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§ NORTH AMERICA
Health Canada
Health Canada — Therapeutic Products Directorate
Canada
Health Canada regulates medical devices through a four-class risk-based system. Class I devices require an establishment license, while Class II-IV require pre-market review. Canada is an MDSAP participating country, meaning manufacturers can leverage a single audit for multiple regulatory submissions.
DEVICE CLASSES
Class I, II, III, IV
APPROVAL PATHWAY
MDEL (Class I), MDL (Class II-IV)
KEY REGULATORY FUNCTIONS
- ▸Medical Device License (MDL)
- ▸MDSAP single audit program
- ▸Incident reporting via MEDDEV
- ▸Medical Device Establishment License (MDEL)
OFFICIAL WEBSITE
https://www.canada.ca/en/health-canada.html →MedFlux monitors Health Canada regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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