Medical Devices Compliance Program

The Medical Devices Compliance Program (MDCP) of the Regulatory Operations and Enforcement Branch oversees post-market compliance and enforcement, recall reporting, inspections, shortage reporting and licensing of establishments related to medical devices. Access services and information below for a convenient way of interacting with MDCP to meet your regulatory requirements.

Services and Information

Recall reporting for medical devices

Access an initial or final recall report form

Shortage reporting for medical devices

List of devices that require mandatory shortage reporting, report a shortage or end of a shortage, industry guidance, list of shortages

Medical devices establishment licence (MDEL) application

Apply, change or cancel an MDEL, reinstate an MDEL after a suspension or cancellation

Report a medical device problem

Report a problem or incident with a medical device sold in Canada

Exceptional importation and sale

How to import and sell designated medical devices, request form, regulatory requirements

Medical device compliance program bulletins

Updates and communication on regulatory activities, process changes and initiatives

Foreign risk notification for medical devices

What, when and how to submit a foreign risk notification

Medical device inspections

Inspection results of medical device establishments

Resources

Forms, guidance, policies and laws

Access links to forms, laws, guidance documents, etc.

Medical devices establishment licence listing

Live list and information about companies with an establishment licence

Drug and health product compliance monitoring reports

Compliance monitoring reports on medical devices

Contact us

Found out how to contact us

Advisories, warnings and recalls

List of recalls, advisories and safety alerts

Health product advertising incidents

Report marketing complaints, access advertising complaints addressed by Health Canada

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