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| + | == '''Updates''' == | ||
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| + | === The language about summary reporting has changed in the Medical Devices Regulations. What is the difference? Have the requirements changed? === | ||
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| + | 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. | ||
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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. | ||
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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]. | ||
Revision as of 11:57, 2 March 2023
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 Reports (October 2021)
- Medical Devices Regulations: Summary Reports: Tips and Tricks for Success (June 2022)
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.
Foreign risk notification (FRN)
- Foreign Risk Notification (FRN) Form
- Permission for the importer to report on behalf of the manufacturer (Health Canada "FRM-0090")
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 guidance document.
