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Canada

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Canada

Medical Device Registration in Canada

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

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