Medical Devices Regulations

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• (b) [Repealed, SOR/2023-277, s. 10]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