Medical Devices Regulations

59 (1) 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 in Canada that involves the device if

• (a) the device is sold in Canada; and

• (b) the incident

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

  • (ii) 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 the incident to recur.

(1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.

(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.