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LATAM MedTech Insights

LATAM MedTech Insights

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 2025 Ran Chen
Episodes
  • LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

    LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market
    Aug 26 2025
    Many MedTech innovators see their FDA approval or CE mark as a golden ticket to Latin America, often targeting Chile first due to its reputation as an accessible market. However, the ground rules are changing fast. What was once a largely voluntary system is now shifting to a mandatory registration framework for all medical devices, creating new hurdles for unprepared companies. This episode of LATAM MedTech Insights dives into the reality of entering the Chilean market today. We uncover why your existing certifications are not a direct passport for sales but are the critical foundation for a successful regulatory submission to Chile's health authority, the ISP. What you'll learn in this episode: - Why was Chile historically considered an "easy" market in LATAM, and why is this no longer true? - Is registration with the ISP now mandatory for all medical devices? - Can I sell my device directly in Chile if it has FDA 510(k) clearance? - What is the role of a Certificate of Free Sale (CFS) in the Chilean registration process? - How does the ISP review technical dossiers based on CE marking or FDA approval? - What are the biggest mistakes companies make when entering the Chilean MedTech market? - Do I need a local legal representative or registration holder in Chile? - How long does the registration process typically take for a device with prior CE/FDA approval? Navigating the nuances of market access in Chile and across Latin America requires local expertise and a strategic approach. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, acting as your local representative and using advanced AI tools to streamline global market access. Let us help you turn your existing approvals into successful registrations. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 mins
  • Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights

    Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights
    Aug 25 2025
    In this episode of LATAM MedTech Insights, we explore the non-negotiable Spanish labeling requirements for medical devices in Colombia. We delve into INVIMA's regulations under Decree 4725 and explain why simply having FDA or CE approval isn't enough to guarantee a smooth market entry. We’ll walk through a real-world case study of a US company whose launch was delayed by six months due to overlooked translation of their device's software and manual. This costly mistake highlights the critical importance of a localized approach and the severe commercial impact of non-compliance. Learn what "labeling" truly covers and how to avoid common pitfalls. Key Questions Answered in This Episode: - What specific Colombian decree mandates Spanish for medical device labels? - Does "labeling" include just the box, or also the software and user manual? - Can I use a simple sticker with Spanish translation over my original English label? - What are the real business costs of getting the language requirement wrong in Colombia? - Why is a direct machine translation of my IFU a high-risk strategy? - How early in my product development should I plan for multi-language labeling? - What's the best practice for designing packaging for both US and Colombian markets? At Pure Global, we specialize in navigating these complex regulatory landscapes. We provide end-to-end solutions, from local representation to AI-powered technical dossier preparation, ensuring your MedTech and IVD products meet all local requirements in over 30 countries. Don't let language be a barrier to your success. Contact us for a consultation at info@pureglobal.com or visit https://pureglobal.com/.
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    4 mins
  • Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

    Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.
    Aug 24 2025
    In this episode of LATAM MedTech Insights, we dive into one of the most critical and often misunderstood aspects of entering the Argentine medical device market: the role of the local registration holder. While ANMAT's requirement for a local representative seems straightforward, the legal implications of who you choose can have massive consequences for your business. We explore why appointing your commercial distributor as your registration holder can be a high-risk strategy. This episode uncovers how this common practice can lead to a complete loss of market access, forcing companies to restart the costly and time-consuming registration process from zero. We detail the strategic advantages of separating your regulatory representation from your commercial partnerships to ensure business continuity and protect your investment. **What You'll Learn:** - Why is ANMAT's requirement for a local registration holder more than just an administrative step? - What are the hidden risks of appointing your distributor as your registration holder in Argentina? - Who legally owns your medical device registration in Argentina, and why does it matter? - If you split with your local partner, what happens to your hard-won market approval? - How can an independent representative provide business continuity and control over your assets? - Is this registration ownership model unique to Argentina, or is it a common theme in LATAM? - What key criteria should you use when selecting a local registration holder in Argentina? At Pure Global, we specialize in providing independent, expert local representation to safeguard your market access. We act as your registration holder across Latin America, ensuring you maintain full control over your assets while having the flexibility to build the best commercial strategy. Ready to secure and streamline your entry into Argentina? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.
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    10 mins
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