Changes

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 ===

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.

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].