Forward Regulatory Plan 2021-2023: Modernizing Medical Device Establishment Licensing (MDEL) Framework

Title of Regulatory Initiative

Modernizing Medical Device Establishment Licensing (MDEL) Framework

Enabling Act

Food and Drugs Act


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:

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’ section.

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 (U.S.), which would support regulatory harmonization for medical devices under the Canada-U.S. Regulatory Cooperation Council.

This proposal also addresses 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 amendments would maintain Canada's international reputation as a country exporting good quality medical devices, which would create a level playing field for Canada's medical device sector.

The proposed amendments would improve the predictability and efficiency of recalls for industry because of clearer requirements and timelines. The proposal would also decrease the burden on industry relating to the reporting of low risk issues for medical devices.

The proposed amendments would close regulatory loopholes, extending regulatory oversight to facilities distributing safe medical devices to the global markets.


Drug establishment licence (DEL) and MDEL holders were broadly surveyed between April and June 2019.

Industry and stakeholders were surveyed during consultations in 2016.

Health Canada intends to undertake a stakeholder consultation process on this proposal prior to Canada Gazette, Part I, publication.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2022.

Further information

Related information on medical device establishment licensing (MDEL) can be found on Health Canada’s website.

Additional information can be requested from the departmental contact.

Departmental contact information

Catherine Hudon
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 343-540-8524

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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