Distributor AFE & Operating Licence Requirements
Brazilian medical device distributors (wholesale distributors, not retail) must hold:
- ANVISA AFE for distribution activities;
- Municipal Licença de Funcionamento for each distribution warehouse; and
- A registered Responsável Técnico (in most cases).
Key compliance obligations for distributors:
| Obligation | Detail |
|---|---|
| Storage conditions | Adequate temperature, humidity, and security controls as required by device type |
| Inventory traceability | Maintain records linking each device batch to supplier and customer |
| NOTIVISA registration | Must be registered to report adverse events |
| Recall cooperation | Must cooperate with and implement recalls initiated by the registration holder or ANVISA |
| Cold chain (if applicable) | Medical devices requiring cold chain must be stored and transported under temperature-controlled conditions |
Distributors who fail to meet these obligations face state VISA enforcement actions and may have their AFE suspended or cancelled.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
Storage conditions must comply with RDC 751/2022 and device-specific requirements in the product registration dossier. Temperature and humidity ranges must be monitored and documented, particularly for temperature-sensitive devices (e.g., vaccines, biologics, certain in vitro diagnostics). Documentation of storage condition monitoring must be maintained for at least 5 years.