Forward Regulatory Plan 2021-2023: Amendments to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations)
Title of Regulatory Initiative
Amendments to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations)
Food and Drugs Act
Health Canada proposes to amend the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) to address some stakeholder concerns that have been identified since the coming into force of the CTO Regulations in 2007.
These changes will help align the CTO Regulations with current standards of practice and include:
- Updating the regulations to reflect the current organizational structure of donation and transplantation systems in Canada.
- Moving human heart valves under the CTO Regulations from the Medical Devices Regulations. Since 2018, Health Canada has implemented an interim enforcement policy to permit establishments to distribute human heart valves in Canada if they continue to follow the Medical Devices Regulations or elect to follow the CTO Regulations, until such time that this proposed regulatory amendment could be made.
Regulatory cooperation efforts (domestic and international)
This regulatory initiative would align the classification of human heart valves used in transplantation with that of the U.S. Food and Drug Administration. Other proposed changes are intended to better reflect the organizational structure of provincially funded donation and transplantation systems.
Potential impacts on Canadians, including businesses
Amendments to the CTO Regulations could potentially result in an increase in the supply of human heart valves available in Canada due to better harmonization with the United States. Human heart valves will be included under the scope of the CTO Regulations and will no longer be regulated as class IV medical devices. This will reduce barriers to market entry in Canada for U.S. based tissue banks that process human heart valves, due to better harmonization of requirements with US Regulations. Costs savings for tissue banks that distribute human heart valves in Canada may also be realized due to savings associated with the cost of medical device licensure and quality systems accreditation by third party auditing organizations.
Amendments are also being proposed to take into consideration newer initiatives such as the Canadian Blood Services’ national Kidney Paired Donation (KPD) program, which will help ensure that the appropriate establishments are accountable for performing donor suitability assessments. This may reduce costs by eliminating redundancy in the system.
Previous consultations have taken place with tissue banks and some living organ donor programs. Targeted consultations with donation and transplantation programs across Canada will be conducted in fall 2021.
Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part l, public comment period, which is expected to take place in spring 2022.
Additional information can 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:
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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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