Updates to the medical device establishment licence application (FRM-0292) and instructions

MDEL Bulletin December 4, 2023, from the Medical Devices Compliance Program

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On December 4, 2023, Health Canada’s Regulatory Operations and Enforcement Branch revised the medical device establishment licence (MDEL) application form. The form is used to:

The intent is to include a revised definition from the medical device establishment licensing guidance (GUI-0016) and updated instructions for amendments. We have added information related to medical device shortage reporting. We also incorporated some changes to the information on small business mitigation and fees, in addition to some clarifications throughout the document.

This bulletin also describes an earlier change we made to the form to include suppliers under the manufacturer information section.

View the revised form and instructions:

Key changes in the application

We made the following key changes to the application:

Previously, section 5 was for manufacturer information. We changed this to manufacturer/supplier information. We made this change so that we may be clear on the activity(ies) you as the applicant or licence holder are conducting, in order that you may be properly licensed.

Contact us

For questions about medical device establishment licences and the application process, email the Medical Device Establishment Licence Unit: mdel.questions.leim@hc-sc.gc.ca.

For questions about invoicing and fees for an MDEL, email the Cost Recovery Invoicing Unit: criu-ufrc@hc-sc.gc.ca.

For information about methods for payment of fees and questions about your account, email the accounts receivable staff: ar-cr@hc-sc.gc.ca.

For questions about medical device shortage and discontinuation reporting, email the Medical Device Shortages Unit: MD.shortages.penurie.de.IM@hc-sc.gc.ca.

For questions about medical devices (including classification, labelling, clinical trials and obtaining a medical device licence), email the Medical Devices Directorate: meddevices-instrumentsmed@hc-sc.gc.ca. 

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