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" and the "Classification of Products under the Food and Drugs Act (F&DA) ".

COVID-19

Latest developments on drugs and health products related to COVID-19.

• Medical devices for use in relation to COVID-19 [2023-02-22]
• Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice [2023-02-22]
• List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 [2023-02-22]
• Updated Consultation on amendments to regulations to import and sell COVID-19 medical devices [2022-10-25]
• Updated policy position COVID-19 rapid antigen self-testing devices used for serial testing: Notice to industry [2022-10-14]
• Keeping Health Products In Canada Safe [2022-04-05]
• Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
• Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19: Notice [2022-02-21]
• Updates to list of medical devices for mandatory shortage reporting: Notice [2022-02-10]
• Webinar tutorial on the 2022 annual licence review application process [2022-02-01]
• Subscribe to MedEffect e-Notice [2022-01-18]
• Health Canada Launches Electronic Manufacturer's Certificate to Export [2022-01-04]
• Information for patients: A guide to self-testing for COVID-19 [2021-12-17]
• What MDEL holders need to know about annual licence review for 2022 [2021-12-14]
• Interim Enforcement approach for Federal, Provincial and Territorial COVID-19 Testing Initiatives [2021-12-13]
• Failure to pay 2021 annual licence review fees will result in cancellation of MDELs [2021-12-03]
• 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]
• 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 
  [2020-04-05]
• 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]

2024

• Nasal rinsing devices and the risk of infection [2024-09-11]
• Medical device safety [2024-07-31]
• Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices [2024-07-25]
• Share your views: Updates made to list of recognized standards for medical devices and draft guidance [2024-07-25]
• Transparency for machine learning-enabled medical devices: Guiding principles [2024-06-13]
• Medical masks and respirators [2024-06-12]
• Draft guidance on how to interpret 'significant change' of a medical device [2024-02-07]
• Share your views: Draft guidance on how to interpret 'significant change' of a medical device [2024-02-07]

2023

• Updates to the medical device establishment licence application (FRM-0292) and instructions [2023-12-04]
• Predetermined change control plans for machine learning-enabled medical devices: Guiding principles [2023-10-24]
• Share your views: Consultation on draft guidance for determining medical device application type [2023-09-11]
• Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) [2023-08-30]
• Share your views: Draft Pre-market guidance for machine learning-enabled medical devices [2023-08-30]
• Potential risk of falls from infant incubators and radiant warmers [2023-07-13]
• Patient lifts and risk of fall [2023-06-14]
• Serious adverse drug reactions and medical device incidents reported by Canadian hospitals [2023-03-23]
• Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies [2023-03-23]
• Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice [2023-03-23]
• Tubed medical devices and children [2023-01-27]
• Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10]

2022

• Pulse oximeters [2022-12-30]
• What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 [2022-12-02]
• Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21]
• Medical devices contained in electronic health record (EHR) products: Notice to industry [2022-10-31]
• Mpox (monkeypox) tests: Notice to industry [2022-10-19]
• Subscribe to medical device updates [2022-09-16]

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.

Related Resources

The Regulatory Operations and Enforcement Branch 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.