ASEAN MedTech Insights copertina

ASEAN MedTech Insights

ASEAN MedTech Insights

Di: Ran Chen
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A proposito di questo titolo

 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 2026 Ran Chen Economia Scienza Scienze biologiche
Episodi
  • Pure Global: Malaysia & Thailand's MedTech Shortcut - A New Regulatory Reliance Shake-Up.

    Pure Global: Malaysia & Thailand's MedTech Shortcut - A New Regulatory Reliance Shake-Up.
    Jan 22 2026
    This week, we unpack the major regulatory announcement from Malaysia and Thailand that's set to reshape market access in ASEAN. The MDA and Thai FDA have launched a pilot program for regulatory reliance, creating a new, faster pathway for Class B, C, and D medical devices. This move promises to slash approval times and costs for manufacturers. We explore what this "sandbox" for ASEAN collaboration means for your business. Imagine you are launching a new cardiovascular device. Instead of two lengthy, independent reviews, you can now leverage your approval in one country to accelerate registration in the other. But this opportunity comes with strategic questions: which market should you prioritize for the initial review, and how do you prepare a submission that satisfies both regulators from the outset? Key Takeaways: - What specific device classes are included in the new Malaysia-Thailand regulatory reliance pilot? - How does this program change the traditional market entry strategy for MedTech companies in ASEAN? - Could this pilot program be the first step towards a unified ASEAN-wide approval system? - What are the potential risks or hidden complexities companies should watch out for? - How does this initiative affect local Malaysian and Thai manufacturers compared to international ones? - What documentation from the first approval is required to qualify for the fast-track process in the second country? - Are there lessons to be learned from similar reliance programs in other regions, like Europe? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. We act as your local representative in over 30 markets, developing efficient pathways for regulatory approval. For help navigating the new ASEAN regulatory landscape, contact Pure Global at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Pure Global: Singapore's AI MedTech Rush - Cracking the HSA's New Fast-Track Code.

    Pure Global: Singapore's AI MedTech Rush - Cracking the HSA's New Fast-Track Code.
    Jan 21 2026
    Singapore's Health Sciences Authority (HSA) has just launched the AI-Med Fast-Track program, a game-changing initiative for the approval of AI-powered medical devices. This move drastically cuts down approval timelines, positioning Singapore as a dominant force in the ASEAN digital health sector and creating new, urgent challenges and opportunities for MedTech companies globally. This episode delves into the specific requirements of this new accelerated pathway. We analyze the critical demands for data transparency, algorithm validation, and the emphasis on localized clinical data. We explore how this impacts product launch strategies, investment, and regional competition, forcing companies to rethink their entire ASEAN market access plan. Key Takeaways: - How will Singapore's new AI fast-track approval process impact MedTech investment in the rest of ASEAN? - What specific data privacy and algorithm validation standards must companies now meet to qualify? - Is this new pathway a real advantage or a regulatory trap with hidden documentation complexities? - How can foreign companies leverage this Singaporean approval for faster entry into neighboring markets? - What are the biggest mistakes a company can make when submitting an application under these new guidelines? - Does this signal a major shift from traditional hardware towards software as a medical device in the region? - How should startups adjust their fundraising and product development timelines in response to this change? Navigating these rapid regulatory changes requires specialized expertise. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Get your strategy right from the start. Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a consultation.
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    2 min
  • Pure Global: The Malaysia-Thailand MedTech Reliance Pilot's Hidden Traps

    Pure Global: The Malaysia-Thailand MedTech Reliance Pilot's Hidden Traps
    Jan 20 2026
    This week, we dissect the newly announced Malaysia-Thailand Medical Device Regulatory Reliance Pilot. Set to launch in February 2026, this program promises to fast-track market access, but the reality is far more complex than the headlines suggest. We go beyond the official announcements to reveal the hidden requirements and potential pitfalls that could derail your MedTech product launch. Imagine your company, with a fully approved device in Malaysia, eagerly applies for the Thai reliance program, only to be hit with a three-month delay. The reason? A subtle difference in risk management documentation that was never an issue before. This is the exact kind of costly mistake that many will make. We explain how to avoid it. What you'll learn in this episode: - Is your medical device's risk class even eligible for this pilot program? - Why might your complete Malaysian technical dossier be rejected by Thai regulators? - What are the most common documentation gaps between the two authorities? - How does the pilot's timeline *really* compare to a standard submission? - What is the unspoken rule about local agent communication that could make or break your application? - Could this "fast-track" program actually become a strategic bottleneck for your ASEAN expansion? - Which specific clauses in Thailand's regulations must be addressed even in a reliance submission? Navigating the nuances of ASEAN's evolving regulatory landscape is critical for success. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and AI-powered data tools to streamline global market access. Let us help you turn regulatory complexity into a competitive advantage. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
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