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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2024-03-06 and last amended on 2023-11-24. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2023-277, s. 1

  • — SOR/2023-277, s. 2

    • 2 The heading before section 68.01 of the Regulations is replaced by the following:

      Definitions and Interpretation

  • — SOR/2023-277, s. 3

      • 3 (1) The definitions COVID-19 and COVID-19 medical device in section 68.01 of the Regulations are repealed.

      • (2) The definitions List of Medical Devices for an Urgent Public Health Need, List of Medical Devices for Expanded Use and UPHN medical device in section 68.01 of the Regulations are replaced by the following:

        List of Medical Devices for an Urgent Public Health Need

        List of Medical Devices for an Urgent Public Health Need means the List of Medical Devices for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)

        List of Medical Devices for Expanded Use

        List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)

        UPHN medical device

        UPHN medical device means any of the following medical devices for an urgent public health need:

        • (a) a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;

        • (b) a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)

  • — SOR/2023-277, s. 4

    • 4 The Regulations are amended by adding the following after section 68.01:

      • 68.011 For the purposes of paragraphs 68.21(1)(h), (i) and (j), and sections 68.24, 68.3, 68.31 and 68.34, a medical device for which the manufacturer holds an authorization is considered not to be a UPHN medical device if

        • (a) the device is not set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and does not belong to a category of medical devices that is set out in column 2 of Part 2 of that list; or

        • (b) the device is set out in column 2 of Part 1 of that list or belongs to a category of medical devices that is set out in column 2 of Part 2 of that list but is not authorized in relation to a corresponding medical condition that is set out, as the case may be, in column 1 of Part 1 or column 1 of Part 2.

  • — SOR/2023-277, s. 5

    • 5 Subsection 68.02(2) of the Regulations is repealed.

  • — SOR/2023-277, s. 6

    • 6 Subsection 68.03(1) of the Regulations is replaced by the following:

        • 68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a medical device if the manufacturer holds an authorization for the device.

  • — SOR/2023-277, s. 7

    • 7 The Regulations are amended by adding the following after section 68.03:

      Advertising — Authorized Class I Medical Device
      • 68.031 No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless

        • (a) the manufacturer holds an amended authorization; or

        • (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been authorized in accordance with Canadian law.

  • — SOR/2023-277, s. 8

    • 8 Section 68.04 of the Regulations is repealed.

  • — SOR/2023-277, s. 9

    • 9 Section 68.1 of the Regulations is replaced by the following:

        • 68.1 (1) The Minister may add a medical condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that

          • (a) the medical condition presents, or is the result of, a significant risk to public health in Canada; and

          • (b) immediate action is required to deal with the risk.

        • (2) The Minister may add a medical device to column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the device that is related to the corresponding medical condition that is set out in column 1.

        • (3) The Minister may add a category of medical devices to column 2 of Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the devices that belong to that category that is related to the corresponding medical condition set out in column 1.

  • — SOR/2023-277, s. 10

      • 10 (1) Paragraph 68.12(b) of the Regulations is repealed.

      • (2) Subparagraph 68.12(c)(ii) of the Regulations is replaced by the following:

        • (ii) the urgent public health need for the device or the absence of any such need;

  • — SOR/2023-277, s. 11

    • 11 Paragraph 68.13(f) of the Regulations is replaced by the following:

      • (f) in the case of a Class I or II device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

  • — SOR/2023-277, s. 12

    • 12 Section 68.17 of the Regulations is replaced by the following:

      • 68.17 The Minister shall refuse to amend an authorization for a medical device if the effect of the proposed amendment would be that the device would not be authorized in relation to at least one of the following medical conditions:

        • (a) a medical condition that qualified the device as a UPHN medical device when the application for the authorization was submitted under section 68.11;

        • (b) a medical condition in relation to which the device was authorized when the application to amend the authorization was submitted under section 68.14, in the case where

          • (i) the holder of the authorization previously submitted an application to amend the authorization under section 68.14 to have the device authorized in relation to the medical condition,

          • (ii) the medical condition qualified the device as a UPHN medical device when that previous application was submitted, and

          • (iii) the authorization was amended under section 68.15 on the basis of that previous application;

        • (c) a medical condition in relation to which the device was not authorized when the application to amend the authorization was submitted under section 68.14, in the case where

          • (i) the holder of the authorization submitted the application to have the device authorized in relation to the medical condition, and

          • (ii) the medical condition qualified the device as a UPHN medical device when the application was submitted.

  • — SOR/2023-277, s. 13

    • 13 Section 68.21 of the Regulations is amended by adding the following after subsection (1):

      • (1.1) If a medical device ceases to be a UPHN medical device after an application for an authorization is submitted under section 68.11 but before the Minister issues the authorization under section 68.12, the reference to “the device ceases to be a UPHN medical device” in subparagraph (1)(h)(i), (i)(i) or (j)(i), as the case may be, shall be read as “the Minister issued the authorization”.

      • (1.2) Subsection (1.1) ceases to apply in respect of the medical device if the device is authorized in relation to a medical condition that qualifies it as a UPHN medical device.

  • — SOR/2023-277, s. 14

    • 14 Paragraph 68.22(c) of the English version of the Regulations is replaced by the following:

      • (c) the holder of the authorization informs the Minister under section 68.25 that the holder has discontinued the sale of the device in Canada.

  • — SOR/2023-277, s. 15

    • 15 The Regulations are amended by adding the following after section 68.24:

      Notification — Suspension or Revocation
        • 68.241 (1) This section applies to the holder of an authorization for a medical device that was issued in respect of an application submitted on the basis of subsection 68.11(4).

        • (2) If the holder of an authorization for a medical device receives or becomes aware of information to the effect that the authorization or licence for sale of the device that was issued by the regulatory agency is suspended or revoked, the holder shall notify the Minister within 72 hours after they receive or become aware of the information, whichever occurs first.

        • (3) However, the holder is not required to notify the Minister if they or the holder referred to in paragraph 68.3(1)(b) submits that information under section 68.3.

  • — SOR/2023-277, s. 16

    • 16 Section 68.26 of the Regulations is replaced by the following:

      • 68.26 If the manufacturer of a medical device holds an authorization for the device, the importer of a shipment of the device shall ensure that the shipment is accompanied by a copy of the authorization.

  • — SOR/2023-277, s. 17

    • 17 Section 68.3 of the Regulations is replaced by the following:

        • 68.3 (1) This section applies to the following holders of therapeutic product authorizations:

          • (a) a holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device; and

          • (b) a holder of an establishment licence to import Class II, III or IV medical devices that imports a device referred to in paragraph (a).

        • (2) The holder of a therapeutic product authorization shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of a device referred to in paragraph (1)(a), regarding

          • (a) risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;

          • (b) changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in that list; and

          • (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in that list.

        • (3) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

        • 68.301 (1) Despite subsection 68.3(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.

        • (2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.

  • — SOR/2023-277, s. 18

    • 18 The portion of subsection 68.31(1) of the Regulations before paragraph (a) is replaced by the following:

        • 68.31 (1) The holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device shall prepare

  • — SOR/2023-277, s. 19

    • 19 Subsection 68.34(1) of the Regulations is replaced by the following:

        • 68.34 (1) If a new or modified quality management system certificate is issued in respect of a medical device for which the manufacturer holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.

  • — SOR/2023-277, s. 20

    • 20 Section 68.35 of the Regulations is replaced by the following:

      • 68.35 Subject to sections 21, 23 and 44, if an authorization for a medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer may sell the device, despite any other provision in Part 1, for a period of six months beginning on the day on which the authorization is cancelled.

  • — SOR/2023-277, s. 21

    • 21 The Regulations are amended by adding the following before section 68.36:

      • 68.351 The Minister may add a medical condition to column 1 of the List of Medical Devices for Expanded Use only if the Minister has reasonable grounds to believe that

        • (a) the medical condition presents, or is the result of, a significant risk to public health in Canada; and

        • (b) immediate action is required to deal with the risk.

  • — SOR/2023-277, s. 22

      • 22 (1) The portion of subsection 68.36(1) of the Regulations before paragraph (b) is replaced by the following:

          • 68.36 (1) The Minister may add a licensed medical device, or a Class II, III or IV medical device for which the manufacturer holds an authorization, to column 2 of the List of Medical Devices for Expanded Use and an expanded use to column 3 only if the following conditions are met:

            • (a) the Minister has reasonable grounds to believe that there is an urgent public health need for the expanded use of the device that is related to the corresponding medical condition that is set out in column 1;

      • (2) Paragraphs 68.36(2)(a) and (b) of the Regulations are replaced by the following:

        • (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;

        • (b) the device is set out in column 2 of that list; and

        • (c) the expanded use of the device is set out in column 3 of that list.

      • (3) Subsection 68.36(3) of the Regulations is replaced by the following:

        • (3) In the case of a Class II, III or IV medical device for which the manufacturer holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

          • (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;

          • (b) the device is set out in column 2 of that list; and

          • (c) the expanded use of the device is set out in column 3 of that list.

  • — SOR/2023-277, s. 23

    • 23 The portion of section 68.37 of the Regulations before paragraph (a) is replaced by the following:

      • 68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including

  • — SOR/2023-277, s. 24

    • 24 Subsections 68.38(1) and (2) of the Regulations are replaced by the following:

        • 68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 of that list that the holder possesses or to which they have reasonable access.

        • (2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV medical device set out in column 2 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 3 of that list that the holder possesses or to which they have reasonable access.

  • — SOR/2023-277, s. 25

    • 25 The Regulations are amended by replacing “COVID-19 medical device” with “medical device” in the following provisions:

      • (a) the portion of subsection 68.03(2) before paragraph (a) and subsection 68.03(3);

      • (b) subsection 68.11(1), the portion of subsection 68.11(3) before paragraph (a) and paragraph 68.11(4)(a);

      • (c) the portion of section 68.12 before paragraph (a);

      • (d) the portion of section 68.13 before paragraph (a);

      • (e) the portion of section 68.15 before paragraph (a);

      • (f) the portion of section 68.16 before paragraph (a);

      • (g) section 68.18;

      • (h) section 68.19;

      • (i) the portion of section 68.2 before paragraph (a);

      • (j) the portion of subsection 68.21(1) before paragraph (a);

      • (k) the portion of section 68.22 before paragraph (a);

      • (l) section 68.23;

      • (m) the portion of section 68.24 before paragraph (a);

      • (n) section 68.25;

      • (o) the portion of subsection 68.27(1) before paragraph (a) and paragraphs 68.27(2)(a), (b) and (i);

      • (p) the portion of paragraph 68.28(2)(c) before subparagraph (i);

      • (q) paragraph 68.31(2)(d), the portion of subsection 68.31(4) before paragraph (a) and subsection 68.31(6);

      • (r) the portion of subsection 68.32(1) before paragraph (a); and

      • (s) subsection 68.33(1).

  • — SOR/2023-277, s. 26

    • 26 The Regulations are amended by replacing “manufacturer of the device” with “manufacturer” in the following provisions:

      • (a) paragraph 68.12(a); and

      • (b) paragraphs 68.16(a) and (c).

  • — 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:

        • The following provision is not in force.

          (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.


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