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

Food and Drugs Act

Description

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:

Phase II is targeting fall 2023. The proposed amendments to the Medical Devices Regulations would:

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

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, 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.

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:

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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