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Medical Devices Regulations

Version of section 59 from 2006-03-22 to 2021-06-22:

  •  (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.

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