Medical Devices Regulations (SOR/98-282)

• 61. (1) After the preliminary report is made in accordance with section 60, a final report shall be submitted to the Minister in accordance with the timetable established under paragraph 60(2)(h).

• (2) The final report shall contain the following information:

  • (a) a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died;

  • (b) a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident; and

  • (c) any actions taken as a result of the investigation, which may include

    • (i) increased post-market surveillance of the device,

    • (ii) corrective and preventive action respecting the design and manufacture of the device, and

    • (iii) recall of the device.

• 61.1 (1) Despite subsection 59(1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer’s behalf if the information that the manufacturer and importer must include is identical.

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

62. [Repealed, SOR/2002-190, s. 5]

63. 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.

64. 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.