『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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  • Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN

    Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN
    2025/08/25
    Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Representative (LAR). This isn't merely an administrative step; it's a strategic decision that defines who controls your product's registration license and, ultimately, your access to one of Southeast Asia's largest markets. This episode of ASEAN MedTech Insights explores the two primary options for an LAR—appointing your distributor versus partnering with an independent third party. We uncover the hidden risks of tying your regulatory license to a commercial partner and explain why an independent representative provides the flexibility and control necessary for long-term success and scalability in the complex Indonesian archipelago. For example, consider a European diagnostics firm that allowed its sole distributor in Indonesia to hold its product licenses. When a disagreement arose over sales performance, the firm decided to switch partners, only to find their licenses were held hostage by the original distributor. This forced them into a costly, two-year re-registration process, effectively locking them out of the market and forfeiting significant revenue. Key Takeaways: * Why is appointing a Local Authorized Representative a mandatory first step for selling medical devices in Indonesia? * What are the hidden risks of allowing your distributor to be your legal license holder? * How does the ownership of the registration license (Izin Edar) impact your ability to change commercial partners? * What happens to your market access if your relationship with a distributor-representative ends poorly? * Why is an independent representative model considered a safer, more flexible strategy for market entry? * How can you build a multi-distributor network in Indonesia without re-registering your product for each one? * What is the strategic difference between regulatory control and commercial strategy in the ASEAN context? At Pure Global, we provide MedTech and IVD companies with end-to-end regulatory solutions, including acting as your independent Local Authorized Representative in Indonesia and over 30 markets worldwide. Our combination of local expertise and advanced AI tools streamlines your global market access. To maintain full control of your assets and build a flexible market strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
  • Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

    Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand
    2025/08/24
    In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thailand? We dive into the specifics of the Thai FDA's expedited pathways, explaining how you can leverage your prior approvals to gain a competitive edge in one of Southeast Asia's most dynamic markets. We explore the "Concise Evaluation Route," detailing which device classes are eligible and what the process actually entails. This is not a simple green light; it's a streamlined review that still demands meticulous preparation. A U.S. diagnostics company learned this the hard way. They assumed their FDA approval was a golden ticket into Thailand, only to face significant delays due to misunderstandings about local license holder requirements and the specific format needed for their technical documentation, costing them an estimated six months in lost revenue and market momentum. Key Takeaways: * What exactly is Thailand's "Concise Evaluation Route" and does my device qualify? * Is my FDA 510(k) or CE mark an automatic passport to the Thai market? * Beyond my approval certificate, what key documents does the Thai FDA still require? * Why is a local Thailand license holder mandatory even with an expedited application? * How can I format my existing technical files to meet the ASEAN CSDT standard? * What are the most common mistakes that lead to delays, even on an expedited pathway? * Are there language requirements for labeling and instructions that I need to know? * How does the expedited process in Thailand compare to other ASEAN countries like Malaysia or Vietnam? Struggling to turn your global approvals into rapid ASEAN market access? Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI to streamline your entry into over 30 global markets. We act as your local representative and ensure your submission is right the first time. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 分
  • Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success

    Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success
    2025/08/23
    This episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device Authority (MDA). We break down the essential steps for foreign manufacturers, from the critical appointment of a local Authorized Representative (AR) to understanding the four-tiered device classification system and the electronic submission process through the MeDC@St portal. We explore the detailed requirements for creating a Common Submission Dossier Template (CSDT) and the mandatory conformity assessments by CABs for higher-risk devices. For instance, a promising US-based scaleup developing a novel diagnostic tool faced significant setbacks. They underestimated the nuances of the MeDC@St system, leading to repeated submission rejections. Their chosen local AR lacked the specific expertise to guide them, delaying their market entry by nearly a year and allowing a competitor to gain a foothold. This highlights how procedural knowledge is as crucial as product innovation. Key Takeaways for This Episode: 1. Why is appointing a Malaysian Authorized Representative the non-negotiable first step for market entry? 2. How does Malaysia's risk-based classification (Class A to D) impact your registration timeline and costs? 3. What are the most common errors foreign manufacturers make when submitting documents via the MeDC@St online portal? 4. When is a review by a Conformity Assessment Body (CAB) required, and how does it differ from other regulatory audits? 5. What specific post-market surveillance activities are mandatory to maintain your device registration in Malaysia? 6. Can your existing CE Mark or FDA approval accelerate the MDA registration process? 7. What are the key legal responsibilities your Authorized Representative holds on your behalf? Pure Global offers end-to-end regulatory consulting to streamline this entire process. We combine local expertise with advanced AI tools to ensure your MedTech and IVD products achieve efficient market access in Malaysia and beyond. To learn how we can act as your local representative and manage your regulatory journey, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
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