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