Medical Devices Compliance Program Bulletin
The Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch (ROEB) oversees the national compliance and enforcement program for medical devices. MDCP manages the risk posed to public health and safety by medical devices in a number of ways:
- compliance promotion activities
- medical device establishment licensing
- inspections
- compliance, investigation and enforcement
- reporting and mitigation of medical device shortages
Through compliance promotion activities, MDCP strives to prevent problems from occurring in the first place by:
- raising awareness and educating regulated parties about their obligations under the Food and Drugs Act and Medical Devices Regulations
- providing information to consumers to enable them to make well-informed medical device choices
In line with these efforts, MDCP is proud to make available the Medical Devices Compliance Program Bulletin. This bulletin provides information on our regulatory activities, process changes and hot issues. Check back often for new content.
2024 bulletins
- April 18, 2024 updates to list of medical devices for mandatory shortage and discontinuation reporting [2024-04-18]
- February 1, 2024 updates to list of medical devices for mandatory shortage and discontinuation reporting [2024-02-01]
2023 bulletins
- Updates to the medical device establishment licence application (FRM-0292) and instructions [2023-12-04]
- What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2023-11-15]
- November 1st, 2023 updates to list of medical devices for mandatory shortage and discontinuation reporting
- Updates to the guidance on medical device establishment licensing (GUI-0016) [2023-09-06]
- Cancellation of MDELs for non-compliance with annual licence review requirements [2023-06-29]
- May 23, 2023 updates to list of medical devices for mandatory shortage and discontinuation reporting [2023-05-23]
- Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations [2023-05-16]
- February 7, 2023 updates to list of medical devices for mandatory shortage and discontinuation reporting [2023-02-07]
- Updated guidance on how to apply for a manufacturer's certificate to export [2023-01-18]
- January 10, 2023 updates to list of medical devices for mandatory shortage and discontinuation reporting [2023-01-10]
2022 bulletins
- Extension of interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives [2022-12-21]
- What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 [2022-12-02]
- November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting [2022-11-08]
- New e-learning course on understanding how medical devices are regulated in Canada [2022-10-28]
- Health Canada will continue to issue electronic manufacturer's certificate to export [2022-08-23]
- Health Canada is modernizing and transforming the Medical Devices Compliance Program [2022-07-21]
- June 9, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting [2022-06-09]
- Cancellation of MDELs for non-compliance with annual licence review requirements [2022-05-30]
- May 18, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting [2022-05-18]
- Updates to list of medical devices for mandatory shortage and discontinuation reporting [2022-05-04]
- Extension of interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives [2022-03-18]
- Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
- Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022 [2022-02-16]
- Updates to list of medical devices for mandatory shortage reporting: Notice [2022-02-10]
- New one-stop web page for the medical device industry [2022-02-08]
- Webinar tutorial on the 2022 annual licence review application process [2022-02-01]
- Notice: Consultation for proposed amendments to the Medical Device Regulations [2022-01-07]
- Health Canada Launches Electronic Manufacturer's Certificate to Export [2022-01-04]
2021 bulletins
- 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]
- Health Canada amends the Medical Devices Regulations to include mandatory shortage reporting [2021-11-30]
- Updates to list of medical devices for mandatory reporting shortages related to COVID-19: Notice [2021-10-22]
- Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice [2021-09-01]
- Updates to list of medical devices for mandatory reporting shortages related to COVID-19: Notice [2021-08-11]
- New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021 [2021-07-29]
- Names of medical device establishments' senior officials to be posted [2021-07-28]
- 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]
- Cancellation of MDELs for non-compliance with annual licence review requirements [2021-05-27]
- Health Canada updates list of medical devices for mandatory reporting of shortages [2021-04-08]
- Health Canada responds quickly to potential medical device shortages during COVID-19 [2021-03-26]
- Join a WebEx tutorial on the 2021 annual licence review (ALR) application process [2021-01-22]
2020 bulletins
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