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ASEAN MedTech Insights

ASEAN MedTech Insights

Auteur(s): Ran Chen
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À propos de cet audio

 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 Science Sciences biologiques Économie
Épisodes
  • Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights

    Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights
    Oct 21 2025
    Getting a high-risk, Class III medical device to market is a major hurdle. While securing FDA approval is a huge milestone, many companies assume this translates to easy access in key ASEAN markets like Singapore. In this episode, we explore the reality of this process. We break down Singapore's Health Sciences Authority (HSA) abridged evaluation route for devices with prior FDA approval. Discover how this pathway can accelerate your market entry, but also learn about the critical nuances and local requirements that are often overlooked. Case In Point: We examine the case of a US company with an FDA-approved cardiovascular stent. They expected a quick registration in Singapore but hit unexpected roadblocks. Learn how they navigated the requirement for a local registrant and addressed specific HSA queries, ultimately cutting their registration time in half compared to a full evaluation. In This Episode, You'll Learn: - Why is Singapore a top-tier entry point for MedTech in ASEAN? - How does the HSA view prior approval from the US FDA? - What exactly is an "abridged evaluation," and how does it differ from a full review for a Class III device? - Is FDA approval a guarantee for faster registration in Singapore? - What are the common pitfalls companies face even with a strong US dossier? - Why is a local Singapore Registrant essential for your application? - What kind of questions can you expect from the HSA during the review? Navigating global regulations requires local expertise and a strategic approach. At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, using local experts and advanced AI to streamline your global market access. Don't let regulatory hurdles slow your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.
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    2 min
  • Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval

    Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval
    Oct 19 2025
    This episode of ASEAN MedTech Insights delves into a powerful strategy for navigating the complex regulatory landscape of Southeast Asia. We uncover how MedTech companies can strategically leverage Singapore's Health Sciences Authority (HSA) approval to significantly accelerate market entry into other key ASEAN nations. Discover how a single, robust regulatory approval can act as a key to unlock multiple markets, saving you invaluable time and resources. We will explore a common scenario: a company with an innovative device ready for Asia faces the daunting prospect of separate, lengthy registration processes in Malaysia, the Philippines, and Thailand. This fragmented approach often leads to years of delays and spiraling costs, draining momentum and capital before the first product is even sold. This episode provides a direct solution to this critical pain point. Key Questions Answered in This Episode: * Why is Singapore's HSA considered a "gold standard" reference agency in the ASEAN region? * Which specific ASEAN countries offer expedited registration for devices with HSA approval? * How can leveraging HSA approval cut your market entry timeline in Malaysia by months? * What is the Common Submission Dossier Template (CSDT) and how can you repurpose it for multiple ASEAN markets? * What are the documentation pitfalls to avoid when using this abridged pathway strategy? * How does this strategy apply differently to Class B versus higher-risk Class C and D devices? * What are the specific advantages for companies that already have a CE mark or FDA clearance? At Pure Global, we specialize in creating and executing these efficient, multi-market regulatory strategies. Our local experts and advanced AI tools streamline the entire process, from initial HSA submission to post-market surveillance across the ASEAN region. To transform your market access plan, contact our experts at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 min
  • ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts

    ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts
    Oct 18 2025
    In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: device classification and grouping. A misstep here can lead to costly delays and outright rejections from the Health Sciences Authority (HSA). We explore how ASEAN innovators can navigate this complex landscape. We break down the four-tier risk classification system and reveal how a strategic approach to device grouping can save you hundreds of thousands of dollars and slash your time-to-market, turning a regulatory burden into a competitive edge. Consider this scenario: A Malaysian IVD company wants to launch a family of five diabetes test kits. Are they facing five separate, costly registration processes? We explore how they navigated this exact challenge, avoiding months of delays and a massively inflated budget by leveraging expert grouping advisory. Key Takeaways from this episode: * Why is Singapore's four-tier risk classification system more nuanced than it appears? * What common mistake in device classification can lead to a complete rejection of your HSA submission? * How can you legally bundle multiple medical devices into a single, cost-effective application? * What are the three essential criteria for successful device grouping in Singapore? * How does a product's intended use dramatically impact its classification and potential for grouping? * When should you seek local expert advisory before even starting your technical dossier? * What are the unwritten rules of the HSA that you won't find in the official guidelines? Tired of regulatory guesswork? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging local expertise and advanced AI to streamline market access in Singapore and over 30 markets worldwide. Whether it's developing a bulletproof registration strategy or acting as your official local representative, we clear the path for your innovation. Contact our experts today at info@pureglobal.com or learn more at https://pureglobal.com/.
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    2 min
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