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Medical Devices Regulations

Version of section 68.28 from 2023-02-22 to 2024-01-02:

  •  (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 COVID-19 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.

  • SOR/2023-19, s. 7

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