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LATAM MedTech Insights

LATAM MedTech Insights

Written by: 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 2026 Ran Chen Biological Sciences Economics Science
Episodes
  • Pure Global: Brazil's ANVISA Shockwave - Navigating the New Digital MedTech Registration Chaos.

    Pure Global: Brazil's ANVISA Shockwave - Navigating the New Digital MedTech Registration Chaos.
    Jan 13 2026
    In this episode, we dissect the sudden and disruptive launch of ANVISA's new mandatory digital submission platform in Brazil, which has caught many international MedTech manufacturers off guard. We explore the immediate operational challenges, from language barriers to technical glitches, and discuss the strategic implications for companies planning to enter or expand within Latin America's largest market. We delve into the real-world impact through the case of a European firm whose multi-million dollar product launch was jeopardized overnight. Their meticulously prepared technical dossier was rendered incompatible with the new system, forcing them into a desperate race against time to reformat and resubmit, highlighting the critical need for regulatory agility and expert local representation. 本期干货 1. What are the three most critical technical changes in ANVISA's new PDR platform? 2. Why was no grace period offered for such a major regulatory transition? 3. How does this shift specifically impact the approval timeline for high-risk devices? 4. What are the hidden documentation requirements not listed in the official guidance? 5. How can AI-powered tools accelerate the adaptation of your technical dossier for the new format? 6. Is your current local representative equipped to handle this digital-only transition? 7. What are the key financial risks associated with submission errors on the new platform? 8. How can you leverage this regulatory shift as a competitive advantage? Struggling with market access in Latin America? Pure Global offers end-to-end regulatory consulting, leveraging local expertise and advanced AI to streamline your path to market in over 30 countries, including Brazil, Mexico, and Colombia. Don't let regulatory surprises derail your launch. Contact our experts at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 mins
  • Pure Global: Mexico's COFEPRIS Shortcut - A New MedTech Backdoor for US/EU Devices?

    Pure Global: Mexico's COFEPRIS Shortcut - A New MedTech Backdoor for US/EU Devices?
    Jan 12 2026
    This week, we dive into the groundbreaking news from Mexico's regulatory agency, COFEPRIS. A new fast-track "equivalency agreement" has been announced, set to revolutionize market access for medical device companies with existing US FDA or European CE Mark approval. This episode unpacks the details of this new pathway, exploring the immense opportunities it creates for international MedTech firms. We break down what this regulatory shift means for your business strategy in Latin America. This isn't just a minor update; it's a strategic move by Mexico to become the primary landing spot for MedTech innovation and investment in the region. We analyze the immediate benefits and the potential long-term competitive advantages for companies that act quickly. ## What You'll Learn: * What is the new COFEPRIS "equivalency agreement" and how does it actually work? * Which specific device classes are eligible for this new fast-track process? * How does this change Mexico's position against other LATAM markets like Brazil? * What are the critical documentation requirements needed to leverage your existing FDA or CE approval? * Are there any hidden pitfalls or new compliance details to watch out for in this streamlined process? * How can this new rule drastically reduce your company’s time-to-market and registration costs? * What does this mean for local Mexican manufacturers and the competitive landscape? * Is this the first step toward broader regulatory harmonization across Latin America? Navigating these complex changes requires local expertise and a global perspective. Pure Global offers end-to-end regulatory consulting for MedTech companies, combining local experts with AI tools to streamline global market access. We act as your local representative to ensure you can capitalize on new regulations efficiently. To learn how we can accelerate your entry into the Mexican market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 mins
  • Brazil's AI MedTech Gold Rush: ANVISA's Hidden Rules | Pure Global Insights

    Brazil's AI MedTech Gold Rush: ANVISA's Hidden Rules | Pure Global Insights
    Jan 11 2026
    This week, we dissect the groundbreaking news from Brazil's ANVISA: a new fast-track approval pathway for AI-powered medical devices. This move promises to slash approval times and revolutionize the digital health landscape, but the opportunities are wrapped in complex new challenges. We go beyond the headlines to explore the intricate new requirements for clinical data, cybersecurity, and local data privacy laws that could derail even the most prepared global companies. Discover why this "shortcut" might be a longer road than expected without the right local strategy. A specific case: A successful European AI diagnostic tool, fully approved in the EU, gets rejected by ANVISA's new fast-track system. The fatal flaw? Its clinical data wasn't validated on Brazil's diverse population demographics, making it unusable in the local context. This is the exact pitfall we help you avoid. Key Takeaways This Episode: - What are the three specific types of AI software ANVISA is prioritizing? - Why might the 90-day approval promise be misleading for foreign manufacturers? - How does Brazil's LGPD data privacy law create new compliance traps in the fast-track application? - What's the number one mistake companies make when submitting clinical data for the Brazilian market? - How can you prove your algorithm is free from demographic bias for ANVISA's review? - Which specific cybersecurity protocols are now mandatory for the fast-track application? - Is it now easier or harder for startups to compete with established players under this new system? Navigating the complexities of market access in Latin America requires localized expertise and a strategic partner. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using local experts and advanced AI to streamline your path to market. To tackle challenges like ANVISA's new regulations and accelerate your entry into Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 mins
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