『ASEAN MedTech Insights』のカバーアート

ASEAN MedTech Insights

ASEAN MedTech Insights

著者： Ran Chen
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 Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world's fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.Copyright 2025 Ran Chen
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  • Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy

    Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy
    2025/08/28
    This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification under the ASEAN Medical Device Directive and how it dictates your regulatory pathway, whether it's a simple notification for Class A devices or a full registration for Classes B, C, and D. We uncover the real-world timelines that often extend beyond official government estimates and break down the full cost structure, which includes not only FDA fees but also mandatory local representative fees and potential dossier preparation costs. This episode is essential for any MedTech company looking to enter one of Southeast Asia's most promising markets with a clear and realistic strategy. A common pain point we see is a company with a new Class C device budgeting only for the official FDA application fee, expecting a nine-month approval. They are then caught off guard by thousands of dollars in mandatory local representative fees and a timeline that stretches to over a year due to multiple rounds of technical questions from the regulator, derailing their entire regional launch plan. Key Takeaways: 1. Why is the risk classification of my device the most critical first step for registering in the Philippines? 2. What is the ASEAN Common Submission Dossier Template (CSDT) and why might my existing technical file be insufficient? 3. How do official timelines from the Philippine FDA differ from the real-world time it takes to get approval? 4. What are the "hidden" costs of registration, such as local representative fees, that go beyond government charges? 5. How can a single round of questions from the regulator add months, not weeks, to my product launch? 6. Is the "simple" notification pathway for Class A devices truly fast and straightforward? 7. Why is choosing the right local partner or importer one of the most important strategic decisions you will make? 8. What post-market responsibilities must I be prepared for even before I submit my application? Don't let regulatory hurdles block your access to the vibrant Philippine market. At Pure Global, we offer end-to-end regulatory consulting, combining deep local expertise with advanced AI tools to streamline your global market access. We act as your local representative, manage your technical dossier, and provide a clear strategy for success. Ready to expand into the ASEAN region with confidence? Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    3 分
  • MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia

    MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia
    2025/08/27
    This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk classification system. We break down the four-tier framework—from low-risk Class A to high-risk Class D—that governs how devices are regulated across all 10 member states. Understanding this system is non-negotiable for any manufacturer looking to tap into this dynamic and growing market. We go beyond the basics to explore the critical nuances that determine a device's classification. You'll learn why a product's 'intended use' can be more important than its physical design and how this impacts your entire regulatory strategy. We provide clear, real-world examples for each class, giving you the practical insights needed to position your product correctly from day one. Consider this: Your company has developed a groundbreaking Software as a Medical Device (SaMD) for remote patient monitoring. You see huge potential in the rapidly digitizing healthcare systems of Vietnam and the Philippines. However, you're struggling to classify it. Is it a low-risk Class B wellness app or a high-risk Class C diagnostic tool? A mistake here could lead to submission rejection, months of delays, and significant financial loss, putting your entire market entry plan at risk. 本期干货 1. Why is the AMDD considered a revolutionary step for MedTech access in Southeast Asia? 2. What is the single most important factor that determines your device's risk class? 3. How can two physically similar devices end up in completely different risk classes (B vs. C)? 4. What are some surprising examples of devices that fall into the highest-risk Class D category? 5. Why isn't a simple thermometer always considered a low-risk Class A device? 6. How does the principle of "intended use" create major regulatory hurdles in markets like Malaysia or Thailand? 7. What are the critical first steps to ensure your device classification is accurate *before* you prepare your technical dossier? 8. Which common devices, like blood bags or ventilators, fall into the Class C category and why? Navigating the diverse regulatory landscapes of ASEAN requires more than just knowledge—it demands local expertise. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining on-the-ground experts in over 30 markets with advanced AI tools to streamline your global market access. From initial regulatory strategy and technical dossier submissions to acting as your local representative, we make complex markets simple. Stop guessing and start scaling. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to accelerate your journey into the ASEAN market.
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    4 分
  • Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.

    Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.
    2025/08/26
    This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's strict and specific labeling and language regulations. We demystify the requirements under key decrees like Decree 98/2021/ND-CP, providing a clear path to compliance for foreign manufacturers. We break down the practical solutions that successful companies use, focusing on the accepted practice of supplementary labeling. Learn what mandatory information must be translated into Vietnamese and how to manage the critical Instructions for Use (IFU) to avoid your products being held at customs. This is a must-listen for any regulatory affairs professional, exporter, or business leader looking to succeed in the vibrant Vietnamese market. A specific case: Imagine this. Your state-of-the-art medical device, fully compliant in Europe and the US, is stuck at a Vietnamese port. The shipment is delayed, storage costs are mounting, and your local partner is frustrated. The reason is a simple missing Vietnamese-language sticker and a non-translated user manual. This common, costly scenario is entirely avoidable, and we explain how. What you'll learn in this episode: 1. What is the single mandatory language for all medical device labels in Vietnam? 2. Can I use a sticker on my original packaging to meet local requirements, and what are the rules? 3. What specific information must be included on a compliant Vietnamese label? 4. Are English Instructions for Use (IFU) ever acceptable, or must they always be translated? 5. What is the most common labeling mistake that causes customs delays for MedTech companies in Vietnam? 6. How does Decree 98/2021/ND-CP fundamentally change the labeling strategy for market entry? 7. Who is legally responsible for ensuring the label is correct before the product reaches the end-user? 8. Are there any exceptions for electronic or online user manuals? 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 act as your local representative to ensure your market entry is smooth, compliant, and successful. To avoid common pitfalls and accelerate your growth in Vietnam and beyond, contact our experts at info@pureglobal.com or visit us at https://pureglobal.com/.
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    3 分
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