HCmeddev

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 guidance documents

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.

Presentation slide decks

Information sessions were offered by Health Canada in February 2021 related to the new post-market provisions. The presentation slide decks are available for viewing.

Questions & answers

Questions & answers documents were prepared in response to enquiries received.

Forms

Forms have been created to support compliance with the new regulations.