Health Canada requires the manufacturer and importer to submit both a preliminary and a final mandatory report constituting the details of any incident relating to the failure of a medical device or any inadequacy in its labelling or in its directions for use occurring in Canada (all devices) or outside Canada (Class I devices) or which led to the death or a serious deterioration in the state of health of an individual.
The preliminary report should be submitted to Health Canada within 10 calendar days of the occurrence of the incident if it has occurred in Canada and as soon as possible for any foreign incident. It should outline the reportable incident which has taken place, and complete details pertaining to the investigative process initiated by the reporter to determine the root cause. A timetable mentioning the proposed dates for implementing the action plan and final report submission must be included. The final report must then be submitted after the design and implementation of corrective and preventive actions is finalized including an analysis of the results and conclusions of the investigation. The reports should be highly detailed consisting of the specifics relating to the incident, medical device that caused it, the source of the reported event.
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