Leveraging Your FDA De Novo for Brazilian Market Access

This episode breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the De Novo is a powerful asset, it does not grant automatic approval. We cover the essential steps, from determining your device's risk classification under Brazilian regulations to understanding the different registration pathways (*Notificação* vs. *Registro*), the mandatory requirement of a Brazil Registration Holder (BRH), and the importance of compiling a technical dossier using your existing FDA data. • Does an FDA De Novo grant guarantee ANVISA approval in Brazil? • What is the most critical first step when seeking Brazilian market access? • How does Brazil's risk classification system differ from the FDA's? • What is the difference between the *Notificação* and *Registro* pathways? • Is it possible to register a device in Brazil without a local office? • What is a Brazil Registration Holder (BRH) and why are they essential? • How can the data from my De Novo submission accelerate ANVISA registration? • What are INMETRO and ANATEL certifications, and does my device need them? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.