Selling or importing medical devices: obtain and maintain the appropriate federal establishment licence
Distinguish product and establishment licences, map activities and classes, attest procedures and renew annually.
An MDEL does not license a Class II, III or IV device. Separately verify product licensing and establishment exemptions.
Confirm the scope
Identify the legal entity, sites, manufacturers, suppliers, importing or distributing activities, classes and devices.
Prepare the information
Check whether an MDEL is required and whether every Class II to IV device also holds the necessary product licence.
Complete the process
Establish distribution, complaint, mandatory-reporting, recall, storage, record and supplier-verification procedures.
Keep follow-up records
Complete FRM-0292, pay fees, await the licence and manage annual review, changes, inspection and corrective action.
Medical Device Establishment Licence application — Health Canada