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What Must Be Reported — Adverse Events & Technical Complaints

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ANVISA's post-market surveillance program for medical devices is called Tecnovigilância (technopharmacovigilance). It distinguishes between adverse events (eventos adversos) and technical complaints (queixas técnicas).

Adverse events — any unintended and undesired effect resulting from device use, including deaths, serious injuries, and near-misses.

Technical complaints — device malfunctions, deviations from quality standards, or failures that could have caused or did cause an adverse event, even if no harm occurred.

Both types of reports must be submitted via NOTIVISA. See NOTIVISA for how to report.

Who must report?​

  • Manufacturers and importers (registration holders) — mandatory
  • Distributors — mandatory when they become aware of an adverse event
  • Healthcare facilities (hospitals, clinics, laboratories) — mandatory for serious adverse events
  • Healthcare professionals — encouraged (voluntary reporting also accepted)
Official sources

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