continue to comply with the applicable Directive, have no significant changes in design and intended purpose, present no unacceptable risk, and the manufacturer must have put in place an MDR Article 10(9) quality management system by 26 May 2024 and lodged a notified-body application with a written agreement signed by 26 September 2024 (Article 120(3c) as inserted by Regulation (EU) 2023/607).
Regulation (EU) 2023/607 also deleted the sell-off deadline, so devices lawfully placed on the market during the transitional period may continue to be made available.
A Commission proposal of 16 December 2025 to revise the MDR and IVDR was pending when checked and is not reflected in the dates above.
Effective from 2023-03-20
English source. The excerpt is quoted from the amending act; the inserted text uses the defined terms of Regulation (EU) 2017/745 / 93/42/EEC / 90/385/EEC and names no third-country approval.
LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA
Prior approval / evidence record
Clinical evaluation is not re-performed in Lebanon; the work of GHTF regulatory authorities is used
The Lebanese assessment of an implantable device does not address the clinical-evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re-reviewed in Lebanon.
Source Approval
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Edge Type
Assessment Report Reliance
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Stated in Part 2 of the procedure as the assessment strategy for implantable medical devices; the same section records that the unit verifies quality data, document authenticity and coherence with the online database instead.
The unit's effort is redirected to a sampling verification driven by the device's importance and criticality, its safety profile and the manufacturer's history.
edgeType `assessment_report_reliance` is an existing registry token, used deliberately here because the mechanism is reliance on another authority's completed assessment work rather than a documentary evidence requirement (which is filed separately as `reliance.accepted-conformity-certificate-menu`).
Effective from 2013-11-01
Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."
LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA
Prior approval / evidence record
Conformity to a GHTF reference-authority regulation is a precondition of Lebanese marketing authorisation
To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist.
Source Approval
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The list of jurisdictions is closed: Canada, Australia, Japan, the United States, EU member states. Korea, China and the United Kingdom are not named.
Conformity to one of the five is a precondition for the Lebanese authorisation, not a substitute for it — the MOPH health technology unit still evaluates the file and the Minister of Health issues the final decision.
Lebanese standards, where they exist, must be met in addition (LIBNOR standards, certification by the Industrial Research Institute).
The same closed list is restated at statutory level by Decision No. 455/1 of 16 April 2013, Article One (European Union, United States, Canada, Japan, Australia).
Instrument in force: the November 2013 national procedure read with Decisions 455/1 (2013) and 1506 (2014).
Effective from 2013-11-01
Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."
LebanonUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities
Prior approval / evidence record
Registration file must carry at least one accepted foreign conformity certificate — FDA, CE, TGA/Health Canada/Japan or IRI
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
Source Approval
US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The requirement is drafted as "at least one of" — one accepted certificate is sufficient documentary conformity evidence, but the substance of the review still runs locally.
Brazil ANVISA is added to the accepted certificate sources by Decision 1506/2014, Annex 2 (DMI-02) — see reliance.imdrf-free-sale-certificate-mandatory for the separate mandatory IMDRF free-sale certificate.
The notified body's name and number must appear clearly on the CE certificate.
Decision No. 455/1 Article Six imposes the same menu for implantable devices (EU declaration of conformity with notified-body certificates; FDA 510(k)/PMA marketing approval; a conformity certificate from the competent health authorities of Switzerland, Australia, Canada or Japan; or an IRI certificate for national products and products from countries not listed above).
Effective from 2013-11-01
Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."
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.
In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.)
Source Approval
Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Edge Type
Origin Country Evidence
Market Access Strength
Evidence Only
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Mandatory whatever the origin of the device: the decision states the device must be sold in one of these countries regardless of where it is manufactured.
This is a documentary requirement and does not itself shorten the Lebanese assessment; it is filed alongside the conformity certificate menu.
Decision 1506/1 Annex 2 (form DMI-02) lists the accepted certificates as FDA 510K/PMA, the CE certificate types (FullQAS, TypEC, VerifEC, ProdtnQAS, ProdctQAS, DesEC, DeclEC), Canada CMDCAS, Japan JIS, Australia TGA, Brazil ANVISA, free sale certificate, certificate for foreign government and the IRI certificate.
Effective from 2014-02-18
Source language Arabic; the PDF is a scan with no text layer and the text was recovered by OCR (pdftoppm -r 300 -png + tesseract -l ara+eng), so the wording is an OCR reading and Arabic-Indic digits are unreliable — hence source-backed-partial. OCR original: "إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government صادرة عن احدى الدول المنتمية الى مجموعة IMDRF (International Medical Devices Regulators Forum) اي انها تباع في واحدة من هذه الدول مهما كان منشؤها." Translation: "In addition to the documents required under Article Six of Decision No. 455/1 of 16/4/2013, the registration application shall be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum); that is, that it is sold in one of these countries, whatever its origin." The article number (المادة الرابعة, Article Four) is legible in the OCR.
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.
Special-access-type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non-commercial exemptions.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Conditions
Eligibility: device approved at least one year in the reference jurisdiction; same design and intended purpose as approved; no reported deaths, serious deteriorations or open field safety corrective actions in the last year; not rejected/withdrawn by a recognised authority; special/emergency access-type approvals excluded.
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
US FDA 510(k) clearance or Premarket Approval (PMA) qualifies for the verification route.
Conditions
EUA, Expanded Access (emergency/compassionate use) and HDE authorisations excluded.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)
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.
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
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
US FDA marketing authorization (510(k)/De Novo/PMA)
Edge Type
Equivalence Or Abridged Review
Market Access Strength
facilitated
Regulatory Layer
Product Marketing
Local Application Required
Yes
Target Decision Retained
Yes
Detail
Available through COFEPRIS-04-050 where the approving regulator qualifies as an ARR (IMDRF Management Committee member country) under the Lineamientos.
Conditions
Device and approval must fall within the current Lineamientos; COFEPRIS retains the decision.
Effective from 2025-07-19
ARR status now defined by IMDRF Management Committee membership rather than a fixed country list in the old guide.
MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP
Prior approval / evidence record
Class III
Id
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)
For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.
Conditions
Device and approval must fall within the current Lineamientos scope; local application and decision retained by COFEPRIS.
Effective from 2025-07-19
Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.
A US FDA 510(k) clearance, De Novo grant or PMA approval gives no market-access route of its own in Moldova. Neither Law No 102/2017 nor AMDM's Administrative Procedure of 08.09.2026 names a US or other third-country marketing approval: the documents the Procedure makes mandatory are the manufacturer's declaration of conformity, the valid CE/EU certificate for the risk classes for which a notified body is required, and the act designating the authorised representative, and the rejection grounds include the absence of the CE/EU certificate for classes where it is necessary. An FDA-only holder therefore has two options only: obtain CE marking and use the CE route, or use the separate national route for devices without CE marking, which is a national conformity-assessment-and-registration route and not recognition of the FDA clearance. The same answer applies to a Japan PMDA approval, a Korea MFDS approval and a China NMPA registration.
Source Jurisdiction Id
usa
Source Authority Id
fda
Source Approval
US FDA 510(k) clearance, De Novo grant or PMA approval
Target Jurisdiction Id
moldova
Edge Type
No Reliance Route
Market Access Strength
none
Regulatory Layer
Product Marketing
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The mandatory document list is exhaustive as drafted ("următoarele documentele sunt obligatorii"); the Procedure lists no third-country approval.
Rejection ground 40.5 is the absence of the CE/EU certificate for the risk classes for which it is necessary, and 40.4 the absence of the CE/EU declaration of conformity.
A device without CE marking may still reach the market through the separate national route recorded under reliance.national-route-for-devices-without-ce-marking in this file - that route is not recognition of the FDA clearance.
The same conclusion holds for a Japan PMDA approval, a Korea MFDS approval and a China NMPA registration: no instrument retrieved names any of them.
Romanian source. Point 23 makes the CE/EU certificate and the CE/EU declaration of conformity the mandatory conformity documents; the only alternative document expressly listed is the authorised-representative designation act. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.
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.
For imported medical devices the registration dossier's technical part is lighter than for locally manufactured devices: under arrêté n° 2855-15 art. 2, 1) b) the technical pieces for an imported device of any class are the manufacturer's declaration of conformity to the essential requirements (or equivalent requirements), the draft labelling and, where applicable, draft instructions for use, and a sale-model sample or prototype; the technical documentation with a conformity check-list, the corresponding standards and the internal documents relied on — a mandatory item for locally manufactured devices under art. 2, 2) b) — is not a filing item but may be requested from the establishment during the evaluation of the device's clinical data. The AMMPS checklist (footnote 5 to item 10) restates this as 'la documentation technique n'est pas obligatoire' for imported devices and adds that clinical data must be supplied for class III. This documentary lightening is keyed to the device's imported status, not to a named reference authority; for classes Is, Im, IIA, IIB and III the imported device must in any event file the origin-country competent-authority certificate (CE, FDA, CVL or equivalent), so in practice that certificate plus the declaration of conformity and, for classes IIA–III, an ISO 13485 certificate stand in for the technical file. The 120-day review clock and the national decision are unchanged.
Source Approval
EU CE marking certificate; US FDA attestation; or origin-country marketing authorisation / certificat de vente libre (CVL) equivalent — the certificate that made the device registrable in its origin country
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The lightening is attached to the technical-documentation item only; the administrative pieces, declaration of conformity, ISO 13485 certificate (classes IIA/IIB/III), origin-country certificate (classes Is/Im/IIA/IIB/III), labelling and IFU drafts and sample are still required.
For a class III imported device, clinical data must be filed (checklist footnote 5); the AMMPS may also call for the check-list documentation during clinical-data evaluation (arrêté art. 2, 1) b), last paragraph).
Locally manufactured (FL) devices must file the technical documentation with check-list (arrêté art. 2, 2) b)); semi-finished imports (ISF) file the imported-device administrative pieces plus the local-manufacture technical pieces and a GMP certificate (art. 2, 3)).
There is no recognition or abridged-review procedure behind this: the AMMPS recognition guidelines (LD RE-001, LD EA-013) cover medicines and vaccines only.
French original footnote (5) to dossier item 10. Translation: '(5) For imported DMs: the technical documentation is not mandatory, only the clinical data have to be supplied for class III DMs'. The waiver is an administrative-practice rule on the AMMPS's official dossier form, not a provision of loi 84-12 or décret 2-14-607; it is therefore bounded to the dossier item it annotates.
A medical-device registration application must include a certificate issued by the competent authority of the country of origin: an EU CE marking certificate, an 'FDA' attestation, a marketing-authorisation / free-sale certificate (CVL), or an equivalent. The item is mandatory for risk classes IIA, IIB and III and for sub-classes Is and Im of class I. It does not shorten the Moroccan review: the device is still registered nationally and the certificate sits alongside the national dossier.
Source Approval
EU CE marking certificate; US FDA attestation; or an origin-country marketing authorisation / certificat de vente libre (CVL) or equivalent issued by the competent authority of the country of origin
Edge Type
Origin Country Evidence
Market Access Strength
Evidence Only
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Applies to classes Is, Im, IIA, IIB and III; plain class I devices are outside the list.
The certificate must come from the competent authority of the country of origin, not from the manufacturer.
Footnote 1 of the same checklist adds that a CE design-examination certificate is required in addition to the CE quality-system certificate for class III devices.
The dossier is filed by the Moroccan establishment (declared manufacturing or importing establishment), not by the foreign manufacturer.
French original. Translation: '4- CE marking certificate or "FDA" attestation or marketing authorisation (CVL) or equivalent issued by the competent authorities in the country of origin (for DM belonging to risk classes IIA, IIB and III and sub-classes Is and Im of class I)'. Checklist Réf. DE ER DM/01, édition 9, date d'application 30/01/2025. The checklist is the AMMPS's own official dossier form; the same list is re-issued on each edition.
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.
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.
Product verification/validation section accepts the origin-jurisdiction certificate: for EU-route devices CE/EC certificate, full quality assurance or design examination certificate (Class D adds TSE-free certificate if biological); for US-route devices 510(k) or PMA (Class D adds AATB certificate if from US and biological).
Conditions
EU route: Class C (IIb/III) and Class D (other III/IV/AIMD).
US route: Class C accepts PMA or 510(k); Class D accepts PMA.
GD5 mirrors this for IVDs (CE certificate, Full/Production Quality Assurance, Type Examination; US route PMA/510K).
The registration dossier must include a free sale certificate from the competent authority in the origin country, or a Certificate of Foreign Government (CFG) if the product is from the USA, or CDNE (certificate for medical device not exported from the United States), plus a list of countries where the device is marketed.
Conditions
Required in Section 10 of the Class C&D dossier; applies to registered device establishments.
PakistanAustralia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · US FDA · Austria · Belgium · Denmark · France · Germany · Ireland · Italy · Netherlands · Norway · Spain · Sweden · WHO · EU conformity assessment
Regulatory reference
Rule 67 lists reliance reference countries plus WHO prequalification and CE marking
Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.
Conditions
Reliance subject to evidence and supporting documents
A device that has no Paraguayan sanitary registration may be imported for compassionate use where it has been authorised by a foreign reference regulatory agency included in the annual official list under Ley N° 7256/2024, and is required to treat a patient or group of patients urgently as determined by the treating specialist or the MSPBS. The route is an import authorisation, not a registration.
Source Approval
Authorisation by a foreign reference regulatory agency included in the Listado Anual Oficial under Ley N° 7256/2024 (2026 list: US FDA, EU Commission/EMA, Japan MHLW/PMDA, Korea MFDS, ANMAT, ANVISA, ISP and others)
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
No DINAVISA registration may exist for the product.
Urgency determined by the treating specialist or by the MSPBS.
Requires an import authorisation under the resolution's requirements (Art. 3 et seq.).
Companion limb (Art. 2(a)) covers products in the investigational phase, where no foreign authorisation is required.
Effective from 2025-06-30
Source language: Spanish. Translation: 'Medicines or medical devices Registered by a Regulatory Authority: Medicines or medical devices that have been authorised by a foreign reference regulatory agency included in the official annual list pursuant to Law N° 7256/2024 or its updates, that do not have a sanitary registration issued by DINAVISA and that are required to treat a patient or group of patients urgently, determined by the treating specialist physician, or the Ministry of Public Health and Social Welfare.' Art. 12 (OCR renders it 'Artículo 129') sets the resolution in force from 30 June 2025.
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
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.
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.
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.
The Listado Anual Oficial that Res. 226/2024 Art. 8(a) incorporates by reference does name US FDA, the European Commission (DG SANTE)/EMA, Japan MHLW/PMDA and Korea MFDS — but every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos médicos, so on the published instrument the simplified device route is not anchored to any device-scoped reference authority.
Source Approval
none
Edge Type
International Listing
Market Access Strength
none
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The 2026 list is emitted by Resolución DINAVISA N° 182/2026 in compliance with Art. 3 of Ley N° 7256/2024; it abrogates Resolución DINAVISA N° 148/2024 and Resolución DINAVISA N° 192/2025.
The listed agencies' own names include medical devices (AEMPS, JAZMP, URPL), but their stated Alcance in this list is medicamentos y vacunas.
This fact records the list's stated scope only; it is not evidence that DINAVISA refuses device reliance in practice, and no DINAVISA instrument was found that scopes the device route to a named device authority.
Effective from 2026-05-01
Source language: Spanish. Translation of the quoted entries: 'United States: US FDA. Scope: Medicines and vaccines.' / 'European Commission (DG SANTE); European Medicines Agency (EMA); National Regulatory Authorities. Scope: Medicines and vaccines.' / 'Republic of Korea: Ministry of Food and Drug Safety (MFDS). Scope: Medicines and vaccines.' / 'Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA). Scope: Medicines' and a second Japan entry 'Pharmaceuticals and Medical Devices Agency (PMDA). Scope: Vaccines'. The resolution is dated 'de mayo de 2026'; the day glyph is illegible in the scan and is not reproduced. effectiveFrom is the month of signature only.
ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA
Prior approval / evidence record
Simplified registration route for class II-IV devices authorised by a listed reference authority
A class II, III or IV medical device already authorised by an authority of a country on the Listado Anual Oficial (emitted under Ley N° 7256/2024 Art. 3) or by an authority with a published bilateral recognition agreement enters the 'Proceso simplificado de Registro Sanitario' instead of full integral analysis. The applicant still files every Art. 6 requirement and still needs a Paraguayan registration, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier.
Source Approval
Any marketing authorisation issued by an authority of a country on the Listado Anual Oficial — the 2026 list (Resolución DINAVISA N° 182/2026) names US FDA, European Commission (DG SANTE)/EMA and EU national authorities, Japan MHLW/PMDA, Korea MFDS, Singapore HSA, Indonesia BPOM, ANMAT, ANVISA and ISP — each entry stated as scoped to medicamentos and/or vacunas
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Applies to applications for IMPORTED class II, III and IV medical devices and their accessories: Art. 8's chapeau reads 'las solicitudes de inscripción de Dispositivos Médicos importados deberán ajustarse y tramitarse según la Clase... (Clase II, III y IV)'.
The foreign authorisation must come from an authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024, or from an authority with a bilateral recognition agreement that so provides, published on the DINAVISA website.
The applicant still files all requirements of Art. 6; DINAVISA evaluates the technical information declared in DINAVISAPy and the documents filed for items b), c), d), g) and h).
Only if the conditions do not differ from what the origin regulatory authority authorised.
45-business-day evaluation clock under Art. 9.
Res. 226/2024 Art. 8(a) names the 2024 list (Resolución DINAVISA N° 148/2024); that list was replaced by Res. 192/2025 and then by Res. 182/2026, the text referring to the list 'y sus actualizaciones'.
Effective from 2024-09-16
Source language: Spanish. Translation: 'Applications for registration of products classified by DINAVISA as class II, III and IV medical devices that are authorised by authorities of the countries on the Annual Official List emitted in Resolución DINAVISA N° 148/2024 and its updates, as well as those Regulatory Authorities with which bilateral agreements for the recognition of authorisations exist, which so provide, published on the DINAVISA website, shall be subject to the simplified Sanitary Registration Process.' OCR of the two-column official PDF was normalised: 'Clase l' rendered as 'Clase II' and 'N*148/2024' as 'N°148/2024'.
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
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.
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
For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.
Conditions
List per Art. 9 D.S. 016-2011-SA.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
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
Class B/C/D devices with product approval issued by the NRA of any ASEAN member country under AMDD-CSDT requirements receive abridged processing: complete legal requirements plus the latest technical dossier submitted to the reference NRA; technical documents are not technically reviewed except labeling; the reference-NRA CPR is verified; turnaround 30 working days from receipt of proof of payment.
Conditions
Same medical device as approved by the reference NRA (attestation in notarized application form).
Not applicable to devices with CPR based on abridged approval in countries outside ASEAN.
Excludes IVDs and refurbished devices.
FDA may forego abridged processing on negative foreign reports or conflicting NRA views; unauthorized change triggers automatic LTO/CMDR suspension and voluntary recall undertaking.
Implements WHO good reliance practices under RA 9711 and RA 11032.
For MoPH technical evaluation of medical equipment in a healthcare facility, each device must be supported by an original FDA/CE certification or an equivalent approval.
Conditions
Applies to medical equipment used within licensed healthcare facilities.
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
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.
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA
Prior approval / evidence record
Class C
Id
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
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA
Prior approval / evidence record
Class B
Id
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
SingaporeUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA
Prior approval / evidence record
Class D
Id
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
US FDA marketing authorizations are accepted as reference approvals; qualifying submissions are 510(k) clearance, De Novo and PMA. Class I and II-exempt FDA clearances do not qualify.
Conditions
same labelled use
only 510(k) clearance, De Novo or PMA qualify
one qualifying approval for the Abridged route
three years' safe marketing for one-approval expedited/immediate routes
two approvals can unlock other expedited/immediate routes
Confirms baseline reliance edge and adds the qualifying-submission detail; '510K clearance', 'De Novo', 'PMA' quoted on overview page.
For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.
Conditions
IVD list: 'USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries'.
Reference NRA evidence: product registration certificate or free sale certificate issued by the reference authority.
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.
ANMPS's device technical dossier guide names two further conformity regimes and their proof documents. For devices conforming to United States legislation: a copy of the 510(k) premarket notification for class I and class II devices, and a copy of the PMA (Premarket Approval) for class III devices. For devices conforming to Canadian legislation: a copy of the medical device licence issued by Health Canada. As with the EU route, these are dossier items inside a Tunisian evaluation, not a substituted approval.
Source Approval
US FDA 510(k) premarket notification (class I and class II) and US FDA PMA premarket approval (class III); Health Canada medical device licence
Edge Type
Origin Country Evidence
Market Access Strength
Evidence Only
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The US and Canadian items are alternatives to the EU item, keyed to which legislation the device conforms to — a device is expected to be able to show conformity under one of the three named regimes.
The guide nowhere states that a foreign approval shortens the ANMPS evaluation clock, and no such clock is published.
The guide is a guidance document under a procedure whose legal basis is the import technical-control regime, not a devices statute — see legal-basis.import-technical-control-regime.
Effective from 2026-03-02
French original. Translation: 'g. For devices conforming to American legislation — A copy of the 510K pre-market notification (class I and class II). — A copy of PMA conformity (Premarket Approval) (class III). h. For devices conforming to Canadian legislation — A copy of the medical device licence issued by Health Canada.' Retrieved as full raw text of the ANMPS PDF.
Usable as supporting technical evidence only. Market entry runs on a CE or Turkish notified-body certificate, and a US clearance substitutes for neither.
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
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.
A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.
Source Approval
WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority
Edge Type
Qms Audit Reliance
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Track 2 requires documented evidence of conformity from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, OR WHO Prequalification, OR any other international organisation recognised by NDA.
A Certificate of Analysis confirming compliance to a quality system standard in Table 3 must also be filed.
The accepted standards in DAR/GDL/028 Table 3 are ISO 13485 or ISO 13488 (Australia, Canada, European Union), GMP QS Standard for medical appliances #1128 (Japan) and QS 21 CFR part 820 (United States).
Track 2 still requires evidence of repeat sales in the country of manufacture and a completed submission checklist, and NDA retains the registration decision.
edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.
UgandaUS FDA · Health Canada · Japan MHLW / PMDA · EU conformity assessment
Prior approval / evidence record
For classes B, C and D, certification from a recognised country (or CE certification) is mandatory; only class A may be exempted
Uganda treats recognised-country certification as an eligibility gate, not merely as evidence. DAR/GDL/028 s. 4.11 states that devices not certified by any of the recognised countries will be examined and may be exempted from recognised-country certification only if they are class A; for other classes the recognised-country or CE certification is a must. The recognised countries are the United States (FDA clearance/approval), Canada, Japan (MHLW clearance/approval) and Europe. For Europe the certificate required scales with class: full quality assurance / EC Type Examination Certificate for class B and C, and full quality assurance / EC Design Examination Certificate for class D, and the notified body must itself be approved by European health authorities.
Source Approval
US FDA clearance/approval; Canada clearance/approval; Japan MHLW clearance/approval; Europe EC quality-system certification with an EC Type Examination Certificate (class B and C) or EC Design Examination Certificate (class D) issued by a notified body approved by European health authorities
Edge Type
Eligibility Gate
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
Applies to appliances classified B, C or D; a class A appliance may be examined and exempted from recognised-country certification if appropriate.
Evidence must be provided as original authenticated documents.
For Europe the certificate type is class-dependent: EC Type Examination Certificate for class B and C, EC Design Examination Certificate for class D.
The notified body must be approved officially by European health authorities and the committee will ask for documented evidence of the notified body's registration or licensing.
This gate sits above the track structure: an uncertified class B/C/D product cannot fall back to Track 3, because Track 3 still requires a Manufacturer's Declaration of Conformity rather than third-party certification, and s. 4.11 makes recognised-country or CE certification a must for those classes.
Excerpt is a contiguous verbatim run from s. 4.11 with the class-by-class European detail joined by [...]. edgeType 'eligibility_gate' is reused from the existing vocabulary (1 prior use) rather than inventing a token: the mechanism is that recognised certification is a precondition for classes B-D, which is what that token means. marketAccessStrength is 'facilitated' rather than 'evidence_only' because holding the certificate changes which applications can be accepted at all, not just how much paperwork is filed. There is an internal tension in the source between s. 4.11 (certification is a must for classes B-D) and s. 4.12.3 (Track 3 for products with no certification to any listed quality system standard); both are recorded, and the tension is stated in conditions rather than resolved by assumption.
UgandaAustralia TGA · Health Canada · EU conformity assessment · Japan MHLW / PMDA · US FDA · IMDRF member authorities
Prior approval / evidence record
Track 1: an IMDRF founding-member licence opens an abridged evaluation (Australia, Canada, EU, Japan, USA)
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Source Approval
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Edge Type
Abridged Or Recognition Route
Market Access Strength
facilitated
Regulatory Layer
Premarket Review
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The recognised approval is country-specific: DAR/GDL/028 Table 2 names GMPALS licence or CE mark for Australia, an appliance licence for Canada, CE mark for the European Union, an appliance licence for Japan, and a 510K appliance letter for the United States.
Track 1 still requires a national application on Form 7 and NDA retains the registration decision; the foreign licence abridges the evaluation, it does not replace the registration.
Track 1 additionally requires a Certificate of Analysis confirming compliance to a quality system standard from DAR/GDL/028 Table 3 (ISO 13485 or ISO 13488 for Australia, Canada and the EU; GMP QS Standard for medical appliances #1128 for Japan; QS 21 CFR part 820 for the United States) and evidence of repeat sales in the country of manufacture.
CE-marked products enter track 1 via the European Union founding-member entry; there is no separate CE-only track.
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
UgandaAustralia TGA · Health Canada · EU conformity assessment · Japan MHLW / PMDA · US FDA · IMDRF member authorities
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Authority
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
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.
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.
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
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.
Devices registered by the following are registered in Uzbekistan by the recognition route: US FDA; EU bodies authorized to issue CE conformity certificates; EMA (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (United Kingdom). Foreign certificates are verified against the issuing regulator's official registers/website; if not verifiable through open sources they must be apostilled or consularly legalized.
Conditions
Certificate authenticity checked via official registers; Centre may send an official request — no reply within 60 working days leads to refusal.
Recognition route: 15 working-day review, no samples, no local laboratory tests, no clinical studies, no production inspection.
Effective from 2026-02-26
WHO-prequalified IVDs registered in cooperation with WHO get a separate 60-working-day route.
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.
VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS
Prior approval / evidence record
Class C
Id
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
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
VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS
Prior approval / evidence record
Class D
Id
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
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
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
Statement
ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non-IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non-IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance.
Regulatory Layer
Product Marketing
Local Application Required
Yes
Target Decision Retained
Yes
Conditions
The approval information is a mandatory field on the Annex I application form, so withholding it is not an option; but the guidelines attach no procedural consequence to holding or not holding it.
'Expedited evaluation' is defined in the non-IVD guideline as 'the express evaluation of a product application within a 90 - day period'; the Authority authorises it and the guideline states no criteria, so reliance on a foreign approval as the trigger is aspirational rather than an operating rule.
ZAMRA's published fee schedule carries a 'Fast track fees' head at 'Double the applicable MA applicable fee', confirming that a fast track exists commercially but again without stating a foreign-approval trigger.
The same absence holds for IVDs: the IVD guideline (ZAMRA/MA/GUD/0003) has no recognition or abridged procedure based on a foreign marketing authorisation, although it defines a 'Fast Track process' as 'the authorised expedited evaluation or assessment of an application submitted for the purpose of grant of Marketing Authorisation'.
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
ZambiaIMDRF member authorities · WHO · US FDA · EU conformity assessment
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
Authority
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
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.
An FDA, CE, PMDA, MFDS or NMPA approval holder has nowhere to file it in Zimbabwe. Zimbabwe does not operate a general medical device registration pathway: the Medicines and Allied Substances Control Act's registration machinery covers medicines, and devices enter control only through ministerial regulations made under section 38(1)(b). The only device classes ever brought under control are male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). For any other device - an infusion pump, an orthopaedic implant, a CT scanner, an IVD - there is no marketing authorisation to apply for, so no foreign approval can open, shorten or substitute for one. MCAZ's own Strategic Plan 2026-2030 records the Medical Devices Unit's entire regulatory function as the assessment of male condoms and medical gloves, and lists an 'expanded scope to medical devices and allied substances' as an effect of a Medical Products and Allied Substances Control Bill that is still only proposed.
Source Approval
none
Edge Type
No Reliance Route
Market Access Strength
none
Regulatory Layer
Product Marketing
Local Application Required
No
Target Decision Retained
Yes
Conditions
sourceApproval is recorded as 'none' because there is no device registration route for a foreign approval to attach to. This is a structural no-route, not a policy of refusing foreign approvals.
The absence is transitional rather than permanent: the Strategic Plan and the Reliance Policy both look forward to device regulation, but neither has been brought into force.
The claim rests on the Act's long title and structure (Part IV, 'REGISTRATION OF MEDICINES', ss.26-41, is the only registration regime in the Act) read together with the exhaustive MCAZ listing of device instruments (only the Condom Regulations, the Glove Regulations and their 2014 amendments) and the Strategic Plan 2026-2030 statement that the Medical Devices Unit's functions are 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005', 'Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006' and 'Factory inspections (cGMP) of condom and glove manufacturing facilities'. No device registration guideline, application form or device fee schedule exists in MCAZ's published document set.
Prior approvals and evidence for United States (11 records)
FDA (with TGA Australia, ANVISA Brazil, Health Canada, and MHLW/PMDA Japan) participates in the Medical Device Single Audit Program and may accept MDSAP audit reports as a substitute for routine Agency inspections; firms with Electronic Product Radiation Control (EPRC) activities remain subject to direct FDA inspection for those activities.
MDSAP official documents moved to the TGA-managed MDSAP website (FDA update of 2025-12-18).
FDA does not recognize regulatory authorizations from other countries (for example EU CE marking under MDR/IVDR): any device imported or marketed in the US must independently meet the applicable FDA requirements (registration, listing, 510(k)/PMA, QMS, labeling, US agent, MDR, inspections).
FDA establishment registration and listing confers no product authorization: the resulting entry in FDA's registration and listing database does not denote approval, clearance, or authorization of the facility or its devices; FDA does not issue device registration certificates, and presenting such certificates as evidence of FDA endorsement is misleading (misbranding).
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.
Review clocks
What review, validation, and applicant stop-clock rules apply?
If additional information requested by FDA for a 510(k) is not submitted within 30 days following the date of the request, the Commissioner considers the premarket notification withdrawn (21 CFR 807.87(m)).
After FDA issues an Additional Information letter for a De Novo request, the submitter has 180 calendar days to respond, with no extensions; the request is on hold during this period and hold days are excluded from review days.
Special access & derogation
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
An investigational device that is not approved for marketing may be made available under a treatment IDE for patients outside the clinical trial when it is intended for a serious or immediately life-threatening disease or condition, no comparable or satisfactory alternative is available, the device is under investigation for the same use (or the trials are complete), and the sponsor is actively pursuing marketing authorization. Treatment use may begin 30 days after FDA receives the treatment IDE unless FDA responds earlier in writing.
Conditions
The four eligibility criteria in 21 CFR 812.36(b) must all be satisfied.
The sponsor and investigators remain subject to the IDE, informed-consent, IRB, safeguard, and reporting requirements in 21 CFR 812.36(c)-(f).
Submission communications & appeal
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
A PMA applicant who receives a not approvable letter or an order denying approval may request administrative review under section 515(d)(4) and (g) of the FD&C Act, as referenced in 21 CFR 814.40(a).
UDI, listing & traceability
Which UDI, device listing, database, and traceability duties apply?
Reports of corrections and removals submitted under 21 CFR 806.10 must include the unique device identifier of each device involved (21 CFR 806.10(c)(5)).
PMA periodic reports must identify each device identifier (UDI-DI) currently in use for the device and any device identifier that has been discontinued (21 CFR 814.84(b)(4)).
Vigilance & incident reporting
What is reportable, by whom, where, in what format, and by what deadline?
Manufacturers must report to FDA no later than 30 calendar days after the day they receive or otherwise become aware of information, from any source, that reasonably suggests a device they market may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur (21 CFR 803.50).
Manufacturers must submit a five-day report no later than 5 work days after the day they become aware that (a) an MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, or (b) FDA has made a written request for a report (21 CFR 803.53(a)-(b)).
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
