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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2019-07-01 and last amended on 2019-06-17. Previous Versions

PART 1General (continued)

Recall (continued)

 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.

  •  (1) The Minister shall issue an authorization referred to in subsection 71(1) to a manufacturer or importer if the Minister determines that

    • (a) the benefits that may be obtained by the patient through the use of the device outweigh the risks associated with its use;

    • (b) the health or safety of patients, users or other persons will not be unduly affected;

    • (c) a licensed device that would adequately meet the requirements of the patient is not available in Canada; and

    • (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1.

  • (2) The authorization issued under subsection (1) shall specify

    • (a) the number of units of the device authorized to be imported;

    • (b) the number of units of the device authorized to be sold; and

    • (c) the name of the health care professional to whom the manufacturer or importer may sell the device.

Additional Information

 If the information and documents submitted in respect of an application made pursuant to section 71 are insufficient to enable the Minister to determine whether the conditions set out in subsection 72(1) have been met, the manufacturer, importer or health care professional shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.

 The Minister may, in respect of an authorization that has been issued,

  • (a) request the manufacturer, importer or health care professional to submit information in respect of the device if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that the device for which the authorization has been issued no longer meets the conditions set out in subsection 72(1); and

  • (b) issue a written cancellation of the authorization, giving reasons, if

    • (i) the Minister determines that the conditions set out in subsection 72(1) are no longer met, or

    • (ii) the information referred to in paragraph (a) has not been submitted.

 
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