Forward Regulatory Plan 2023-2025: Modernizing the Medical Device Establishment Licensing (MDEL) Framework
Title of Regulatory Initiative
Modernizing the Medical Device Establishment Licensing (MDEL) Framework
Health Canada plans to advance Modernizing the Medical Device Establishment Licensing Framework in two phases.
Phase I - The proposed amendments to the Medical Devices Regulations would improve and modernize the regulatory oversight over medical devices in Canada. This would be achieved through:
- Modernizing the medical device establishment licence application requirements to reflect existing practices;
- Providing the Minister with the ability to issue terms and conditions on a medical device establishment licence to mitigate risks to health and safety and strategically target non-compliance; and
- Establishing a regulatory framework for recalls of medical devices ordered by the Minister, updating the definition of recall and clarifying industry-reporting obligations.
Phase II - The proposed amendments to the Medical Devices Regulations would:
- Improve and modernize the regulatory oversight of the medical devices supply chain in Canada. This would be achieved through addressing uncertainties around importation introduced into the Regulations from a previous regulatory amendment; and,
- Provide the Minister with additional compliance and enforcement tools to address issues in a more targeted and strategic manner and provide additional post-market oversight.
This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap. This regulatory initiative is associated with Health Canada’s Regulatory Stock Review Plan.Note: For regulatory consistency, Phase I amendments to the Medical Devices Regulations will proceed jointly with the Phase I amendments to the Food and Drug Regulations that are part of the Modernizing the Drug Establishment Licensing (DEL) Framework initiative.
Regulatory cooperation efforts (domestic and international)
The proposed amendments would align Canadian requirements for medical device recalls with the United States (U.S.), which would support regulatory harmonization for medical devices under the Canada-U.S. Regulatory Cooperation Council.
This proposal would also address a recommendation from Canada’s Economic Strategy Tables to adopt requirements that align with international best practices by increasing international harmonization while protecting the health and safety of people in Canada .
Potential impacts on people in Canada, including businesses
The proposed Framework would create a level playing field with other jurisdictions (e.g., United States, European Union, Switzerland, and the United Kingdom) for Canada’s medical device sector.
It would improve the predictability and efficiency of recalls for industry and decrease the burden on industry relating to the reporting of low-risk issues for medical devices.
These amendments are expected to broadly benefit the health of all people in Canada who use, or may use, medical devices. The amendments are not expected to disadvantage people in Canada based on their gender, race, culture, or other personal or group characteristics.
It would also improve regulatory oversight of facilities distributing safe medical devices to global markets and people in Canada.
Industry and stakeholders were consulted in 2016.
Drug and medical device establishment licence holders were consulted between April and June 2019.
Policy consultations and stakeholder engagement on the proposed Phase I measures took place in fall 2021/winter 2022. Health Canada also published a Notice of Intent in Canada Gazette, Part I, on December 11, 2021, to inform stakeholders of the proposed policy direction, and to provide opportunities for comment on the proposed policy approach.
Phase 1: Health Canada pre-published the proposed amendments in the Canada Gazette Part I, on April 15, 2023, with a 75-day public comment period.
Health Canada plans to publish the amended regulations in the Canada Gazette Part II in winter 2024.
Phase II: The Modernizing Medical Device Establishment Licensing Phase II package is targeting pre-publication of proposed amendments to the Medical Devices Regulations in Canada Gazette, Part I in fall 2024.
Related information on medical device establishment licensing can be found on Health Canada’s website.
Additional information can be requested from the departmental contact.
Departmental contact information
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
Consult Health Canada's acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada's implementation of government-wide regulatory management initiatives
Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:
To learn about upcoming or ongoing consultations on proposed federal regulations, visit:
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