Canada Regulatory Medical Devices

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Medical devices - Canada.ca

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

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 taking steps to further ensure the safety, effectiveness and quality of the medical …

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 …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

For more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

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' …

Canada - Medical Devices - International Trade …

https://www.trade.gov/country-commercial-guides/canada-medical-devices

Canada’s medical devices industry is highly diversified, and most firms are small and medium-sized enterprises (SMEs). The primary activities include research and …

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 device regulations, classification & submissions

https://learn.marsdd.com/article/medical-device-regulations-classification-and-submissions/

Applicable medical device regulations/ directives: Canada i: Medical Devices Regulations (SOR/98–282). Schedule 1. Classification rules for medical devices. 7. …

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