Medical Devices Regulations

68.15 The Minister shall amend an authorization for a 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.