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  1. Medical Devices Regulations - SOR/98-282 (Section 68.21)
    •  (1) The Minister may cancel an authorization for a medical device by written notice to the holder, giving reasons, if

      • (a) the Minister has reasonable grounds to believe that the holder has contravened these Regulations or any provision of the Act relating to medical devices;

      • [...]

      • (h) in the case of a Class I device that is not a UPHN medical device,

        • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, submit an application under section 45 for an establishment licence that would authorize the holder to sell or import the device,

      • (i) in the case of a Class II device that is not a UPHN medical device,

        • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

          [...]

        • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f); or

      • (j) in the case of a Class III or IV device that is not a UPHN medical device,

        • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

          [...]

        • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(3)(j) or (4)(p), as the case may be.

    • (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.

    [...]


  2. Medical Devices Regulations - SOR/98-282 (Section 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

    • (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.

    [...]


  3. Medical Devices Regulations - SOR/98-282 (Section 68.01)

     The following definitions apply in this Part.

    COVID-19 medical device

    COVID-19 medical device [Repealed, SOR/2023-277, s. 3]

    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)

    [...]


  4. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (SCHEDULE 8 : Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization —)

    SCHEDULE 8(Section 60)Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device

    [...]

    Marginal note:Definition of private label medical device

    1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.

    Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6
    Category Description Fee ($) Fee ($) Fee ($) Fee ($)
    Fiscal Year Fiscal Year Fiscal Year Fiscal Year
    2020-2021 2021-2022 2022-2023 2023-2024
    1 Applications for Class II licence Applications for Class II medical device licence other than those referred to in item 10 450 478 505 533
    2 Applications for Class II licence amendment or applications to amend Class II authorization Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 272 272 272 272
    3 Applications for Class III licence Applications for Class III medical device licence other than those referred to in item 4 or 10 7,477 8,912 10,347 11,783
    4 Applications for Class III licence (near patient) Applications for Class III medical device licence for a near patient in vitro diagnostic device 12,851 16,064 20,081 25,102
    5 Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — changes in manufacturing process, facility or equipment or manufacturing quality control procedures 1,903 2,379 2,974 3,717
    6 Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — significant changes other than those referred to in item 5 6,608 7,558 8,508 9,458
    7 Applications for Class IV licence Applications for Class IV medical device licence other than those referred to in item 10 24,345 24,748 25,151 25,554
    8 Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturing Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device — changes referred to in paragraph 34(a) or 68.13(a) of the Medical Devices Regulations that relate to manufacturing 1,903 2,379 2,974 3,717
    9 Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes not related to manufacturing Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for Class IV medical device that is not a UPHN medical device — any other changes referred to in paragraph 34(a) or (b) or 68.13(a) or (b) of the Medical Devices Regulations 8,057 9,983 11,752 13,521
    10 Applications for Class II, III or Class IV licence, applications to amend such a licence or applications to amend Class II, III or Class IV authorization — private label medical device Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or Class IV medical device that is not a UPHN medical device — private label medical device 147 147 147 147

    [...]


  5. Regulations for the Monitoring of Medical Assistance in Dying - SOR/2018-166 (Section 13)
    Marginal note:Report
    • [...]

    • Marginal note:Content — period covered by report

      (2) The report must contain information relating to requests for medical assistance in dying received by preliminary assessors or practitioners, and the provision of medical assistance in dying during the period covered by the report, including

      • [...]

      • (b) the characteristics, including medical characteristics, of persons who have made a request;

      • [...]

      • (d) the nature of the intolerable physical or psychological suffering of persons who received medical assistance in dying;

      • (e) the reasons for which persons who have made a request did not receive medical assistance in dying, including which of the eligibility criteria they did not meet;

      • (f) the places in which medical assistance in dying was provided;

      • (g) time periods relating to the handling of requests for, and the provision of, medical assistance in dying;

      • [...]

      • (i) the nature of involvement of practitioners in requests and the provision of medical assistance in dying, including the respective involvement of medical practitioners and nurse practitioners; and

      • (j) information as to whether persons who have made a request consulted with practitioners concerning their health, for a reason other than seeking medical assistance in dying, before practitioners received their requests for medical assistance in dying.

    • (3) The report must also contain

      • [...]

      • (b) information on trends in relation to requests for, and the provision of, medical assistance in dying; and

    [...]



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