Canada Medical Device Regulatory Body

Medical devices - Canada.ca

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

Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. …

About medical devices - Canada.ca

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

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

Clinical trials (investigational tests) are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. The Medical Devices …

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

Anyone who imports a medical device into Canada must also meet all applicable requirements of the FDA and associated Regulations. Some requirements include the …

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/

69 - PART 2 - Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access 69 - Application 70 - General 71 - Authorization 73 - Additional …

Guidance Document - Guidance on the Risk …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html

Only calibrators, testers and quality control support devices offered for sale as part of medical device systems or as medical devices themselves fall under this …

Health Canada CMDR Medical Device Registration and Approval

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

Before you can market your medical device in Canada, you must comply with the Medical Device Single Audit Program (MDSAP), which includes compliance with the quality …

Health Canada medical device regulations

https://gowlingwlg.com/en/insights-resources/articles/2019/health-canada-medical-device-regulations/

In late 2018, a series of news articles took aim at Canada's regulation of medical devices, alleging that Health Canada's medical device approval and adverse …