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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2020-09-09 and last amended on 2019-12-16. Previous Versions

PART 1General (continued)

Recall

 Sections 64 and 65 do not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

 The manufacturer and the importer of a medical device shall, on or before undertaking a recall of the device, each provide the Minister with the following:

  • (a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

  • (b) the name and address of the manufacturer and importer, and the name and address of the establishment where the device was manufactured, if different from that of the manufacturer;

  • (c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered;

  • (d) an evaluation of the risk associated with the defectiveness or possible defectiveness;

  • (e) the number of affected units of the device that the manufacturer or importer

    • (i) manufactured in Canada,

    • (ii) imported into Canada, and

    • (iii) sold in Canada;

  • (f) the period during which the affected units of the device were distributed in Canada by the manufacturer or importer;

  • (g) the name of each person to whom the affected device was sold by the manufacturer or importer and the number of units of the device sold to each person;

  • (h) a copy of any communication issued with respect to the recall;

  • (i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion;

  • (j) the proposed action to prevent a recurrence of the problem; and

  • (k) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the recall.

 The manufacturer and the importer of a medical device shall, as soon as possible after the completion of a recall, each report to the Minister

  • (a) the results of the recall; and

  • (b) the action taken to prevent a recurrence of the problem.

  •  (1) Despite sections 64 and 65, the manufacturer of a medical device may permit the importer of the device to prepare and submit, on the manufacturer’s behalf, the information and documents with respect to the recall if the information and documents that the manufacturer and importer must submit are identical.

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

  • SOR/2002-190, s. 6

Implant Registration

  •  (1) Subject to section 68, the manufacturer of an implant shall provide, with the implant, two implant registration cards that contain

    • (a) the name and address of the manufacturer;

    • (b) the name and address of any person designated by the manufacturer for the collection of implant registration information;

    • (c) a notice advising the patient that the purpose of the cards is to enable the manufacturer to notify the patient of new information concerning the safety, effectiveness or performance of the implant, and any required corrective action; and

    • (d) a statement advising the patient to notify the manufacturer of any change of address.

  • (2) An implant registration card shall be designed for the recording of the following information:

    • (a) the name of the device, its control number and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

    • (b) the name and address of the health care professional who carried out the implant procedure;

    • (c) the date on which the device was implanted;

    • (d) the name and address of the health care facility at which the implant procedure took place; and

    • (e) the patient’s name and address or the identification number used by the health care facility to identify the patient.

  • (3) The two implant registration cards referred to in subsection (1) shall be printed in both official languages; however, the manufacturer may choose to provide four cards, two in English and two in French.

  •  (1) Subject to subsection (2), a member of the staff of the health care facility where an implant procedure takes place shall, as soon as possible after the completion of the procedure, enter the information required by subsection 66(2) on each implant registration card, give one card to the implant patient and forward one card to the manufacturer of the implant or the person designated pursuant to paragraph 66(1)(b).

  • (2) The patient’s name and address shall not be entered on the implant registration card forwarded to the manufacturer or person designated pursuant to paragraph 66(1)(b) except with the patient’s written consent.

  • (3) The health care facility, the manufacturer or the person designated pursuant to paragraph 66(1)(b) shall not disclose the patient’s name or address, or any information that might identify the patient, unless the disclosure is required by law.

  •  (1) The manufacturer of an implant may apply in writing to the Minister for authorization to use an implant registration method other than the implant registration cards described in section 66.

  • (2) The Minister shall authorize the use of the implant registration method proposed in the application referred to in subsection (1) if the Minister determines that the method will enable the manufacturer to achieve the purpose set out in paragraph 66(1)(c) as effectively as the use of implant registration cards.

  • (3) Where an authorization has been granted pursuant to subsection (2), the manufacturer shall implement the alternative implant registration method, and sections 66 and 67 shall apply with such modifications as are necessary.

PART 2Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access

Application

  •  (1) This Part applies to custom-made devices and medical devices that are to be imported or sold for special access.

  • (2) In this Part, special access means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.

General

 No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation.

Authorization

  •  (1) If a health care professional wishes to obtain a medical device referred to in section 70, the professional shall apply to the Minister for an authorization that would permit the manufacturer or importer of the device to sell, or to import and sell, the device to that professional.

  • (2) The application shall contain the following:

    • (a) the name of the device, its class and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

    • (b) the number of units required;

    • (c) the name and address of the manufacturer or importer;

    • (d) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the device;

    • (e) the diagnosis, treatment or prevention for which the device is required;

    • (f) a statement that sets out

      • (i) the reasons the device was chosen for the diagnosis, treatment or prevention,

      • (ii) the risks and benefits that are associated with its use, and

      • (iii) the reasons the diagnosis, treatment or prevention could not be accomplished using a licensed device that is available for sale in Canada;

    • (g) the name and address of each health care facility at which the device is to be used by that professional;

    • (h) the known safety and effectiveness information in respect of the device;

    • (i) a written undertaking by the health care professional that the professional will inform the patient for whom the device is intended of the risks and benefits associated with its use;

    • (j) the directions for use, unless directions are not required for the device to be used safely and effectively; and

    • (k) in the case of a custom-made device, a copy of the health care professional’s written direction to the manufacturer giving the design characteristics of the device.

 
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