Medical Devices Regulations

68.28 (1) The holder of the authorization shall, after making the preliminary report, submit a final report to the Minister in accordance with the timetable established under paragraph 68.27(2)(h).

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

• (a) a description of the incident, including the number of persons who have died or experienced a serious deterioration in the state of their health;

• (b) a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident; and

• (c) any actions taken in respect of the medical device as a result of the investigation referred to in paragraph 68.27(2)(h), which may include

  • (i) increased post-market surveillance of the device,

  • (ii) corrective and preventive action respecting the design and manufacture of the device, and

  • (iii) recall of the device.