Explore the medical device requirements currently available for Canada, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising to the general public of any contraceptive device is prohibited except as authorized by regulation; MDR s.24 authorizes advertising for condoms only where the claim is limited to reducing the risk of contracting or transmitting sexually transmitted diseases.
MDR s.24 supplies the regulating authorization for condom claims.
No person may advertise a device to the general public as a treatment, preventative or cure for any disease, disorder or abnormal physical state listed in Schedule A.1 of the Food and Drugs Act, and a device so advertised or so represented on its label may not be sold.
What expires, what is retained periodically, and when must renewal start?
A Class II-IV Medical Device Licence has no fixed expiry: it is maintained through an annual confirmation/licence renewal submitted before November 1 each year, together with the annual right-to-sell fee.
The annual statement either confirms that all information and documents supplied are still correct or describes changes (s.43(1)(a)-(b)); s.43 was recently amended by SOR/2026-96.
If the annual confirmation is not filed the Minister may cancel the medical device licence; a licence holder who discontinues sale of the device must notify the Minister within 30 days and the licence is cancelled when the Minister is informed. For MDELs, failing to file the Annual Licence Review before April 1 means the licence is cancelled starting April 1 and licensable activities must stop.
MDEL cancellation consequence per FAQ Q29: 'Health Canada will cancel your Medical Device Establishment Licence (MDEL) starting on April 1'; resuming requires a new application and a new MDEL number (Q35).
Maintenance is annual on two separate clocks: MDLs are renewed by the annual confirmation before November 1 (s.43 MDR) with the right-to-sell fee; MDELs are maintained by the Annual Licence Review filed before April 1 each year (s.46.1 MDR) even when nothing has changed, with the MDEL fee payable on invoice.
Right-to-sell annual fee covers the twelve month period beginning November 1 (MDL side); ALR fee covers the following fiscal year (MDEL side).
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Before making a listed change the manufacturer must apply to the Minister for a licence amendment: a significant change to a Class III or IV device; a change that would affect the class of the device; a change in the manufacturer's name; a change in the device's name; a change to the device identifier (across a system, test kit, group, family or group family); and, for Class II devices, a change to the medical conditions, purposes or uses for which the device is made, sold or represented. Other changes are handled internally and disclosed in the annual s.43 confirmation.
Baseline confirmed against the regulation text.
A new (rather than amended) MDL application is required where the product is a new device to the market or the change goes beyond amendment scope, notably a change that would affect the classification of the device under the Schedule 1 rules (s.34(b)); s.34 amendments preserve the existing licence.
Baseline list verified: amendment route covers specified identity changes; anything reclassifying the device or constituting a different device needs a new application.
A manufacturer who is issued a new or modified quality system certificate for a licensed device must submit it to the Minister within 30 days after it is issued.
Which clinical or IVD performance evidence or study is required and accepted?
No person may import or sell a medical device for investigational testing involving human subjects unless, for Class II, III and IV devices, the manufacturer or importer holds an authorization under s.83(1) and keeps the records required by s.81; for Class I devices only the s.81 records are required.
Investigational devices are exempt from MDL fees (fees hub); ITA service standard is 30 calendar days.
For Class II devices and Class III or IV in vitro diagnostic devices that are not for near-patient use, the investigational testing application need only contain the reduced information set (the s.81 items in paragraphs (a), (b) and (h) to (j)) rather than the full application content.
Is the product a device, IVD, accessory, software, or borderline product locally?
The Medical Devices Regulations define 'medical device' as a device within the meaning of the Food and Drugs Act but exclude any device intended for use on animals; veterinary devices are therefore outside the medical device regime.
FAQ quotes the s.1 MDR definition verbatim.
A device is an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, manufactured, sold or represented for use in: diagnosing, treating, mitigating or preventing disease/disorder/abnormal physical state; restoring, modifying or correcting body structure or function; diagnosing pregnancy; care during pregnancy/birth; or preventing conception.
The excerpt is the definitional exclusion that separates devices from drugs; the MDEL FAQ Q1 reproduces the same definition.
Software that a medical device consists of or contains is within device scope: it must be designed to perform as intended by the manufacturer and its performance must be validated (MDR s.20).
Which evidence, local deltas, formats, and signatures are required?
Class II MDL application (s.32(2)): device name, identifier and class; conditions, purposes and uses of the device; an indication of the standards met in design and manufacture; a copy of the label and directions for use; and a certificate to CAN/CSA-ISO 13485 issued by a recognized registrar, with an attestation that the manufacturer has objective evidence for the safety and effectiveness requirements.
Applications are made in a format established by the Minister and filed via REP.
Class III MDL application (s.32(3)) adds: a description of how the device works and the materials used; a list of the countries other than Canada where the device has been sold; summaries of all studies on safety and effectiveness; a bibliography of all reports; and the quality system certificate.
Foreign sales history is a dossier element Canada requires rather than a reliance pathway.
Class IV MDL application (s.32(4)) adds: a risk assessment comprising an analysis and evaluation of the risks; detailed information on all studies carried out to demonstrate safety and effectiveness; a quality program plan; details of manufacturing, packaging, sterilization, installation and servicing procedures; and the quality system certificate.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
No AR Manufacturer Holds MDL Importer Distributor Hold MDEL
Canada has no authorized-representative requirement: the MDL stays with the manufacturer (s.26) and each Canadian importer or distributor holds its own MDEL (s.44). A person outside Canada selling devices into Canada is itself considered a distributor and requires an MDEL (MDEL FAQ Q3).
Not Applicable For Importer Or Distributor Changes
Baseline value confirmed: a supply-chain party change is not an AR change and does not by itself transfer the MDL.
'Manufacturer' means a person who sells a medical device under their own name (or under a trademark, trade name or label applied by them); the manufacturer is the MDL holder regardless of where the device is manufactured.
Which establishment licences, importer permissions, and distribution controls apply?
Exempt from holding an MDEL: retailers (including Class I manufacturers selling solely to end users); healthcare facilities; Class II-IV manufacturers selling only their own licensed or Part 2/Part 3 devices; Class I manufacturers importing or distributing solely through an MDEL holder; dispensers; personal-use importers; sellers of animal-use-only devices (label must state animal use); sellers of only custom-made, special access or investigational devices; exporters under Food and Drugs Act s.37; and storage-only warehouses.
No person may import or sell a medical device in Canada unless they hold a Medical Device Establishment Licence, except where exempted; MDELs cover importers and distributors of all classes and Class I manufacturers, and are issued by the Regulatory Operations and Enforcement Branch on the basis of signed attestations verified at inspection.
Senior official must attest to documented procedures under s.45(g),(h),(h.1),(i) MDR (FAQ Q14).
What regulator fee applies to this class, route, event, and date?
No MDL application fees apply for: Class I medical devices, custom-made medical devices, medical devices for special access, and medical devices for investigational testing involving human subjects.
There is no fee for amending a Medical Device Establishment Licence or for making a section 48 notification; fees apply only to new MDEL applications, Annual Licence Review and reinstatement applications, equally to foreign and domestic establishments.
Which label and IFU elements, languages, symbols, and translation controls apply?
The manufacturer of an implant must provide two implant registration cards with the implant (one to be kept by the patient and one returned), stating for example the implant's identifier and the date it was provided.
Labels and accompanying directions for use may be in either English or French (s.23(1)); the other official language must be provided as soon as possible at the purchaser's request (s.23(2)); both languages are required on the label where the device is sold to the general public for the items in s.21(1)(a) and (e) to (j), such as directions for use (s.23(3)). Regulatory submissions may be in either official language.
Corrects the baseline, which stated labels/IFU were generally English and French: s.23 requires one official language generally, the second only on request, both only for general-public devices. s.21(2) also requires label information in a legible, permanent and prominent manner; s.21(1)(g) requires the control number on Class III and Class IV device labels.
Which current law, regulation, guidance, and transition provisions apply?
Medical device fees (MDL application review, MDEL, right to sell) are charged under the Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124).
MDEL FAQ Q39 confirms: fees charged as per the Fees in Respect of Drugs and Medical Devices Order.
Food and Drugs Act (R.S.C., 1985, c. F-27)
Medical Devices Regulations (SOR/98-282), consolidated current to 2026-06-21
Includes SOR/2024-136 (added s.63.2 recall notice) and SOR/2026-96 (s.43 amendment)
Section pages show provision-level amendment notes, e.g. s.43 lists SOR/2026-96, s. 41(E).
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Medical device licence holders must submit periodic summary reports containing a concise critical analysis of available scientific information on safety and effectiveness: Class II devices on a biennial basis, Class III and IV devices on an annual basis; changes in the benefit-risk profile must be notified within 72 hours.
Related record duties: manufacturers, importers and distributors keep distribution records (s.52) and complaint/problem records (s.57).
Which current form, portal, account, and submission package must be used?
MDEL applications, amendments, notifications and Annual Licence Review are submitted by email only using the Medical Device Establishment Licence Application form FRM-0292; mailed applications are not processed.
FRM-0292 instructions page also directs all completed forms to this mailbox.
MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.
REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.
Which QMS, audit, inspection, and certificate scope is accepted or required?
MDR s.32 requires a certificate to CAN/CSA-ISO 13485 issued by a registrar recognized under s.32.1
Health Canada requires MDSAP: the transition announced December 2015 was completed in 2019 and all manufacturers holding Canadian medical device licences now participate; CMDCAS was replaced
No
Effective from 2019-01-01
Baseline confirmed; source upgraded from fda.gov to the Health Canada MDSAP page.
Which recall, FSCA, notice, and authority-coordination duties apply?
A manufacturer or importer who decides to recall a medical device must give the Minister written notice of the decision and submit an initial report within 24 hours after making the decision.
Effective from 2024-12-14
Section added by SOR/2024-136 (in force 2024-12-14 per the consolidation's amendment list).
The manufacturer or importer must provide the Minister, on or before the day the recall begins, a report on the reason for the recall, the defect, an evaluation of the risks, the quantity of devices distributed, and the proposed strategy for conducting the recall.
Which registration, notification, listing, reliance, or conformity route applies?
Class I market access runs through the Medical Device Establishment Licence: Class I manufacturers, and importers or distributors of all four classes, hold an MDEL to permit importation or sale instead of a product licence.
Class II, III and IV devices require a Medical Device Licence (MDL) held by the manufacturer before any person may import or sell them; Class I devices are outside the product-licence route and are controlled through establishment licensing.
Baseline confirmed and upgraded to the regulation text; Class II-IV applications also require the MDSAP/ISO 13485 quality system certificate under s.32.
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.
Prior approval / evidence record
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.
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
Origin Country Evidence
Evidence Only
Import Control
Yes
Yes
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".
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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
geo:aus
Health Canada medical-device licence
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
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).
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)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
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."
Prior approval / evidence record
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.
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
Origin Country Evidence
Evidence Only
classification
Yes
Yes
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.)."
Regulatory reference
Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity-assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
Prior approval / evidence record
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.
none
No Reliance Route
none
Premarket Review
Yes
Yes
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)).
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)
No
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.
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)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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.
Prior approval / evidence record
Health Canada
Yes
Recognised AREE for IN 290/2024, evidenced by the Medical Device Licence
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Health Canada Medical Device Licence is accepted under the optimized review procedure for class III/IV device registration.
Effective from 2024-06-03
Prior approval / evidence record
Optimized analysis (procedimento otimizado, IN 290/2024)
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.
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
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.
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
Procurement Admission
Evidence Only
procurement
No
No
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.
Prior approval / evidence record
class-iia
Class IIa
medium
Registration (NSO)
2
2
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
1
2
months
2
3
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iib
Class IIb
high
Registration (RSO)
90
90
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
6
12
months
4
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada
Yes
Reference-country origin under Decreto 3275/2009
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
Prior approval / evidence record
Homologación for reference countries (Decreto 3275/2009)
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.
None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
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.
Prior approval / evidence record
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
Yes
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.
No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.
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)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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.
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.
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.
Effective from 2027-01-28
Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).
Regulatory reference
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.
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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
Health Canada
Yes
Medical Device Licence satisfies D002
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
Regulatory reference
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.
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.
Prior approval / evidence record
Health Canada
Yes
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Regulatory reference
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.
Health Canada listed as accepted approval per the AMAR registration guidelines PDF.
Prior approval / evidence record
Health Canada or Australia TGA
Yes
REG-2024/06 restricts the regulatory certificate types that can be entered on an application to CE, FDA, FDA K510, Australian Ministry of Health and Canadian Ministry of Health, so a Canadian or Australian approval is a first-class reference certificate on the same terms as a US or EU one.
Same track placement as the US and EU certificates above
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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).
Regulatory reference
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).
Prior approval / evidence record
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
Yes
Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Assessment Report Reliance
facilitated
Premarket Review
Yes
Yes
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."
Prior approval / evidence record
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.
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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."
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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."
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
Yes
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.)
Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
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.
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)
Yes
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
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.
Regulatory reference
Health Canada Licence qualifies for the verification route.
Prior approval / evidence record
class-b
Class B
medium
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
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
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
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
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Prior approval / evidence record
class-d
Class D
highest
Full Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
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
2026-08-25
3
6
months
3
6
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
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.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:mex
Health Canada medical device licence
Equivalence Or Abridged Review
facilitated
Product Marketing
Yes
Yes
Same COFEPRIS-04-050 mechanism as other ARR approvals under the Lineamientos.
Effective from 2025-07-19
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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.
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.
Regulatory reference
The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
Regulatory reference
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.
Effective from 2018-01-16
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
Yes
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
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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
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.
From 30-120 business days down to 15 business days
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
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.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
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
Yes
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.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
IBR/Expedited/Full Route
0
220
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
6
12
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
IBR/Expedited/Full Route
0
160
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
3
9
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
Yes
At Class B this is the IBR trigger and registration is granted on submission. At Class C and D it is the ECR-2 or EDR trigger.
Class B immediate against 160 working days; Class C 120 against 220; Class D 180 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada, Australia TGA, Japan MHLW
Yes
A Canadian or Australian device registration licence, or a Japanese Ninsho certification or Shonin approval, counts as a reference approval on the same terms as the US and EU.
Same as the abridged route figures above; two of them together trigger IBR, ECR-2 or EDR
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Health Canada is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for the reliance-based registration routes.
Confirms baseline reliance edge.
Prior approval / evidence record
class-d
Class D
highest
IBR/Expedited/Full Route
180
310
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
9
18
months
6
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre-market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.
The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.
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.
Prior approval / evidence record
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
Health Canada medical-device licence
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
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.
US FDA 510(k) premarket notification (class I and class II) and US FDA PMA premarket approval (class III); Health Canada medical device licence
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
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.
Prior approval / evidence record
Health Canada medical device licence
No
Named in the ANMPS dossier guide as the conformity evidence for devices declaring conformity to Canadian legislation. Dossier evidence only.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Health Canada or Australia TGA
Yes
A Canadian or Australian registration can serve as the free sale or registration certificate from the country of origin, but EDE names EC, 510(k) and PMA as the conformity certificate types.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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
Yes
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
Prior approval / evidence record
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'.
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
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
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.
Prior approval / evidence record
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.
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
Eligibility Gate
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
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.
Prior approval / evidence record
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.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
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
Prior approval / evidence record
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
Yes
DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
International Reliance (draft legislation, not in force)
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
Not quantified — the draft fixes no review period
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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).
Prior approval / evidence record
Origin Country Evidence
Evidence Only
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
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.
Product Marketing
Yes
Yes
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'.
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
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
Regulatory reference
Health Canada issues a Class II-IV medical device licence only on its own review of the application prescribed by section 32 of the Medical Devices Regulations (SOR/98-282); the Regulations contain no reliance or abridged licence route based on a foreign marketing authorisation, so a China NMPA registration certificate does not shorten or replace the Canadian licence review. NMPA appears in Health Canada's List of Regulatory Agencies only for the sections 61.2/68.3 foreign risk notification duty.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
canada
NMPA Class II/III -> Canada Class II-IV licences
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: Section 32 prescribes the content of a Class II, III or IV licence application; no provision refers to foreign marketing authorisations. Canada.ca list entry: 'National Medical Products Administration' under 'China' (Date modified 2024-01-24).
Prior approval / evidence record
EU CE Mark
No
Not recognized
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)
No
eSTAR pilot closed, no formal recognition
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
MDSAP
Yes
MANDATORY for Class II-IV since 2019
Required
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
Page issued 2024-01-03, modified 2024-01-24.
Regulatory reference
Medical Device Single Audit Program (MDSAP)
A single audit by a recognized MDSAP Auditing Organisation provides the QMS evidence for Canadian device licensing; it does not by itself authorize the product
Yes
Yes
Effective from 2019-01-01
Baseline confirmed and source upgraded from fda.gov to the Health Canada MDSAP page; MDR s.32 requires the certificate to CAN/CSA-ISO 13485 from a registrar recognized under s.32.1.
What review, validation, and applicant stop-clock rules apply?
Applicants have 10 days to respond to an administrative screening information request, 15 days to respond to a screening deficiency letter, and 10 or 60 days at review stage (10 days for an additional-information noncompliance letter, 60 days for a deficiency letter); non-response ends in rejection (screening stage, 10% of fee charged for Class III/IV) or refusal (review stage).
Administrative screening itself takes 4 days; regulatory screening 12 days (Class II/private label) or 12 days regulatory and technical screening (Class III/IV), plus 3 days administrative processing.
The MDEL performance standard is 120 calendar days from receipt of a complete application; the clock pauses when a deficiency notice is issued (restarting when the response is received) and during cost-recovery holds for unpaid fees.
If a regulatory decision is not provided within the performance standard, applicants are credited 25% of the fee originally paid (FAQ Q43).
Class III/IV review periods (Review 1: 57 calendar days Class III, 72 days Class IV; Review 2: 42 days) exclude 3 days of administrative processing and pause while the application awaits the applicant's response to additional-information letters.
Usually no more than two additional information letters are issued per review.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation (MDR Part 2 route, outside the MDL system and exempt from MDL fees).
Labels under this Part must state whether the device is custom-made or imported/sold for special access (s.75).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Where the Minister refuses to issue or amend a licence, the applicant must be notified in writing of the reasons for the refusal and be given an opportunity to be heard.
A manufacturer may seek reconsideration of a rejection or refusal decision by filing a request for reconsideration (RR) within 30 days; the Medical Devices Directorate then proceeds by an internal review or an external panel review pathway chosen by the Director General, with the DG reconsideration decision issued within 5 days of receiving recommendations.
Timelines are MDD target timelines in calendar days; fee-related reconsiderations go to the Cost Recovery Invoicing Unit (FAQ Q61).
Which UDI, device listing, database, and traceability duties apply?
The Medical Devices Active Licence Listing (MDALL) is the public database of all licensed Class II, III and IV devices; only products appearing in the listing may be offered for general marketing purposes in Canada, and searches can be made by company name, company ID, licence name, licence number, device name and device identifier. Class I devices and ITA/special access devices do not appear.
Device Identifier defined as a unique series of letters or numbers assigned by the manufacturer, often the catalogue number.
Health Canada's first consultation on a proposed UDI system opened June 28, 2021 and closed September 30, 2021. The consultation sought feedback on potential implementation of an IMDRF-aligned system; it did not itself create a UDI requirement.
Consultation question 3: 'Do you agree with Health Canada's proposal to exempt custom-made devices and Class I devices?'
What is reportable, by whom, where, in what format, and by what deadline?
A licence holder (or importing MDEL holder) must notify Health Canada of a decision or action by a foreign regulatory agency, from the List of Regulatory Agencies incorporated by reference, concerning a serious risk of injury to human health, within 72 hours after the holder receives or becomes aware of it, whichever occurs first.
Manufacturers and importers must report incidents to the Minister in a preliminary report within 10 days after becoming aware of an incident that caused death or serious deterioration of health, and within 30 days where death or serious deterioration could result if the incident recurred; incidents outside Canada are reported as soon as possible once corrective action is intended or required by a foreign agency.
Final reports follow under s.61 in accordance with the established timetable.
Mandatory problem reporting runs through Health Canada's Canada Vigilance - Medical Device Problem Reporting Program; the Medical Device Foreign Risk Notification form (listed 2022-06-10) is used for s.61.2 notifications, and a separate medical device problem report form exists for health care professionals.
canada:medical-device
canada
Risk classes I through IV.
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
Health Canada
official-source-verified
Medical Devices Regulations (SOR/98-282), s. 6 and Schedule 1
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/section-6.html
2026-08-25
Canada
canada
CA
🇨🇦
Health Canada
Health Canada
americas
1
4-class (I, II, III, IV)
class-i
Class I
low
MDEL Only (no device license)
4
4
months
official-verified
Health Canada MDEL FAQs — 120 calendar-day performance standard, 1 April annual licence review, 25% fee credit when the standard is missed
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html
2026-08-30
2
3
months
No
No
No
class-ii
Class II
medium
Device License
0.5
0.5
months
official-verified
Health Canada service standards — medical device submission evaluations (first-review calendar-day table, published for fiscal year 2020 to 2021 and still the current edition)
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html
2026-08-30
1
1.5
months
No
No
Yes
class-iii
Class III
high
Device License with clinical data
2
2
months
official-verified
Health Canada service standards — medical device submission evaluations (first-review calendar-day table, published for fiscal year 2020 to 2021 and still the current edition)
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html
2026-08-30
3
4
months
No
No
Yes
class-iv
Class IV
highest
Device License
2.5
2.5
months
official-verified
Health Canada service standards — medical device submission evaluations (first-review calendar-day table, published for fiscal year 2020 to 2021 and still the current edition)
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html
2026-08-30
4
5
months
Yes
No
Yes
FDA 510(k)
No
eSTAR pilot closed, no formal recognition
None
EU CE Mark
No
Not recognized
None
MDSAP
Yes
MANDATORY for Class II-IV since 2019
Required
Yes
Canadian Importer
Yes
MANDATORY for Class II-IV - must obtain before submission
The device licence itself does not expire, but MDR s. 43 requires the manufacturer to file a signed annual statement before 1 November each year, and the establishment licence separately requires an Annual Licence Review before 1 April
official-verified
Health Canada service standards — medical device submission evaluations (first-review calendar-day table, published for fiscal year 2020 to 2021 and still the current edition)
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html
2026-08-30
Health Canada MDEL FAQs — 120 calendar-day performance standard, 1 April annual licence review, 25% fee credit when the standard is missed
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html
2026-08-30
Medical Devices Regulations (SOR/98-282) — s. 43 annual licence statement before 1 November
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-4.html
2026-08-30
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Health Canada. Appoint a Canadian Importer.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Health Canada including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Health Canada reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Health Canada may issue questions.
4 months
⚙️
5
Registration Approval
Upon successful review, Health Canada issues Canada market authorization certificate.
1-2 weeks
✅
Canada
canada
CA
Health Canada
643
643
CAD
Yes
14163
30713
CAD
Yes
mdl-application-class-ii
MDL Application - Class II
CAD
643
CAD 643
Per application
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
mdl-application-class-iii
MDL Application - Class III
CAD
14163
CAD 14,163
Per application
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
mdl-application-class-iii-near-patient
MDL Application - Class III near-patient IVD
CAD
30169
CAD 30,169
Per application
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
mdl-application-class-iv
MDL Application - Class IV
CAD
30713
CAD 30,713
Per application
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
private-label-application
Private-label device application
CAD
179
CAD 179
Per application
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
annual-right-to-sell
Annual right to sell - Class II/III/IV
CAD
460
CAD 460
Annual per licensed device
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-licensed-class-medical-devices-funding-fees-drugs.html
Health Canada annual right-to-sell fee for licensed Class II-IV devices
2026-04-01
2026-08-25
establishment-licence-mdel
Medical Device Establishment Licence
CAD
5519
CAD 5,519
Per application; same fee for annual review and reinstatement
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-establishment-licence-funding-fees-drugs-health-products.html
Health Canada 2026 Medical Device Establishment Licence fee
2026-04-01
2026-08-25
amendment-class-ii
Amendment - Class II licence
CAD
331
CAD 331
Per amendment
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
amendment-class-iii-iv-changes-in-manufacturing
Amendment - Class III/IV changes in manufacturing
CAD
4470
CAD 4,470
Per amendment
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
amendment-class-iii-significant
Amendment - Class III significant changes not related to manufacturing
CAD
11369
CAD 11,369
Per amendment
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
amendment-class-iv-significant
Amendment - Class IV significant changes not related to manufacturing
CAD
16251
CAD 16,251
Per amendment
exact-current
official-verified
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
Health Canada 2026 medical-device licence application fees
2026-04-01
2026-08-25
2026-08-25
official-verified
Health Canada 2026 medical-device licence application fees
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
2026-04-01
2026-08-25
Health Canada annual right-to-sell fee for licensed Class II-IV devices
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-licensed-class-medical-devices-funding-fees-drugs.html
2026-04-01
2026-08-25
Health Canada 2026 Medical Device Establishment Licence fee
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-establishment-licence-funding-fees-drugs-health-products.html
2026-04-01
2026-08-25
Health Canada FAQ: medical device establishment licensing fees
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html
2026-08-25
2026-08-25
exact-current
Yes
canada
Canada
high
health-canada-electrical-emc-evidence
Health Canada electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
MDL applications for class II-IV devices must include a CAN/CSA-ISO 13485 certificate from a registrar recognized under s.32.1 MDR (s.32(2)-(4)); in practice an MDSAP certificate from a recognized MDSAP Auditing Organisation (CMDCAS transition completed 2019). Design and safety duties ss.9-20 MDR (incl. s.10 risk management and s.20 software validation) stand behind every application.
unresolved
ised-equipment-certification-registration
ISED equipment certification/registration
Radio Spectrum
Mandatory If Feature
Radio Equipment
candidate
radiation-emitting-devices-act-compliance
Radiation Emitting Devices Act compliance
Non Ionizing Radiation
Mandatory If Feature
Radiation Emitting Product
No general premarket registration or authorization under REDA.
reviewed
provincial-electrical-radiation-approval
Provincial electrical/radiation approval
Ionizing Radiation
Mandatory For Use Site
Installation Or Facility
unresolved
ISED
equipment certification and registration
https://www.ised-isde.canada.ca/site/spectrum-management-system/en/equipment-certification-and-registration-services
Health Canada
Radiation Emitting Devices Act and Regulations
https://www.canada.ca/en/health-canada/services/health-risks-safety/radiation/radiation-emitting-devices/acts-regulations.html
Health Canada
radiation safety codes
https://www.canada.ca/en/health-canada/services/health-risks-safety/radiation/radiation-emitting-devices/safety-codes.html
Justice Canada
Medical Devices Regulations s.32 CAN/CSA-ISO 13485 certificate
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/section-32.html
Health Canada
MDSAP transition completion and CMDCAS end
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html
