Government of Canada / Gouvernement du Canada
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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2020-10-21 and last amended on 2019-12-16. Previous Versions


  • — SOR/2003-173, s. 6

    • 6 The manufacturer of a medical device for which a medical device licence has been issued before the coming into force of these Regulations shall, before November 1, 2003, submit to the Minister, together with the statement required by subsection 43(1) of the Medical Devices Regulations, a copy of the quality system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p) of those Regulations, as applicable.]

  • — SOR/2019-63, s. 2

      • 2 (1) Despite subsection 43.12(1) of the Medical Devices Regulations, information in respect of a clinical study or investigational testing, as defined in section 43.11 of those Regulations, that is confidential business information and that is contained in an application with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:

      • (2) Subsection (1) does not apply to information referred to in subsection 43.12(2) of the Medical Devices Regulations.

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