Medical Devices Regulations

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.