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Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy
Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success.
We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical choice of a Brazil Registration Holder (BRH), and robust post-market surveillance. Learn how these elements are interconnected and why managing them under one expert team provides a significant competitive advantage in this complex market.
**A cautionary tale:** Imagine spending over a year and thousands of dollars to prepare your device registration, only to discover that the distributor you appointed as your local representative (BRH) has decided to partner with a competitor. Because they legally own your registration license, you have completely lost market access and must start the entire process from scratch, giving your competition a two-year head start.
**In this episode, you will learn:**
* Why is Brazil's four-class risk system more nuanced than it appears?
* What are the most common documentation mistakes that lead to ANVISA rejections?
* How can the choice of your Brazil Registration Holder (BRH) make or break your entire LATAM strategy?
* Are you truly in control of your device registration if your distributor is your BRH?
* What specific post-market surveillance activities does ANVISA require beyond simple adverse event reporting?
* Why is having a single, integrated team for registration and post-market support a competitive advantage in Brazil?
* What is BGMP certification and why is it non-negotiable for higher-risk devices?
At Pure Global, we offer end-to-end regulatory solutions for MedTech and IVD companies. Our integrated approach combines local Brazilian expertise with advanced AI tools to streamline market access, from initial strategy to post-market surveillance. Contact us to learn how our unified team can de-risk and accelerate your entry into the Brazilian market. Email us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenBrazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success.
We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical choice of a Brazil Registration Holder (BRH), and robust post-market surveillance. Learn how these elements are interconnected and why managing them under one expert team provides a significant competitive advantage in this complex market.
**A cautionary tale:** Imagine spending over a year and thousands of dollars to prepare your device registration, only to discover that the distributor you appointed as your local representative (BRH) has decided to partner with a competitor. Because they legally own your registration license, you have completely lost market access and must start the entire process from scratch, giving your competition a two-year head start.
**In this episode, you will learn:**
* Why is Brazil's four-class risk system more nuanced than it appears?
* What are the most common documentation mistakes that lead to ANVISA rejections?
* How can the choice of your Brazil Registration Holder (BRH) make or break your entire LATAM strategy?
* Are you truly in control of your device registration if your distributor is your BRH?
* What specific post-market surveillance activities does ANVISA require beyond simple adverse event reporting?
* Why is having a single, integrated team for registration and post-market support a competitive advantage in Brazil?
* What is BGMP certification and why is it non-negotiable for higher-risk devices?
At Pure Global, we offer end-to-end regulatory solutions for MedTech and IVD companies. Our integrated approach combines local Brazilian expertise with advanced AI tools to streamline market access, from initial strategy to post-market surveillance. Contact us to learn how our unified team can de-risk and accelerate your entry into the Brazilian market. Email us at [email protected] or visit https://pureglobal.com/.