Difference between revisions of "HCmeddev"
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* [[Media:Deck Info Session Feb 2021 FINAL EN.pdf|Information session: Regulations Amending the Medical Devices Regulations (February 2021)]] | * [[Media:Deck Info Session Feb 2021 FINAL EN.pdf|Information session: Regulations Amending the Medical Devices Regulations (February 2021)]] | ||
| + | * [[Media:Post-market regulations FRN FINAL June 2021.pdf|Medical Devices Regulations: Foreign risk notification (June 2021)]] | ||
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=== Foreign risk notification === | === Foreign risk notification === | ||
| − | * [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - FRN]] | + | * [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - Foreign Risk Notification (FRN)]] |
== '''Forms''' == | == '''Forms''' == | ||
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=== Foreign risk notification === | === Foreign risk notification === | ||
| − | * | + | * Foreign Risk Notification Form - Coming soon! |
*[[Media:FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx|Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")]] | *[[Media:FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx|Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")]] | ||
[[fr:SCinstrmed]] | [[fr:SCinstrmed]] | ||
Revision as of 15:57, 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 have been offered by Health Canada related to the new post-market provisions. Presentation slide decks are available for viewing.
- Information session: Regulations Amending the Medical Devices Regulations (February 2021)
- Medical Devices Regulations: Foreign risk notification (June 2021)
Questions & answers
Questions & answers documents were prepared in response to enquiries received.
Foreign risk notification
Forms
Forms are available to support compliance with the new regulations.
Foreign risk notification
- Foreign Risk Notification Form - Coming soon!
- Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")
