Health Canada Therapeutic Products Directorate Medical Devices Bureau

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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 device meets the safety, effectiveness and quality requirements of the Food and Drugs Act and its Regulations. We also work collaboratively … See more

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 …

Pharmaceutical Drugs Directorate - Canada.ca

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

The Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate (TPD)) is Canada's regulator of prescription pharmaceutical drugs for human use. …

Medical Devices Active Licence Listing (MDALL)

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

Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this …

Notice: Health Canada’s Approach to Digital Health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-digital-health-technologies.html

As the federal regulator of medical devices, Health Canada is supporting the market emergence of current and future medical devices using a digital health …

Management of applications for medical device licences …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations/guidance-document.html

Class III and Class IV device licence applications will be identified as deficient if the review components are not provided in sufficient detail as described in the …

Drug/Medical Device Combination Products - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/drug-medical-device-combination-products.html

The Therapeutic Products Directorate ( TPD) and the Biologics Genetic Therapies Directorate ( BGTD) are aware of the regulatory burden that this creates for sponsors …

Marketed Health Products Directorate - Canada.ca

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

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Canada - Healthcare and Medical Equipment | Privacy …

https://www.privacyshield.gov/article?id=Canada-Healthcare-andMedical-Equipment

Medical devices are regulated federally by Health Canada’s Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada’s Food and Drugs Act …

Medical Device Registration Canada, Health Canada, …

https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-canada