Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Medical Devices Regulations

Version of section 59 from 2021-06-23 to 2022-06-01:

  •  (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.

  • SOR/2020-262, s. 14
Date modified: