AFE for Manufacturers, Importers & Distributors
The AFE granted by ANVISA is specific to the type of activity being performed. The key AFE types for medical devices are:
| AFE type | Activity | Key requirements |
|---|---|---|
| Fabricante (Manufacturer) | Manufacture of medical devices for the Brazilian market | CBPF GMP compliance; Responsável Técnico; site inspection |
| Importador (Importer) | Import of foreign-manufactured medical devices | Verification of foreign manufacturer GMP; Responsável Técnico; CNPJ |
| Distribuidor (Distributor) | Wholesale distribution of medical devices | Adequate storage facilities; Responsável Técnico; CNPJ |
| Exportador (Exporter) | Export of Brazilian-manufactured devices | AFE for manufacture (or import) is typically prerequisite |
A company may hold AFEs for more than one activity type if it performs multiple activities. Each activity type must be separately authorised on the AFE.
Renewal of AFE is required periodically — ANVISA specifies the renewal period in the AFE itself.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.