Forward Regulatory Plan 2022-2024: Regulations amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices)

Title of Regulatory Initiative

Regulations amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices)

Enabling Act

Food and Drugs Act

Description

The proposed regulatory amendments to the Medical Devices Regulations would enable the implementation of an agile, modern licensing scheme to regulate medical devices throughout their lifecycles.

Specifically, the proposed amendments would: (1) improve and maintain medical device safety; (2) enable access to new innovations; and, (3) help support economic growth.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap.

This regulatory initiative is associated with Health Canada's stock review plan.

Additional notes:

Some components of this initiative were previously included in the initiative entitled: Exemptions for certain Digital Software.

To ensure regulatory consistency, some components of this initiative will be incorporated into the Regulations Amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs) initiative.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States and European Union.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to businesses involved in the sale of medical devices in Canada.

It is anticipated that the proposal would improve risk-based regulation of medical devices, both before and after they are on the market; increased support for better decision-making by patients, health care practitioners and provinces/territories; reduced pre- and on-market costs for lower risk medical devices; and increased encouragement for businesses to bring innovative, safe, high-quality medical devices on to the Canadian market.

Consultations

As part of Phase 1 of the proposed Agile Regulations for Licensing Drugs initiative, Health Canada launched in July 2021 a Notice of Intent proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.

Health Canada plans to pre-publish the Phase 1 proposed changes in the Canada Gazette, Part I, in fall 2022.

Stakeholder engagement was undertaken in 2020 and 2021 in the context of the Interim Orders for the importation and sale of medical devices for use in relation to COVID-19 that have some similar regulatory approaches to those in this proposal.

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 fall 2023 and last 70 days.

Further information

Related information can be found on:

Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality

Regulatory innovation for health products: Agile licensing for medical devices

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

November 2020

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:

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: