LATAM MedTech Insights Podcast Por Ran Chen arte de portada

LATAM MedTech Insights

LATAM MedTech Insights

De: Ran Chen
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Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.Copyright 2025 Ran Chen Ciencia Ciencias Biológicas Economía
Episodios
  • Brazil's SaMD Cybersecurity Shockwave: Pure Global on ANVISA's Hidden Demands.

    Brazil's SaMD Cybersecurity Shockwave: Pure Global on ANVISA's Hidden Demands.
    Dec 17 2025
    Last week, Brazil's ANVISA unleashed a pivotal update for Software as a Medical Device (SaMD) with its new resolution, RDC 992/2025. While appearing to align with international standards, this new regulation introduces complex cybersecurity and data privacy requirements tied specifically to Brazil's LGPD law, creating unexpected hurdles for global manufacturers. In this episode of LATAM MedTech Insights, we dissect the fine print of ANVISA's new rules. We explore the immediate operational impacts, from mandatory local data protection officers to new clinical data requirements for AI-driven software, and discuss the strategic adjustments companies must make to maintain or gain market access in Latin America's largest market. Case Study: Imagine you're a US-based scaleup with a groundbreaking AI diagnostic tool. Your EU MDR and FDA clearances are in hand, and Brazil is your next target. Suddenly, your registration is stalled. Why? Your application didn't address specific LGPD data transfer protocols and your designated data officer isn't based in Brazil. This is the new reality—a costly and time-consuming roadblock that a standard regulatory checklist would have missed. Key Takeaways: 1. What are the three 'hidden' requirements in ANVISA's new SaMD rule that most foreign companies will miss? 2. How does Brazil's LGPD law now directly impact your medical device's technical file? 3. Is your current cybersecurity plan sufficient for the new Brazilian standards? 4. Why might your existing AI/ML validation data be rejected by ANVISA? 5. What's the new mandatory role you might need to hire in Brazil to keep your SaMD on the market? 6. How does this update affect legacy SaMD products already registered in Brazil? 7. What are the critical deadlines you cannot afford to ignore over the next six months? Navigating the evolving regulatory landscape in Latin America requires more than just a checklist; it demands localized, expert strategy. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise with advanced AI tools to streamline your global market access. We act as your local representative, manage your technical dossier, and ensure continuous compliance. Don't let regulatory surprises derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 m
  • Brazil's MDR Surprise: ANVISA's Hidden Clause for MedTech Imports | Pure Global

    Brazil's MDR Surprise: ANVISA's Hidden Clause for MedTech Imports | Pure Global
    Dec 16 2025
    This week, we dissect the immediate fallout from ANVISA's surprise regulatory shift in Brazil. While the move towards EU MDR alignment was expected, a hidden clause mandating local usability studies for high-risk devices has caught many international MedTech firms by surprise, threatening to delay launches and inflate budgets. We explore the specifics of the new RDC 987/2025 resolution and what it means for companies who previously relied on their CE marking for a smoother entry into Latin America's largest market. This episode is a must-listen for regulatory affairs professionals, product managers, and executives focused on global expansion. A leading German cardiac stent company had its Brazilian launch plan finalized, with its budget approved and timeline set. Last week’s ANVISA announcement instantly invalidated their strategy. Now, they're facing an unexpected nine-month delay and an unbudgeted six-figure cost for a mandatory local study they never saw coming. Key questions from this episode: - Does ANVISA's new rule make your existing technical file obsolete for Brazil? - What are the hidden costs and timeline impacts of the mandatory in-country usability studies? - How can you leverage your existing data to potentially streamline this new local requirement? - Could this regulatory shift in Brazil signal a trend for other LATAM markets? - Is your local representative in Brazil equipped to manage these new complex clinical requirements? - What steps should you take today to de-risk your 2026 LATAM launch plans? Navigating sudden regulatory changes requires deep local expertise and a proactive strategy. At Pure Global, we offer end-to-end regulatory consulting, acting as your local representative in over 30 markets, including Brazil. We use advanced AI and data tools combined with on-the-ground expertise to streamline global market access and ensure you're always ahead of the curve. Don't let regulatory surprises derail your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 m
  • Brazil's ANVISA AI Gambit: Pure Global on Hacking the MedTech Approval Backlog.

    Brazil's ANVISA AI Gambit: Pure Global on Hacking the MedTech Approval Backlog.
    Dec 15 2025
    Last week, Brazil's regulatory agency, ANVISA, unveiled a groundbreaking 2025 plan to tackle its notorious medical device approval backlogs. The initiative, named "AnvisAI," leverages artificial intelligence to create an automated fast-track system for lower-risk devices, aiming to cut review times by more than half and reshape the market access landscape. This move signals a major shift, potentially transforming Brazil from one of the most challenging LATAM markets into a hub for MedTech innovation. This episode unpacks the details of the AnvisAI project, exploring what it means for manufacturers' regulatory strategies and the immediate opportunities it creates for faster market entry. We explore a critical case study: Imagine launching an innovative Software as a Medical Device (SaMD) and facing a 24-month approval delay, tying up capital and stalling growth. ANVISA's new AI-driven pathway could slash that wait time to just a few months, completely changing the financial and strategic calculus for entering Brazil. Key Takeaways: 1. What exactly is the "AnvisAI" project and how will it re-classify devices for the new fast-track? 2. Which specific device classes stand to benefit the most from automated approvals? 3. What are the hidden data and documentation requirements for submissions to the new AI system? 4. How does this decision position Brazil against other LATAM markets like Mexico and Colombia? 5. What are the immediate actions MedTech companies should take to adapt their registration strategy? 6. Will this new system require changes to post-market surveillance and vigilance reporting? 7. How does this initiative align with Brazil's broader National AI Strategy? Navigating Brazil's rapidly evolving regulatory landscape requires local expertise and advanced technological tools. At Pure Global, we offer end-to-end regulatory consulting solutions, combining on-the-ground experts in Brazil with proprietary AI tools to streamline your market access. From regulatory strategy and dossier preparation to acting as your local representative, we help you leverage these new opportunities for faster growth. To learn how we can accelerate your entry into the Brazilian market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 m
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