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
How to apply for advanced notice of importation (ANI)
Request a copy of the ANI form
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
E-learning course
Learn about Medical Device Establishment Licensing and post-market regulatory responsibilities (refer to Bulletin for more details).
Features
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