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SISCOMEX & Customs Interface for Medical Devices

BR-unique

SISCOMEX (Sistema Integrado de Comércio Exterior) is Brazil's integrated foreign trade platform, managed by Receita Federal (customs) and ANVISA, among others. All imports of medical devices into Brazil must be processed through SISCOMEX.

SISCOMEX process for medical device imports​

  1. Importer registers the shipment in SISCOMEX using the device's NCM code and ANVISA registration number.
  2. ANVISA Import Licence (LI) requested — ANVISA reviews the import request and grants an LI if the product is registered and the importer holds a valid AFE.
  3. Customs clearance — Receita Federal processes the customs declaration, applying import duties (II — Imposto de Importação) and other applicable taxes (IPI, PIS/COFINS, ICMS).
  4. Physical inspection (if required by ANVISA or Receita Federal).
  5. Goods released — importer takes delivery.

Import duties and taxes​

Medical devices in Brazil are subject to federal import duties (II — Imposto de Importação) and indirect taxes (IPI — Imposto sobre Produtos Industrializados, PIS — Programa de Integração Social, COFINS — Contribuição para Financiamento da Seguridade Social, and ICMS — Imposto sobre Circulação de Mercadorias e Serviços). Some device types receive preferential import duty rates or exemptions, particularly devices not manufactured domestically or those serving specific health priorities. The NCM (Nomenclatura Comum do MERCOSUL) code determines the applicable federal tariff rate; state ICMS rates vary by destination state. Importers should consult with customs brokers regarding applicable duty rates prior to shipment.

Official sources

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

Note: Medical devices must be registered with ANVISA (Registro) before they can be imported into Brazil. Registration is a prerequisite for obtaining an ANVISA Import Licence (LI) in SISCOMEX.

AFE (Autorização de Funcionamento de Empresa) is a facility operating permit issued by ANVISA. All importers of medical devices must hold a valid AFE before they can import devices into Brazil.

If ANVISA denies the Import Licence (LI) request — for example, due to lack of device registration, invalid AFE, or safety concerns — the importer must resolve the underlying issue before resubmitting. The shipment will not clear customs until a valid LI is issued.