Expert Medical Device Regulatory Services in Brazil
Brazil is Latin America’s largest medical-device market, and navigating its regulatory regime successfully requires specialist insight. At DDReg, we deliver high-level regulatory affairs consulting for manufacturers wanting entry, registration, and lifecycle support in Brazil. Our services cover everything from classification and dossier strategy to acting as your Brazilian Registration Holder (BRH) and post-market compliance. Whether you are looking for Brazil ANVISA medical device registration, Brazil IVD device registration, or require a trusted Brazil registration holder (BRH) service, DDReg is your partner of choice.
Why Work with DDReg for Medical Device Registration in Brazil?
- Full-spectrum support: from classification to post-market lifecycle.
- Proven expertise: with Agência Nacional de Vigilância Sanitária (ANVISA) filings and Brazilian GMP (BGMP).
- Local representation: we act as or help you appoint a Brazil Registration Holder (BRH) so you comply with local legal requirements.
- Strategic, not just operational: we align regulatory strategy with your commercial goals in Brazil.
Understanding the Brazil Device Regulatory Framework
Understanding the Brazil Device Regulatory Framework
| Risk Class | Description | Regulatory Pathway | Renewal / Validity |
|---|---|---|---|
| Class I (Low Risk) | e.g., simple materials, non-invasive devices | Notification (“Notificação”) | Valid indefinitely (no expiry) |
| Class II (Medium Risk) | Moderate risk devices | Notification (“Notificação”) | Valid indefinitely (no expiry) |
| Class III (High Risk) | e.g., implants, critical use devices | Registration (“Registro”) – full dossier + BGMP | Valid for 10 years, renewable |
Key regulations: RDC 751/2022 governs medical devices. Foreign manufacturers must appoint a Brazil registration holder (BRH). Additional certifications may be required (e.g., INMETRO for electromedical devices, ANATEL for wireless/telecom).
Our Medical Devices Regulatory Service Offerings in Brazil Include :
Our Medical Devices Regulatory Service Offerings in Brazil Include :
- Regulatory strategy & pathway assessment
- ANVISA medical device classification services
- Brazil IVD device registration support
- Brazil ANVISA dossier preparation (Notification & Registration)
- Brazil registration holder (BRH) services / local representation
- BGMP (Brazil Good Manufacturing Practices) readiness & audit coordination
- INMETRO / ANATEL conformity coordination (where applicable)
- Labeling, Instructions for Use (IFU) Portuguese translation & review
- Submission & liaison with ANVISA
- Post-market surveillance, vigilance, renewals and amendments in Brazil
- Local regulatory intelligence and monitoring of ANVISA updates
- Lifecycle management of medical devices in Brazil