Health Canada Medical Device Annual Report

Medical Device reports and publications - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medical-devices.html

Medical Devices Performance Reports. The Medical Devices Performance Reports provide detailed metrics about the timeliness of pre-market medical devices …

Canada Health Act Annual Report 2020-2021 - Canada.ca

https://www.canada.ca/en/health-canada/services/publications/health-system-services/canada-health-act-annual-report-2020-2021.html

The report provides information about the operating principles of the Department and its legislative responsibilities, as well as an overview and description of the operations of the …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

Foreign Risk Notification, Annual Summary Reports, and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/proposed-amendment-medical-device-regulations/document.html

The annual summary report (ASR) is intended to be a comprehensive assessment of all known safety information for a licensed medical device. Sections 61.4 and 61.5 of the …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html

A summary report is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. The summary report regulatory requirement does not apply to …

Annual Reporting requirements to Health Canada - Elsmar Cove …

https://elsmar.com/elsmarqualityforum/threads/annual-reporting-requirements-to-health-canada.55904/

Re: Annual reporting to Health Canada jradford said: We just had our annual audit, and there was a NC written because "there is no evidence that the …

Health Minister Jean-Yves Duclos tables the 2021-22

https://www.canada.ca/en/health-canada/news/2023/02/health-minister-jean-yves-duclos-tables-the-2021-22-canada-health-act-annual-report-in-parliament.html

Today, the Honourable Jean-Yves Duclos, Minister of Health, tabled the 2021-2022 Canada Health Act Annual Report in Parliament. This tabling follows the …

Fees for Medical Devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html

Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual …

Guidance Document - Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html

Health Canada carries out post-market monitoring and assessment of medical devices. The fees for the right to sell a licensed medical device are used to pay …

Recent Changes to Medical Device Regulations in Canada

https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/

Jul 15, 2021. In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most …