Medical Devices Regulations

64 A manufacturer or importer of a medical device shall, on or before the day on which the manufacturer or importer begins a recall of the device that has not been ordered by the Minister, provide the Minister with the following information and documents in writing:

• (a) the name of the device;

• (b) the identifier of the device, 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;

• (c) in the case of a licensed device, the medical device licence number;

• (d) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;

• (e) the name and address of

  • (i) the manufacturer,

  • (ii) the establishment where the device was manufactured, if different from that of the manufacturer, and

  • (iii) the importer;

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

• (g) an evaluation of the risk associated with the defectiveness or potential defectiveness of the device;

• (h) 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;

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

• (j) 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;

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

• (l) the proposed strategy for conducting the recall, including

  • (i) the date for beginning the recall,

  • (ii) the time and manner in which the Minister will be informed of the progress of the recall, and

  • (iii) the proposed date of its completion;

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

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