Forward Regulatory Plan 2022-2024: Regulations Amending the Medical Devices Regulations (Interim Order No.3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19)
Title of Regulatory Initiative
Regulations Amending the Medical Devices Regulations (Interim Order No.3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19)
Enabling Act
Description
Health Canada is proposing amendments to the Medical Devices Regulations, to ensure that the authorizations, obligations and oversight made possible by Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for use in relation to COVID-19 continues.
The proposed amendments would transition COVID-19 medical devices into Medical Devices Regulations.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
The proposed amendments would continue to align Health Canada's emergency provisions with global best practices.
Potential impacts on Canadians, including businesses
The proposed amendments would apply to businesses involved in the importation and sale of medical devices for use in relation to COVID-19 authorized through the Interim Order.
It is anticipated that Canadians and health care providers would continue to have access to devices for the diagnosis, treatment, mitigation or prevention of COVID-19. In addition, the proposed amendments would ensure that regulatory obligations or other requirements set up under the Interim Order continue uninterrupted after the Interim Order expires.
Consultations
Stakeholder engagement and consultation on some proposed amendments were held between November 2020 and January 2021as well as between May 2 and May 22, 2022.
Health Canada plans to seek an exemption from pre-publication in the Canada Gazette, Part I, and if approved, plans to publish the proposed changes in the Canada Gazette, Part II in spring 2023.
Further information
Related information can be found on:
Consultation on amendments to regulations to import and sell COVID-19 medical devices.
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
April 2022
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:
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