Ran Chen

ASEAN MedTech Insights

Life Sciences Technology Business English

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.

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10 February 2026

Singapore-Malaysia MedTech Corridor: Unpacking the New Regulatory Shortcut with Pure Global.

This week, we dive into the groundbreaking new regulatory pilot program launched between Singapore and Malaysia. This collaboration promises a faster, streamlined approval process for medical devices, creating a powerful new corridor for market access in ASEAN. But what looks like a simple shortcut is filled with critical details that can make or break your entry strategy.Imagine your company,...

08 February 2026

Pure Global: Malaysia & Thailand's New Fast-Track--A Unified Market or a Hidden Trap?

This week, we dive into a major regulatory shift that just launched in ASEAN. On February 1st, Malaysia and Thailand kicked off a groundbreaking pilot program for medical device regulatory reliance. This collaboration promises to slash market-entry timelines and could be the first critical step towards a more unified and accessible market in Southeast Asia.However, this expedited pathway is not...

07 February 2026

Pure Global: Singapore's New AI Sandbox - The MedTech Fast-Track or a Hidden Trap?

Singapore's Health Sciences Authority (HSA) has just unveiled a new "Regulatory Sandbox" for AI-powered medical software. This program promises a faster route to market for innovators but comes with a new set of complex compliance and data monitoring requirements that are catching many companies off guard. It represents both a massive opportunity and a potential minefield.This shift directly...

06 February 2026

Pure Global: Malaysia's MedTech Gambit - The Race Against ASEAN Harmonization.

Last week, Malaysia’s Medical Device Authority (MDA) unveiled a game-changing fast-track registration pathway for breakthrough medical technologies. This aggressive move aims to attract global innovators and position Malaysia as ASEAN’s top MedTech hub.This episode of ASEAN MedTech Insights unpacks what this new regulation means on the ground. We explore how this challenges the long-standing goal...

05 February 2026

Pure Global: Malaysia-Thailand MedTech's New Fastlane—A Hidden Shortcut?

In this episode, we dissect the groundbreaking regulatory reliance pilot program launched by Malaysia's MDA and Thailand's FDA. This initiative creates a new, streamlined path for Class B, C, and D medical devices, promising to significantly cut down registration timelines and costs for manufacturers targeting these key ASEAN markets.This program offers a massive opportunity, but it's not a...

03 February 2026

Pure Global: Malaysia's MedTech Compliance Shockwave - Navigating New Registration Hurdles

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 manufacturers off guard and demanding immediate action to maintain market access. We explore what has changed, which devices are most affected, and the concrete...

02 February 2026

Pure Global: Malaysia-Thailand's MedTech Fast Track - Unlocking The New Reliance Loophole.

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 accelerate registration in the other. It's a potential game-changer for the region, but the clock is ticking on this limited-time opportunity.We...

01 February 2026