Unlocking Brazil's MedTech Market: A Pure Global Deep Dive on ANVISA Medical Device Registration for Your LATAM Strategy

Brazil represents the largest MedTech market in Latin America, but its regulatory landscape, governed by the agency ANVISA, is one of the most demanding in the world. This episode breaks down the essential steps and common pitfalls companies face when seeking medical device approval in this complex market. We provide a clear overview of the multi-layered process, from initial facility certification to final product registration.

We explore the critical requirements that every MedTech manufacturer must meet, including the often-underestimated B-GMP certification, the different registration pathways based on device risk class, and the strategic importance of selecting the right Brazil Registration Holder (BRH). We also share a crucial real-world example: learn about a company that appointed its distributor as its BRH, only to find itself trapped and unable to change commercial partners without losing its hard-won market registration, forcing a complete restart of the entire process.

This episode's key takeaways:

- Why is a B-GMP certificate the first, and often biggest, hurdle to clear before even submitting your device dossier?

- What is the crucial difference between the 'Notificação' and 'Registro' pathways under the new RDC 751/2022 regulation?

- Why is choosing your Brazil Registration Holder one of the most critical strategic decisions you will make?

- What common mistake can lead to a complete loss of control over your product's registration in Brazil?

- How do you prepare a technical dossier that meets ANVISA’s specific and demanding requirements?

- Do you need additional certifications like INMETRO or ANATEL for your device?

- How can you avoid years of delays and unexpected costs when entering the Brazilian market?

Navigating the complexities of the Brazilian market requires local expertise and a robust regulatory strategy. At Pure Global, we offer end-to-end solutions, acting as your local representative and using advanced tools to streamline dossier submissions. Ready to build your LATAM market access strategy? Contact our experts at [e-mail] or visit https://pureglobal.com/.