Notificação — Class I Devices
The Notificação pathway applies to Class I devices. Largely administrative — no detailed pre-market technical review required before market placement.
Requirements
| Requirement | Detail |
|---|---|
| AFE | Valid Autorização de Funcionamento de Empresa |
| Responsável Técnico | Appointed and registered |
| GMP compliance | Self-declaration (or CBPF for manufacturers) |
| Technical information | Basic device description and intended use |
| Labelling | Brazilian Portuguese; compliant with RDC 754/2022 |
| NOTIVISA registration | Company must be registered for adverse event reporting |
Process: Log in to Peticionamento Eletrônico → Select "Notificação — Classe I" → Complete form → Upload documents → Pay fee → ANVISA assigns notification number.
Even for Class I devices, holders must report adverse events via NOTIVISA and maintain a PMS system.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.