Medical Device Registration in
Ministry of Health:
Public Health Agency of Canada
Medical Device Regulation:
Food and Drugs Act
Medical Device Regulations (SOR/98-282)
French & English
Class I, II, III and IV
- Determine the classification on the device.
- Class I – Medical Device Establishment License (MDEL) Application
- Other – Medical Device License (MDL) Application
- The agency will evaluate the application
- If approved, the manufacturer can market the device in Canada.
- MDEL/MDL Application
- Declaration of Conformity (DoC)
- ISO 13485 + MDSAP certificate
- Technical File
Adverse event to be reported within 72 hours after the occurrence.
ISO 13485 + MDSAP
- MDEL – 120 calendar days
- Class II – 2 months
- Class III & IV – 4-8 months
Annual renewal of license
Labelling in French and English