
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 | 85 | Founded | 5 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesScienceTechnology | |||

In this episode, we dissect a subtle but powerful regulatory shift in Malaysia that impacts the entire direct-to-consumer MedTech market. Last week, the Medical Device Authority (MDA) tightened its enforcement on the personal use importation exemptio... more
In this episode of ASEAN MedTech Insights, we dissect a game-changing regulatory update from Malaysia. The Medical Device Authority (MDA) has expanded its reliance program, now officially recognizing approvals from Singapore's HSA and Thailand's FDA.... more
This week, we dive into the groundbreaking regulatory reliance program just announced between Malaysia and Thailand. This pilot program, running from February to April 2026, could fundamentally change the way medical devices are registered in the reg... more
In this episode, we dissect the sudden and dramatic regulatory shift in Malaysia that just took effect. As of January 1st, 2026, the Medical Device Authority (MDA) has increased the fees for Class A medical devices by over 1,000%, a move that is resh... more
Indonesia's new 'One-Health' digital portal, launched last week, promised to revolutionize MedTech market access with a streamlined, fast-track approval process. But behind the government's headlines lies a more complicated truth of digital hurdles a... more
In early January 2026, Malaysia's regulators enacted a pivotal shift in the rules for AI-powered medical software. This move introduces a higher bar for clinical evidence and cybersecurity, creating new challenges and opportunities for MedTech innova... more
Malaysia has just launched a mandatory new regulatory framework for all AI-powered medical software, effective January 2026. This week, we dissect what this means for MedTech innovators and manufacturers aiming for the ASEAN market.
This isn't just ... more
In the fast-evolving ASEAN MedTech landscape, Malaysia just raised the compliance stakes. In the last week of 2025, the Medical Device Authority (MDA) released stringent new guidelines for device advertising and post-market surveillance. This episode... more
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #66 |








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 85 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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