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, 2021.

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.

If you have questions, please contact Health Canada's Medical Devices Directorate at '''hc.mdd.postmarket-postcommercialisation.dim.sc@canada.ca'''.

== '''Links to online resources''' ==

== '''Links to online resources''' ==

=== Foreign risk notification ===

=== Foreign risk notification ===

* Foreign Risk Notification (FRN) Form

* X

*[[Media:FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx|Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")]]

*[[Media:FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx|Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")]]

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