Incident Reporting Procedure (SYS-035)

The video provided below shows you exactly what you will receive when you purchase our Incident Reporting procedure (SYS-035).

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(The video above describes the previous revision of this procedure and does not reflect Health Canada’s updates from Mandatory Problem Reporting to the new Incident Reporting requirements. A new video specifically for the updated Incident Reporting procedure is on its way soon.)

The purpose of the procedure is to define requirements for reporting adverse events to Health Canada. This procedure is the primary document meeting the applicable regulatory requirements for adverse event reporting under Sections 59-61 of the Canadian MDR as defined in the Quality System Manual (POL-001).

These documents are updated for

  • ISO 13485:2016
  • SOR 98-282, Last Amended December 23, 2021
  • SOR/2020-262

. The following is a list of documents included:

  • SYS-035 A, Incident Reporting Procedure
  • FRM-053 A, Health Canada Incident Report
  • SOR 98-282, Last Amended December 23, 2021
  • Incident Reporting For Medical Devices Guidance
  • Foreign Risk Notification For Medical Devices Guidance
  • List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations

Mandatory Problem Reporting Procedure Incident Reporting Procedure (SYS 035)
SYS-035 Incident Reporting Procedure

SYS-035, Mandatory Problem Reporting Procedure; Included with this procedure is the most recent copy of SOR 98/282, a Mandatory Problem Reporting guidance and links to download our slide deck and webinar recording on Complaint Handling and Vigilance.

Price: $299.00

Unique Features of this Incident Reporting Procedure

Well-written procedures typically state that you should review and update your risk management documentation when you are investigating complaints–especially when there is a new adverse event to report. However, this procedure includes references to the risk management process and makes recommendations on specifically what to review and update. Specifically, it recommends that the scale used to quantitatively estimate severity of potential harm be aligned to identify which scores require Incident reporting, and which scores do not require reporting.

The section of the procedure that is specific to monitoring and measurement also identifies specific metrics related to the Incident reporting process to track and report to Top Management during Management Review meetings. These metrics include tracking the closure of complaints, preliminary reporting timelines and final reporting timelines. The procedure even includes links to the post-market surveillance procedure to remind you to update your post-market surveillance plan to ask questions related to new or revised risks related to the adverse event you are reporting.

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