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Annual Adverse Event Summary Report

BR-unique

In addition to individual adverse event reports, ANVISA's RDC 753/2022 requires that registration holders submit an annual summary report (relatório anual de tecnovigilância) covering all adverse events and technical complaints reported in the previous calendar year.

Content of the annual report​

The annual report must include:

  • Total number of adverse events and technical complaints reported during the year;
  • Summary of event types, severity, and device models affected;
  • Status of investigations and corrective actions;
  • Analysis of trends identified from complaint and adverse event data; and
  • PMS plan updates as a result of the year's data.

The annual report must be submitted via Peticionamento Eletrônico by the deadline specified by ANVISA (typically 31 March each year for the previous calendar year).

Official sources

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