Difference between revisions of "HCmeddev"
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If you have questions, please contact Health Canada's Medical Devices Directorate at hc.mdd.postmarket-postcommercialisation.dim.sc@canada.ca. | 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 == | + | == '''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. | 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. | ||
| − | [[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]] |
| − | == Presentation slide decks == | + | == '''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. | 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. | ||
| − | [[Media:Deck Info Session Feb 2021 FINAL EN.pdf|Information session slide deck]] | + | * [[Media:Deck Info Session Feb 2021 FINAL EN.pdf|Information session slide deck]] |
| − | == Questions & answers == | + | |
| + | == '''Questions & answers''' == | ||
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 === | ||
| − | |||
| − | == Forms == | + | * [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - FRN]] |
| + | |||
| + | == '''Forms''' == | ||
Forms have been created to support compliance with the new regulations. | Forms have been created to support compliance with the new regulations. | ||
=== Foreign risk notification === | === Foreign risk notification === | ||
| − | + | ||
| + | * Foreign Risk Notification (FRN) Form | ||
| + | * Permission for the importer to report on behalf of the manufacturer (Health Canada "Form 090") | ||
[[fr:SCinstrmed]] | [[fr:SCinstrmed]] | ||
Revision as of 08:39, 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 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 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 "Form 090")
