Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
Health Canada
Register your medical device in Canada.
Obtain a Medical Device Licence (MDL) for Classes II/III/IV, with mandatory MDSAP and a Canadian MDEL holder for importation.
Speak to a specialistThe authority
Health Canada (Sante Canada)
Health Canada
Regulatory authority
Canada
The federal department responsible for Canadian public health. It regulates medicines, medical devices and health products under the Food and Drugs Act.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, no MDL (only MDEL for the importer) | Bandages, gauze, basic instruments |
| Class II | Low-to-moderate risk, requiring MDL | Infusion pumps, diagnostic equipment |
| Class III | Moderate-to-high risk, requiring MDL and more extensive review | External pacemakers, surgical equipment |
| Class IV | Critical high risk, requiring full MDL | Cardiac implants, valves, haemodialysis equipment |
Registration process
How we manage your project
- 01
MDSAP6-12 months
Obtain MDSAP certification through an authorised Auditing Organization (mandatory for Class II/III/IV)
- 02
Classification2 weeks
Determine the class (I-IV) under the Medical Devices Regulations
- 03
Technical dossier2-4 months
Prepare the Medical Device Licence Application in English or French
- 04
MDL submission2-3 weeks
Submit to Health Canada through REP (Regulatory Enrolment Process)
- 05
Health Canada review60-75 days
Class II: 60 days. Class III: 60 days. Class IV: 75 days
- 06
MDEL for the importer2-3 months
The Canadian importer needs an MDEL (Medical Device Establishment Licence)
Total timeframe9-15 months including MDSAP
Local representativeCanadian MDEL holder (for importation)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Mandatory Problem Reporting and Annual Licence Review |
| Renewal | Indefinite licence with annual listing |
| Required QMS | MDSAP (mandatory for Class II/III/IV) |
How HSC helps
Canada with MDSAP and a Medical Device Licence, respecting each market's requirements.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about Health Canada
Next step
Ready to start your project in Canada?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist