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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. |
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− | == 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. |
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− | [[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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− | == 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. |
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− | [[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. |
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| === Foreign risk notification === | | === Foreign risk notification === |
− | [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - FRN]]
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− | == Forms == | + | * [[Media:Questions and Answers FRN FINAL EN.pdf|Questions & answers - FRN]] |
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| + | == '''Forms''' == |
| Forms have been created to support compliance with the new regulations. | | Forms have been created to support compliance with the new regulations. |
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| === Foreign risk notification === | | === Foreign risk notification === |
− | [[Media:HC medical device FRN Form FINAL 2021-05-28.pdf|Form (blank) - FRN]]
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| + | * Foreign Risk Notification (FRN) Form |
| + | * Permission for the importer to report on behalf of the manufacturer (Health Canada "Form 090") |
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| [[fr:SCinstrmed]] | | [[fr:SCinstrmed]] |