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Foreign Manufacturer Certificate (FSC)

The Free Sale Certificate (FSC) — also called Certificado de Livre Venda or Certificate to Foreign Government (CFG) — is a document issued by the regulatory authority in the exporting country certifying that the medical device is legally manufactured and sold there.

ANVISA requires an FSC as part of the Registro or Cadastro dossier for all imported medical devices.

Acceptable FSC formats​

ANVISA accepts FSCs issued by:

  • FDA (US FDA Letter to Foreign Government / CFG);
  • EU Competent Authorities or EU-Authorised notified bodies (CE certificate);
  • TGA (Australia);
  • Health Canada;
  • HSA (Singapore); and
  • Other regulatory authorities recognised by ANVISA or MERCOSUL.

FSC requirements​

  • Must be issued by a competent regulatory authority;
  • Must identify the specific device (name, model, manufacturer);
  • Must confirm the device is legally marketed in the issuing country; and
  • Must be current and typically issued no more than 2 years before submission to ANVISA (though ANVISA may accept older FSCs on a case-by-case basis if the device remains legally marketed in the issuing country).

FSCs should be accompanied by a certified Portuguese translation.

Official sources

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

FSCs from MERCOSUL regulatory authorities (MERCOSUL member countries' competent authorities) are also accepted by ANVISA as part of MERCOSUL regulatory harmonization agreements. This includes authorities from Argentina, Paraguay, and Uruguay.