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Medical Devices Regulations

Version of section 68.32 from 2023-02-22 to 2024-01-02:

  •  (1) The Minister may, for the purposes of determining whether there is sufficient evidence to support the conclusion that the benefits associated with a COVID-19 medical device outweigh the risks, request that the holder of an authorization for the device submit, within a specified time limit, any of the following:

    • (a) summary reports; or

    • (b) information on the basis of which summary reports were prepared.

  • (2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.

  • SOR/2023-19, s. 7

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