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| 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. | | 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. |
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− | If you have questions, please contact Health Canada's Medical Devices Directorate at '''mdd.postmarket-postcommercialisation.dim@hc-sc.gc.ca'''. | + | If you have questions, please contact MDD's post-market division at '''mdd.postmarket-postcommercialisation.dim@hc-sc.gc.ca''' or the BSN Chairs at '''hpfb-bsn@hc-sc.gc.ca'''. |
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| == '''Links to online resources''' == | | == '''Links to online resources''' == |
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| === Foreign risk notification (FRN) === | | === Foreign risk notification (FRN) === |
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− | *[[Media:Questions and Answers – FRN V2 EN.pdf|Questions & answers – Foreign Risk Notification (FRN)]] | + | *[[Media:Questions and Answers FRN EN 2023-09-07.pdf|Questions & answers – Foreign Risk Notification (FRN)]] |
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| === Summary Report === | | === Summary Report === |
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| While the language in the summary reporting provisions has been revised to be clearer, the intent is the same. As such, the requirements have not changed. | | While the language in the summary reporting provisions has been revised to be clearer, the intent is the same. As such, the requirements have not changed. |
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− | To understand and comply with the regulatory requirements for summary reports, refer to our [https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html guidance document]. | + | To understand and comply with the regulatory requirements for summary reports, refer to our [https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html guidance document]. |