Ministry of Health: 

Public Health Agency of Canada

Regulatory Authority:       

Health Canada

Medical Device Regulation:

Food and Drugs Act

Medical Device Regulations (SOR/98-282)

Official Language:

French & English

Classification:        

Class I, II, III and IV

Registration Process:       

• 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.

Documents Required:      

• MDEL/MDL Application
• Declaration of Conformity (DoC)
• ISO 13485 + MDSAP certificate
• Labelling
• Technical File

Post-market surveillance: 

Adverse event to be reported within 72 hours after the occurrence.

Applicable QMS:    

ISO 13485 + MDSAP

Registration Timeline:      

• MDEL – 120 calendar days
• Class II – 2 months
• Class III & IV – 4-8 months

Authorized Representative:        

No

License Validity:     

Annual renewal of license

Special Notes:       

Labelling in French and English