Medical Device Registration Services - Canada

Regulatory Department

Health Canada

Regulation

  • Food and Drugs Act (R.S.C., 1985, c. F-27)

  • Medical Devices Regulations (SOR/98-282)

Recognised Quality Management System

MDSAP (Click here to learn more)

Regulatory Classification & Registration Process

Class I – Lowest Risk

Class II

  • MDSAP Certification

  • Medical Device Licence (MDL) required

  • Medical Device Establishment Licence (MDEL) required for both manufacturers and importers/distributors

  • Registered and listed on Medical Device Establishment Licence Listing

  • Timeframe: 2 months

Class III

  • MDSAP Certification

  • Medical Device Licence (MDL) required

  • Medical Device Establishment Licence (MDEL) required for both manufacturers and importers/distributors

  • Registered and listed on Medical Device Establishment Licence Listing

  • Timeframe: 4-5 months

Class IV – Highest Risk

  • MDSAP Certification

  • Medical Device Licence (MDL) required

  • Medical Device Establishment Licence (MDEL) required for both manufacturers and importers/distributors

  • Registered and listed on Medical Device Establishment Licence Listing

  • Timeframe: 6-8 months

Looking to register your medical device in Canada? Contact us today!