Summary – Time, Cost, and Complexity of Registration
| Device classification
in Canada |
Class I | Class II | Class III | Class IV |
| How long you should expect to wait after submission until approval is granted? | Up to 120 calendar days | 15 calendar days | 75 calendar days (typically broken down as 15 days for screening and 60 days for review). | 90 calendar days |
| Validity period for device registrations | A MDEL for Class I devices in Canada is valid for one year. | Valid indefinitely, provided the manufacturer complies with annual renewal requirements. | Valid indefinitely, provided the manufacturer complies with annual renewal requirements. | Valid indefinitely, provided the manufacturer complies with annual renewal requirements. |
| Registration renewal should be started this far in advance | The MDEL renewal (Annual Licence Review) must be submitted before April 1 of each year. It is recommended to start this process well in advance, ideally in early spring or as soon as the package is received. | The MDL renewal application and fee must be submitted by November 1 of each year to avoid cancellation. Health Canada sends out renewal packages early in August, therefore, preparation should begin in late summer (August/September). | The MDL renewal application and fee must be submitted by November 1 of each year to avoid cancellation. Health Canada sends out renewal packages early in August, therefore, preparation should begin in late summer (August/September). | The MDL renewal application and fee must be submitted by November 1 of each year to avoid cancellation. Health Canada sends out renewal packages early in August, therefore, preparation should begin in late summer (August/September). |
| Complexity of the registration process for this classification | Low | Low-Moderate | Moderate-High | High |
| Overall cost of gaining regulatory approval | Low | Low-Moderate | Moderate-High | High |
Class I Pathway–Medical Device Establishment Licence (MDEL) Required for:
- Class I manufacturers
- Importers and distributors of medical devices (all classes), unless exempt
Submit MDEL Application:
- Establishment information
- Activities (manufacture, import, distribute)
- Pay applicable fees
Class II–IV Pathway : Medical Device Licence (MDL) Application
Should include:
- Device classification and intended use
- Labelling (Instructions for Use) in English & French
- Risk management report (ISO 14971)
- Clinical evidence (Class III/IV)
- Declaration of conformity (Class III/IV)
- MDSAP certificate
- Device description and supporting documentation demonstrating safety and effectiveness
Application Submission
- Class I: Submit MDEL application and fees
- Class II: Submit MDL application using REP + MDSAP certificate + fees
- Class III & IV: Submit MDL application using REP + MDSAP certificate + supporting evidence (e.g., safety and effectiveness data depending on class)
Review Step (Class II–IV only)
- Health Canada reviews MDL application
- Review is conducted according to device class and submission type.
Approval Step
- Class I: MDEL issued
- Class II–IV: MDL issued
Approved licences are listed in Health Canada databases.
Final Step – Market Authorization & Ongoing Compliance
Manufacturers must maintain:
-
- Valid MDSAP certification (Class II–IV)
- Annual MDEL review (if applicable)
- Comply with post-market requirements
Unique to Health Canada: MDSAP Requirement
- All Class II, III, and IV devices, manufacturers must provide a valid Medical Device Single Audit Program (MDSAP) certificate issued by a recognized auditing organization as part of the licence application
- The MDSAP certificate must remain valid to maintain the device licence.
Important Health Canada Links
- Market Authorization monthly update
- Risk classification tool
Our team has a track record of successful MDL and MDEL registrations with Health Canada, and MDSAP certifications.