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Revision as of 11:28, 9 June 2021
Welcome!
This page was developed to share resources related to the new post-market provisions under the Medical Devices Regulations, published in Canada Gazette, Part II on December 23, 2021.
If you have questions, please contact Health Canada's Medical Devices Directorate at hc.mdd.postmarket-postcommercialisation.dim.sc@canada.ca.
Links to online resources
Four guidance documents are available to support the interpretation of the new or updated post-market provisions in the Medical Devices Regulations that were published in Canada Gazette Part II on December 23, 2020. The "List of regulatory agencies and foreign jurisdictions" sets out the regulatory agencies and foreign jurisdictions for the purposes of section 61.2 of the Regulations.
Presentation slide decks
Information sessions were offered by Health Canada in February 2021 related to the new post-market provisions. The presentation slide deck is available for viewing.
Questions & answers
Questions & answers documents were prepared in response to enquiries received.
Foreign risk notification
Forms
Forms have been created to support compliance with the new regulations.
Foreign risk notification
- Foreign Risk Notification (FRN) Form
- Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")
