LATAM MedTech Insights

Ran Chen
  • 0.0 (0)
  • LIFE SCIENCES

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.

  1. 6H AGO

    Pure Global: Brazil's AI MedTech Gambit—Navigating ANVISA's New Fast-Track Paradox.

    This week, we dive into a landmark regulatory shift in Brazil. ANVISA has just launched a new, expedited approval pathway for AI-powered medical software, potentially slashing market entry timelines. This episode breaks down the immense opportunity this presents for MedTech innovators looking to enter Latin America's largest market. But there's a critical catch. This accelerated access comes with a new, aggressive post-market surveillance system that demands continuous real-world data reporting. We explore this paradox: while the front door is easier to open, the rules for staying inside have become far more complex. We discuss what this means for manufacturers, from operational burdens to the risk of registration suspension. **Key Takeaways:** * What specific change did ANVISA just implement for AI-powered medical software? * Why is faster approval only half the story for manufacturers entering Brazil? * What are the new, stringent quarterly data reporting requirements? * How does this shift the regulatory burden from pre-market to post-market? * What kind of operational systems must companies now build to ensure compliance? * Which foreign approvals can be leveraged for this new fast-track process? * Could this new Brazilian model become a blueprint for other LATAM countries? At Pure Global, we specialize in navigating these complex regulatory landscapes. From initial market strategy and registration to fulfilling rigorous post-market surveillance requirements, our local experts and advanced AI tools ensure you can access and maintain your presence in over 30 global markets, including Brazil. Get in touch with us to future-proof your MedTech products in Latin America. Contact us at info@pureglobal.com or visit https://pureglobal.com/.

    2 min

  2. 1D AGO

    Pure Global: Brazil's SaMD Shake-Up - Navigating ANVISA's Unseen AI Hurdles

    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.

    2 min

  3. 2D AGO

    Pure Global: Brazil's High-Risk Device Code Unlocked - The New ANVISA Reliance Shortcut.

    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/.

    2 min

  4. 3D AGO

    Brazil's AI Diagnostic Gold Rush: Pure Global on ANVISA's Hidden Data Hurdles

    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/.

    2 min

  5. 4D AGO

    Brazil's SaMD Cybersecurity: Pure Global on ANVISA's Hidden Data Demands.

    This week, we dissect the groundbreaking new cybersecurity resolution from Brazil's ANVISA that is sending ripples through the MedTech world. The new rules for Software as a Medical Device (SaMD) go far beyond international standards, demanding a proactive, localized approach to cybersecurity and data validation that presents both challenges and opportunities. We explore how this regulation transforms the compliance burden, requiring continuous threat monitoring and incident reporting tailored specifically for the Brazilian market. This is no longer a simple paperwork exercise; it's a fundamental shift in how MedTech companies must manage their products' lifecycle in Latin America. A case in point: An EU-based scaleup, with a fully CE-marked AI diagnostic software, initiated their Brazilian market entry, assuming a smooth process. They were stalled for nine months. The reason? ANVISA's new rule required them to prove their algorithm's efficacy and lack of bias using a specific, anonymized dataset from three different Brazilian states, a requirement not explicitly detailed in the main resolution but enforced during the technical review. This unforeseen obstacle forced them into costly and time-consuming local clinical partnerships, delaying their revenue generation by almost a year. Key takeaways from this episode: - How does ANVISA's new lifecycle approach to cybersecurity change your post-market surveillance duties? - Are your global cybersecurity incident response plans sufficient for Brazil's new 72-hour reporting rule? - What are the new, unwritten rules for validating your AI or ML algorithm with local Brazilian patient data? - Why might your existing international technical dossier now be rejected by ANVISA? - How can you turn these stringent data requirements into a competitive advantage in the Brazilian market? - What specific documentation is now required to prove your software's resilience against cyber threats? - How will this new regulation impact market access timelines and costs for foreign SaMD manufacturers? Pure Global offers end-to-end regulatory consulting to help MedTech and IVD companies navigate these complexities. From developing a robust regulatory strategy and compiling a compliant technical dossier to acting as your official local representative, we streamline global market access. Our expertise, combined with advanced AI tools, ensures you can meet demanding local requirements efficiently. Don't let regulatory surprises derail your launch. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence in Brazil.

    2 min

  6. 5D AGO

    Brazil SaMD Shake-Up: Pure Global on ANVISA's Hidden Compliance Traps

    This week on LATAM MedTech Insights, we dissect the groundbreaking new Software as a Medical Device (SaMD) regulation just released by Brazil's ANVISA. This isn't just another update; it's a complete strategic reset for any digital health company targeting the Brazilian market. We explore the critical changes in risk classification for AI-driven software and the stringent new cybersecurity mandates that have just come into effect. Imagine a cutting-edge European AI diagnostics startup, poised to enter Brazil as its gateway to Latin America. Last week, their entire market access strategy was invalidated by ANVISA's new resolution. Their product's classification has jumped from low-risk to high-risk, demanding extensive clinical data they haven't prepared for. This episode details the pivots and strategies companies in this exact situation must now consider. Key Takeaways: 1. What specific event triggered ANVISA's major overhaul of its SaMD regulations? 2. How do the new AI risk classifications diverge from established FDA or EU guidelines? 3. What are the most overlooked cybersecurity requirements in the new Brazilian framework? 4. For SaMDs now classified as high-risk, what are the specific clinical evidence demands? 5. How will this regulatory shift impact foreign investment in Brazil's digital health sector? 6. Are there any provisions for legacy software already on the market? 7. What new documentation for data privacy is now mandatory for submission? Navigating this new landscape is complex, but Pure Global is built for this challenge. We offer end-to-end regulatory consulting, using our local Brazilian expertise and advanced AI tools to streamline your path to market. From developing a new regulatory strategy to compiling your technical dossier for ANVISA, we ensure your innovation meets these new standards efficiently. Don't let regulatory shifts derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market access.

    2 min

  7. 6D AGO

    Pure Global: Brazil's AI MedTech Gold Rush. ANVISA's Secret Fast-Track to Market Access.

    This week, we dissect the groundbreaking new resolution from Brazil's ANVISA that's set to revolutionize the AI-powered medical device landscape. We explore how this regulatory shift dramatically accelerates market access for Software as a Medical Device (SaMD) companies. Learn what this means for startups and established players eyeing the largest MedTech market in Latin America, and how the rules have fundamentally changed for innovators who were previously locked out by slow, hardware-focused regulations. A real-world pain point: Imagine spending two years and hundreds of thousands of dollars trying to get your innovative diagnostic AI approved in Brazil, only to be stuck in a regulatory framework designed for physical hardware. That was the reality. We discuss how the new rules directly address this critical pain point, potentially turning a 24-month nightmare into a 6-month opportunity. Key Takeaways: * What specific changes did ANVISA just implement for AI medical software? * How does the new risk classification system impact my product's registration timeline? * Which types of AI devices benefit the most from this fast-track process? * Is this a signal for other LATAM regulators like COFEPRIS or INVIMA to follow? * What are the immediate steps my company should take to leverage this opportunity? * Are there any hidden compliance traps in the new Brazilian regulations? * How can foreign companies navigate the updated submission process effectively? At Pure Global, we specialize in navigating these complex regulatory shifts. Our combination of local expertise in Brazil and advanced AI tools can streamline your market access strategy under these new rules. For end-to-end regulatory consulting for MedTech and IVD companies, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    2 min

  8. FEB 15

    Brazil's RDC 751 Maze: Pure Global on MedTech Registration's Hidden Traps

    Brazil's medical device market has undergone its most significant regulatory overhaul in two decades with the full implementation of RDC 751/2022. This new framework replaces the long-standing RDC 185/2001, introducing a new risk classification system and technical documentation structure that aligns more closely with global standards like the EU MDR. While this harmonization presents long-term benefits, the immediate transition creates critical challenges for MedTech manufacturers. Companies must now navigate new submission pathways, restructure their technical dossiers to meet IMDRF standards, and ensure their labeling and post-market activities are fully compliant, facing risks of rejection and market access delays if unprepared. A US-based scaleup, planning a routine renewal for their Class II device in Brazil, recently discovered their existing technical file was obsolete under RDC 751. They are now facing a complete dossier overhaul and the risk of a gap in their market authorization, jeopardizing a key distribution contract and threatening their revenue stream in the region. What You'll Learn: - How does the new four-class risk system in Brazil impact your existing product portfolio? - What are the critical differences between the old submission process and the new technical dossier requirements? - Is your current product labeling and IFU compliant with the latest ANVISA updates? - What are the most common rejection points for submissions under the new RDC 751? - How can leveraging your EU MDR documentation give you a head start in Brazil? - What specific post-market surveillance changes must you implement immediately? - Are there any critical transition deadlines you might have missed? Pure Global offers end-to-end regulatory consulting to navigate these complex changes. We combine local expertise in Brazil with advanced AI tools to streamline your market access. Don't let regulatory shifts disrupt your strategy. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/ for a consultation.

    2 min
See All (117)

About

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.

Information

  • Creator
    Ran Chen
  • Years Active
    2025 - 2026
  • Episodes
    117
  • Rating
    Clean
  • Copyright
    © Copyright 2026 Ran Chen
  • Show Website
    LATAM MedTech Insights