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 within 72 hours of detecting a serious adverse event (death, serious injury, or malfunction) and maintain post-market surveillance (PMS). Reporting is mandatory for IVDs under RDC 36/2015 and for all Class I devices under Instrução Normativa No. 16/2012 (NOTIVISA); failure to report may result in administrative penalties or notification suspension.
Verify all information against official ANVISA sources before making regulatory decisions.
Class I device holders must report serious adverse events (SAEs) causing death, serious injury, or device failure requiring intervention within 72 hours of detection. Non-serious adverse events may be aggregated and reported quarterly. NOTIVISA registrations require annual post-market surveillance summaries documenting complaint trends and any product modifications; failure to report may result in notification suspension or product recall.