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ASEAN MedTech Insights - Podcast

ASEAN MedTech Insights

 Ran Chen

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.

Business Science Life Sciences Technology
Update frequency
every day
Average duration
3 minutes
Episodes
17
Years Active
2025
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Pure Global's ASEAN MedTech Insights: Navigating Indonesia's Regulatory Maze - Why Your Class A Medical Device Still Needs a Local Authorized Representative

Pure Global's ASEAN MedTech Insights: Navigating Indonesia's Regulatory Maze - Why Your Class A Medical Device Still Needs a Local Authorized Representative

Thinking of launching your Class A medical device in Indonesia? Many manufacturers assume that a low-risk classification means a simple, direct path to market. This common misconception can lead to c…
00:03:23  |   Fri 05 Sep 2025
Pure Global's ASEAN MedTech Insights: Navigating Thailand's FDA for Low-Risk Medical Devices - A Deep Dive into the Listing vs. Notification Process for Fast-Track Market Entry

Pure Global's ASEAN MedTech Insights: Navigating Thailand's FDA for Low-Risk Medical Devices - A Deep Dive into the Listing vs. Notification Process for Fast-Track Market Entry

This episode of ASEAN MedTech Insights demystifies the process of registering low-risk medical devices with the Thailand FDA. We clarify the critical difference between the 'Listing' pathway for Clas…
00:02:45  |   Thu 04 Sep 2025
Pure Global's ASEAN MedTech Insights: Navigating Vietnam's Mandatory Declaration for Class A Medical Devices, Not an Exemption

Pure Global's ASEAN MedTech Insights: Navigating Vietnam's Mandatory Declaration for Class A Medical Devices, Not an Exemption

Many MedTech manufacturers believe that low-risk, Class A medical devices are exempt from registration in Vietnam. This common misconception can lead to significant import delays, financial penalties…
00:03:01  |   Wed 03 Sep 2025
Pure Global Presents: The Fastest Way to Register a Class I Medical Device in Malaysia - An ASEAN MedTech Insights Deep Dive for Navigating the MDA & MeDC@St System

Pure Global Presents: The Fastest Way to Register a Class I Medical Device in Malaysia - An ASEAN MedTech Insights Deep Dive for Navigating the MDA & MeDC@St System

This episode of ASEAN MedTech Insights demystifies the process of registering a Class I medical device in Malaysia. We break down why the "simplest" classification can often lead to unexpected delays…
00:02:58  |   Tue 02 Sep 2025
Navigating ASEAN's CSDT for Low-Risk Medical Devices: A Pure Global Deep Dive into Regulations in Singapore, Malaysia & Thailand

Navigating ASEAN's CSDT for Low-Risk Medical Devices: A Pure Global Deep Dive into Regulations in Singapore, Malaysia & Thailand

This episode of ASEAN MedTech Insights dives into a critical question for manufacturers of low-risk devices: Is the full ASEAN Common Submission Dossier Template (CSDT) actually required to enter the…
00:02:55  |   Mon 01 Sep 2025
Navigating Singapore's HSA: A Pure Global Guide to Class A Medical Device Registration and Fast-Tracking Your ASEAN Market Access

Navigating Singapore's HSA: A Pure Global Guide to Class A Medical Device Registration and Fast-Tracking Your ASEAN Market Access

This episode of ASEAN MedTech Insights demystifies the common misconception surrounding Class A medical device registration in Singapore. We uncover why being "exempt" from full registration doesn't …
00:02:36  |   Sun 31 Aug 2025
Navigating MedTech in Malaysia: A Deep Dive into Post-Market Surveillance and Vigilance Requirements with Pure Global's ASEAN Insights

Navigating MedTech in Malaysia: A Deep Dive into Post-Market Surveillance and Vigilance Requirements with Pure Global's ASEAN Insights

In this episode of ASEAN MedTech Insights, we explore the essential post-market surveillance and vigilance requirements for medical devices in Malaysia. We break down the key regulations under the Me…
00:03:00  |   Sat 30 Aug 2025
ASEAN MedTech Insights by Pure Global: Navigating Clinical Trial Requirements for Medical Devices in Indonesia, Thailand, and Vietnam

ASEAN MedTech Insights by Pure Global: Navigating Clinical Trial Requirements for Medical Devices in Indonesia, Thailand, and Vietnam

This episode of ASEAN MedTech Insights tackles a crucial question for global manufacturers: Are local clinical trials required to register your medical device in Southeast Asia? We move beyond the ge…
00:02:57  |   Fri 29 Aug 2025
Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy

Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy

This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification …
00:03:24  |   Thu 28 Aug 2025
MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia

MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia

This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk classification system. We break down the four-tie…
00:03:31  |   Wed 27 Aug 2025
Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.

Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.

This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's strict and specific labeling and language regulatio…
00:02:43  |   Tue 26 Aug 2025
Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN

Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN

Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Representative (LAR). This isn't merely an administra…
00:03:02  |   Mon 25 Aug 2025
Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thai…
00:02:28  |   Sun 24 Aug 2025
Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success

Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success

This episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device Authority (MDA). We break down the essential step…
00:02:25  |   Sat 23 Aug 2025
ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways

ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways

This episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (HSA). We explore the critical role of reference ag…
00:03:10  |   Fri 22 Aug 2025
Unlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.

Unlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.

In this episode of ASEAN MedTech Insights, we explore the ASEAN Common Submission Dossier Template (CSDT). Designed to unify medical device registration across Southeast Asia, the CSDT promises a sim…
00:03:18  |   Thu 21 Aug 2025
Unlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech Firms

Unlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech Firms

This episode of ASEAN MedTech Insights dives deep into the strategic process of medical device registration in Singapore with the Health Sciences Authority (HSA). We explore why this island nation is…

00:03:24  |   Tue 19 Aug 2025
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