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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

02:02

Pure Global's ASEAN MedTech Insights: Unlocking...

ASEAN MedTech Insights ·

2025/10/19

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 regulatory approval can act as a key to unlock multiple markets, saving you invaluable time and resources. We will explore a common scenario: a company

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02:08

ASEAN MedTech Insights: Cracking Singapore's HSA Code...

ASEAN MedTech Insights ·

2025/10/18

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 landscape. We break down the four-tier risk classification system and reveal how a strategic approach to device grouping can save you hundreds of thousands

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01:57

Pure Global’s ASEAN Playbook: Baking AMDD-Driven...

ASEAN MedTech Insights ·

2025/10/17

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 like Singapore can create significant barriers to entry in countries with specific national language requirements, such as Thailand and Indonesia.We

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02:06

Pure Global's ASEAN MedTech Insights: Mastering...

ASEAN MedTech Insights ·

2025/10/16

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 currently in or planning to enter the fast-growing Vietnamese market. We break down what these changes mean for your product registration, documentation, and

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02:17

Philippines MedTech Expansion: A Deep Dive with Pure...

ASEAN MedTech Insights ·

2025/10/15

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 appointment of a Local Authorized Representative.We explore the entire process, from securing the essential License to Operate (LTO) to navigating the AMDD

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02:07

Navigating Indonesia's MedTech Maze: Why Your Local...

ASEAN MedTech Insights ·

2025/10/14

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 your technical dossier, only to have your product registration in Indonesia tied to an underperforming distributor. You're losing sales and want to

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01:53

Pure Global's Guide to ASEAN Market Entry: Mastering...

ASEAN MedTech Insights ·

2025/10/13

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 explore the entire journey, from the initial shock of regulatory requirements to the detailed steps for a successful submission. Learn why existing

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01:58

Navigating Thailand's New AMDD Regulations: Why Pure...

ASEAN MedTech Insights ·

2025/10/12

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.This episode of ASEAN MedTech Insights dives deep into the challenges and solutions for entering the Thai market. We explore why using a distributor as

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02:05

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

ASEAN MedTech Insights ·

2025/10/11

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 manufacturers assume their low-risk Class A devices can be sold in Singapore without regulatory steps, leading to costly mistakes. We share a real-world case

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01:55

Singapore MedTech Alert: Is Your Distributor Holding...

ASEAN MedTech Insights ·

2025/10/10

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 begins.We explore why the common practice of appointing a commercial distributor as your legal Registrant is fraught with risk. This arrangement can lead

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02:49

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

ASEAN MedTech Insights ·

2025/10/09

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 core challenges and opportunities, from navigating country-specific registration processes to balancing the adoption of advanced smart-pump technology

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03:14

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

ASEAN MedTech Insights ·

2025/10/08

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 Philippines. The primary focus is on the significant challenge facing global MedTech manufacturers: navigating the fragmented and demanding regulatory

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03:45

Navigating the ASEAN ECG Market: Pure Global's Guide...

ASEAN MedTech Insights ·

2025/10/07

The market for ECG monitoring systems in Southeast Asia is expanding rapidly, fueled by rising healthcare needs and technological adoption. This episode of ASEAN MedTech Insights explores the vast opportunities and critical regulatory challenges across key ASEAN markets, providing a strategic guide for MedTech manufacturers looking to enter or expand in the region.We delve into the fragmented regulatory landscape, where a one-size-fits-all approach leads to costly delays. For example, a European

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02:51

Unlocking ASEAN's Billion-Dollar Orthopedic Market: A...

ASEAN MedTech Insights ·

2025/10/06

The ASEAN market for orthopedic joint replacement implants is experiencing explosive growth, fueled by aging populations and a rising demand for better healthcare. However, the path to market entry is filled with complex and fragmented regulations, creating significant hurdles for manufacturers. This episode of ASEAN MedTech Insights explores the specific challenges and opportunities in key markets like Singapore, Vietnam, and Malaysia. Imagine your state-of-the-art knee implant, a success in

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02:54

From Pandemic Demand to Sustainable Growth: Pure...

ASEAN MedTech Insights ·

2025/10/05

In this episode of ASEAN MedTech Insights, we explore the dynamic evolution of the ventilator and respiratory therapy equipment market in Southeast Asia. The discussion moves beyond the initial COVID-19 demand surge to uncover the new, sustainable growth drivers shaping the industry today, from demographic shifts to the rise of local manufacturing.We dissect the fragmented nature of the ASEAN market, where the needs of a high-tech Singaporean hospital starkly contrast with the demands of rural

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03:02

From FDA & CE to ASEAN Success: Pure Global's Guide...

ASEAN MedTech Insights ·

2025/10/04

The market for Continuous Glucose Monitoring (CGM) devices in Southeast Asia is experiencing explosive growth, fueled by rising diabetes rates and a digitally-savvy population. This episode of ASEAN MedTech Insights explores the immense opportunities for CGM manufacturers in countries like Singapore, Malaysia, Indonesia, and Thailand. While the potential is undeniable, the path to market is filled with complex challenges. Each ASEAN nation has a unique and independent regulatory system, creating a

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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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81 results

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