Forward Regulatory Plan 2021-2023: Regulations amending the Medical Devices Regulations (Agile Regulations)
Title of Regulatory Initiative
Regulations amending the Medical Devices Regulations (Agile Regulations)
Enabling Act
Food and Drugs Act
Description
Health Canada is proposing to amend the Medical Devices Regulations to implement an agile, modern licensing scheme to effectively regulate medical devices throughout their life.
This initiative is intended to address stakeholder comments that the current licensing system for most health products is rigid and hard to understand.
Specifically, the ability to place terms and conditions on product approvals will be amended, such that information could be further gathered and other measures implemented post-market and used to adjust a licence as appropriate.
Additionally, it is proposed to include provisions to leverage foreign reviews and decisions by other trusted foreign regulators.
Health Canada will also explore if adjustments are needed to improve the medical device classification system for lower risk products.
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.
Note: These amendments were previously a component of ‘Regulations amending the Food and Drug Regulations – Part C, and the Medical Devices Regulations (Flexible Lifecycle-based Licensing for Drugs and Medical Devices’) but has now been separated into its own initiative.
Regulatory cooperation efforts (domestic and international)
It is anticipated that the eventual implementation of an agile, modern approach will create better alignment with international jurisdictions, such as the United States who has already taken a more adaptive approach to the licensing of health products for certain categories of devices.
Potential impacts on Canadians, including businesses
The proposal would impact the following key stakeholders: industry and their associations, patient and consumer groups, health professionals and their associations, and researchers.
This proposal would support a more agile approach to the authorization of medical devices. It would allow for a more efficient response to changes in what is known about the product’s risks and benefits and real-world evidence gathered in the post-market experience, ultimately optimizing the benefits and risks of a product as new data is generated.
Consultations
During the COVID-19 pandemic, Health Canada introduced temporary measures to expedite the authorization for sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians. The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 has similar agile approaches to those in this proposal. Stakeholder feedback on these temporary regulations will help inform the policy approach.
The Department intends to engage with key stakeholders in 2021 and 2022 as it develops this proposal. Further details will be made available once plans are finalized.
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 2022.
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 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:
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