Holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1 in order to continue doing business.

Those with a suspended MDEL are exempt from applying.

An annual licence review (ALR) ensures that MDEL holders are:

• Adhering to regulatory requirements
• Maintaining their licence information up to date with Health Canada

In December of each year, Health Canada will send the ALR package to the establishment contact on file. Please ensure that the establishment contact information on file is current so that you receive your ALR package on time.

Timelines

A complete and paid application must be reviewed and processed within 120 calendar days.

Every year in December, we send an ALR application package to all active MDEL holders as a courtesy. If you have not received your ALR package by the middle of January, please contact us at mdel.questions.leim@hc-sc.gc.ca.

If an applicant does not want to continue doing business after April 1, 2023, then must indicate this on their ALR package using the cancellation form and then authority will cancel the licence.

If authority does not receive any application before April 1, 2023, then the licence will be revoked.

Related links

• Medical device establishment licence (MDEL) application: Instructions (FRM-0292)
• Annual review documents (information)
• Guidance on medical device establishment licensing (GUI-0016) – Summary
• Guidance: Fees for the review of medical device establishment licence applications
• How to pay your establishment licence fees