Medical Devices Regulations (SOR/98-282)

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:

      • (a) the Minister issued a licence under paragraph 36(1)(a) of the Medical Devices Regulations;

      • (b) the Minister amended a licence under paragraph 36(1)(b) of the Medical Devices Regulations;

      • (c) the Minister refused to issue or amend a licence under section 38 of the Medical Devices Regulations.

    • (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.

• — SOR/2023-19, s. 10

  • • 10 (1) In sections 11 to 19, Interim Order No. 3 means Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on February 21, 2022 and published in the Canada Gazette, Part I, on March 12, 2022.

    • (2) Unless the context requires otherwise, words and expressions used in sections 11 to 19 have the same meaning as in the Medical Devices Regulations.

    • (3) For the purposes of sections 11 to 19, a reference to “instrument médical destiné à être utilisé à l’égard de la COVID-19” in the French version of Interim Order No. 3 and the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic shall be read as “instrument médical contre la COVID-19”.

• — SOR/2023-19, s. 11

  • 11 Despite subsection 68.11(1) of the Medical Devices Regulations, an application for an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application for an authorization submitted under section 68.11 of the Medical Devices Regulations.

• — SOR/2023-19, s. 12

  • • 12 (1) An authorization for importation or sale of a COVID-19 medical device that was issued by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization issued under section 68.12 of the Medical Devices Regulations.

    • (2) Any terms and conditions of an authorization for importation or sale referred to in subsection (1) are deemed to have been imposed by the Minister under section 68.19 of the Medical Devices Regulations on the other authorization referred to in that subsection.

• — SOR/2023-19, s. 13

  • 13 A COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not labelled in accordance with subsection 21(2) of the Medical Devices Regulations in the six-month period that begins on the day on which these Regulations come into force the device may, despite that subsection, be sold during that period.

• — SOR/2023-19, s. 14

  • 14 Section 68.35 of the Medical Devices Regulations shall be read without reference to subsection 21(2) of those Regulations in regard to any portion of the period referred to in that section that falls within the period referred to in section 13.

• — SOR/2023-19, s. 15

  • 15 An application to amend an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application to amend an authorization submitted under section 68.14 of the Medical Devices Regulations.

• — SOR/2023-19, s. 16

  • 16 An authorization for importation or sale of a COVID-19 medical device that was amended by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization that is amended to the same extent under section 68.15 of the Medical Devices Regulations.

• — SOR/2023-19, s. 17

  • 17 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for additional information or material, including samples, is deemed to be a request for additional information or material under section 68.23 of the Medical Devices Regulations.

• — SOR/2023-19, s. 18

  • • 18 (1) In the case of a COVID-19 medical device that is not a UPHN medical device on the day on which these Regulations come into force, a reference in subparagraphs 68.21(1)(h)(i), (i)(i) and (ii) and (j)(i) and (ii) of the Medical Devices Regulations to “the device ceases to be a UPHN medical device” shall be read as “the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) come into force”.

    • (2) Subsection (1) ceases to apply in respect of a COVID-19 medical device referred to in that subsection if the device becomes a UPHN medical device.

• — SOR/2023-19, s. 19

  • 19 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for information in relation to the expanded use of a COVID-19 medical device or another medical device set out in the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic, referred to in the definition List of Medical Devices for Expanded Use in subsection 1(1) of the Interim Order, is deemed to be a request for information in relation to the expanded use under subsection 68.38(1) or (2) of the Medical Devices Regulations, as the case may be.

• — SOR/2023-277, s. 27

  • • 27 (1) In this section, authorization has the same meaning as in section 68.01 of the Medical Devices Regulations.

    • (2) In respect of an authorization for a medical device that is issued before the day on which these Regulations come into force, paragraph 68.17(a) of the Medical Devices Regulations is to be read as follows:

      • (a) COVID-19;

    • (3) Section 68.17 of the Medical Devices Regulations, as it read immediately before the day on which these Regulations come into force, applies in respect of an application to amend an authorization that was submitted under section 68.14 of the Medical Devices Regulations before the day on which these Regulations come into force and in respect of which no decision has been made before that day.