Government of Canada / Gouvernement du Canada
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Medical Devices Regulations

Version of section 61.5 from 2021-12-23 to 2023-02-21:

  •  (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, on or before the day specified in the request, any of the following:

    • (a) summary reports; or

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

  • (2) The licensee shall submit to the Minister the summary reports or information, or both, that the Minister requests not later than the day specified in the request.

  • SOR/2020-262, s. 16

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