ASEAN MedTech Insights by Pure Global: Navigating Clinical Trial Requirements for Medical Devices in Indonesia, Thailand, and Vietnam

This episode of ASEAN MedTech Insights tackles a crucial question for global manufacturers: Are local clinical trials required to register your medical device in Southeast Asia? We move beyond the general guidelines of the ASEAN Medical Device Directive (AMDD) to uncover the complex and varied requirements of individual member states. We explore why your CE marking or FDA approval might not be enough, especially in key markets like Indonesia, Thailand, and Vietnam. Learn about the specific scenarios where regulators are likely to request local patient data for high-risk and novel devices, and how to prepare a regulatory strategy that anticipates these challenges and minimizes delays. **Case Study:** Imagine your company has a revolutionary Class C cardiovascular stent with full CE marking. You submit your dossier in Indonesia, a key growth market, expecting a straightforward registration. Months later, the regulator returns with a major deficiency, requesting a local bridging study to validate the stent's performance in Indonesian patients. This unexpected demand could delay your market entry by over a year and add hundreds of thousands of dollars in costs. We discuss why this happens and the strategic documentation needed to prevent it. **Key Takeaways:** 1. Why is the ASEAN Medical Device Directive (AMDD) only a starting point for your clinical strategy? 2. Which ASEAN country is most likely to demand local clinical data for high-risk devices? 3. How can approval from a specific "reference country" help you bypass trial requirements in Thailand? 4. What specific arguments do regulators in Vietnam use to question foreign clinical data? 5. Is your Clinical Evaluation Report (CER) properly structured to address the nuances of ASEAN populations? 6. What are "bridging studies," and what are the common triggers for regulators to request them? 7. How do requirements for a Class B device differ between Malaysia and Indonesia? 8. For a novel device, what proactive steps can you take to avoid a clinical trial request? At Pure Global, we provide end-to-end regulatory consulting to help MedTech innovators navigate these complex market access challenges. Our blend of local expertise in over 30 markets, including all key ASEAN countries, and advanced AI tools allows us to build efficient, technology-driven strategies for your device registration and post-market compliance. Don't let regulatory hurdles block your expansion. Contact us for a consultation at [email protected] or visit us at https://pureglobal.com/.

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