Medical Devices Regulations

36 (1) If the Minister determines that a medical device in respect of which an application is submitted meets the applicable requirements of sections 10 to 20, the Minister shall

• (a) issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or

• (b) amend the medical device licence, in the case of an application for a medical device licence amendment.

(2) The Minister may, at any time, impose terms and conditions on a medical device licence or amend such terms and conditions after considering

• (a) whether there are uncertainties relating to the benefits or risks associated with the device;

• (b) whether the requirements under the Act are sufficient for the following objectives to be met:

  • (i) maintaining the safety and effectiveness of the device,

  • (ii) optimizing the benefits and managing the risks associated with the device, and

  • (iii) identifying any changes relating to those benefits and risks and managing uncertainties related to the benefits and risks;

• (c) whether the proposed terms and conditions may contribute to those objectives being met;

• (d) whether compliance with the proposed terms and conditions is technically feasible; and

• (e) whether there are less burdensome ways for those objectives to be met.

(3) [Repealed, SOR/2024-238, s. 41]

(4) [Repealed, SOR/2024-238, s. 41]