This episode of MedTech Global Insights delves into the complexities of entering Brazil's lucrative medical device market. We uncover the critical regulatory hurdles set by ANVISA and explain why a robust, expert-led strategy is essential for success. We explore the common pitfalls that can delay market entry for years and discuss the strategic advantages of partnering with a specialized consultant.

Discover the story of a promising European IVD company that lost nearly two years and significant investment due to easily avoidable regulatory mistakes in Brazil. Their struggle with appointing a local representative, navigating document translations, and missing a crucial product certification highlights the hidden complexities that can derail even the most innovative products. This case study reveals the critical importance of deep local expertise.

Key Takeaways:

- What is a Brazilian Registration Holder (BRH) and why is it the single most important decision for market entry?

- How can you leverage ANVISA's new reliance pathways to accelerate your product registration?

- What are the most common documentation and technical file mistakes that lead to rejection by ANVISA?

- Why is the INMETRO certification a hidden barrier for many electronic medical devices?

- How do you maintain control of your product registration when working with local distributors?

- What are the key elements of an effective post-market surveillance strategy in Brazil?

- How can AI-powered tools reduce the time and cost of compiling regulatory submissions?

- What should you look for when choosing a regulatory affairs consulting partner for Latin America?

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