
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 AS... more
| Publishes | Daily | Episodes | 104 | Founded | 5 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | TechnologyLife SciencesScience | |||

In this episode, we dissect the breaking news from Malaysia as its Medical Device Authority begins full enforcement of a new, stricter device classification system. This move is sending ripples through the industry, catching many foreign manufacturer... more
This week, we dive into the landmark regulatory reliance pilot program launched between Malaysia and Thailand. This new initiative creates a fast-track market access route for medical devices, allowing manufacturers to use one country's approval to a... more
This week, we dissect the groundbreaking announcement from Singapore and Malaysia that is sending shockwaves through the ASEAN MedTech scene. Regulators have fast-tracked a new, stringent framework for AI and digital health devices, creating an urgen... more
This week, we dissect the surprise regulatory shake-up in Malaysia's MedTech scene. The Medical Device Authority (MDA) just dropped new, stricter draft guidance for AI-driven diagnostic software, catching many companies off guard. This isn't a minor ... more
Malaysia just dropped a bombshell on the MedTech world. A brand-new regulatory framework for AI-powered medical devices has been rolled out, effectively changing the rules of market entry overnight. This episode breaks down exactly what the Malaysian... more
This week on ASEAN MedTech Insights, we're diving into the urgent regulatory crisis hitting the in-vitro diagnostics sector in Vietnam. A new government decree, now in full force, is causing major disruptions for foreign manufacturers who were once c... more
Last week, Singapore's Health Sciences Authority (HSA) issued a critical update to its guidance for Software as a Medical Device (SaMD), with major implications for AI and machine learning technologies. This change subtly but significantly redefines ... more
This episode unpacks the groundbreaking new regulatory reliance pilot program announced by Malaysia and Thailand. We explore how this collaboration creates an accelerated market access pathway for medical device manufacturers, allowing them to levera... more
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #199 |







Listeners, social reach, demographics and more for this podcast.
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Focusing on the rapidly evolving medical technology sector in Southeast Asia, the content centers on regulatory challenges, innovation, and market entry strategies across the region's diverse landscapes. Episodes cover a wide range of topics, from regulatory insights and evolving healthcare technologies to strategies for entering specific national markets within ASEAN. Key themes include artificial intelligence in healthcare, software as a medical device (SaMD), and the complexities of obtaining approvals from local regulatory authorities. With insights from experts and industry leaders, this podcast provides valuable knowledge for professionals looking to navigate the MedTech ecosystem in ASEAN countries.
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ASEAN MedTech Insights launched 5 months ago and published 104 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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Recent guests on ASEAN MedTech Insights include:
1. Pure Global
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