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State & Municipal VISA Bodies

BR-unique

State and municipal Vigilância Sanitária (VISA) bodies have independent enforcement authority and licensing powers that directly affect device companies' ability to operate — regulation does not stop at the federal ANVISA level.

State VISA bodies​

Each of Brazil's 26 states and the Federal District has its own VISA body. Their key roles include:

  • GMP inspections of manufacturers and importers;
  • Market surveillance — pulling non-compliant products from the market;
  • Issuing or revoking state-level endorsements for AFE applications; and
  • Enforcing ANVISA decisions locally.

Municipal VISA bodies​

Municipal VISA bodies are responsible for issuing the Licença de Funcionamento (operating licence) to premises, required in addition to the federal AFE.

A device company must typically hold:

  1. ANVISA AFE (federal) — for the company entity;
  2. State VISA endorsement — for GMP-related activities (in some states);
  3. Municipal Licença de Funcionamento — for each physical site.

Official resources​