LATAM MedTech Insights

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.

  1. 42M 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

  2. 1D 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

  3. 3D AGO

    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

  4. 4D AGO

    Pure Global: Brazil's New SaMD Hurdle & ANVISA's Unspoken Rules.

    This week on LATAM MedTech Insights, we dissect the immediate impact of a surprise guidance note issued by Brazil's ANVISA. This new clarification on regulation RDC 751 is tightening the screws on foreign medical device manufacturers, especially those in the digital health and SaMD space. We explore the heightened requirements for technical dossiers and clinical data that are catching companies off guard. Discover why your existing FDA or CE mark documentation may no longer be enough for the Brazilian market. We use the real-world example of an AI diagnostic company suddenly facing major delays and costs, highlighting the critical need for a proactive and localized regulatory strategy to avoid common pitfalls. Key questions from this episode: - What specific change in ANVISA’s enforcement of RDC 751 caught the industry by surprise last week? - Why is foreign clinical data now facing greater scrutiny for SaMD submissions in Brazil? - How has the role of the Brazil Registration Holder (BRH) shifted from a legal formality to a critical strategic partner? - What are the three biggest mistakes manufacturers make when preparing their technical dossier for ANVISA? - Is Brazil's regulatory landscape becoming a barrier or an opportunity for high-quality MedTech? - Could your device's cybersecurity protocols be the hidden factor that leads to rejection? - How do you demonstrate clinical applicability to Brazil's diverse population without running entirely new trials? Navigating complex regulatory shifts like this is what we do best. Pure Global offers end-to-end solutions for MedTech companies, combining local experts in Brazil with advanced AI tools to streamline your path to market. From regulatory strategy and local representation to compiling your technical dossier, we ensure you're prepared for ANVISA's toughest questions. Don't let regulatory hurdles block your entry into Latin America's top market. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.

    2 min

  5. 5D AGO

    Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules

    Brazil's digital health market is booming, but a recent regulatory update from its agency, ANVISA, has changed the rules of the game for 2026. The new guidance for Software as a Medical Device (SaMD) goes far beyond basic registration, introducing stringent cybersecurity and lifecycle management requirements that are catching many international companies off guard. In this episode, we break down what these changes mean for you. We explore why your existing FDA or CE Mark documentation is no longer sufficient for Brazil and how adapting to these new rules can become your key competitive advantage in Latin America's largest market. **Case Study:** Imagine your company has a cutting-edge AI diagnostic tool, ready to conquer the Brazilian market. You’ve prepared your clinical data, but you suddenly face a rejection because your submission lacks a detailed cybersecurity vulnerability report adapted to Brazil's data privacy laws (LGPD). This unexpected roadblock could delay your launch by over a year, allowing local competitors to capture the market first. Are you prepared for this new reality? **Key questions answered in this episode:** * What specific cybersecurity standards has ANVISA recently mandated for SaMD? * How can you leverage your existing technical file for a successful Brazilian submission? * What are the three most common pitfalls for foreign firms under the new guidelines? * Why is post-market surveillance now as critical as the initial registration? * How does Brazil's new framework signal a larger regulatory trend across LATAM? * What is the crucial first step to take before submitting your digital health product to ANVISA? At Pure Global, we specialize in demystifying these complex regulatory landscapes. Our local experts in Brazil, combined with our AI-driven data tools, provide end-to-end support for your MedTech and IVD products. We transform regulatory hurdles into market opportunities. Ready to accelerate your entry into Brazil? Contact us at info@pureglobal.com or visit https://pureglobal.com/.

    2 min

  6. 6D AGO

    Brazil's SaMD Surprise: Hacking ANVISA's New Rules | A Pure Global LATAM MedTech Insight

    This episode of LATAM MedTech Insights dives into the critical new regulatory guidance from Brazil's ANVISA for Software as a Medical Device (SaMD). As Brazil doubles down on localized requirements, we explore why simply having FDA or CE approval is no longer enough to guarantee market access. We uncover the hidden complexities of ANVISA's risk classification and the growing importance of local data and cybersecurity compliance. We examine a case study of a digital health company whose market launch was delayed by nine months due to unexpected data privacy requirements. This costly setback highlights a critical pain point: underestimating Brazil's unique regulatory interpretation can derail your entire market entry strategy, even with a globally successful product. Key Questions Answered: - Is ANVISA's evolving SaMD framework a hidden barrier or a clear pathway for prepared companies? - How can your SaMD's risk classification unexpectedly change when entering Brazil? - What are the three most common LGPD (Brazil's Data Protection Law) mistakes foreign MedTech firms make? - Why is your choice of a local Brazil Registration Holder (BRH) more critical than ever for software devices? - What post-market surveillance strategies for SaMD will satisfy ANVISA's new focus? - How can you leverage your existing clinical data for the Brazilian market without starting from scratch? Navigating global markets requires more than just a great product; it demands expert regulatory strategy. Pure Global offers end-to-end solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline market access in over 30 countries, including Brazil. Whether you're a startup or a multinational, we are your local representative, ensuring a clear path to registration and post-market compliance. Don't let regulatory hurdles block your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more.

    2 min

  7. FEB 11

    Pure Global: Brazil's AI Software Maze - Cracking ANVISA's New Unspoken Code

    Brazil's regulatory landscape for AI and software medical devices just got a lot more complex. In this episode, Pure Global dives into ANVISA's latest unspoken rules that demand localized clinical data and stricter adherence to Brazil's data privacy laws, moving beyond simple acceptance of FDA or CE marks. We explore why your existing global dossiers might now be insufficient for the Brazilian market. We break down the new expectations for cybersecurity and the critical importance of validating your technology on local patient populations to ensure a successful product registration. **Case Study:** A U.S. diagnostics firm with a breakthrough AI-powered imaging tool had their Brazilian market entry delayed by six months. Their mistake? They submitted their FDA-cleared validation package without a supplemental study on a Brazilian patient cohort, leading to a cascade of questions from ANVISA that brought their launch to a halt. **Key Takeaways:** * Why is ANVISA now looking beyond FDA and CE approvals for SaMD? * What specific type of local clinical data can make or break your AI device submission in Brazil? * How can Brazil's data privacy law (LGPD) unexpectedly block your medical device approval? * What are the new cybersecurity vulnerabilities ANVISA is actively screening for? * Is it possible to use this regulatory shift to gain an advantage over slower competitors? * What is the number one assumption foreign companies make that leads to rejection? Struggling to keep up with the fast-paced changes in LATAM's regulatory landscape? Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline your market access. We act as your local representative, manage technical submissions, and ensure post-market compliance. Don't let regulatory hurdles block your expansion. Contact us for a strategic consultation at info@pureglobal.com or visit us at https://pureglobal.com/.

    2 min

  8. FEB 10

    Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.

    This week, we dive into a sudden and impactful regulatory shift in Brazil. ANVISA, the country's health agency, released a new resolution last week that specifically targets Software as a Medical Device (SaMD), creating significant new hurdles for manufacturers, especially those using AI and machine learning. This update introduces stringent cybersecurity protocols, challenging data localization laws, and a more rigid process for software updates. We explore what these changes mean on the ground through a practical case study. A U.S. diagnostics company, on the verge of launching its FDA-cleared AI cardiac software in Brazil, now finds its entire market entry strategy jeopardized by these new rules. Their reliance on U.S.-based cloud servers and agile development cycles directly conflicts with ANVISA's new mandates, forcing them to consider a costly strategic pivot or abandon the market. Key Takeaways: - What are the three core pillars of ANVISA's new SaMD regulation announced last week? - Why is the new data sovereignty rule a major obstacle for global MedTech companies? - How does the updated change control process impact companies using agile development? - What specific cybersecurity standards are now mandatory for software devices in Brazil? - Can you still leverage your FDA or CE marking for an expedited review under these new rules? - What is the first step you should take if your product is affected by this sudden change? Navigating the complexities of LATAM's regulatory environment is critical for success. At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. Whether you're dealing with new software regulations in Brazil or planning a multi-market launch, we provide the strategic guidance and in-country representation you need. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.

    2 min
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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
    112
  • Rating
    Clean
  • Copyright
    © Copyright 2026 Ran Chen
  • Show Website
    LATAM MedTech Insights