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PODCAST

ASEAN MedTech Insights

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.

science life sciences

All Episodes

01:42

Pure Global: Malaysia-Thailand's MedTech Fast-Track,...

ASEAN MedTech Insights ·

2026/01/11

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 region, creating a new "fast-track" lane for market access. We explore what this "regulatory sandbox" means for the future of ASEAN MedTech integration.Imagine launching your new Class C diagnostic device in Southeast Asia. Previously, you faced two

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01:54

Pure Global Insights: Malaysia's Class A Fee Shock &...

ASEAN MedTech Insights ·

2026/01/09

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 reshaping the market entry strategy for countless MedTech firms.We explore the real-world impact of this change beyond the numbers. This is not just a fee increase; it's a signal of Malaysia's maturing regulatory landscape. We discuss the strategic

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01:58

Indonesia's New MedTech Portal: Pure Global on...

ASEAN MedTech Insights ·

2026/01/08

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 and unforeseen administrative traps that are catching foreign manufacturers off guard.This episode reveals the hidden challenges of the new system. We share a case study of a European IVD firm whose straightforward, CE-marked product application became

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01:51

Kuala Lumpur's AI MedTech Code: Pure Global on...

ASEAN MedTech Insights ·

2026/01/07

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 innovators targeting one of ASEAN's key markets.This episode of ASEAN MedTech Insights delves into the specifics of these new regulations. We analyze what the increased demands for data and security mean for product development, registration timelines, and

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01:55

Kuala Lumpur's AI MedTech Gambit: Inside Malaysia's...

ASEAN MedTech Insights ·

2026/01/06

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 a minor policy update; it's a fundamental shift in how digital health products are approved and monitored. We explore the new risk-based classification system, the complex requirements for managing adaptive algorithms, and the stringent new rules on

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02:01

Pure Global: Malaysia's MedTech Crackdown - New...

ASEAN MedTech Insights ·

2026/01/03

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 of ASEAN MedTech Insights breaks down exactly what these changes mean for manufacturers and why your current marketing and quality assurance strategies might now be non-compliant.We dive deep into the expanded definition of "advertising," which now

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01:55

Pure Global: Singapore's AI MedTech Rules & The...

ASEAN MedTech Insights ·

2026/01/02

In the final days of 2025, Singapore's Health Sciences Authority (HSA) launched a new regulatory framework for AI-powered medical devices, introducing the concept of a "Living Dossier." This move signals a major shift from one-time approvals to continuous lifecycle management, creating significant new compliance challenges for MedTech companies targeting the ASEAN market. This episode unpacks what these new post-market surveillance and algorithm change management rules mean for the industry. We

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01:50

Pure Global: Malaysia-Thailand's MedTech Secret...

ASEAN MedTech Insights ·

2025/12/21

This week, we dive into the landmark announcement of a pilot regulatory reliance program between Malaysia and Thailand. This move could signal the beginning of a new era for MedTech market access in Southeast Asia, but the opportunity comes with hidden complexities. We break down what this "secret handshake" between the two regulators means on the ground for your business.Imagine your company just spent a year and significant resources getting your innovative device approved in Malaysia. You hear

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01:52

Malaysia's MedTech Fast-Track: Pure Global on the...

ASEAN MedTech Insights ·

2025/12/20

Malaysia just opened a new fast-track for medical device registration, but what's the catch? In this episode of ASEAN MedTech Insights, we dissect last week's announcement from the Medical Device Authority (MDA) and reveal the hidden shift in regulatory focus. While market access is becoming faster, the demands for post-market surveillance have intensified, creating a potential trap for unprepared companies. We explore why this move, designed to attract innovation, is also a high-stakes gamble. We

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01:49

Pure Global: Bangkok's AI MedTech Rules - The New...

ASEAN MedTech Insights ·

2025/12/19

This week on ASEAN MedTech Insights, we dissect the groundbreaking new guidelines for AI-powered software released by Thailand's FDA. This is not a minor update; it's a fundamental shift that redefines the rules for market entry, creating complex new hurdles for digital health innovators targeting one of Southeast Asia's most important markets.Imagine a health-tech company poised to launch its revolutionary AI diagnostic app in Thailand. They've spent a year preparing their submission. Suddenly,

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01:47

Pure Global: Jakarta's MedTech Registration & The...

ASEAN MedTech Insights ·

2025/12/18

This week on ASEAN MedTech Insights, we dissect the sudden and impactful expansion of Indonesia's local content requirements (TKDN) for medical devices. The government's unexpected decision to mandate 40% local sourcing for new categories of diagnostic imaging equipment has left many foreign manufacturers in a state of regulatory paralysis, forcing an immediate rethink of their market access strategies.We explore the ripple effects of this policy, which goes beyond simple assembly to include local

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02:09

Singapore AI MedTech: Pure Global on Cracking the...

ASEAN MedTech Insights ·

2025/12/17

Singapore is a leader in the ASEAN MedTech landscape, especially in adopting AI for healthcare. However, the Health Sciences Authority (HSA) has introduced sophisticated new guidelines for AI-powered medical devices that focus on the entire product lifecycle. This creates significant new challenges for manufacturers, who must now plan for continuous validation and post-market changes to their algorithms.In this episode, we explore a critical pain point through a case study of an AI diagnostics

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01:50

Pure Global: Singapore & Malaysia's AI MedTech...

ASEAN MedTech Insights ·

2025/12/16

This week, we dissect the groundbreaking joint "AI-Enabled Device Fast-Track Program" launched by Singapore and Malaysia. This new regulatory pathway promises to slash market approval times for AI medical software but introduces complex and continuous post-market compliance obligations that could catch many companies off guard.We explore the strategic implications for MedTech innovators, covering both the immense opportunity for rapid dual-market access and the hidden operational burdens of the

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01:51

Pure Global: Kuala Lumpur's RegTech Game - Beyond the...

ASEAN MedTech Insights ·

2025/12/15

This week, we go beyond the conference brochures and flashy booths of the International Medical Device Exhibition & Conference (IMDEC) in Kuala Lumpur. We dissect the real conversations and policy shifts that are redefining MedTech market access in Malaysia and setting the tone for the entire ASEAN region. We uncover how AI is moving from a buzzword to a core component of the Medical Device Authority's (MDA) strategy. For MedTech manufacturers, this means the rules are changing. A European company

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02:06

Kuala Lumpur's AI Approval Paradox: Pure Global on...

ASEAN MedTech Insights ·

2025/12/14

This week on ASEAN MedTech Insights, we delve into a groundbreaking development from Malaysia. The Medical Device Authority has just launched a new fast-track approval pathway for AI-driven diagnostic software, promising to slash review times and position the nation as a top destination for digital health innovation.But this speed comes with a significant catch. The new framework imposes some of the most stringent post-market surveillance and data localization requirements in the entire ASEAN

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02:20

Malaysia's SaMD Fast-Track: Pure Global on ASEAN's...

ASEAN MedTech Insights ·

2025/12/13

Malaysia's Medical Device Authority (MDA) has just unveiled a simplified regulatory framework for Software as a Medical Device (SaMD). This strategic shift is poised to slash market-entry timelines and costs, turning Malaysia into a magnet for digital health innovation across the ASEAN region. In this episode, we dissect the MDA's announcement from IMDEC 2024. We explore what this streamlined, risk-based approach means for MedTech developers, how it dismantles long-standing regulatory barriers, and

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01:51

Pure Global: Jakarta's MedTech Blackout - Navigating...

ASEAN MedTech Insights ·

2025/12/12

In this episode, we unpack an urgent regulatory update from Indonesia. The Ministry of Health has announced a temporary but total shutdown of its medical device online registration systems scheduled for mid-December 2025 to early January 2026. This freeze will halt all new applications, renewals, and payment processing, creating a significant challenge for MedTech companies. We explore the direct consequences of this system blackout. This isn't just an administrative delay; it's a critical threat

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02:21

Pure Global | Malaysia's AI MedTech: Inside the...

ASEAN MedTech Insights ·

2025/12/11

Malaysia's Medical Device Authority (MDA) has launched its first regulatory sandbox, a pivotal move for AI-driven medical devices in the ASEAN region. This controlled environment allows innovators to test and validate "Software as a Medical Device" (SaMD) in collaboration with regulators, balancing accelerated innovation with stringent patient safety. This initiative directly addresses a critical industry pain point: the struggle for AI MedTech startups to gain approval for adaptive algorithms

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02:18

Pure Global: Navigating Malaysia's Deadline Maze &...

ASEAN MedTech Insights ·

2025/12/10

The ASEAN MedTech landscape is in constant motion. This week, we dissect two major regulatory shifts that could make or break your market access strategy. Malaysia's Medical Device Authority has unexpectedly extended the deadline for its mandatory import licenses, offering a lifeline to hundreds of companies. What does this "grace period" truly mean for your supply chain, and what are the hidden risks of delaying compliance? Simultaneously, the Philippines has overhauled its Compassionate Special

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02:03

Kuala Lumpur's MedTech Fee Hike & Jakarta's Freeze: A...

ASEAN MedTech Insights ·

2025/12/09

As 2025 wraps up, MedTech companies face a critical wave of last-minute regulatory shifts in Southeast Asia. This episode of ASEAN MedTech Insights dives into urgent updates from Malaysia and Indonesia that could make or break your market access strategy for the new year. We uncover Malaysia's double-edged sword: a welcome extension on import permit enforcement, but a painful five-fold increase in Class A device registration fees. We also sound the alarm on Indonesia's month-long shutdown of its

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