Who Regulates Medical Devices In Canada

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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 taking …

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

An importer is any person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device coming into Canada. Anyone who imports a medical …

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

There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class …

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

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

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - Manufacturer’s Obligations; …

Canada - Medical Devices - International Trade …

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

U.S. exporters need to be aware that all medical devices are regulated by Health Canada’s Medical Device Bureau of the Therapeutic Products Directorate and …

Regulating health products - Canada.ca

https://www.canada.ca/en/health-canada/corporate/mandate/regulatory-role/what-health-canada-regulates-1/health-products.html

Our Special Access Programmes allow physicians to access certain drugs and medical devices that are not currently authorized for sale in Canada. Some health products, like …

Regulatory Requirements for Advertising - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising.html

Contact the Regulatory Advertising Section in Health Canada's Marketed Health Products Directorate: Section of Transparency and Advertising Regulatory Surveillance Marketed …

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