Licensing a Medical Device in Canada

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Overview of Submission and Regulatory Requirements

N.B. All these documents should be kept on record by the responsible parties, even if they are not part of the submission package.

Required Submission Documents Regulatory Requirements
Responsible Parties Manufacturer All parties engaged in importation or sales activities Manufacturer
Documentation Medical device licence application and fee form Objective evidence for safety & effectiveness Quality Management System (QMS) Certificate Compliant Label Complaint Handling Record Distribution Records Must hold an active establishment licence Recall Notice Mandatory Problem Preliminary and Final Report
Class I Requires Medical Device Establishment Licence    
Class II Provide attestation Exempt if holding an active medical device licence
Class III / IV Exempt if holding an active medical device licence

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