Import Documentation — ANVISA Licence to Import
In addition to holding an ANVISA product registration and AFE, importers of medical devices in Brazil must obtain an ANVISA Import Licence (Licença de Importação or LI) for each shipment of regulated medical devices. This is processed via SISCOMEX (Brazil's integrated customs system).
Key import documentation
| Document | Purpose |
|---|---|
| ANVISA product registration number | Proof the device is authorised for the Brazilian market |
| ANVISA AFE (importer) | Proof the importer is authorised to import medical devices |
| Free Sale Certificate (FSC / CFG) | Issued by the exporting country's regulatory authority — proves the device is legally sold there |
| ANVISA Import Licence (LI) | Obtained via SISCOMEX for each shipment |
| Certificate of Analysis / CoA | For each batch being imported — demonstrates conformity to registered specifications |
| Invoice (Fatura Comercial) | Commercial invoice |
| Packing List | |
| Bill of Lading / Airway Bill | Shipping document |
ANVISA clearance at ports of entry
ANVISA has inspectors at major Brazilian ports of entry (São Paulo/Guarulhos, Rio de Janeiro, Manaus, etc.) who conduct document checks and, for higher-risk devices, physical inspections of incoming shipments.
Verify all information against official ANVISA sources before making regulatory decisions.
The ANVISA Import Licence (LI) must be obtained before shipment dispatch and is typically processed within 5 to 10 business days via SISCOMEX. Import duty rates vary by NCM code (typically 12–18% ad valorem for medical devices). IPI (Imposto sobre Produtos Industrializados) may also apply depending on device classification. Importers should budget for these costs when planning imports.