Licensing a Medical Device in Canada

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 Importer Distributor			Manufacturer Importer
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

2019-01-24