D01
Authority & regime
- Competent authority
- Health Canada (Health Products and Food Branch) is the federal regulator of medical devices; device licences are administered by the Medical Devices Directorate.
1 source-linked fact
Checked 2026-08-25
Health Canada · AmericasCanada medical device regulatory resources
Every Canada dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
10 free resources24/25 topics with records13 regulations trackedAug 2026 fees reviewed
Everything we track for Canada
Medical device registration database
Search official Health Canada device registration records.
Medical device regulations
Browse official Health Canada regulations and guidance documents.
Registration timeline
Compare official and realistic approval times by device class and pathway.
Government registration fees
Review current Health Canada application, review, and renewal fees.
AI registration cost and timeline planner
Estimate the likely Health Canada pathway, government fees, dossier preparation time, review timeline, and registration steps.
Medical device regulation news
Follow recent Health Canada policy, guidance, and compliance updates.
AI medical device classifier
Describe your device and get a preliminary Health Canada risk class with an explanation and source links.
Additional certification and licence checker
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AI similar registered product finder
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Regulatory requirements data
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Changes after registration
Explore questions and sources →Common questions about changing a registered medical device in Canada. Each question separates published rules from details still awaiting verification.
- Does changing a device brand name or logo require an update? →Source-linked rules available
- How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
- What changes when the manufacturer's office address changes? →Source-linked rules available
- Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
- Can a registration transfer to a different legal entity? →Source-linked rules available
- Can several changes be filed together? →Source-linked rules available
Structured regulatory requirements
Explore all 63 source-linked facts →24 of 25 research dimensions currently covered · 31 official sources · latest verification 2026-10-21
Market entry
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D02
Legal basis & guidance
- Fee-setting authority
- 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).
- Primary legal instruments
- act: Food and Drugs Act (R.S.C., 1985, c. F 27) · regulations: Medical Devices Regulations (SOR/98 282), consolidated current to 2026 06 21 · recent amendments: Includes SOR/2024 136 (added…
2 source-linked facts
Checked 2026-08-25
D03
Device definition & scope
- Animal-use devices out of scope
- 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 t…
- Device definition (Food and Drugs Act)
- 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…
3 source-linked facts
Checked 2026-08-25
D04
Classification rules
- Risk classes I through IV.
- Class I, Class II, Class III, Class IV
1 maintained scheme
Checked 2026-08-25
D05
Registration pathways
- Class I route (MDEL-based)
- 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…
- Market-access route (MDL)
- 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…
3 source-linked facts
Checked 2026-10-21
D06
Reliance & recognition
- Recognized foreign regulators (incorporated list)
- 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 refere…
- MDSAP QMS audit reliance
- program: Medical Device Single Audit Program (MDSAP) · effect: A single audit by a recognized MDSAP Auditing Organisation provides the QMS evidence for Canadian device licensing; it does no…
3 source-linked facts
Checked 2026-09-15
D07
Economic-operator roles
- No authorized-representative role
- path code: no AR manufacturer holds MDL importer distributor hold MDEL · notes: Canada has no authorized representative requirement: the MDL stays with the manufacturer (s.26) and each Cana…
- Manufacturer role
- '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 w…
4 source-linked facts
Checked 2026-10-21
D08
Establishment, import & distribution
- MDEL exemptions
- 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 Par…
- Establishment licence requirement
- 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…
2 source-linked facts
Checked 2026-08-25
D09
Dossier requirements
- Class II application dossier
- 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 t…
- Class III application dossier
- 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 o…
5 source-linked facts
Checked 2026-10-21
D10
Official forms & portals
- MDEL application form and channel
- MDEL applications, amendments, notifications and Annual Licence Review are submitted by email only using the Medical Device Establishment Licence Application form FRM 0292; mailed applicati…
- REP submission portal
- 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 compa…
3 source-linked facts
Checked 2026-10-21
Submission & evidence
D11
Label, IFU & language
- Implant registration cards
- 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 an…
- Label and IFU language rules
- 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)…
4 source-linked facts
Checked 2026-10-21
D12
QMS, audit & inspection
- QMS audit evidence for market access
- regulatory requirement: MDR s.32 requires a certificate to CAN/CSA ISO 13485 issued by a registrar recognized under s.32.1 · operative regime: Health Canada requires MDSAP: the transition a…
1 source-linked fact
Checked 2026-08-25
D13
Standards, testing & ancillary approvals
- Health Canada electrical/EMC evidence
- Electrical safety
- ISED equipment certification/registration
- Wireless / radio
- Radiation Emitting Devices Act compliance
- Laser / UV / ultrasound
4 maintained overlays
D14
Fees
- MDL Application - Class II
- CAD 643
- MDL Application - Class III
- CAD 14,163
11 maintained fee lines · 3 related facts
Checked 2026-10-21
D15
Review clocks
- Class I · MDEL Only (no device license)
- 4 months
- Class II · Device License
- 2 weeks
- Class III · Device License with clinical data
- 2 months
4 maintained pathways · 4 related facts
Checked 2026-10-21
D16
Approval validity & renewal
- MDL validity
- 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 rig…
- Expiry or lapse consequence
- 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…
3 source-linked facts
Checked 2026-08-25
Lifecycle & post-market
D17
Change control
- Change requiring licence amendment
- Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the ma…
- Classification-change licence amendment
- Before a change that would affect the device classification, the manufacturer must apply for an amendment of its medical device licence under section 34(b).
6 source-linked facts
Checked 2026-10-21
D18
UDI, listing & traceability
- MDALL public licence listing
- 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 mar…
- Actual device identifier rather than an assumed UDI
- Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer assigned identifying…
3 source-linked facts
Checked 2026-10-21
D19
Clinical investigation & performance
- Investigational testing authorization
- 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 authorizat…
- Reduced ITA dossier
- 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…
2 source-linked facts
Checked 2026-08-25
D20
Special access & derogation
- Special access and custom-made authorization
- 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 P…
1 source-linked fact
Checked 2026-08-25
D21
Manufacturer PMS
- Periodic summary reports
- 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…
1 source-linked fact
Checked 2026-08-25
D22
Vigilance & incident reporting
- Foreign risk notification (72 hours)
- 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,…
- Incident reporting deadlines
- 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 he…
3 source-linked facts
Checked 2026-08-25
D23
Recall, FSCA & market surveillance
- Recall decision notice (24 hours)
- 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 decisio…
- Recall strategy report
- 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 o…
2 source-linked facts
Checked 2026-08-25
D24
Advertising, claims & promotion
- Contraceptive advertising restriction
- 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 t…
- Schedule A advertising ban
- 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…
2 source-linked facts
Checked 2026-08-25
D25
Submission communications & appeal
- Statutory right to be heard
- 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.
- Administrative reconsideration
- 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 i…
2 source-linked facts
Checked 2026-08-25
Government fees
Full fee schedule (11 lines) →Health Canada registration fees in CAD · reviewed 2026-08-25
Registration timeline
Full registration timeline →Health Canada (Health Canada) review clocks and planning ranges · 4-class (I, II, III, IV) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class I(MDEL Only (no device license)) MDEL performance standard: 120 calendar days to issue a decision on a new, annual licence review, or reinstatement application Class I devices carry no device licence at all — the MDEL is the only authorisation, and it licenses the establishment rather than the product The MDEL has to be kept alive by an Annual Licence Review filed before 1 April every year, even when nothing has changed. Miss it and Health Canada cancels the licence from 1 April, after which licensable activities stop and a fresh MDEL application is the only way back The 120-day standard has a remedy attached: if Health Canada misses it, 25% of the fee paid is credited back to the applicant | 4 months | 2-3 months | Verified |
| Class II(Device License) First-review service standard: 15 calendar days for the licence application (also 15 for amendments and private-label applications) MDSAP mandatory since 2019 The standard measures first review only, from receipt of a complete application to the decision, and excludes time the applicant spends responding | 2 weeks | 1-1.5 months | Verified |
| Class III(Device License with clinical data) First-review service standard: 60 calendar days for the licence application (near-patient IVDs included); manufacturing and significant non-manufacturing changes also 60 MDSAP mandatory Clinical data required | 2 months | 3-4 months | Verified |
| Class IV(Device License) First-review service standard: 75 calendar days for the licence application and Class IV changes MDSAP mandatory Most rigorous review | 2.5 months | 4-5 months | Verified |
- 1Pre-Submission Preparation(1-3 months)
- 2Application Submission(1-2 weeks)
- 3Administrative Review(2-4 weeks)
- 4Technical Evaluation(4 months)
- 5Registration Approval(1-2 weeks)
Latest regulation news
All Canada regulation news →Newest official Health Canada headlines from the daily-refreshed feed — every row links directly to the authority publication.
Oct 15HCHealth CanadaHealth Canada Authorization Summary: Drugs and Medical Devices Approved from July 1 to September 30, 2026CanadaOct 15HCHealth CanadaHealth Canada Quarterly Update: Modernization of Health Product Authorizations for July to September 2026CanadaJul 15HCHealth CanadaHelping Canadians access safe, effective treatments and medicines fasterCanadaJul 15HCHealth CanadaDrugs and medical devices authorized, April 1 to June 30, 2026CanadaSep 14, 25HCHealth CanadaRegulatory enrolment processCanada
CanadaOct 15HCHealth CanadaHealth Canada Quarterly Update: Modernization of Health Product Authorizations for July to September 2026CanadaJul 15HCHealth CanadaHelping Canadians access safe, effective treatments and medicines fasterCanadaJul 15HCHealth CanadaDrugs and medical devices authorized, April 1 to June 30, 2026CanadaSep 14, 25HCHealth CanadaRegulatory enrolment processCanadaKey regulations
All 13 Canada regulations →Official Health Canada rules and guidance · 13 of 13 documents linked to official sources
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