Medical Devices Regulations (SOR/98-282)

58. The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out

• (a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and

• (b) an effective and timely recall of the device.

• 59. (1) Subject to subsection (2), the manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring inside or outside Canada and involving a device that is sold in Canada and that

  • (a) is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its the directions for use; and

  • (b) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur.

• (2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.

• 60. (1) A preliminary report shall be submitted to the Minister

  • (a) in respect of an incident that occurs in Canada

    • (i) within 10 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, or

    • (ii) within 30 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were it to recur; and

  • (b) in respect of an incident that occurs outside Canada, as soon as possible after the manufacturer has indicated, to the regulatory agency referred to in paragraph 59(2), the manufacturer’s intention to take corrective action, or after the regulatory agency has required the manufacturer to take corrective action.

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

  • (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) if the report is made by

    • (i) the manufacturer, the name and address of that manufacturer and of any known importer, and the name, title and telephone and facsimile numbers of a representative of the manufacturer to contact for any information concerning the incident, or

    • (ii) the importer of the device, the name and address of the importer and of the manufacturer, and the name, title and telephone and facsimile numbers of a representative of the importer to contact for any information concerning the incident;

  • (c) the date on which the incident came to the attention of the manufacturer or importer;

  • (d) the details known in respect of the incident, including the date on which the incident occurred and the consequences for the patient, user or other person;

  • (e) the name, address and telephone number, if known, of the person who reported the incident to the manufacturer or importer;

  • (f) the identity of any other medical devices or accessories involved in the incident, if known;

  • (g) the manufacturer’s or importer’s preliminary comments with respect to the incident;

  • (h) the course of action, including an investigation, that the manufacturer or importer proposes to follow in respect of the incident and a timetable for carrying out any proposed action and for submitting a final report; and

  • (i) a statement indicating whether a previous report has been made to the Minister with respect to the device and, if so, the date of the report.