LATAM MedTech Insights copertina

LATAM MedTech Insights

LATAM MedTech Insights

Di: Ran Chen
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A proposito di questo titolo

 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 Economia Scienza Scienze biologiche
Episodi
  • Pure Global: Brazil's 3D-Printed MedTech Scramble - Inside ANVISA's Surprise Rule Shake-up.

    Pure Global: Brazil's 3D-Printed MedTech Scramble - Inside ANVISA's Surprise Rule Shake-up.
    Jan 22 2026
    Brazil's regulatory agency, ANVISA, has just released a surprise draft guidance for personalized, 3D-printed medical devices, sending shockwaves through the MedTech industry. With a very short 30-day window for public feedback, international companies are now scrambling to understand the complex new rules for software validation and data privacy that could disrupt their market access strategies. This episode dives deep into the specific challenges and hidden opportunities within this proposal. We analyze the potential requirement for Brazil-specific software validation, which may conflict with existing FDA or CE Mark approvals. We also unpack the ambiguous data localization clauses that could threaten the global operational models of many manufacturers. **Case Study Spotlight:** Imagine your company has perfected a workflow for creating patient-specific implants in a central European facility. You're on the verge of expanding into Brazil, but ANVISA's new rules could suddenly make your data transfer processes non-compliant, forcing a multi-million dollar investment in local infrastructure. Is your current regulatory strategy agile enough to handle this? **Key Questions Answered:** * Is ANVISA's 30-day feedback window a genuine consultation or a new barrier to entry? * What are the specific cybersecurity and data privacy risks hidden in the new draft? * How can you effectively challenge a proposed regulation that conflicts with your global model? * What are the unwritten rules for submitting feedback to ANVISA that actually gets considered? * Could Brazil's new framework for personalized devices set a new, complex standard for all of LATAM? Pure Global offers end-to-end regulatory consulting to help MedTech innovators navigate precisely these kinds of challenges. We combine local, in-country expertise with advanced AI tools to streamline global market access and ensure you're always ahead of regulatory changes. Don't let surprise regulations derail your expansion. Contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 min
  • Pure Global: Brazil's SaMD Shift - Unpacking ANVISA's Hidden Hurdles for Foreign Tech

    Pure Global: Brazil's SaMD Shift - Unpacking ANVISA's Hidden Hurdles for Foreign Tech
    Jan 21 2026
    In this episode of LATAM MedTech Insights, we dissect the critical regulatory updates from Brazil's ANVISA that are reshaping the landscape for Software as a Medical Device (SaMD). This is not a minor tweak; it's a fundamental shift demanding that foreign manufacturers, especially in the AI and digital health sectors, rethink their entire market entry strategy. We explore the immediate implications of these new clarifications, focusing on the heightened demands for localized clinical data and the stringent requirements of Brazil's data privacy laws. This episode provides essential insights for any company looking to stay compliant and competitive in Latin America's largest and most complex market. **A Real-World Challenge:** Imagine you are a US-based scale-up with a revolutionary AI diagnostic tool, poised to enter the Brazilian market. Suddenly, you discover your extensive US and EU clinical data is deemed insufficient by ANVISA. You are now facing an unexpected, year-long delay to conduct local studies, jeopardizing your funding and first-mover advantage. How do you navigate this without derailing your entire LATAM launch? **Key Takeaways From This Episode:** * What specific clinical evidence is ANVISA now demanding for foreign SaMD? * How does Brazil's data privacy law (LGPD) impact your software's architecture? * Why is the risk classification for your AI-driven device more complex than you think? * What is the biggest mistake companies make when interpreting these new guidelines? * Could these stricter regulations hide unforeseen opportunities for well-prepared companies? * How can you leverage regulatory reliance pathways to potentially streamline this process? * What are the three essential questions to ask your local regulatory partner today? Pure Global offers 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. We help you turn regulatory hurdles into market opportunities. To learn more about navigating Brazil's evolving landscape or expanding into over 30 other global markets, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Brazil's AI MedTech Surprise: Decoding ANVISA's New Rules with Pure Global

    Brazil's AI MedTech Surprise: Decoding ANVISA's New Rules with Pure Global
    Jan 20 2026
    This week, we dissect the breaking news from Brazil's regulatory landscape. ANVISA has just rolled out RDC 884, a new resolution that specifically targets AI and machine learning-powered medical software. This move signals a profound shift, moving Brazil away from reliance on foreign approvals and establishing a new, sophisticated framework for digital health technology. In this episode, we explore the critical details of this new regulation. We break down the stricter classification system, the controversial new requirements for localized clinical data, and the tough cybersecurity standards now being enforced. Learn what this means for MedTech innovators and how it will redefine the pathway to one of Latin America's largest markets. **Case Study:** Imagine you're a successful SaMD scale-up with FDA clearance, eyeing expansion. Your entire Brazilian market entry plan, built on leveraging your existing approvals, was just upended by ANVISA's announcement last week. Are you now required to run a costly and time-consuming local clinical trial? How do you prove your algorithm works for Brazil's unique population demographics? **This episode will answer:** - What are the three biggest changes in ANVISA's new AI software regulation? - Why might your existing FDA or CE Mark documentation now be rejected in Brazil? - Is a local clinical investigation mandatory for all AI-driven medical devices? - How can the new cybersecurity rules impact your product's architecture? - What are the hidden costs associated with the new data validation requirements? - Does this resolution create a new competitive advantage for locally-developed AI? - How should this change your strategic approach to the entire LATAM region? Struggling to keep up with regulatory shifts in Latin America? Pure Global offers end-to-end solutions for MedTech and IVD companies, combining local expertise with advanced AI tools to streamline global market access. Whether it's market strategy, local representation, or technical dossier submission, we make global expansion clear and efficient. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 min
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