Medical Devices Regulations

68.27 (1) The holder of an authorization for a medical device shall submit a preliminary report to the Minister in respect of any incident that comes to their attention occurring in Canada that involves the device

• (a) within 10 days after becoming aware of the 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

• (b) within 30 days after becoming aware of the 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.

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

• (a) the name of the medical 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 names and addresses of the holder and of any known importer of the medical device as well as the name, title and contact information of a representative of the holder to contact for any information concerning the incident;

• (c) the date on which the holder became aware of the incident;

• (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 and contact information, if known, of the person who reported the incident to the holder;

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

• (g) the preliminary comments of the holder with respect to the incident;

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

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