What Is a Medical Device Licence?
In Canada, Class II, III, and IV medical devices must have a Medical Device Licence (MDL) issued by Health Canada before they can be sold. Class I devices are exempt from MDL requirements but still require a Medical Device Establishment Licence (MDEL) for the importer or distributor.
Device Classification in Canada
Health Canada uses a four-class system based on risk:
| Class | Risk | Examples | MDL Required? | |---|---|---|---| | Class I | Lowest | Bandages, tongue depressors | No | | Class II | Low-moderate | Powered wheelchairs, pregnancy tests | Yes | | Class III | Moderate-high | Orthopedic implants, dialysis machines | Yes | | Class IV | Highest | Pacemakers, implantable defibrillators | Yes |
Who Can Apply for an MDL?
The MDL applicant must be the manufacturer or an authorized representative with a written agreement from the manufacturer. Foreign manufacturers must designate a Canadian Importer or authorized representative.
Application Requirements by Class
Class II Applications
- Device name and identifier
- Device description and intended use
- Safety and effectiveness evidence (summary acceptable)
- Quality system attestation (ISO 13485 certificate or equivalent)
- Labeling (bilingual English/French)
- Declaration of conformity
Class III and IV Applications
All Class II requirements plus:
- Detailed summary of safety and effectiveness evidence
- Clinical data or clinical literature review
- Risk analysis (per ISO 14971)
- Full technical documentation
- Pre-market review by Health Canada reviewers
Labeling Requirements for Canadian Market
Device labels must be bilingual (English and French) and include:
- Device name and identifier
- Manufacturer name and address
- MDL number (once issued) — for Class II–IV
- Warnings and precautions
- Storage conditions and expiry date where applicable
Common MDL Application Deficiencies
- Incomplete safety and effectiveness summary — particularly clinical data gaps for Class III/IV
- Non-bilingual labeling submitted with the application
- ISO 13485 certificate expired or covering a different scope
- Mismatch between intended use in the application and device labeling
- Missing authorization letter from the foreign manufacturer
Timeline Expectations
- Class II: 15 days (Health Canada target for complete applications)
- Class III: 75 days
- Class IV: 300 days
These timelines apply only to complete applications. Deficiency letters pause the clock.
How United Regulatory Can Help
We prepare complete MDL application packages for Class II, III, and IV devices — technical documentation, safety and effectiveness summaries, bilingual label review, and coordination with Health Canada. Contact us to start your Canadian regulatory strategy.