Rephonic
Artwork for ASEAN MedTech Insights

ASEAN MedTech Insights

Ran Chen
Medical Device Registration
Indonesia
Vietnam
Thailand
ASEAN Medical Device Directive
Singapore
Medical Devices
Health Sciences Authority
Device Classification
ASEAN Common Submission Dossier Template
Philippine Food and Drug Administration
Class A Medical Devices
ISO 13485
Local Representation
ASEAN
Post-Market Surveillance
Malaysia
Common Submission Dossier Template
Medical Device Authority
Class A Devices

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

PublishesDailyEpisodes82Founded5 months ago
Number of ListenersCategories
Life SciencesScienceTechnology

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Artwork for ASEAN MedTech Insights

Latest Episodes

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

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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

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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

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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

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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

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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 conti... more

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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 hidd... more

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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 regulat... more

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Key Facts

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Contact Information
Podcast Host
Number of Listeners
Find out how many people listen to this podcast per episode and each month.

Recent Guests

Pure Global
Company offering expert guidance on regulatory compliance for medical devices in the Philippines.
Pure Global
Episode: Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN

Hosts

Host of ASEAN MedTech Insights
Host discussing regulatory processes and innovations in the ASEAN MedTech landscape.
Pure Global
Representative discussing medical technology developments and regulatory insights.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#192
India/Science/Life Sciences

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Frequently Asked Questions About ASEAN MedTech Insights

What is ASEAN MedTech Insights about and what kind of topics does it cover?

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.

Where can I find podcast stats for ASEAN MedTech Insights?

Rephonic provides a wide range of podcast stats for ASEAN MedTech Insights. We scanned the web and collated all of the information that we could find in our comprehensive podcast database. See how many people listen to ASEAN MedTech Insights and access YouTube viewership numbers, download stats, audience demographics, chart rankings, ratings, reviews and more.

How many listeners does ASEAN MedTech Insights get?

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What are the audience demographics for ASEAN MedTech Insights?

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How many subscribers and views does ASEAN MedTech Insights have?

To see how many followers or subscribers ASEAN MedTech Insights has on Spotify and other platforms such as Castbox and Podcast Addict, simply upgrade your account. You'll also find viewership figures for their YouTube channel if they have one.

How many episodes of ASEAN MedTech Insights are there?

ASEAN MedTech Insights launched 5 months ago and published 82 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact ASEAN MedTech Insights?

Our systems regularly scour the web to find email addresses and social media links for this podcast. We scanned the web and collated all of the contact information that we could find in our podcast database. But in the unlikely event that you can't find what you're looking for, our concierge service lets you request our research team to source better contacts for you.

Where can I see ratings and reviews for ASEAN MedTech Insights?

Rephonic pulls ratings and reviews for ASEAN MedTech Insights from multiple sources, including Spotify, Apple Podcasts, Castbox, and Podcast Addict.

View all the reviews in one place instead of visiting each platform individually and use this information to decide if a show is worth pitching or not.

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What guests have appeared on ASEAN MedTech Insights?

Recent guests on ASEAN MedTech Insights include:

1. Pure Global

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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