Complaint Handling & NOTIVISA Interface
The complaint handling system is both a GMP requirement (RDC 752/2022) and a post-market surveillance requirement (RDC 751/2022 and RDC 753/2022). All complaints received from any source must be documented, investigated, and evaluated.
Interface with NOTIVISA: When a complaint investigation reveals that the complaint meets the criteria for an adverse event or technical complaint under RDC 753/2022, it must be reported via NOTIVISA within the applicable timeframe (7 or 30 calendar days — see Reporting Timeframes).
A summary of complaints and their outcomes must be included in the annual PMS report.
Verify all information against official ANVISA sources before making regulatory decisions.
"Complaint records must include: the date received, source of complaint, detailed description of the issue, lot/batch numbers, manufacturing and expiration dates, actions taken in response, findings of the investigation, and signature of the person responsible for investigation. Investigations must be completed and documented within a defined timeframe specified in the manufacturer's complaint handling procedure."