Canada Medical Device Certification Permit

Canada Medical Device Approval
Medical device sales to Canada require compliance with the Canadian Medical Device Conformity Assessment System (CMDCAS) regulations.
For Class II, III, and IV products, this process must be conducted in parallel with the European Union CE marking regulations and ISO 13485, requiring an ISO 13485 certificate.

The Canadian medical device certification process must be completed before sales begin. The product's ISO 13485 certification must also be finalized.
Consult Eurocert's experts regarding medical devices for Canada.