Medical Devices Regulations
68.12 The Minister shall issue an authorization for a COVID-19 medical device if the following requirements are met:
(a) the manufacturer of the device has submitted an application to the Minister that meets the requirements set out in section 68.11;
(b) the device is a UPHN medical device;
(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;
(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
- Date modified: