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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2022-11-16 and last amended on 2022-09-27. Previous Versions

RELATED PROVISIONS

  • — 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.

  • — SOR/2021-199, s. 10

      • 10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021.

      • (2) In sections 11 to 15, designated biocide, designated drug, designated food for a special dietary purpose, designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.

  • — SOR/2021-199, s. 13

      • 13 (1) Section 62.31 of the Medical Devices Regulations applies in respect of a designated medical device that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

      • (2) Section 62.32 of those Regulations applies to the holder of an establishment licence in respect of a designated medical device that they imported under that Interim Order.

  • — SOR/2021-199, s. 15

    • 15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of

      • (a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and

      • (b) September 1, 2023.

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