The Mandatory Problem Reporting Procedure defines process and regulatory requirements for submitting adverse event reports to Health Canada.
Sections of the Mandatory Problem Reporting Procedure (SYS-035)
As with all of the procedures I write, I included the following sections in the Mandatory Problem Reporting Procedure:
- References and Relationships
- Document Approval
- Revision History
- Responsibilities and Authorities
- Monitoring and Measurement
- Risk Management
Details of the Mandatory Problem Reporting Procedure
This procedure includes exact quotes from the most recent amendment of the Canadian Medical Devices Regulations updated last on April 25, 2017. The procedure is detailed enough to enable a person that has not submitted a mandatory problem report before to do so. In addition, there are detailed instructions for importers of your device–who are also required to submit mandatory problem reports. The procedure is 5 pages in length and includes hyperlinks to the Health Canada webpages specific to the guidance document for Mandatory Problem Reporting.
Unique Features of this Mandatory Problem 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 mandatory problem 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 mandatory problem 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.
Additional Training Available on the Canadian Medical Devices Regulations
Medical Device Academy recorded a webinar on the Canadian Medical Devices Regulations (CMDR and CMDCAS). In addition, Mary Vater, one of our new consultants, will be presenting a new live webinar on Canadian Medical Device Licensing on May 24, 2017.
Purchase the Mandatory Problem Reporting Procedure (SYS-035) – $299
This new procedure defines the process and the regulatory requirements for submitting mandatory problem reports to Health Canada for adverse events that are reportable.