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
Health Canada is planning to advance Modernizing the Medical Device Establishment Licensing Frameworks in two phases.
Phase I is targeting fall 2022. 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 terms and conditions and the ability to partially suspend or cancel a licence when there is non compliance; 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 the last round of regulatory amendments; 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 will 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 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
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.
It would also close regulatory gaps by extending regulatory oversight to facilities distributing safe medical devices to the global markets.
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 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, which is expected to take place in fall 2022.
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 2023.
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
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