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RDC 753/2022 — Adverse Event Reporting & Recalls

RDC 753/2022 governs post-market safety for medical devices in Brazil, specifically:

  • Adverse event (evento adverso) reporting obligations;

  • Technical complaint (queixa técnica) reporting obligations;

  • Reporting timeframes (7-day for deaths/serious unexpected injuries; 30-day for other serious events);

  • NOTIVISA as the mandatory reporting platform;

  • Annual adverse event summary report requirements;

  • Recall (recolhimento) procedures — voluntary and compulsory;

  • Field safety corrective actions (FSCAs) and field safety notices; and

  • ANVISA's powers to order compulsory recalls and device interdictions.

  • NOTIVISA

Official sources

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