Difference between revisions of "HCmeddev"

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(Uploaded V2 of the FRN form)
(Uploaded V2 of the FRN Q&A document)
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=== Foreign risk notification (FRN) ===
 
=== Foreign risk notification (FRN) ===
  
* [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - Foreign Risk Notification (FRN)]]
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*[[Media:Questions and Answers FRN V2 EN.pdf|Questions & answers Foreign Risk Notification (FRN)]]
  
 
== '''Forms''' ==
 
== '''Forms''' ==

Revision as of 16:44, 14 December 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, 2020.

If you have questions, please contact Health Canada's Medical Devices Directorate at mdd.postmarket-postcommercialisation.dim@hc-sc.gc.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.

Presentations

Information sessions have been offered by Health Canada related to the new post-market provisions. Presentation slide decks are available for viewing.

Questions & answers

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

Foreign risk notification (FRN)

Forms

Forms are available to support compliance with the new regulations.

Foreign risk notification (FRN)