Medical Devices Regulations (SOR/98-282)

• 72. (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.

73. 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.

74. 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.

75. No person shall import or sell a medical device in respect of which an authorization has been issued pursuant to section 72, or a Class I or II custom-made device, unless the device has a label that

• (a) sets out the name of the manufacturer;

• (b) sets out the name of the device; and

• (c) specifies whether the device is a custom-made device or is being imported or sold for special access.

76. The manufacturer or importer of a medical device in respect of which an authorization has been issued pursuant to section 72 shall maintain a distribution record in respect of the device in accordance with sections 52 to 56.

77. The health care professional referred to in subsection 71(1) shall, within 72 hours after the occurrence of an incident described in section 59 involving a medical device for which an authorization has been issued pursuant to section 72, report the incident to the Minister and to the manufacturer or importer of the device, and specify the nature of the incident and the circumstances surrounding it.