『LATAM MedTech Insights』のカバーアート

LATAM MedTech Insights

LATAM MedTech Insights

著者： 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
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  • 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.
    2025/08/24
    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 分
  • Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia

    Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia
    2025/08/23
    In this episode of LATAM MedTech Insights, we demystify the complex web of medical device classification rules across Latin America's key markets. While most countries use a risk-based system, the specific requirements of agencies like Brazil's ANVISA, Mexico's COFEPRIS, and Colombia's INVIMA present unique challenges that can derail market entry for unprepared companies. We explore how seemingly minor details in documentation, translation, and local procedural norms can lead to major delays. This episode provides essential insights for any MedTech company looking to expand into this dynamic but demanding region, moving beyond the regulations to discuss real-world examples and common pitfalls. For example, consider a European MedTech company with a CE-marked Class IIa device. They targeted Colombia, assuming a smooth registration process due to the similar classification system. However, they faced a six-month delay because their technical dossier, while compliant in the EU, lacked specific local declarations and formatting required by INVIMA. This small oversight cost them a critical sales season and highlighted the importance of localized expertise. Key questions answered in this episode: - Why isn't there a single classification system for all of Latin America? - What's the crucial difference between Brazil's `Cadastro` and `Registro` pathways? - How can a reference country approval from the FDA help in Mexico, and what is the most common mistake companies make in the process? - Why does Colombia's EU-like system still catch experienced European manufacturers by surprise? - What are the top three documentation details that lead to registration rejection in these key markets? - How do device grouping or family definitions differ between ANVISA, COFEPRIS, and INVIMA? At Pure Global, we specialize in turning these regulatory challenges into market opportunities. Our combination of local experts in over 30 markets and advanced AI-powered data tools ensures your path to registration is clear and efficient. Don't let regulatory details derail your LATAM expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can accelerate your market access.
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    3 分
  • From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access

    From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access
    2025/08/22
    This episode of LATAM MedTech Insights dives deep into the medical device approval process in Mexico, governed by the regulatory body COFEPRIS. We demystify the requirements, from device classification to the critical role of a local registration holder, providing a clear roadmap for international MedTech companies looking to enter this lucrative market. We explore the strategic pathways that can save you valuable time and resources. Discover how leveraging your existing approvals from bodies like the US FDA or Health Canada can dramatically accelerate your journey to market, transforming a potentially lengthy process into a streamlined and predictable one. A US-based scaleup with a novel Class II device faced this exact scenario. Their initial submission was stalled for over a year due to documentation errors and a lack of a clear strategy, costing them valuable time and market opportunity. This episode reveals how leveraging an often-overlooked equivalency pathway could have cut their approval time in half and avoided costly mistakes. Key Takeaways from this episode: 1. What are the four main risk classifications for medical devices in Mexico? 2. How can you use your existing FDA or Health Canada approval to speed up COFEPRIS registration? 3. What is a Mexican Registration Holder (MRH), and why is choosing the right one critical to your business's future? 4. What common documentation mistakes lead to costly delays with COFEPRIS? 5. How does the new "Abbreviated Pathway" coming in 2025 change the game for manufacturers? 6. Is it better to use your distributor as your MRH, or an independent third party? 7. What are the specific post-market surveillance requirements you must meet in Mexico? At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We act as your local representative in over 30 markets, including Mexico, to get your product approved and maintain compliance. Contact us to learn how we can accelerate your entry into the LATAM market at info@pureglobal.com or visit us at https://pureglobal.com/.
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    4 分
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