What medical device establishment licence holders need to know about annual licence review for 2024

MDEL Bulletin, November 15, 2023, 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, submit the cancellation form within the ALR package.

ALR application packages

Health Canada sends the ALR package in December of each year to the establishment contact on file. Please 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 November 30 to mdel.application.leim@hc-sc.gc.ca.

You must email your completed ALR application package as soon as possible and before April 1 of each year even if no information has changed.

When applicable, please ensure you have a valid small business status before you submit your ALR application.
It's important to submit your ALR application as soon as you have received your ALR package especially 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

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 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 at this time. Email your package to mdel.application.leim@hc-sc.gc.ca.

MDEL holders will now have a link in the ALR package email to pre-recorded webinar tutorials on the ALR application process posted on our GCCollab page. The tutorials will help stakeholders who may have questions on how to complete their ALR package.

Cancelling your MDEL

If you have ceased your licensable activities and no longer require an MDEL after April 1, 2024, 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, 2024, 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)

Reminder

For section 6 of the ALR application:

You must confirm or update ''Y/N'' as applicable for required attestation(s).

Attestations in this section must be in line with your activities and medical device class(es) in section 3.

Fees

If you received your new MDEL before April 1, 2024, you will also need to submit an ALR package before this date. You must also pay the applicable fees when you do so. 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 is $5,060. If you qualify as a small business:

you're eligible for a 25% reduction in the fee
the current fee payable for a registered small business is $3,795

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

Small business application

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. You must complete your registration through the Drug and Medical Device Small Business Application portal.

Please note that a company's small business status expires 1 year after registration.

If you previously registered as a small business with us and you still meet the definition, 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 2024 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 it early to ensure it's 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.

It's your responsibility to inform us if the contact person has changed anytime during the year and throughout the ALR process.

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 Guidance on medical device establishment licensing (GUI-0016). You may also find the pre-recorded webinar tutorials on the ALR application process helpful. We will be posting the tutorials on our GCCollab page.

Addressing ALR deficiencies

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

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.

Page details

Date modified:: 2023-11-15

Language selection

Search