Forward Regulatory Plan 2022-2024: Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices

Title of Regulatory Initiative

Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to add a description of adaptive Machine Learning-enabled Medical Devices (MLMD) to Schedule G of the Food and Drugs Act, thereby allowing these devices to be regulated as Advanced Therapeutic Products, given the innovative nature of the devices.

The current Medical Devices Regulations framework cannot appropriately accommodate adaptive MLMD as these devices change post-authorization in real-world settings in response to new inputs. The Advanced Therapeutic Products pathway would allow Health Canada to authorize adaptive MLMD while tailoring pre- and post-market requirements, specific to an adaptive MLMD's unique characteristics, to maintain high standards for patient safety, product quality, and effectiveness.

The proposed addition to Schedule G of the Food and Drugs Act would enable access to these important, complex, and unique technologies, which are expected to positively impact the health of Canadians, while providing regulatory assurances of safety, effectiveness, and quality. The proposed addition would support Canada's competitiveness in this sector.

The proposed addition also enable Health Canada to adapt oversight requirements, iteratively with domestic and international stakeholders, and use this to inform future regulatory approaches.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

Regulatory cooperation efforts (domestic and international)

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

Health Canada will continue engagements with other jurisdictions regarding the jurisdictions' approach to regulating adaptive algorithms, and to socialize Health Canada's Advanced Therapeutic Products pathway, recognizing the need to harmonize with international jurisdictions where appropriate.

Potential impacts on Canadians, including businesses

The proposed addition to Schedule G of the Food and Drugs Act would apply to stakeholders involved in various activities related to adaptive MLMD, such as import, manufacturing, sale, etc.

It is anticipated that this proposal would create a pathway under which adaptive MLMD could be brought to the Canadian market, while protecting health and safety. Canadians would benefit from access to new and advanced healthcare technologies, such as medical devices that learn in real-time (e.g., to deliver more precise medical imaging results).

Consultations

Health Canada is taking a multi-pronged approach to external stakeholder engagement, including an external reference group, targeted meetings, networking, webinars and relevant website communications in 2021 and 2022.

Broader stakeholder engagement will be held as part of the implementation of the Advanced Therapeutic Products pathway and concierge service.

Canadians will have the opportunity to provide comments on the regulatory proposal when the anticipated Notice of Intent is published in Canada Gazette, Part I, in spring 2022.

Further information

Background information on the Advanced Therapeutic Products initiative:

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 1, 2022

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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