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.

Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet "Safe Medical Devices in Canada".

Health Canada's Role

Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.

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What information can you find here?

This section contains fee information, guidance documents, forms and policies needed to submit all of the different types of applications.

The Activities section contains information supporting Health Canada's regulation of medical devices, including announcements, consultations and fact sheets as well as various projects and committees.

Complete listings of Advisories, Warnings and Recalls for health professionals and the public are available in the MedEffect section.

Medical devices may also require certification by the Canadian Nuclear Safety Commission (CNSC) prior to licensing for operational or servicing activities. Please visit the CNSC Web site and read the certification requirements for more information.

Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.

We also provide information to support the role of the federal regulatory authority such as the Medical Devices Global Harmonization Task Force, Science Advisory Committees, Association Meetings and Performance Reports. Many of these activities are carried out with the participation of clients, stakeholders and the general public.

The Progressive Licensing Project has been initiated to develop a drug regulatory system for the future, and gives details of the plan for developing a new framework, and provides an opportunity for discussion with Canadians regarding drug licensing.

The Medical Devices Program Strategic Plan, 2007 - 2012, Building for the Future helps us define our future direction. It emphasizes our commitment to improving our work environment and ensuring the strategic management of our resources.

Related Resources

The Health Products and Food Branch Inspectorate is responsible for managing the national compliance and enforcement program for medical devices. This program has an establishment licensing component, a proactive inspection component and a responsive compliance/investigation component.

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