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Medical Devices Regulations

Version of section 68.12 from 2024-01-03 to 2024-05-28:


 The Minister shall issue an authorization for a medical device if the following requirements are met:

  • (a) the manufacturer has submitted an application to the Minister that meets the requirements set out in section 68.11;

  • (b) [Repealed, SOR/2023-277, s. 10]

  • (c) 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;

  • (d) the Minister has sufficient evidence to support the conclusion that the manufacturer has a quality management system in place that is adequate to

    • (i) control the quality and, if applicable, the purity and sterility of the device and the materials used in the manufacture of the device, and

    • (ii) ensure that the device meets the specifications of the device; and

  • (e) 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
  • SOR/2023-277, s. 10
  • SOR/2023-277, s. 25
  • SOR/2023-277, s. 26

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