Unlocking Brazil's MedTech Market: The Critical Role of a Brazil Registration Holder for Class I Devices | A Pure Global Insight for LATAM Expansion

This episode of LATAM MedTech Insights dives into a critical, often misunderstood, aspect of entering the Brazilian market: the requirement of a Brazil Registration Holder (BRH) for low-risk, Class I medical devices. While these devices follow a simplified "notificação" process instead of a full registration, foreign manufacturers are still legally required to have a local entity representing them before the regulatory body, ANVISA.

We explore why this requirement exists and the significant risks of appointing a commercial distributor as your BRH. This common mistake can lead to a loss of market access, create conflicts of interest, and severely limit your company's commercial flexibility and growth within Latin America's largest MedTech market.

A US-based startup learned this the hard way. They developed a Class I software-as-a-medical-device and, believing the "low-risk" classification meant a simple process, allowed their first Brazilian distributor to become their BRH. When the partnership soured due to poor performance, the startup was shocked to find they couldn't simply switch distributors. The original partner owned the ANVISA registration and refused to transfer it, demanding a hefty buyout. The startup was trapped, unable to sell their product through any other channel, effectively halting their Brazilian expansion for 18 months until the issue was legally resolved.

Key Questions from this Episode:
1. Why is a Brazil Registration Holder mandatory even for low-risk devices that only require a simple notification?
2. What are the hidden dangers of letting your distributor "own" your product registration with ANVISA?
3. How can the wrong BRH choice legally block you from working with other sales partners in Brazil?
4. What is the precise legal role of a BRH in post-market surveillance and incident reporting?
5. Is it possible to transfer your registration from one BRH to another, and what challenges might you face?
6. How does an independent BRH provide the flexibility needed to scale your business across Brazil?
7. What are the key differences between the 'notificação' and the 'registro' pathways at ANVISA?

At Pure Global, we offer end-to-end regulatory consulting solutions, serving as your independent, professional Brazil Registration Holder. We combine local expertise with advanced AI and data tools to streamline your market access while giving you complete control over your commercial strategy. Decouple your regulatory compliance from your distribution network and secure your access to the Brazilian market. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.