Forward Regulatory Plan 2023-2025: Regulations Amending the Medical Devices Regulations (Emergency Pathway for Medical Devices)
Title of Regulatory Initiative
Regulations Amending the Medical Devices Regulations (Emergency Pathway for Medical Devices)
Health Canada is proposing amendments to the Medical Devices Regulations to create an expedited authorization pathway for the importation and sale of new medical devices to be used for diagnosis, treatment, prevention or mitigation in the case of future public health emergencies.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on people in Canada, including businesses
The proposed amendments would apply to businesses involved in the importation and sale of medical devices that may be required to address future public health emergencies in Canada.
It is anticipated that people in Canada and health providers would have accelerated access to medical devices for diagnosis, treatment, mitigation or prevention in the case of future public health emergencies.
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. As well in 2022, stakeholders were consulted on proposed amendments to the Medical Devices Regulations so that COVID-19 medical devices may continue to be sold after the expiry of the Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
Health Canada intends to engage with key stakeholders in 2023. Further details will be made available once plans are finalized.
Additional information on this proposal may be requested from the departmental contact.
Departmental contact information
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Date the regulatory initiative was first included in the Forward Regulatory
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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