Cancellation of MDELs for non-compliance with annual licence review requirements: 2025
MDEL Bulletin, June 13, 2025, from the Medical Devices Compliance Program
On this page
- About the annual licence review
- MDEL holder responsibilities
- Cancellation of MDELs
- To resume licensable activities
- Contact us
About the annual licence review
An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up to date.
As a courtesy, Health Canada sends an ALR application package to all active MDEL holders starting in December, for the upcoming fiscal year. We also send out 2 reminder notices to the licence contact person on file in February and March of the applicable year.
MDEL holder responsibilities
To continue doing licensable activities, active MDEL holders must submit an ALR application before April 1 of each year as per the regulations. Licence holders with a suspended MDEL do not need to apply.
Active MDEL holders must also notify us within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.
Learn more about the authorities set out in the regulations:
Cancellation of MDELs
Every year, Health Canada cancels the MDEL for those licence holders who do not submit their ALR application to us within the required timeframe. We will inform licence holders whose MDEL is cancelled and remove them from the list of active medical device establishment licences.
Information on the number of cancellations for previous years can be found in the Medical Devices Compliance Program bulletins (2021- 2024).
MDEL holders whose establishment licence is cancelled cannot conduct licensable activities. This includes Class I manufacturers that distribute their own devices.
Cancellation means that MDEL holders:
- may not distribute or import all classes of medical devices
- must stop their activities as soon as they receive their cancellation notice
To resume licensable activities
To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence. They must also pay the applicable fee.
For more information on how to re-apply for an MDEL, consult the following guidance documents:
- Guidance on medical device establishment licensing (GUI-0016): Overview
- Fees for the review of medical device establishment licence applications
We keep a list of active MDELs on the medical devices establishment licence listing, from which cancelled MDELs are removed. You may refer to this list to identify companies that:
- import and distribute Class I to IV medical devices
- distribute Class I medical devices for which they are the manufacturer
In line with our compliance and enforcement policy, Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if we find they are conducting non-compliant activities.
Learn more:
Contact us
For questions about medical device establishment licensing and the application process, contact the Medical Devices Establishment Licence Unit by email: mdel.questions.leim@hc-sc.gc.ca.
For questions about invoicing and fees for an MDEL, contact the Cost Recovery Invoicing Unit by email: criu-ufrc@hc-sc.gc.ca.