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.

---

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.