LATAM MedTech Insights Titelbild

LATAM MedTech Insights

LATAM MedTech Insights

Von: Ran Chen
Jetzt kostenlos hören, ohne Abo

Über diesen Titel

 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 2026 Ran Chen Wissenschaft Ökonomie
Folgen
  • Pure Global: Brazil's SaMD Shake-Up - Navigating ANVISA's Unseen AI Hurdles

    Pure Global: Brazil's SaMD Shake-Up - Navigating ANVISA's Unseen AI Hurdles
    Feb 22 2026
    This week on LATAM MedTech Insights, we analyze the seismic new draft regulation from Brazil's ANVISA that is set to overhaul the rules for Software as a Medical Device (SaMD). This proposal introduces stringent new requirements for AI technologies and local data management, promising to reshape market access for all foreign MedTech companies targeting Brazil. We dive into the real-world impact by examining the case of a European AI diagnostics firm. Their expansion strategy, once clear, is now facing critical roadblocks due to unexpected demands for in-country clinical studies and data hosting, threatening significant delays and cost overruns. This story is a crucial lesson for any innovator looking to enter Latin America's most complex market. Key Takeaways: - Why is ANVISA suddenly proposing a major revision to its two-year-old SaMD regulation? - What are the specific new cybersecurity and data hosting rules for AI medical devices? - Will your existing FDA clearance or CE Mark still be enough for your software registration in Brazil? - What defines a "representative Brazilian population" for the new mandatory clinical validation studies? - How can you submit feedback on this draft regulation before it becomes law? - What strategies can turn these new regulatory barriers into a competitive advantage? - How should this change affect your company's five-year expansion plan for Latin America? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI tools to streamline global market access. Whether you are navigating new draft regulations or planning a multi-market launch, we build efficient pathways for your products. Confused about the new ANVISA rules? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.
    Mehr anzeigen Weniger anzeigen
    2 Min.
  • Pure Global: Brazil's High-Risk Device Code Unlocked - The New ANVISA Reliance Shortcut.

    Pure Global: Brazil's High-Risk Device Code Unlocked - The New ANVISA Reliance Shortcut.
    Feb 21 2026
    Brazil's regulatory agency, ANVISA, has just rolled out game-changing new rules that create a fast-track pathway for high-risk medical devices. This episode breaks down the new "reliance" mechanism that allows manufacturers to use existing international approvals for quicker market access, and what the new clinical trial law means for MedTech innovation. We explore how these changes are dismantling long-standing barriers to entry in Latin America's largest market. For any company with an advanced medical device, what was once a multi-year waiting game has just become a strategic race. We discuss how this impacts market entry strategy, cost, and the overall opportunity in Brazil. --- **This Episode's Deep Dive:** Consider a US-based company with an innovative cardiovascular implant (a Class IV device) with full FDA approval. The pain point for them has always been the Brazilian market entry: a separate, two-to-three-year ANVISA review process, huge costs, and unpredictable timelines. Now, with the new reliance pathway, that entire calculus has changed. They can leverage their existing FDA clearance to potentially secure Brazilian registration in under a year, turning a long-term aspiration into an immediate strategic possibility. --- **Key Takeaways (本期干货):** * What exactly is ANVISA's new reliance pathway and does my product qualify? * How does this regulatory shortcut change the ROI calculation for entering Brazil? * Which specific international approvals (like FDA, CE) are recognized for this process? * What are the critical documentation requirements for a successful reliance submission? * Beyond reliance, how does Brazil's new clinical trial law affect our global R&D strategy? * Are there any hidden complexities or potential pitfalls in this new accelerated process? * How should our regulatory team adapt its strategy to capitalize on this change now? --- At Pure Global, we specialize in turning complex regulatory changes into market opportunities. Our local experts in Brazil and our AI-powered data tools provide end-to-end support, from developing the optimal reliance strategy to managing your submission with ANVISA. We help you navigate the new landscape efficiently to accelerate your market access. To learn more about how we can help you successfully launch your MedTech or IVD products in Brazil and over 30 other markets, contact us at info@pureglobal.com or visit https://pureglobal.com/.
    Mehr anzeigen Weniger anzeigen
    2 Min.
  • Brazil's AI Diagnostic Gold Rush: Pure Global on ANVISA's Hidden Data Hurdles

    Brazil's AI Diagnostic Gold Rush: Pure Global on ANVISA's Hidden Data Hurdles
    Feb 20 2026
    In this episode, we dissect the groundbreaking news from Brazil's health agency, ANVISA. Last week, they launched "Agiliza IA Saúde," a new fast-track approval program for AI-powered medical software. This move could unlock massive opportunities in Latin America's largest market, promising to slash registration times for innovative diagnostic technologies. While the opportunity is immense, it comes with a critical challenge. The fast-track is gated by a strict compliance audit tied to Brazil's stringent data protection law, the LGPD. This has created a hidden barrier for international companies who are unprepared for the deep level of data traceability and AI "explainability" that ANVISA now requires, potentially derailing their market entry strategies. **Featured Case:** A European MedTech scale-up with a market-leading AI diagnostic tool saw Brazil's new program as their golden ticket into LATAM. They were ready for a full-scale launch but were stopped cold during the pre-submission phase. Their pain point: they could not adequately prove compliance with LGPD's data processing and localization requirements, a detail they had completely overlooked. Their entire expansion timeline is now on hold, forcing a costly redevelopment of their data governance framework. **Key Takeaways From This Episode:** * What are the specific eligibility criteria for ANVISA's new AI software fast-track program? * How does Brazil's data protection law (LGPD) directly create new challenges for SaMD manufacturers? * What is the "right to explanation" and how does it impact AI-based medical devices? * What are the most common compliance mistakes foreign companies make when entering the Brazilian market? * Is this new ANVISA policy a sign of a wider regulatory trend across Latin America? * How can you build a regulatory strategy that balances speed-to-market with deep compliance? * What level of data traceability and cybersecurity is now considered the standard for Brazil? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise in markets like Brazil with advanced AI tools to streamline global market access. We help you navigate complex requirements like ANVISA's new program to ensure a fast and successful launch. To learn more, contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
    Mehr anzeigen Weniger anzeigen
    2 Min.
Noch keine Rezensionen vorhanden