Difference between revisions of "HCmeddev"
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*[[Media:Deck Information Session – Feb 2021 V2 EN.pdf|Information session: Regulations Amending the Medical Devices Regulations (February 2021)]] | *[[Media:Deck Information Session – Feb 2021 V2 EN.pdf|Information session: Regulations Amending the Medical Devices Regulations (February 2021)]] | ||
*[[Media:Deck Post-market regulations – FRN – Jun 2021 V2 EN.pdf|Medical Devices Regulations: Foreign Risk Notification (June 2021)]] | *[[Media:Deck Post-market regulations – FRN – Jun 2021 V2 EN.pdf|Medical Devices Regulations: Foreign Risk Notification (June 2021)]] | ||
| − | *[[Media: | + | *[[Media:MedTech 2021 Summary Reports GCwiki.pdf|Medical Devices Regulations: Summary Report (October 2021)]] |
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=== Summary Report === | === Summary Report === | ||
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== '''Forms''' == | == '''Forms''' == | ||
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=== Foreign risk notification (FRN) === | === Foreign risk notification (FRN) === | ||
| − | *[ | + | *[https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-form.pdf Foreign Risk Notification (FRN) Form] |
*[[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")]] | ||
[[fr:SCinstrmed]] | [[fr:SCinstrmed]] | ||
Revision as of 10:03, 14 June 2022
Welcome!
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.
Links to online resources
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. The "List of regulatory agencies and foreign jurisdictions" sets out the regulatory agencies and foreign jurisdictions for the purposes of section 61.2 of the Regulations.
Presentations
Information sessions have been offered by Health Canada related to the new post-market provisions. Presentation slide decks are available for viewing.
- Information session: Regulations Amending the Medical Devices Regulations (February 2021)
- Medical Devices Regulations: Foreign Risk Notification (June 2021)
- Medical Devices Regulations: Summary Report (October 2021)
Questions & answers
Questions & answers documents were prepared in response to enquiries received.
Foreign risk notification (FRN)
Summary Report
Forms
Forms are available to support compliance with the new regulations.
