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Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Version of section 3 from 2020-02-04 to 2023-03-06:


Marginal note:Non-application — various therapeutic products

  •  (1) These Regulations do not apply to any of the following therapeutic products:

    • (a) cells, tissues and organs that are for non-homologous use;

    • (b) cells, tissues and organs that are for autologous use;

    • (c) heart valves and dura mater;

    • (d) tissues and cells — except for islet cells, and except for lymphohematopoietic cells that are derived from bone marrow, peripheral blood or cord blood — that have a systemic effect and depend on their metabolic activity for their primary function;

    • (e) medical devices that contain cells or tissues and that are the subject of investigational testing involving human subjects under Part 3 of the Medical Devices Regulations;

    • (f) cells, tissues and organs that are the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations;

    • (g) Class IV medical devices that are regulated under the Medical Devices Regulations;

    • (h) blood components, blood products and whole blood, except for cord blood and peripheral blood for use in lymphohematopoietic cell transplantation;

    • (i) cells and tissues that are regulated under the Assisted Human Reproduction Act or any of its regulations.

    • (j) [Repealed, SOR/2019-192, s. 92]

  • Marginal note:Non-application — regulations

    (2) No other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations.

  • SOR/2019-192, s. 92
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