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Healthcare Facility Reporting Obligations

BR-unique

Healthcare facilities (hospitals, clinics, diagnostic laboratories, blood banks) in Brazil have specific adverse event reporting obligations under ANVISA's Tecnovigilância program. This reflects Brazil's unique three-tier SNVS structure, where healthcare facilities are active participants in post-market surveillance.

Healthcare facilities must:

  • Be registered on NOTIVISA;
  • Report all adverse events involving medical devices that result in patient death or serious injury within 7 calendar days;
  • Report technical complaints involving devices that could have caused serious harm within 30 calendar days;
  • Maintain records of all device incidents; and
  • Cooperate with ANVISA and state VISA investigations.

Healthcare facilities that fail to report adverse events face ANVISA enforcement action including fines (multas) and potential loss of operating licences.

Official sources

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