Forward Regulatory Plan 2022-2024: Modernizing the Medical Device Establishment Licensing (MDEL) Framework
Title of Regulatory Initiative
Modernizing the Medical Device Establishment Licensing (MDEL) Framework
Enabling Act
Description
Health Canada is planning to advance Modernizing the Medical Device Establishment Licensing Frameworks in two phases.
Phase I is targeting winter 2023. 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:
- Streamlining the medical device establishment licence application requirements to reflect existing practices;
- Introducing new authorities for the Minister when there is a non compliance, such as terms and conditions; and,
- Giving the Minister the authority to order recalls of medical devices, harmonize the definition of recall and clarify industry-reporting obligations.
Phase II is targeting fall 2023. 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 clarifying uncertainties around importation introduced into the Regulations from a previous round of regulatory amendment; and,
- Provide the Minister with additional compliance and enforcement authorities to address issues in a more targeted and strategic manner.
This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap under the 'Establishment licensing scheme for drugs and medical devices' and 'Recall reporting expectation' sections.
This regulatory initiative is associated with Health Canada's stock review plan.
Note: This amendment was previously a component of 'Modernizing Drug and Medical Establishment Licensing Frameworks- Amendments to the Food and Drug Regulations and Medical Devices Regulations' and 'Recall of Therapeutic Products' but has now been separated into its own initiative.
Regulatory cooperation efforts (domestic and international)
The proposed amendments would align Canadian requirements for medical device recalls with the United States, 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.
Potential impacts on Canadians, including businesses
Phase I:
The proposed Framework would create a level playing field with other jurisdictions 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.
Phase II:
It would also close regulatory gaps by extending regulatory oversight to facilities distributing safe medical devices to the global markets.
Consultations
Industry and stakeholders were consulted in 2016.
Drug and medical device establishment licence holders were consulted between April and June 2019.
Phase I:
Policy consultations and stakeholder engagement on the proposed 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.
Canadians will have the opportunity to provide comments on Phase I of the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in winter 2023 and last 75 days.
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 winter 2023.
Further information
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
Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Telephone: 343-540-8524
Email: prsd-questionsdspr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory
February 2021
Consult Health Canada's acts and regulations web page for:
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- further information on Health Canada's implementation of government-wide regulatory management initiatives
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