Forward Regulatory Plan 2022-2024: Importation and Sale of Medical Devices for Use in Relation to COVID-19 Regulations

Title of Regulatory Initiative

Importation and Sale of Medical Devices for Use in Relation to COVID-19 Regulations

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for use in relation to COVID-19 (Interim Order), would to ensure that the authorizations, obligations and oversight made possible by the Interim Order continue.

The proposed amendments would transition COVID-19 medical devices into 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 2021.

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

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

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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