This episode of MedTech Global Insights tackles the complex but rewarding process of medical device registration in Brazil. We explore why Brazil's ANVISA is one of the world's most challenging regulatory bodies and break down the critical strategic decisions companies must make to succeed, from selecting a Brazil Registration Holder (BRH) to adapting technical documentation. We provide an insider's view on how to avoid common pitfalls that can cost manufacturers years of delay and lost revenue. Learn how a technology-driven, independent regulatory partner can streamline your entry, giving you control over your commercial strategy and ensuring long-term success in Latin America's largest market. **Case Study:** A successful European orthopedic company entered Brazil by making its distributor the legal registration holder. Discover the critical business limitations they faced when they tried to expand and why this common mistake can trap a company's flagship product in a single, underperforming sales channel. **Key Takeaways:** * Why is selecting an independent Brazil Registration Holder (BRH) the most critical decision for your long-term commercial freedom? * What are the most common dossier errors that lead to rejection by ANVISA? * How can you leverage your existing CE or FDA documentation to accelerate the Brazilian registration process? * What specific post-market surveillance activities in Brazil often catch foreign manufacturers by surprise? * What are the hidden costs of a failed or delayed market entry into Brazil? * How can AI-powered tools dramatically reduce the time and cost of compiling a technical file for ANVISA? * When is it necessary to conduct in-country clinical studies or testing for the Brazilian market? * How does Brazil's classification system for medical devices differ from the EU and US? Contact us for more information at [email protected] or visit https://pureglobal.com/.