Cancellation of MDELs for non-compliance with annual licence review requirements

MDEL Bulletin, May 30, 2022, from the Medical Devices Compliance Program

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 a reminder notice to the licence contact person on file in March 2022.

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. This authority is set out in section 51.1(b) of the Regulations.

Under section 48 of the Regulations, 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.

Cancellation of MDELs

Since the ALR deadline of April 1, 2022, 395 MDEL holders have not submitted an ALR application for the 2021/2022 fiscal year. As this violates section 46.1 of the MDR, we have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled cannot conduct licensable activities. These include class I manufacturing, distributing and/or importing of all classes of medical devices. They must stop their activities immediately once 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, as per section 45 of the Regulations. They must also pay the applicable fees.

For more information on how to re-apply for a MDEL, please refer to the following guidance document:

Guidance on medical device establishment licensing and medical device establishment licence fees (GUI-0016)

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:

are authorized to manufacture Class I medical devices and/or
import and distribute Class I to IV medical devices

We also maintain a list of suspended COVID MDELs.

In line with the compliance and enforcement policy for health products (POL-0001), 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.

Contact us

For questions about medical device establishment licensing and the application process, contact the Medical Device Establishment Licensing 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.

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Date modified:: 2022-05-30

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