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” and the “Classification of Products under the Food and Drugs Act (F&DA) ”.
Latest developments on drugs and health products related to COVID-19.
- COVID-19 rapid antigen testing devices that use serial testing for asymptomatic individuals: Notice to industry [2021-07-09]
- Guidance for transparent medical mask technical specifications [2021-06-30]
- Cancellation of MDELs for failure to pay fees [2021-06-24]
- Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach [2021-06-15]
- Priority COVID-19 test applications: Notice to manufacturers, importers and distributors[SN1] [2021-05-07]
- Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03]
- Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
- Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users [2021-03-01]
- Foreign risk notification for medical devices guidance document: Background [2021-01-14]
- Amendments to the Food and Drugs Act: Guide to new authorities [2021-01-14]
- Incident reporting for medical devices: Guidance document [2021-01-14]
- Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14]
- Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada [2020-12-23]
- List of regulatory agencies and foreign jurisdictions [2020-12-23]
- Medical devices compliance program bulletin [2020-12-03]
- Notice to Stakeholders: New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19) [2020-11-27]
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 [2020-03-18]
- COVID-19 health product industry [2020-04-01]
- Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19
- Medical device shortages [2020-04-05]
- COVID-19 medical devices [2020-04-30]
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 [2020-05-27]
Health Canada's Action Plan on Medical Devices
Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is taking steps to further ensure the safety, effectiveness and quality of the medical devices used by Canadians.
As announced by the Honourable Ginette Petitpas Taylor, Minister of Health, Health Canada has developed an Action Plan to accelerate its efforts to strengthen the regulation of medical devices in Canada, and to better ensure optimal health outcomes for Canadians.
This plan lays out a three-part strategy to further improve how medical devices get on the market, strengthen monitoring and follow-up for devices already in use, and provide Canadians with more information about the medical devices they rely on.
The Department is pleased to announce that it will begin publishing Regulatory Decision Summaries (RDSs) for amendments to Class III and IV medical devices beginning in December 2019.
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?
Information about nanotechnology-based health products and food.
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 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.
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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