Guidance on medical device establishment licensing (GUI-0016): How to maintain your MDEL

On This Page

• Submitting a notification
• Submitting an amendment
• Cancelling your licence

Submitting a notification

Under section 48 of the Medical Devices Regulations (MDR), licence holders must notify Health Canada within 15 calendar days of a change in contact information.

Changes include the following:

• a change in the name or address of your establishment
• a change in the information of the representative associated with your medical device establishment licence (MDEL) application (including name, title, email and phone number)

To notify us:

• submit a revised FRM-0292 (follow the same steps described in the How to apply for an MDEL page)
• email the revised form to mdel.application.leim@hc-sc.gc.ca

Medical device establishment licence application form (FRM-0292)

Note: There are no fees associated with making changes, notifications, or amendments to your MDEL.

Submitting an amendment

You must inform Health Canada other changes affecting the information on your MDEL. For example, if the list of manufacturers, activities or class of devices change, you must submit the information through your annual licence review (ALR) application.

You can make the change(s)before your licence is updated.

If you wish to submit those changes before the next ALR, you can do so through an amendment application using FRM-0292, only from April 1 to mid-November.

Note: If there is a change in your establishment or contact information (as per section 48 of the MDR), you must notify us within 15 calendar days.

Cancelling your licence

You must inform us if you choose to cancel your MDEL. Before you submit the application for a cancellation (using FRM-0292), you must ensure that all activities under the MDEL have stopped.

We will review the cancellation request and notify the contact person by email that the MDEL has been cancelled and is no longer active. We will then remove information related to that MDEL from the following list:

• Medical Devices Establishment Licence Listing