Bästa ASEAN podcaster (2026)

1
Pure Global: Malaysia's MedTech Crackdown - New Hidden Compliance Traps 2:01

13h ago2:01

2:01

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 you…

1
Pure Global: Singapore's AI MedTech Rules & The 'Living Dossier' Headache 1:55

1d ago1:55

1:55

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 tar…

1
Pure Global: Malaysia-Thailand's MedTech Secret Handshake & Your New ASEAN Strategy. 1:50

14d ago1:50

1:50

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 …

1
Malaysia's MedTech Fast-Track: Pure Global on the Hidden Regulatory Gamble. 1:52

15d ago1:52

1:52

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 int…

1
Pure Global: Bangkok's AI MedTech Rules - The New Data Traps for Foreign Firms 1:49

16d ago1:49

1:49

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.Imag…

1
Pure Global: Jakarta's MedTech Registration & The Sudden Local Content Trap 1:47

17d ago1:47

1:47

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…

1
Singapore AI MedTech: Pure Global on Cracking the HSA's New Regulatory Code 2:09

18d ago2:09

2:09

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 continuou…

1
Pure Global: Singapore & Malaysia's AI MedTech Regulation - The New Fast-Track Gambit. 1:50

19d ago1:50

1:50

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 strate…

1
Pure Global: Kuala Lumpur's RegTech Game - Beyond the IMDEC Conference Buzz 1:51

20d ago1:51

1:51

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 buzzwor…

1
Kuala Lumpur's AI Approval Paradox: Pure Global on MedTech's New Speed Trap. 2:06

21d ago2:06

2:06

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 sign…

1
Malaysia's SaMD Fast-Track: Pure Global on ASEAN's Newest MedTech Shortcut 2:20

22d ago2:20

2:20

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 …

1
Pure Global: Jakarta's MedTech Blackout - Navigating the December System Shutdown 1:51

23d ago1:51

1:51

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 chall…

1
Pure Global | Malaysia's AI MedTech: Inside the Sandbox De-Risking Future Medical Devices 2:21

24d ago2:21

2:21

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 safe…

1
Pure Global: Navigating Malaysia's Deadline Maze & Philippine's Compassionate Use Secrets 2:18

25d ago2:18

2:18

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 mea…

1
Kuala Lumpur's MedTech Fee Hike & Jakarta's Freeze: A Pure Global Brief 2:03

26d ago2:03

2:03

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…

1
Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights 2:05

2M ago2:05

2:05

Getting a high-risk, Class III medical device to market is a major hurdle. While securing FDA approval is a huge milestone, many companies assume this translates to easy access in key ASEAN markets like Singapore. In this episode, we explore the reality of this process. We break down Singapore's Health Sciences Authority (HSA) abridged evaluation r…

1
ASEAN MedTech Maze: Pure Global's Guide to Device Registration in Singapore, Malaysia and Beyond 1:50

2M ago1:50

1:50

This episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASEAN Common Submission Dossier Template (CSDT) and contrast it with the on-the-ground realities in key markets.We dive into the distinct regulatory pathways of Singapore, known for its efficiency and re…

1
Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval 2:02

3M ago2:02

2:02

This episode of ASEAN MedTech Insights delves into a powerful strategy for navigating the complex regulatory landscape of Southeast Asia. We uncover how MedTech companies can strategically leverage Singapore's Health Sciences Authority (HSA) approval to significantly accelerate market entry into other key ASEAN nations.Discover how a single, robust…

1
ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts 2:08

3M ago2:08

2:08

In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: device classification and grouping. A misstep here can lead to costly delays and outright rejections from the Health Sciences Authority (HSA).We explore how ASEAN innovators can navigate this complex lan…

1
Pure Global’s ASEAN Playbook: Baking AMDD-Driven English Labeling from Singapore into Your Pan-Asia Dossier Strategy 1:57

3M ago1:57

1:57

In this episode of ASEAN MedTech Insights, we explore the critical importance of a harmonized yet localized labeling strategy for medical device companies targeting Southeast Asia. While the ASEAN Medical Device Directive (AMDD) promotes English as the standard for technical dossiers, relying solely on an English-first approach tailored for markets…

1
Pure Global's ASEAN MedTech Insights: Mastering Vietnam's Regulatory Maze from Decree 98 to Decree 07 for Market Success. 2:06

3M ago2:06

2:06

In this episode of ASEAN MedTech Insights, we unravel the complex regulatory web governing medical devices in Vietnam. We provide a deep dive into the foundational Decree 98/2021, the detailed implementation guide of Circular 05/2022, and the critical deadline extensions provided by Decree 07/2023. This is a must-listen for any MedTech company curr…

1
Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN 2:17

3M ago2:17

2:17

This episode of ASEAN MedTech Insights provides a deep dive into the specific regulatory requirements for medical device registration in the Philippines. We unpack the critical role of the FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR) and explain why foreign manufacturers cannot go it alone, detailing the mandatory app…

1
Trust, Talent, and Transformation: Inside Indonesia’s AI Revolution (featuring Astra, Bank Central Asia, Bank Mandiri and Pertamina) 1:05:50

3M ago1:05:50

1:05:50

In this episode, we feature a panel from the AIBP Conference in Jakarta with Lily Wongso, EVP Enterprise IT Architecture, Data Management & Service Quality, Bank Central Asia (BCA); Kurnia Sofia Rosyada, Group Head of Enterprise Data Analytics, Bank Mandiri; Paul Soegianto, Chief of Group Digital Strategy, Astra International; and Sigit Pratopo, Se…

1
Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with Pure Global 2:07

3M ago2:07

2:07

This episode of ASEAN MedTech Insights tackles a critical hurdle for global MedTech companies eyeing the Indonesian market: the mandatory appointment of a Local Authorized Representative (LAR). We explore why this is more than a procedural step and how the right partner can make or break your market access strategy.Imagine spending months preparing…

1
Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration 1:53

3M ago1:53

1:53

This episode of ASEAN MedTech Insights delves into the critical requirements of Malaysia's Medical Device Act 2012 (Act 737). We unpack the mandatory full registration process that every medical device must undergo, highlighting the specific and often underestimated hurdles that foreign manufacturers face when entering this key ASEAN market.We expl…

1
Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success 1:58

3M ago1:58

1:58

Thailand is a top-tier MedTech market in ASEAN, but its regulatory landscape is shifting. With new rules aligned with the ASEAN Medical Device Directive (AMDD), foreign manufacturers face a critical hurdle: the mandatory appointment of a Local Authorized Representative (LAR). This isn't just a name on a form; it's a legal and strategic necessity.Th…

1
Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule 2:05

3M ago2:05

2:05

This episode of ASEAN MedTech Insights tackles a critical compliance hurdle in Singapore that catches many MedTech companies by surprise. We explore why the "registration-exempt" status for Class A medical devices is not a free pass to the market and detail the mandatory licensing requirements that are often overlooked.Many international manufactur…

1
Singapore MedTech Alert: Is Your Distributor Holding Your HSA Registration Hostage? Pure Global on Securing Your ASEAN Market Access. 1:55

3M ago1:55

1:55

In this episode of ASEAN MedTech Insights, we dive into one of the most critical and overlooked decisions for medical device companies entering the Singapore market: the appointment of your Health Sciences Authority (HSA) Registrant. Singapore is the region's premier hub, but a single misstep here can halt your regional expansion before it even beg…

1
Pure Global's ASEAN MedTech Insights: Cracking the Infusion Pump & Drug Delivery Market in Indonesia, Thailand, and Vietnam 2:49

3M ago2:49

2:49

In this episode of ASEAN MedTech Insights, we explore the booming market for infusion pumps and drug delivery systems across Southeast Asia. While the demand is surging due to rising healthcare needs, foreign manufacturers face a complex web of fragmented regulations, price sensitivity, and logistical hurdles unique to the region. We break down the…

1
Pure Global's ASEAN MedTech Insights: Unlocking the Ultrasound Diagnostic Imaging Market in Thailand, Vietnam, and Indonesia 3:14

3M ago3:14

3:14

This episode of ASEAN MedTech Insights delves into the booming but complex market for ultrasound diagnostic imaging systems in Southeast Asia. We explore the dual demands of the region, from high-end, AI-powered systems in hubs like Singapore to the critical need for portable, point-of-care devices in archipelagic nations like Indonesia and the Phi…

1
Navigating the ASEAN ECG Market: Pure Global's Guide to Regulatory Success in Singapore, Malaysia, Thailand, and Vietnam 3:45

3M ago3:45

3:45

4M ago3:44

3:44

The rise of AI in diagnostics is revolutionizing healthcare, but for MedTech innovators, it presents a complex regulatory challenge. In the key ASEAN market of Malaysia, the risk classification of your predictive software is the single most important factor determining your path to market, influencing everything from cost and timelines to the requi…

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