What medical device establishment licence holders need to know about the annual licence review

MDEL Bulletin, June 24, 2025, from the Medical Devices Compliance Program

About the annual licence review

To continue doing business, holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1. This requirement is in section 46.1 of the Medical Devices Regulations (regulations).

Licence holders with a suspended MDEL do not need to apply.

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

complying with the regulatory requirements
keeping their licence information up-to-date with Health Canada

Licence holders who have ceased their licensable activities and no longer require an MDEL must also inform Health Canada. To do so, complete and submit the cancellation form provided within the ALR package.

ALR application package

Health Canada sends the ALR package in December of each year to the establishment contact on file.

You must:

Ensure the establishment contact on file is up-to-date so you can receive your ALR package on time. To update the contact we have on file, submit a notification application by mid-November to mdel.application.leim@hc-sc.gc.ca.
Email your completed ALR application package to mdel.application.leim@hc-sc.gc.ca as soon as you receive your package and before April 1 of each year even if no information has changed. This is especially important if:
- you're making amendments within your ALR application
  - for example, adding to or revising the list of manufacturers, or changing the activity or class of device
- you have multiple sites, manufacturers or suppliers listed on your application
  - for example, more than 20
When applicable, ensure you have a valid small business status before you submit your ALR application.

As part of your application, a senior official must attest to having certain required procedures in place. This is in accordance with subsections 45(g, h, h.1 and i) of the regulations. As announced in a previous MDEL bulletin, Health Canada posts on their web site the names of senior officials to ensure public accountability of an MDEL holder's activities.

A fillable ALR summary report is available in your ALR package. We encourage you to make your revisions and sign the form electronically as we are not able to process any mailed-in application.

Cancelling your MDEL

If you have ceased your licensable activities and no longer require an MDEL from April 1, you must indicate this on your ALR package using the cancellation form. We will withdraw your licence.

If we do not receive your application before April 1, we will cancel your licence.

If your licence is cancelled or withdrawn, you:

will no longer be authorized to distribute or import your medical devices
must immediately stop importing or selling medical devices

To resume any licensable activities, you will need to apply for a new MDEL.

In line with our compliance and enforcement policy, Health Canada carries out compliance monitoring activities. We may inspect an establishment that had its MDEL cancelled or withdrawn to verify that all licensable activities have stopped. If necessary, we may take further regulatory actions to protect the health and safety of people in Canada.

Learn more:

Compliance and enforcement policy for health products (POL-0001)

Fees

If you received your new MDEL before April 1, you will also need to submit an ALR package before this date. You must also pay the applicable fees. This is in accordance with section 46.1(1) of the regulations.

We will issue an invoice after we receive and screen your ALR application to make sure it's complete. If you do not pay your invoice, we will not process your ALR application and we will cancel your MDEL.

A flat fee is charged for an ALR. The current fee for an MDEL can be confirmed here: Fees for Examination of an Application for an Establishment Licence: Medical Devices. If you qualify as a small business:

you're eligible for a 25% reduction in the fee

For invoicing and questions about fees, please contact the Cost Recovery and Invoicing Unit at criu-ufrc@hc-sc.gc.ca.

Small business application and renewal

A small business is:

any business, including its affiliates, that has fewer than 100 employees or
has between $30,000 and $5 million (CAD) in annual gross revenues

Applicants must:

Be registered as a small business with Health Canada before they submit their ALR application
Complete your registration on the following web page: Small business mitigation for drugs and medical devices: How to apply for or renew small business status

Please note the following:

A company's small business status expires 1 year after registration.
You will need to ensure the status is valid or renewed before you submit your ALR application.
If your unique identifier has changed since your previous registration, you will also need to register again.
If you no longer hold small business status when submitting your ALR application, we will issue an invoice for the full fee.
- Once issued, the invoice for the full fee amount will not be re-visited.
- It will remain payable regardless of any future changes to your small business status.

Please note that the small business registration and the renewal process can take up to 2 weeks. It's important to start this early to ensure it is completed before you submit your ALR application.

For information on how to apply for or renew your small business status, visit the following web page:

Small business mitigation for drugs and medical devices: How to apply for or renew small business status

For questions about your small business status, please email the Small Business Office at sbo-bpe@hc-sc.gc.ca.

Timelines

As a courtesy, we send out an ALR application package to all active MDEL holders starting in December every year.

If you do not receive your ALR package by mid-January, let us know by emailing us at mdel.questions.leim@hc-sc.gc.ca.

We process ALR applications in the order we receive them. Our service standard is 120 calendar days to review and process a complete and paid application.

For more information on the completeness of an application, please refer to our revised Guidance on medical device establishment licensing (GUI-0016). You may also find the pre-recorded webinar tutorials on the ALR application process helpful. The tutorials are posted on our GCCollab page.

Addressing ALR deficiencies

A deficient application does not meet the requirements stated under section 46.1(1) of the regulations.

If your ALR application has deficiencies, we will contact you to correct them. If we do not receive your response to the deficiency notice within the given timeframe or the information is incomplete, we will reject your application and cancel your MDEL.

If your licence is cancelled, you will no longer be authorized to distribute or import your medical devices. To resume licensable activities, you will need to apply for a new MDEL, however, any invoices issued for fees related to processing the ALR application will still be due.

Contact us

For questions about an MDEL and the application process, contact the Medical Device Establishment Licensing Unit by email: mdel.questions.leim@hc-sc.gc.ca.

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2025-06-24

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