Canadian Medical Device Regulations Guidance

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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 the various device licence applications required when seeking an authorization to sell a …

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 …

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 - Canada.ca

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

Medical Devices. Health Canada applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

Guidance on summary reports and issue …

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

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new …

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