ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · Türkiye conformity assessment Prior approval / evidence record
Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country
reliance.origin-country-or-imdrf-authorisation-evidence-for-unregistered-import
- Statement
A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.
- Source Approval
Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Import Control
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The obligation attaches to the import (conformity) certificate for devices without Armenian state registration; for devices that do have Armenian state registration the equivalent item is a copy of the Armenian registration certificate, and the origin-country evidence is not required.
- One of the ten statutory grounds for refusing the import certificate is that the imported device has no Armenian state registration, except in the cases the Law allows (Article 47.2(7)(8)). The origin/IMDRF evidence does not cure that ground where registration was required; it is the supporting document for the unregistered-device import cases the Law permits.
- The file also requires, for every batch, a quality conformity certificate or equivalent, and the instructions for use or a reference to their electronic version (Annex 2, para. 2(2)(b), (c)).
- The document list was extended by Government Decree No. 1731-Ն of 12.10.2023 and No. 1619-Ն of 17.10.2024.
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · IMDRF member authorities · WHO Prior approval / evidence record
Simplified national registration for a device registered in an IMDRF member country or prequalified by WHO
reliance.imdrf-member-or-who-prequalified-simplified-registration
- Statement
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
- Source Approval
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The provision is written as an annex to part 3 of the same article: 'under the procedure laid down by part 3 of this article' devices are registered under the general and simplified procedures. Part 3 is itself the Armenia-only route, and a footnote to Article 46 states that part 3 operates only until the end of the transitional period set by Article 11 of the EAEU Agreement of 23 December 2014 (footnote inserted by Article 3(2) of the Law of 5 December 2024 ՀՕ-502-Ն). The transitional period was extended by the Protocol signed in Moscow on 29 December 2025, which replaced '2025' with '2027' in the first paragraph of Article 11 of that Agreement and '2026' with '2028' in the third and fourth paragraphs.
- Bounded claim: the Law names IMDRF membership and WHO prequalification as the gate for the simplified procedure. It does not name the FDA, the CE mark, the PMDA or the MFDS; those follow from their countries' IMDRF membership, not from the text.
- The operational content of the 'simplified procedure' (dossier list, clocks, certificate form) sits in the Government procedure that Article 46(3) contemplates; that instrument was not located in this session (see unresolved: registration-pathways).
- Devices are registered by the Ministry of Health (the լիազոր մարմին / authorised body) with the examination carried out by the expert organisation designated by Government decision (Article 46(2), (5)).
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Prior approval / evidence record
Singapore HSA product registration — evidence reuse
reliance.reliance-edge-reference-approvals-to-australia-approval-singapore-hsa-australia
- Source Approval
Singapore HSA product registration
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Evidence accepted for ARTG inclusion applications and as basis for abridged TGA conformity assessment
- Singapore HSA is listed among comparable regulators in TGA's market authorisation evidence guidance
- Australian sponsor and Australian requirements remain
BotswanaIMDRF member authorities · WHO · MDSAP Prior approval / evidence record
The broad reliance and mutual-recognition provisions in the 2025 Act and the draft 2026 Regulations are not yet an operating route
reliance.draft-2026-regulations-reliance-provisions-not-in-force
- Statement
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.
- 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 · NMPA · Singapore HSA · WHO Prior approval / evidence record
An exemption from registration can be granted on production of a marketing authorisation from an RRA or other named authority, a CE certificate from an EU notified body, or a WHO EUL/PQ acceptance letter
reliance.exemption-route-accepts-reference-authority-marketing-authorisation
- Statement
For devices that are not on the interim register/listing, BoMRA's exemption guideline makes a foreign marketing authorisation a required piece of evidence: a copy or proof of the marketing authorisation issued by a relevant Reference Regulatory Authority, Singapore HSA, China NMPA (Class A and B only) or SAHPRA (Class A and B only), and/or a CE certificate issued by a European notified body under MDD 93/42/EEC, IVDD 98/79/EC, MDR (EU) 2017/745 or IVDR (EU) 2017/746, and/or proof of a WHO EUL or Prequalification acceptance letter. Approval places the device on an exempted list with a six-month validity.
- Source Approval
Reference Regulatory Authorities recognised by BoMRA; Singapore Health Sciences Authority; China NMPA (Class A and B only); South African Health Products Regulatory Authority (Class A and B only); CE certificate from a European notified body under MDD/IVDD/MDR/IVDR; WHO EUL or WHO Prequalification acceptance letter
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- s. 5.5.4 adds that for a public health emergency product a valid registration certificate/approval/emergency use authorisation issued by ICH member countries as defined prior to 23 October 2013, or by WHO, must be provided.
- s. 5.5.5 states that points 5.5.1 to 5.5.4 do not apply to a local manufacturer.
- The exemption is a limited-duration alternative to registration: s. 7.2 gives the approved product a validity period of six (6) months unless revoked by the Authority or terminated by the applicant.
- The exemption guideline applies to devices including IVDs that are not included in the interim register/listing.
Effective from 2023-04-01
Excerpt read from the OCR pass over BoMRA's scanned copy (download/98/exemptions/25635/...). In s. 5.5.1 the parenthetical '(Only for Class A & B medical devices)' is interleaved by the PDF's line order and applies to China NMPA and to SAHPRA; the wording has not been altered but the reading is flagged. BoMRA's own revision sheet records the addition of 'China National Medical Products Administration (Only for Class A & B medical devices)' at Issue 3.0 and 'by European notified bodies (Except Class A)' at Issue 2.0.
CanadaNMPA · US FDA · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA Regulatory reference
Recognized foreign regulators (incorporated list)
reliance.list-of-regulatory-agencies
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.
- Class I authorization holders excluded.
Page issued 2024-01-03, modified 2024-01-24.
CubaIMDRF member authorities Regulatory reference
Prior registration in origin/IMDRF country exempts listed evidence
reliance.imdrf-evidence-exemption
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.
Regulatory reference
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.
Regulatory reference
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).
EthiopiaUS FDA · Japan MHLW / PMDA · Australia TGA · Singapore HSA · EU conformity assessment · UK MHRA · Health Canada · South Korea MFDS Prior approval / evidence record
Registration route for devices approved by a listed Stringent Regulatory Authority (FDA, EU, Japan, Australia, Singapore, UK, Canada, Korea)
reliance.sra-verification-route
- Statement
A medical device that already holds a marketing authorisation, registration certificate or free-sale certificate from one of the authorities EFDA lists as a Stringent Regulatory Authority can be filed on the SRA route (EFDA/GDL/046 §9.4). The applicant still submits the complete administrative and technical dossier required by the ordinary registration guidelines, but EFDA reviews it as a verification exercise focused on the genuineness of the submitted information rather than a de-novo assessment, so the application takes shorter processing time. EFDA keeps the right to conduct a full assessment and to request further information whenever it deems necessary.
- Source Approval
US FDA marketing authorisation / registration certificate / free-sale certificate; Japan MHLW; Australia TGA; Singapore HSA; a competent authority of one of the 27 EU Member States (Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017); UK MHRA; Health Canada; South Korea MFDS
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- The route is a shortened review, not a dossier waiver: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.'
- The claim must be supported by a marketing authorisation certificate or registration certificate or free-sale certificate issued by the listed authority (or by WHO/UNFPA prequalification evidence).
- EFDA determines eligibility for the SRA route after screening the eRIS submission; an application filed as SRA on misleading information is rejected at screening or evaluation.
- EFDA may still carry out a full assessment and request further information where a foreign approval does not provide the same assurance for use in Ethiopia.
- The SRA list is published in GDL/046 §9.4 and 'will be updated as deemed necessary'.
- The same list also appears (without Singapore HSA, UK MHRA and Korea MFDS) in the non-IVD and IVD registration requirement guidelines, which state that registration with those authorities is 'considered to be registered with Stringent Regulatory Authority approved devices registration procedures'.
Effective from 2026-06-25
Verbatim: 'At present, EFDA accepts the registration submissions as an SRA or prequalified products application if they're supported by one or more of the following document(s). 1. A Marketing Authorization certificate or registration certificate or free sale certificate issued by one of the following competent national regulatory authority: US Food and Drug Administration; Ministry of Health, Labour and Welfare, Japan; Trapeutic Goods Administration, Australia; Health Science Authority, Singapore; Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017.; Medicine and Healthcare Products Regulatory Agency, UK; Health Canada, Canada; Ministry of Food and Drug Safety, South Korea'. The passage also states: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.' Typographical errors are reproduced as they appear in the source.
Prior approval / evidence record
Singapore HSA
- Benefit
Record of approval satisfies D002
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Hong KongNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · South Korea MFDS · Singapore HSA Regulatory reference
Recognised jurisdictions for marketing approvals
reliance.recognised-jurisdictions
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).
LebanonUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities Prior approval / evidence record
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
- Authority
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
- Benefit
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة, form MPH12-26: required documents, the Atomic Energy stamp condition, the LBP 1,000 fiscal stamp, submission on all official working days, and 'مدة انتهاء المعاملة: بين أسبوع وأسبوعين'Ministerial Decision No. 455/1 of 16 April 2013 — تنظيم إدخال واستعمال المواد الطبية المختلفة: the conformity certificate (Art. One), the Industrial Research Institute as the issuing body (Art. Three), entry permits, the statutory charge and customs stamping (Art. Four), and the pre-registration dossier for implantables with the Department of Programs and Projects (Art. Six)Ministerial Decision No. 1506/1 of 1 September 2014 — أحكام توضيحية لتطبيق القرار رقم 1/455: GMDN classification (Art. Two), the four risk levels and the reference-regulator class table (Art. Three), the GHTF/IMDRF free-sale certificate (Art. Four), and the import stop-date for implantables not recorded with the Department of Programs and Projects (Art. Six) Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Free sale certificate / certificate for foreign government from an IMDRF member country is a mandatory registration document
reliance.imdrf-free-sale-certificate-mandatory
- Statement
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.
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA Regulatory reference
Approvals excluded from the verification route
reliance.verification-excluded-schemes
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) Prior approval / evidence record
Class B
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class B registration turn-around 30 working days from complete documents and cleared payment
- ASEAN harmonization applies
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry) Prior approval / evidence record
Class C
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class C registration turn-around 30 working days from complete documents and cleared payment
- Clinical data may be required
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · Thailand Regulatory reference
Recognised foreign approvals for the verification route
reliance.verification-route-authorities
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.
Regulatory reference
Singapore HSA product registration — verification route
reliance.reliance-edge-reference-approvals-to-malaysia-approval-singapore-hsa-malaysia
Registration in the Singapore Medical Device Register (SMDR) qualifies for the verification route.
Conditions
- HSA Special Access Routes excluded; added as a recognised authority in the 2nd edition (13 October 2025).
MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry) Prior approval / evidence record
Class D
- Verification Status
official-verified
- Official Source
- Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
- Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
- Prior Approval Benefits
- EU CE Mark
- MHLW
- TGA
- Health Canada
- FDA
- MHRA
- HSA
- TFDA
- Notes
- MDA/GD/0070 cl. 6.4: Class D registration turn-around 30 working days from complete documents and cleared payment
- Clinical evidence required
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA · IMDRF member authorities · MDSAP · WHO Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
- Name
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
- Description
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
- Timeline Reduction
Resolution within a maximum of 30 working days
- Eligibility
- Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States
- MDSAP full members are recognised for the good-manufacturing-practice certificate
- Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration
- Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP Prior approval / evidence record
Class II
- Pathway
Registration or Equivalency
- Verification Status
official-verified
- Official Source
- Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
- Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
- Prior Approval Benefits
- FDA 510(k)
- Health Canada
- Japan PMDA
- IMDRF Committee Members
- MDSAP
- Notes
- RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen)
- ARR equivalence route (COFEPRIS-04-050, Lineamientos DOF 18-07-2025): maximum 30 working days
- Equivalency route much faster if FDA approved
- Clinical Trial Required
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP Prior approval / evidence record
Class III
- Pathway
Registration or Equivalency
- Verification Status
official-verified
- Official Source
- Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
- Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
- Prior Approval Benefits
- FDA 510(k)/PMA
- Health Canada
- Japan PMDA
- IMDRF Committee Members
- MDSAP
- Notes
- RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen)
- ARR equivalence route (COFEPRIS-04-050): maximum 30 working days
- Equivalency pathway best option with FDA
- Clinical Trial Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
MexicoIMDRF member authorities · MDSAP Regulatory reference
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.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
- Authority
PAHO/WHO reference authority or IMDRF Management Committee member authority
- Benefit
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
ParaguayBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · IMDRF member authorities · Portugal · Spain · South Korea MFDS · Japan MHLW / PMDA · UK MHRA · NMPA · Taiwan TFDA · Australia TGA · WHO Prior approval / evidence record
IVD simplified registration (PSR) for products authorised by PAHO/WHO, IMDRF or bilateral-partner authorities
reliance.ivd-psr-reference-authorities
- Statement
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
- Source Approval
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Applies to class II, III and IV IVDs (Res. 44/2024 Art. 7: 'Clases II, III y IV'); class I IVDs are registered automatically under Res. 266/2022 Art. 14.
- The IVD must actually be commercialised in one of those countries and the foreign registration must correspond specifically to the same product being registered.
- 15 business days to validate; approval by positive silence.
- Objections may be answered only once (Art. 3), with 30 business days to rectify.
- Not applicable to the cases in Arts. 13 and 16 of Res. DINAVISA N° 266/2022 (Art. 11).
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
- Name
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
- Description
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
- Timeline Reduction
From 30-120 business days down to 15 business days
- Eligibility
- Product classified as class II, III or IV under Resolución DINAVISA N° 266/2022 Art. 9
- Current authorisation and commercialisation in a country regulated by a PAHO/WHO reference regulatory authority, by an IMDRF Management Committee member authority, or by an authority with a bilateral agreement with DINAVISA
- The foreign registration must correspond specifically to the same product being registered in Paraguay
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Sri LankaEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Singapore HSA · US FDA · UK MHRA · Norway Regulatory reference
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.
Prior approval / evidence record
Singapore HSA product registration — assessment report reliance
reliance.reliance-edge-hsa-to-thailand-reliance-approval-singapore-hsa-thailand
- Source Approval
Singapore HSA product registration
- Edge Type
Assessment Report Reliance
- Market Access Strength
facilitated
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- medical devices and IVDs subject to route-specific scope
- Singapore registrant consents to Thai FDA access to HSA evaluation report
Page also states verbatim: อย สามารถเข้าถึง evaluation report ที่ออกโดย HSA สิงคโปร์ได้ (Thai FDA can access the HSA evaluation report).
UgandaWHO · IMDRF member authorities · ISO Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
- Authority
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
- Benefit
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
UgandaWHO · IMDRF member authorities · ISO Prior approval / evidence record
Track 2: WHO Prequalification or QMS certification from an IMDRF-accredited body substitutes for an IMDRF-country licence
reliance.track-2-who-prequalification-or-imdrf-accredited-qms
- Statement
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.
Effective from 2020-08-14
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.
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)
reliance.imdrf-reference-country-licence-track-1
- Statement
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.
Effective from 2020-08-14
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
- Benefit
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
ZambiaWHO · US FDA · EU conformity assessment · IMDRF member authorities Prior approval / evidence record
Foreign approval (WHO PQ, US FDA, CE mark, IMDRF member state, SADC registration) is disclosed on the application form but opens no stated route
reliance.foreign-approval-disclosure-no-stated-route
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Source Approval
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
- Benefit
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
