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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.
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'''.
== '''Links to online resources''' ==
== '''Links to online resources''' ==
=== Foreign risk notification (FRN) ===
=== Foreign risk notification (FRN) ===
*[[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)]]
=== Summary Report ===
=== Summary Report ===
[[fr:SCinstrmed]]
[[fr:SCinstrmed]]
== '''Updates''' ==
=== The language about summary reporting has changed in the Medical Devices Regulations. What is the difference? Have the requirements changed? ===
Health Canada amended sections 61.4 to 61.6 of the Medical Devices Regulations (summary reporting provisions) to clarify the language and to align with the summary reporting provisions introduced for Part 1.1 of the Medical Devices Regulations. The new regulations in Part 1.1 describe ongoing regulations that continue accelerated access to COVID-19 medical devices for which there is an urgent public health need without relying on temporary regulatory measures.
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.
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].
