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MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia
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 [email protected] or visit https://pureglobal.com/ to accelerate your journey into the ASEAN market.
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By Ran ChenThis 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 [email protected] or visit https://pureglobal.com/ to accelerate your journey into the ASEAN market.