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NOTIVISA — Adverse Event Reporting Portal

BR-unique

NOTIVISA (Sistema de Notificações em Vigilância Sanitária) is ANVISA's mandatory online portal for adverse event and technical complaint reporting by all economic operators. There is no paper-based alternative.

Registering on NOTIVISA​

All manufacturers, importers, distributors and healthcare facilities must register on NOTIVISA before any reporting obligation arises:

  1. Access notivisa.anvisa.gov.br
  2. Create an account linked to the company's CNPJ
  3. Designate the Responsável Técnico as the NOTIVISA account holder
  4. Complete the company profile

Submitting a report​

  1. Log in to NOTIVISA
  2. Select report type: Adverse Event or Technical Complaint
  3. Complete the report form with device details, event description, patient outcomes
  4. Attach supporting documentation where available
  5. Submit — ANVISA assigns a report number
  6. Follow-up reports may be required as additional information becomes available

Official resources​

Official sources

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