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Medical Devices Regulations

Version of section 68.15 from 2023-02-22 to 2024-01-02:


 The Minister shall amend an authorization for a COVID-19 medical device if the following requirements are met:

  • (a) the holder of the authorization has submitted an application to the Minister that meets the requirements set out in section 68.14;

  • (b) the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to

    • (i) the uncertainties relating to those benefits and risks, and

    • (ii) the urgent public health need for the device or the absence of any such need; and

  • (c) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.

  • SOR/2023-19, s. 7

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