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Pure Global: Brazil's ANVISA 2025 Regs - Navigating Hidden Compliance Traps.
This week on LATAM MedTech Insights, we dissect the latest 2025 medical device registration guidance from Brazil's ANVISA. While the new framework aims to streamline market access, it has introduced a host of undocumented challenges that are causing significant delays for international manufacturers. We explore the gap between the official regulations and the practical hurdles companies are facing right now.
From the specific demands of the new digital submission portal to the increased technical scrutiny placed on local representatives, this episode provides a crucial look at the unwritten rules of Brazilian MedTech regulation. We uncover the real reasons behind recent submission rejections and offer insights into how companies can avoid common pitfalls and accelerate their path to market in Latin America's largest economy.
**Case Study:** A US-based orthopedic device company prepared their ANVISA submission based on their recent FDA 510(k) clearance. They were confident in their data, but their application was stalled for months. The issue? Their designated Brazil Registration Holder (BRH) was unable to adequately respond to ANVISA's technical questions regarding the specific biomechanical properties of the device, a level of scrutiny the company had never anticipated, forcing them to find a new, technically proficient local partner and restart the clock on their review.
**Key Takeaways This Episode:**
* Is your technical dossier truly prepared for ANVISA's new, unwritten formatting rules for 2025?
* How can you adapt your existing FDA or CE Mark data to satisfy Brazil-specific risk analysis requirements?
* Is your chosen Brazil Registration Holder (BRH) merely an administrative contact, or a true technical expert?
* What are the most common, unexpected reasons for rejection under the new digital submission system?
* How do you build a realistic timeline that accounts for unpredictable INMETRO certification delays?
* Are you prepared for ANVISA's increasingly deep technical questions during the review phase?
Navigating these regulatory mazes is our expertise. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise in markets like Brazil with advanced AI tools to streamline your global market access. Don't let regulatory hurdles derail your launch. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can help.
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By Ran ChenThis week on LATAM MedTech Insights, we dissect the latest 2025 medical device registration guidance from Brazil's ANVISA. While the new framework aims to streamline market access, it has introduced a host of undocumented challenges that are causing significant delays for international manufacturers. We explore the gap between the official regulations and the practical hurdles companies are facing right now.
From the specific demands of the new digital submission portal to the increased technical scrutiny placed on local representatives, this episode provides a crucial look at the unwritten rules of Brazilian MedTech regulation. We uncover the real reasons behind recent submission rejections and offer insights into how companies can avoid common pitfalls and accelerate their path to market in Latin America's largest economy.
**Case Study:** A US-based orthopedic device company prepared their ANVISA submission based on their recent FDA 510(k) clearance. They were confident in their data, but their application was stalled for months. The issue? Their designated Brazil Registration Holder (BRH) was unable to adequately respond to ANVISA's technical questions regarding the specific biomechanical properties of the device, a level of scrutiny the company had never anticipated, forcing them to find a new, technically proficient local partner and restart the clock on their review.
**Key Takeaways This Episode:**
* Is your technical dossier truly prepared for ANVISA's new, unwritten formatting rules for 2025?
* How can you adapt your existing FDA or CE Mark data to satisfy Brazil-specific risk analysis requirements?
* Is your chosen Brazil Registration Holder (BRH) merely an administrative contact, or a true technical expert?
* What are the most common, unexpected reasons for rejection under the new digital submission system?
* How do you build a realistic timeline that accounts for unpredictable INMETRO certification delays?
* Are you prepared for ANVISA's increasingly deep technical questions during the review phase?
Navigating these regulatory mazes is our expertise. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise in markets like Brazil with advanced AI tools to streamline your global market access. Don't let regulatory hurdles derail your launch. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can help.