Medical Devices Regulations
Version of section 68.15 from 2023-02-22 to 2024-01-02:
68.15 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
- Date modified: