Canadian Medical Device Regulatory Body

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Medical devices - Canada.ca

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

Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is …

List of regulatory agencies and foreign jurisdictions

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/list.html

Dec 23, 2020

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …

List of Recognized Standards for Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance.html

ASTM F981-04. Standard practice for assessment of compatibility of biomaterials for surgical implants with respect to effect of materials on muscle and bone. …

Health Canada CMDR Medical Device Registration and Approval

https://www.emergobyul.com/services/canadian-cmdr-consulting-health-canada-medical-device-registration

We will complete and file the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf. We can provide onsite …

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

2.9.1 Preliminary report for an incident occurring in Canada. Section 60 (1) ( a) of the Regulations requires that if the death or serious deterioration in health …

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