Cancellation of MDELs for non-compliance with annual licence review requirements
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 (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 at the end of each calendar year. We also sent out 2 reminder notices to the licence contact person on file in February and March 2023.
MDEL holder responsibilities
To continue doing business, 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.
Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application to us within the required timeline.
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
Since the ALR deadline of April 1, 2023, 264 MDEL holders have not submitted an ALR application for the 2023/2024 fiscal year. We have cancelled their MDELs and removed them from the list of active medical device establishment licences.
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, please refer to the following guidance documents:
- Guidance on medical device establishment licensing (GUI-0016)
- 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 and/or
- distribute Class I medical devices for which they are the manufacturer
We also keep a list of suspended COVID MDELs.
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.
Related links
- Medical devices establishment licence listing
- COVID-19 medical device establishment licence (MDEL) suspensions
- Medical device establishment licence (MDEL) application: Instructions (FRM-0292)
- Guidance on medical device establishment licensing (GUI-0016)
- Guidance: Fees for the review of medical device establishment licence applications
- How to pay your establishment licence fees
- Small business mitigation for drugs and medical devices: How to apply for small business status
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