ZARZA We are Zarza, the prestigious firm behind major projects in information technology.
Listen "Unlocking Brazil's MedTech Market: A Pure Global Deep Dive into ANVISA's Class I/II Notification and High-Risk Registration Pathways"
Episode Synopsis
In this episode of LATAM MedTech Insights, we demystify the complex world of Brazil's medical device regulations under ANVISA. We explore the critical differences between the faster 'Notificação' pathway for low-risk devices and the intensive 'Registro' full-review process for high-risk products, revealing why your strategy for one won't work for the other.
This episode is for any MedTech company that sees Brazil as a key market but is concerned about the regulatory hurdles. We break down the real-world implications of each pathway, from documentation requirements to the formidable challenge of the Brazilian Good Manufacturing Practices (BGMP) audit, ensuring you understand exactly what it takes to succeed.
Key questions answered in this episode:
* Why is Brazil's ANVISA a two-speed system for medical devices?
* What is the critical difference between the *Notificação* and *Registro* pathways?
* Could your Class II device from the US or EU require a full, lengthy review in Brazil?
* What is the BGMP audit, and why is it often the biggest hurdle for high-risk device manufacturers?
* How can a local Brazil Registration Holder (BRH) make or break your market entry strategy?
* Are you underestimating the documentation requirements for a "simple" notification?
* How does proper device classification at the start save you months, or even years, in delays?
Pure Global offers end-to-end regulatory consulting to streamline your global market access. We combine local expertise in over 30 markets with advanced AI to get your MedTech and IVD products to market efficiently. To develop your tailored regulatory strategy for Brazil or beyond, contact us at [email protected] or visit https://pureglobal.com/.
This episode is for any MedTech company that sees Brazil as a key market but is concerned about the regulatory hurdles. We break down the real-world implications of each pathway, from documentation requirements to the formidable challenge of the Brazilian Good Manufacturing Practices (BGMP) audit, ensuring you understand exactly what it takes to succeed.
Key questions answered in this episode:
* Why is Brazil's ANVISA a two-speed system for medical devices?
* What is the critical difference between the *Notificação* and *Registro* pathways?
* Could your Class II device from the US or EU require a full, lengthy review in Brazil?
* What is the BGMP audit, and why is it often the biggest hurdle for high-risk device manufacturers?
* How can a local Brazil Registration Holder (BRH) make or break your market entry strategy?
* Are you underestimating the documentation requirements for a "simple" notification?
* How does proper device classification at the start save you months, or even years, in delays?
Pure Global offers end-to-end regulatory consulting to streamline your global market access. We combine local expertise in over 30 markets with advanced AI to get your MedTech and IVD products to market efficiently. To develop your tailored regulatory strategy for Brazil or beyond, contact us at [email protected] or visit https://pureglobal.com/.
In God we trust