Canada MDSAP Guide for Medical Device
Canada Market Access for Medical Device
REGULATORY AGENCY
Health Canada
REGULATIONS
A specific quality systems standard, ISO 13485, is required for Class II, III and IV medical devices as a prerequisite to obtaining device licensing.
Only an ISO 13485 certificate issued by an SCC-qualified CMDCAS* Registrar will be accepted.
* CMDCAS refers to the Canadian Medical Devices Conformity Assessment System.
GUIDELINES
Manufacturers must submit the appropriate certificate with their annual renewal applications.
Requirements involve both an off-site document review and an on-site audit.
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