Forward Regulatory Plan 2021-2023: Regulatory Proposal to Transition the Interim Order Respecting the Importation and Sale of Medical Devices

Title of Regulatory Initiative

Regulatory Proposal to Transition the Interim Order Respecting the Importation and Sale of Medical Devices

Enabling Act

Food and Drugs Act

Description

On March 1, 2021, the Minister of Health signed the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for use in relation to COVID-19. Health Canada intends to maintain the flexibilities and regulatory oversight provided by the Interim Order until at least fall 2021. By then, Health Canada intends to bring forward regulatory amendments that would allow for the transition of products already authorized so that they can continue to be sold beyond fall 2021.

The Interim Order:

New regulations are being proposed in order to ensure that the authorizations, obligations and oversight made possible by the Interim Order continue uninterrupted, for a period of time, after expiry of the Interim Order to address the ongoing COVID-19 health care emergency.

Regulatory cooperation efforts (domestic and international)

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

The proposed regulatory changes will continue to align Health Canada’s emergency provisions with global best practices to authorize unapproved products or authorize unapproved uses for authorized products for use in a public health emergency to diagnose, treat, or prevent serious, or life threatening diseases when there are no adequate approved and available alternatives.

Potential impacts on Canadians, including businesses

These proposed regulatory changes are necessary to ensure that:

Consultations

Due to the fact that the Interim Order is only temporary in nature, an expedited regulatory development process is anticipated to introduce regulations that will support the transition of products authorized under the Interim Order. Policy consultations and stakeholder engagement on the proposed transition measures were held in fall 2020.

Health Canada will seek an exemption from pre-publication in the Canada Gazette, Part I.

The publication of the regulatory proposal in the Canada Gazette, Part II, is expected to take place in fall 2021.

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: 613-946-6586
Email: hc.lrm-mlr.sc@canada.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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