Health Canada And Medical Devices

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Medical devices - Canada.ca

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

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. Additional …

Medical Devices Directorate – Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that the …

Drug and Medical Device Databases - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-and-medical-device-databases.html

Purpose. The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases. These guidelines are designed to …

Health Canada launches eSTAR pilot programs to …

https://www.torys.com/our-latest-thinking/publications/2023/02/health-canada-launches-estar-pilot-programs

Recently, Health Canada announced two pilot programs for eSTAR, an interactive PDF form that guides an applicant through the process of preparing a medical …

Health Canada Issues Final Guidance on …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

The evidence required to support a medical device license application is proportional to the risk of the device. Class I devices represent the lowest possible risk …

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

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

SCHEDULE 1 - Classification Rules for Medical Devices SCHEDULE 2 - Implants SCHEDULE 3 - Export Certificate for Medical Devices Related Information Related …

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