Lifecycle of a Medical Device in Brazil

1. CLASSIFY THE DEVICE
   └─ Determine Class I / II / III / IV under RDC 751/2022
   └─ IVDs: apply RDC 36/2015 classification

2. ESTABLISH REGULATORY PATHWAY
   └─ Class I → Notificação
   └─ Class II → Cadastro
   └─ Class III / IV → Registro

3. PREPARE TECHNICAL DOSSIER
   └─ Device description, essential requirements, risk management
   └─ GMP compliance (CBPF certificate for manufacturer)
   └─ Clinical/performance evidence as required by class

4. OBTAIN AFE (company authorisation)
   └─ Submit AFE application via Peticionamento Eletrônico
   └─ State VISA endorsement where applicable

5. SUBMIT REGISTRATION APPLICATION
   └─ Via Peticionamento Eletrônico on ANVISA portal
   └─ Pay petitioning fees (taxas de peticionamento)
   └─ ANVISA technical review (timelines vary by class)

6. PRODUCT ON MARKET
   └─ Affix Brazilian labelling (Portuguese required)
   └─ Implement PMS plan
   └─ Monitor and report adverse events via NOTIVISA
   └─ Maintain GMP compliance / CBPF certificate

7. CHANGES & RENEWALS
   └─ Post-registration changes → Petição de Alteração
   └─ Registration valid for 10 years → renewal required
   └─ AFE renewal on schedule

Key timelines

Activity	Typical timeframe
Class I Notificação	Days to weeks
Class II Cadastro	3–6 months
Class III/IV Registro	12–36 months
AFE grant	2–4 months
Registration renewal	10-year cycle

Official resources

• ANVISA — Peticionamento Eletrônico