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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

03:06

Pure Global's ASEAN MedTech Insights: Navigating the...

ASEAN MedTech Insights ·

2025/10/03

This episode of ASEAN MedTech Insights explores the booming but complex market for hemodialysis machines in Southeast Asia. We uncover the drivers behind the surging demand, such as rising rates of chronic kidney disease in countries like Malaysia, Thailand, and Vietnam, and examine the significant growth opportunities for MedTech manufacturers. However, the path to market is filled with regulatory hurdles. We break down the fragmented nature of ASEAN's regulatory landscape, where a successful

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03:09

Unlocking Southeast Asia's MRI Market: A Pure Global...

ASEAN MedTech Insights ·

2025/10/02

The market for MRI systems in ASEAN is expanding rapidly, driven by increased healthcare investment and demand for advanced diagnostics. However, medical device manufacturers often underestimate the complexities of navigating the region's fragmented regulatory landscape. While the ASEAN Medical Device Directive (AMDD) aims for harmonization, each member state presents unique challenges in device classification, registration, and post-market surveillance.This episode delves into the practical

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03:20

ASEAN CT Scanner Market Deep Dive: A Pure Global...

ASEAN MedTech Insights ·

2025/10/01

In this episode of ASEAN MedTech Insights, we delve into the rapidly expanding market for Computed Tomography (CT) scanners in Southeast Asia. We explore the vast differences between mature markets like Singapore, which demand high-tech, AI-integrated systems, and high-growth emerging markets like Indonesia and Vietnam, where the focus is on accessibility and volume.This episode unpacks the complex and fragmented regulatory environment that often surprises global manufacturers. We share a detailed

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03:00

Navigating the ASEAN Maze: Pure Global's Guide to...

ASEAN MedTech Insights ·

2025/09/30

In this episode of ASEAN MedTech Insights, we delve into the rapidly expanding market for drug-eluting cardiovascular stents across Southeast Asia. As lifestyle diseases rise, so does the demand for these life-saving devices, but the path to market is filled with complex and fragmented regulatory hurdles. We explore this landscape, from Singapore's streamlined efficiency to the bureaucratic complexities of markets like Indonesia, offering a strategic overview for manufacturers looking to

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02:50

Mastering Vietnam's MedTech Market: A Pure Global...

ASEAN MedTech Insights ·

2025/09/29

This episode of ASEAN MedTech Insights provides a practical guide for MedTech manufacturers on preparing a Common Submission Dossier Template (CSDT) for market entry into Vietnam under the stringent Decree No. 98/2021/ND-CP. We dissect the critical components of the technical file, from risk classification and language requirements to the specific nuances of providing clinical evidence for the Vietnamese market.We offer actionable advice and highlight common pitfalls that can lead to costly delays

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03:18

Pure Global's Guide to the Philippines' Post-Market...

ASEAN MedTech Insights ·

2025/09/28

This episode of ASEAN MedTech Insights provides a deep dive into the mandatory post-market alert system requirements for medical devices in the Philippines, as stipulated by Administrative Order No. 2018-0002. We explore how this regulation aligns the Philippines with the ASEAN Medical Device Directive (AMDD) and what this harmonization means for manufacturers operating across Southeast Asia. We unpack the specific obligations for MedTech companies, detailing the types of adverse events and Field

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02:59

Unlock ASEAN MedTech Markets with Pure Global: A...

ASEAN MedTech Insights ·

2025/09/27

This episode of ASEAN MedTech Insights demystifies the essential first step for market entry: medical device risk classification. We provide a clear breakdown of the ASEAN Medical Device Directive's four-tier system (Class A, B, C, and D), explaining how to navigate the harmonized rules based on the ACCSQ/MDPWG/GL-2 guidelines. This is your essential guide to ensuring your product's regulatory pathway is built on a solid foundation.Learn the core principles that determine a device's risk level,

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03:42

Cracking the ASEAN Code: A Pure Global Deep Dive into...

ASEAN MedTech Insights ·

2025/09/26

This episode of ASEAN MedTech Insights dives deep into one of the most critical and often misunderstood aspects of medical device registration in Southeast Asia: the requirements for clinical evidence. We unpack the ASEAN Consultative Committee for Standards and Quality (ACCSQ) guidance document ACCSQ/MDPWG/GL-1, explaining how to build a robust Clinical Evaluation Report (CER) for the Common Submission Dossier Template (CSDT).We explore how manufacturers can leverage existing clinical data from

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03:29

Pure Global Presents: Your Strategic Roadmap to...

ASEAN MedTech Insights ·

2025/09/25

This episode of ASEAN MedTech Insights provides a deep dive into the essential requirements of Indonesia's Minister of Health Regulation No. 62 of 2017. We break down the critical pillars for medical device registration, including the mandatory appointment of a local license holder, the four-tier risk classification system, and the meticulous documentation required in the CSDT format.We move beyond the legal text to explore the practical realities and strategic challenges that foreign

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03:05

Pure Global's Guide to Singapore's MedTech...

ASEAN MedTech Insights ·

2025/09/24

In this episode of ASEAN MedTech Insights, we demystify the core technical specifications required under Singapore's Health Products (Medical Devices) Regulations 2010. We explore why Singapore serves as a crucial launchpad for the broader ASEAN market and break down the specific documentation demands of the Health Sciences Authority (HSA).We delve into the ASEAN Common Submission Dossier Template (CSDT), detailing the critical elements that manufacturers often overlook, from granular device

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03:06

Cracking the Code of Thai FDA Approval: Pure Global's...

ASEAN MedTech Insights ·

2025/09/23

This episode of ASEAN MedTech Insights unpacks the essential steps to comply with Thailand’s Medical Device Act B.E. 2551. We explore the Thai FDA's risk-based classification system, the different registration pathways available to foreign manufacturers, and the critical role of a local authorized representative.Navigating this landscape is challenging. For example, a company with a successful, FDA-approved device might assume a smooth entry into Thailand, only to face unexpected delays and costs

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03:12

Navigating Malaysia's Medical Device Act 737: An...

ASEAN MedTech Insights ·

2025/09/22

This episode of ASEAN MedTech Insights dives deep into the current implementation status of Malaysia's Medical Device Act 737. We move beyond the basics of initial registration and explore the new era of stricter enforcement that all MedTech manufacturers must navigate. We discuss the critical updates from the Medical Device Authority (MDA) and what they mean for your operations, post-market responsibilities, and overall compliance strategy in one of Southeast Asia's key markets. We uncover the

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02:41

Pure Global Presents: Mastering the ASEAN CSDT for...

ASEAN MedTech Insights ·

2025/09/21

This episode of ASEAN MedTech Insights dives deep into the complexities of the ASEAN Common Submission Dossier Template (CSDT). We move beyond the checklist to uncover the unwritten rules and nuanced expectations of regulators in key markets like Malaysia, Vietnam, and Indonesia. Learn why a one-size-fits-all approach fails and how specific, localized details are crucial for a successful medical device registration.We share a case study of a Swiss medical device company whose launch in Southeast

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03:17

Unlocking ASEAN MedTech Markets: Pure Global's Deep...

ASEAN MedTech Insights ·

2025/09/20

In this episode of ASEAN MedTech Insights, we explore the ambitious ASEAN Medical Device Directive (AMDD). Designed to create a harmonized, single market for medical devices across ten nations, the AMDD promises streamlined access and unified standards. We break down its core requirements, from the four-tier risk classification system to the crucial Common Submission Dossier Template (CSDT). However, the vision of harmonization meets the complex reality of national implementation. We uncover why

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02:52

Cracking the Code: Pure Global's Expert Guide to...

ASEAN MedTech Insights ·

2025/09/19

This episode of ASEAN MedTech Insights unpacks the specific regulatory process for importing and licensing AI-based medical software in Thailand. We explore the Thai FDA's unique requirements, including the crucial "Efficiency Review" for all AI and machine learning technologies, and provide actionable advice for manufacturers looking to enter this dynamic market.We break down the journey through a common scenario: an international company has a proven AI-powered diagnostic software that's

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03:44

Cracking the Code: A Pure Global Deep Dive into Risk...

ASEAN MedTech Insights ·

2025/09/18

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 required depth of clinical data. Get it wrong, and you face significant delays and financial loss.Consider this scenario. A startup develops a groundbreaking

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02:42

Leveraging US FDA & CE Marks for AI Medical Devices...

ASEAN MedTech Insights ·

2025/09/17

This episode of ASEAN MedTech Insights dives into a crucial question for global MedTech companies: Does Singapore's Health Sciences Authority (HSA) recognize foreign approvals for AI-powered medical devices? We explore how securing clearance from major bodies like the US FDA or receiving a CE Mark in Europe can be a powerful asset, but not an automatic ticket, for market entry into Singapore.We break down the HSA's reference agency framework and explain the different evaluation pathways available

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02:42

Cracking the Code: A Pure Global Guide to Clinical...

ASEAN MedTech Insights ·

2025/09/16

This episode of ASEAN MedTech Insights dives deep into the specific clinical evidence requirements for AI-powered medical devices seeking market approval in Indonesia. We uncover why a standard CE mark or FDA clearance is often not enough and explore the nuances of demonstrating your product's efficacy for the diverse Indonesian population.Imagine a MedTech company with a breakthrough AI diagnostic tool, already approved in the United States. They anticipate a quick entry into the large Indonesian

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03:27

Cracking the Code: A Pure Global Guide to SaMD...

ASEAN MedTech Insights ·

2025/09/15

This episode of ASEAN MedTech Insights provides a deep dive into the specific requirements for registering Software as a Medical Device (SaMD) in the Philippines. We explore the critical steps from risk classification and dossier preparation to the final submission process, offering practical insights for MedTech innovators targeting this key ASEAN market. Imagine you've developed a groundbreaking AI diagnostic app, poised to revolutionize patient care. You're targeting the fast-growing Philippine

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04:06

Navigating Vietnam's SaMD Cybersecurity Maze: A Pure...

ASEAN MedTech Insights ·

2025/09/14

In this episode of ASEAN MedTech Insights, we demystify the process of meeting cybersecurity requirements for Software as a Medical Device (SaMD) in Vietnam. While Vietnam lacks a specific cybersecurity law for MedTech, the regulatory expectations are high, embedded within the existing framework of Decree 98. We explore the essential documentation, from risk management to post-market surveillance, that manufacturers must prepare. We break down how to proactively demonstrate your SaMD's security to

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85 results

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