Canada Medical Device Regulations

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 Implementing the General Council Decision. 43.2 - Application. 43.3 - …

Medical devices - Canada.ca

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

Subscribe to medical device updates [2022-09-16] Health Canada's Action Plan on Medical Devices. Canadians rely on medical devices to maintain and improve …

Legislation and Guidelines - Medical devices - Canada.ca

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

Go to the Justice Canada Web site. Type Medical Devices Regulations in the Title field. In the yellow box beside Search in , select Regulations, then select Search. Select Canada …

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

https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html

Guidance documents – Medical devices - Canada.ca

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

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Frequently Asked Questions - Medical Devices Regulations

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

The purpose of the Medical Devices Regulations is to help protect the health and safety of Canadians with respect to the sale of medical devices. The term 'medical device' covers …

About medical devices - Canada.ca

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

Types of medical devices. Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and …

Canada - Regulatory Market Profile

https://www.rimsys.io/regulatory-market-profiles/canada

There are four major steps to bringing a medical device to market in Canada: Classify your device. Establish QMS procedures. Class II, III, IV must demonstrate compliance with …