Medical Devices Regulations

61 (1) After the preliminary report is made in accordance with section 60, a final report shall be submitted to the Minister in accordance with the timetable established under paragraph 60(2)(h).

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

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

• (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 as a result of the investigation referred to in paragraph 60(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.