Government of Canada / Gouvernement du Canada
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Medical Devices Regulations

Version of section 9 from 2016-07-17 to 2020-06-17:

  •  (1) A manufacturer shall ensure that the medical device meets the applicable requirements of sections 10 to 20.

  • (2) A manufacturer shall keep objective evidence to establish that the medical device meets those requirements.

  • SOR/2015-193, s. 7
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