Difference between revisions of "HCmeddev"
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== '''Links to online resources''' == | == '''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''. | + | 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''. |
* [[Media:Guidance document links Post-Market FINAL EN.pdf|Links to guidance documents]] | * [[Media:Guidance document links Post-Market FINAL EN.pdf|Links to guidance documents]] | ||
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Questions & answers documents were prepared in response to enquiries received. | Questions & answers documents were prepared in response to enquiries received. | ||
| − | === Foreign risk notification === | + | === Foreign risk notification (FRN) === |
* [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - Foreign Risk Notification (FRN)]] | * [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - Foreign Risk Notification (FRN)]] | ||
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Forms are available to support compliance with the new regulations. | Forms are available to support compliance with the new regulations. | ||
| − | === Foreign risk notification === | + | === Foreign risk notification (FRN) === |
| − | * Foreign Risk Notification Form - Coming soon! | + | * Foreign Risk Notification (FRN) 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 16:15, 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 (FRN)
Forms
Forms are available to support compliance with the new regulations.
Foreign risk notification (FRN)
- Foreign Risk Notification (FRN) Form - Coming soon!
- Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")
