Medical Devices Bureau Therapeutic Products Directorate

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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 Therapeutic Products Directorate (TPD): 1. reviews scientific information to assess the safety, efficacy, and quality of a prescription drug 2. assesses the potential benefits and risks of a prescription drug 3. reviews Clinical Trial Applications (CTAs) for prescription drugs to ensure that the … See more

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

All applications will be subject to an examination for validity of regulatory information for the type of application in question e.g., device risk classification, licence …

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 …

Canada - Healthcare and Medical Equipment - export.gov

https://www.export.gov/apex/article2?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 and Medical Device Regulations. Medical devices are categorized in four classes determined by applying the classification rules for medical devices.

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 …

Regulatory Submissions for Medical Devices | dicentra.com

https://dicentra.com/medical-devices/regulatory-submissions

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the regulatory body responsible for licensing Medical Devices in Canada. Below are the following types of submissions dicentra can help prepare in Canada: Medical Devices Active Licence Listing (MDALL) – an MDALL is provided for all licenced Class II-IV devices

Therapeutic Products Directorate Medical Devices Bureau …

https://publications.gc.ca/collections/collection_2018/sc-hc/H166-1-2017-eng.pdf

Therapeutic Products Directorate – Medical Devices Bureau - 30 January 2018 TPD Yearly Medical Device Submission Performance Report: 2016/17 Page 5 Medical devices in Canada are categorized into four Classes (I, II, III and IV) on the basis of the risks associated with their use and the controls necessary to provide

Drugs and Health Products - Canada.ca

https://www.canada.ca/en/health-canada/corporate/contact-us/drugs-health-products.html

Therapeutic Products Directorate: General enquiries; Bureau of Cardiology, Allergy and Neurological Sciences (BCANS) Clinical and Pre-clinical Reviews (prescription …

Canada - Medical Devices - International Trade Administration

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

The key product and services segmentation of the industry are cardiovascular and respiratory devices which make up 22.3% of the market, followed by surgical …

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, …

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