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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2024-12-15 and last amended on 2024-12-14. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2024-110, s. 83

  • — SOR/2024-238, s. 41

    • 41 Subsections 36(2) to (4) of the Medical Devices RegulationsFootnote 2 are replaced by the following:

      • (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.

  • — SOR/2024-238, s. 42

    • 42 Section 37 of the Regulations is replaced by the following:

      • 37 If the terms and conditions of a medical device licence for an in vitro diagnostic device require that tests be performed to ensure that the device continues to meet the applicable requirements set out in sections 10 to 20, no person shall sell a device from a lot of the in vitro diagnostic device unless

        • (a) the results and protocols of the tests performed on devices in the lot have been provided to the Minister; and

        • (b) the Minister determines, on the basis of the results and protocols provided that the devices in the lot continue to meet the applicable requirements set out in sections 10 to 20.

  • — SOR/2024-238, s. 50

    • 50 Any terms and conditions that, immediately before the day on which section 41 of these Regulations comes into force, are set out in a medical device licence referred to in subsection 36(1) of the Medical Devices Regulations are deemed to be imposed by the Minister under subsection 36(2) of the Medical Devices Regulations, as that subsection reads as of that day.


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