Updates to the guidance on medical device establishment licensing (GUI-0016)

MDEL Bulletin September 6, 2023, from the Medical Devices Compliance Program

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On September 6, 2023, Health Canada's Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL).


View the revised guide:

Key changes in the guide

We made the following key changes :

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 our 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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