Forward Regulatory Plan 2022-2024: Regulations Amending the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Title of Regulatory Initiative

Regulations Amending the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Enabling Act

Food and Drugs Act


Health Canada is proposing amendments to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations to reflect the current standards of practice and organizational structure of the donation and transplantation systems in Canada.

Specifically, the proposed amendments would: (1) improve alignment with current Canadian transplantation systems; and, (2) transfer the regulation of human heart valves out of the Medical Devices Regulations.

Regulatory cooperation efforts (domestic and international)

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

The amendments would align the classification of human heart valves used in transplantation with that of the United States Food and Drug Administration.

These amendments would also better reflect the organizational structure of provincially funded donation and transplantation systems.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to stakeholders involved in the transplantation of human cells, tissues and organs in Canada.

Health Canada would expect this proposal to increase the supply of human heart valves available in Canada due to reduced barriers to market entry in Canada for United States-based tissue banks that process human heart valves. There may also be reduced costs related to eliminating redundancy in the system, for example, costs related to distribution and donor suitability assessments.


Targeted 30-day consultations with donation and transplantation programs were launched on January 5, 2022.

Stakeholder engagement and consultation was previously held with tissue banks and some living organ donor programs.

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 spring 2023 and last 70 days.

Further information

Related information can be found on:

Cells, Tissues and Organs

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

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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