ASEAN MedTech Insights
Episodes
Singapore AI MedTech: Pure Global on Cracking the HSA's New Regulatory Code
17 Dec 2025
Contributed by Lukas
Singapore is a leader in the ASEAN MedTech landscape, especially in adopting AI for healthcare. However, the Health Sciences Authority (HSA) has intro...
Pure Global: Singapore & Malaysia's AI MedTech Regulation - The New Fast-Track Gambit.
16 Dec 2025
Contributed by Lukas
This week, we dissect the groundbreaking joint "AI-Enabled Device Fast-Track Program" launched by Singapore and Malaysia. This new regulatory pathway ...
Pure Global: Kuala Lumpur's RegTech Game - Beyond the IMDEC Conference Buzz
15 Dec 2025
Contributed by Lukas
This week, we go beyond the conference brochures and flashy booths of the International Medical Device Exhibition & Conference (IMDEC) in Kuala Lumpur...
Kuala Lumpur's AI Approval Paradox: Pure Global on MedTech's New Speed Trap.
14 Dec 2025
Contributed by Lukas
This week on ASEAN MedTech Insights, we delve into a groundbreaking development from Malaysia. The Medical Device Authority has just launched a new fa...
Malaysia's SaMD Fast-Track: Pure Global on ASEAN's Newest MedTech Shortcut
13 Dec 2025
Contributed by Lukas
Malaysia's Medical Device Authority (MDA) has just unveiled a simplified regulatory framework for Software as a Medical Device (SaMD). This strategic ...
Pure Global: Jakarta's MedTech Blackout - Navigating the December System Shutdown
12 Dec 2025
Contributed by Lukas
In this episode, we unpack an urgent regulatory update from Indonesia. The Ministry of Health has announced a temporary but total shutdown of its medi...
Pure Global | Malaysia's AI MedTech: Inside the Sandbox De-Risking Future Medical Devices
11 Dec 2025
Contributed by Lukas
Malaysia's Medical Device Authority (MDA) has launched its first regulatory sandbox, a pivotal move for AI-driven medical devices in the ASEAN region....
Pure Global: Navigating Malaysia's Deadline Maze & Philippine's Compassionate Use Secrets
10 Dec 2025
Contributed by Lukas
The ASEAN MedTech landscape is in constant motion. This week, we dissect two major regulatory shifts that could make or break your market access strat...
Kuala Lumpur's MedTech Fee Hike & Jakarta's Freeze: A Pure Global Brief
09 Dec 2025
Contributed by Lukas
As 2025 wraps up, MedTech companies face a critical wave of last-minute regulatory shifts in Southeast Asia. This episode of ASEAN MedTech Insights di...
Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights
22 Oct 2025
Contributed by Lukas
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...
ASEAN MedTech Maze: Pure Global's Guide to Device Registration in Singapore, Malaysia and Beyond
21 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASE...
Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval
20 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights delves into a powerful strategy for navigating the complex regulatory landscape of Southeast Asia. We uncover h...
ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts
19 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: dev...
Pure Global’s ASEAN Playbook: Baking AMDD-Driven English Labeling from Singapore into Your Pan-Asia Dossier Strategy
18 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the critical importance of a harmonized yet localized labeling strategy for medical device compa...
Pure Global's ASEAN MedTech Insights: Mastering Vietnam's Regulatory Maze from Decree 98 to Decree 07 for Market Success.
17 Oct 2025
Contributed by Lukas
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...
Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN
16 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a deep dive into the specific regulatory requirements for medical device registration in the Philippin...
Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with Pure Global
15 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights tackles a critical hurdle for global MedTech companies eyeing the Indonesian market: the mandatory appointment ...
Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration
14 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights delves into the critical requirements of Malaysia's Medical Device Act 2012 (Act 737). We unpack the mandatory ...
Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success
13 Oct 2025
Contributed by Lukas
Thailand is a top-tier MedTech market in ASEAN, but its regulatory landscape is shifting. With new rules aligned with the ASEAN Medical Device Directi...
Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule
12 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights tackles a critical compliance hurdle in Singapore that catches many MedTech companies by surprise. We explore w...
Singapore MedTech Alert: Is Your Distributor Holding Your HSA Registration Hostage? Pure Global on Securing Your ASEAN Market Access.
11 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we dive into one of the most critical and overlooked decisions for medical device companies entering the Si...
Pure Global's ASEAN MedTech Insights: Cracking the Infusion Pump & Drug Delivery Market in Indonesia, Thailand, and Vietnam
10 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the booming market for infusion pumps and drug delivery systems across Southeast Asia. While the...
Pure Global's ASEAN MedTech Insights: Unlocking the Ultrasound Diagnostic Imaging Market in Thailand, Vietnam, and Indonesia
09 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights delves into the booming but complex market for ultrasound diagnostic imaging systems in Southeast Asia. We expl...
Navigating the ASEAN ECG Market: Pure Global's Guide to Regulatory Success in Singapore, Malaysia, Thailand, and Vietnam
08 Oct 2025
Contributed by Lukas
The market for ECG monitoring systems in Southeast Asia is expanding rapidly, fueled by rising healthcare needs and technological adoption. This episo...
Unlocking ASEAN's Billion-Dollar Orthopedic Market: A Pure Global Guide to Navigating Joint Implant Regulations in Singapore, Thailand, and Vietnam
07 Oct 2025
Contributed by Lukas
The ASEAN market for orthopedic joint replacement implants is experiencing explosive growth, fueled by aging populations and a rising demand for bette...
From Pandemic Demand to Sustainable Growth: Pure Global's Guide to the ASEAN Ventilator and Respiratory Therapy Market in Singapore, Malaysia, and Indonesia
06 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the dynamic evolution of the ventilator and respiratory therapy equipment market in Southeast As...
From FDA & CE to ASEAN Success: Pure Global's Guide to Unlocking the Booming CGM MedTech Markets in Singapore, Malaysia, and Indonesia.
05 Oct 2025
Contributed by Lukas
The market for Continuous Glucose Monitoring (CGM) devices in Southeast Asia is experiencing explosive growth, fueled by rising diabetes rates and a d...
Pure Global's ASEAN MedTech Insights: Navigating the Hemodialysis Machine Market in Malaysia, Thailand, and Vietnam for Global Success
04 Oct 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights explores the booming but complex market for hemodialysis machines in Southeast Asia. We uncover the drivers beh...
Unlocking Southeast Asia's MRI Market: A Pure Global Guide to Navigating Regulations in Singapore, Malaysia, and Vietnam
03 Oct 2025
Contributed by Lukas
The market for MRI systems in ASEAN is expanding rapidly, driven by increased healthcare investment and demand for advanced diagnostics. However, medi...
ASEAN CT Scanner Market Deep Dive: A Pure Global Guide to Navigating Regulatory Hurdles in Singapore, Thailand, and Indonesia
02 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we delve into the rapidly expanding market for Computed Tomography (CT) scanners in Southeast Asia. We expl...
Navigating the ASEAN Maze: Pure Global's Guide to Drug-Eluting Stent Registration in Singapore, Malaysia, and Thailand
01 Oct 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we delve into the rapidly expanding market for drug-eluting cardiovascular stents across Southeast Asia. As...
Mastering Vietnam's MedTech Market: A Pure Global Deep Dive into CSDT Technical Files for Decree 98 Success in ASEAN.
30 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a practical guide for MedTech manufacturers on preparing a Common Submission Dossier Template (CSDT) f...
Pure Global's Guide to the Philippines' Post-Market Alert System: Mastering AO 2018-0002 for MedTech Success in ASEAN
29 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a deep dive into the mandatory post-market alert system requirements for medical devices in the Philip...
Unlock ASEAN MedTech Markets with Pure Global: A Masterclass on Device Risk Classification in Singapore, Malaysia, and Vietnam under ACCSQ/MDPWG/GL-2
28 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights demystifies the essential first step for market entry: medical device risk classification. We provide a clear b...
Cracking the ASEAN Code: A Pure Global Deep Dive into Clinical Evidence Requirements for MedTech Success in Singapore, Malaysia & Vietnam
27 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into one of the most critical and often misunderstood aspects of medical device registration in Sout...
Pure Global Presents: Your Strategic Roadmap to Medical Device Licensing in Indonesia & ASEAN - Demystifying MOH Regulation No. 62 of 2017
26 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a deep dive into the essential requirements of Indonesia's Minister of Health Regulation No. 62 of 201...
Pure Global's Guide to Singapore's MedTech Regulations: Unlocking ASEAN Market Access Through Technical Specifications
25 Sep 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we demystify the core technical specifications required under Singapore's Health Products (Medical Devices)...
Cracking the Code of Thai FDA Approval: Pure Global's Expert Insights on Complying with Thailand’s Medical Device Act B.E. 2551 for ASEAN MedTech Innovators.
24 Sep 2025
Contributed by Lukas
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...
Navigating Malaysia's Medical Device Act 737: An ASEAN MedTech Insight for 2025 Compliance with Pure Global's Expert Analysis
23 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into the current implementation status of Malaysia's Medical Device Act 737. We move beyond the basi...
Pure Global Presents: Mastering the ASEAN CSDT for MedTech Success in Singapore, Malaysia, and Vietnam
22 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into the complexities of the ASEAN Common Submission Dossier Template (CSDT). We move beyond the che...
Unlocking ASEAN MedTech Markets: Pure Global's Deep Dive into the AMDD for Singapore, Thailand, and Vietnam
21 Sep 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the ambitious ASEAN Medical Device Directive (AMDD). Designed to create a harmonized, single mar...
Cracking the Code: Pure Global's Expert Guide to Licensing AI Medical Software for Import into Thailand's Booming ASEAN MedTech Market.
20 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights unpacks the specific regulatory process for importing and licensing AI-based medical software in Thailand. We e...
Cracking the Code: A Pure Global Deep Dive into Risk Classification for Predictive AI Software in Malaysia and ASEAN
19 Sep 2025
Contributed by Lukas
The rise of AI in diagnostics is revolutionizing healthcare, but for MedTech innovators, it presents a complex regulatory challenge. In the key ASEAN ...
Leveraging US FDA & CE Marks for AI Medical Devices in Singapore: An ASEAN Market Guide by Pure Global
18 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives into a crucial question for global MedTech companies: Does Singapore's Health Sciences Authority (HSA) re...
Cracking the Code: A Pure Global Guide to Clinical Evidence for AI Medical Devices in Indonesia and the Broader ASEAN Market
17 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into the specific clinical evidence requirements for AI-powered medical devices seeking market appro...
Cracking the Code: A Pure Global Guide to SaMD Medical Device Registration in the Philippines for ASEAN MedTech Innovators
16 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a deep dive into the specific requirements for registering Software as a Medical Device (SaMD) in the ...
Navigating Vietnam's SaMD Cybersecurity Maze: A Pure Global Guide for MedTech Innovators in the ASEAN Market
15 Sep 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we demystify the process of meeting cybersecurity requirements for Software as a Medical Device (SaMD) in V...
Does Thailand's FDA Have a Secret AI Pathway? Pure Global Unpacks SaMD Regulations for ASEAN MedTech Innovators
14 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives into the regulatory landscape for AI-driven diagnostic tools in Thailand. As artificial intelligence tran...
Cracking the Code in Southeast Asia: Pure Global's Guide to the Latest ASEAN Medical Device Directive (AMDD) for AI Software in Singapore, Malaysia & Beyond
13 Sep 2025
Contributed by Lukas
The rise of AI in ASEAN's MedTech landscape is explosive, but the regulatory pathways are a complex and fragmented maze. This episode of ASEAN MedTech...
Malaysia's SaMD Maze: Your Expert Guide with Pure Global on Navigating MDA Classification in the Heart of ASEAN
12 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a deep dive into the regulatory landscape for Software as a Medical Device (SaMD) in Malaysia. We unra...
Pure Global's Guide to Singapore's HSA AI Medical Device Registration: Key Insights for MedTech Success in ASEAN
11 Sep 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we demystify the regulatory landscape for AI-powered medical devices in Singapore. As a leading MedTech hub...
Navigating ASEAN MedTech Regulations with Pure Global: A Deep Dive into Class A Device Classification in Singapore, Malaysia, and Indonesia
10 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights tackles the critical first step for market entry: correctly classifying your medical device under the ASEAN Med...
Navigating ASEAN's MedTech Maze: Are Low-Risk Device Exemptions a Myth in Singapore, Malaysia, and Thailand? A Pure Global Insight.
09 Sep 2025
Contributed by Lukas
Navigating the complex regulatory landscape of Southeast Asia can be challenging, especially when it comes to low-risk medical devices. While the term...
Unlocking ASEAN Markets: Pure Global's Expert Guide to Simplified Class B Medical Device Registration in Singapore, Malaysia, and Beyond
08 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives into the most efficient way to get your Class B medical device to market across Southeast Asia: the simpl...
Philippine MedTech Entry Costs: Pure Global's Guide to Navigating the 2024 FDA Fee Shock for Class A Medical Devices
07 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into the true cost of bringing a low-risk medical device to the Philippine market. We uncover the re...
Pure Global's ASEAN MedTech Insights: Navigating Indonesia's Regulatory Maze - Why Your Class A Medical Device Still Needs a Local Authorized Representative
06 Sep 2025
Contributed by Lukas
Thinking of launching your Class A medical device in Indonesia? Many manufacturers assume that a low-risk classification means a simple, direct path t...
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
05 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights demystifies the process of registering low-risk medical devices with the Thailand FDA. We clarify the critical ...
Pure Global's ASEAN MedTech Insights: Navigating Vietnam's Mandatory Declaration for Class A Medical Devices, Not an Exemption
04 Sep 2025
Contributed by Lukas
Many MedTech manufacturers believe that low-risk, Class A medical devices are exempt from registration in Vietnam. This common misconception can lead ...
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
03 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights demystifies the process of registering a Class I medical device in Malaysia. We break down why the "simplest" c...
Navigating ASEAN's CSDT for Low-Risk Medical Devices: A Pure Global Deep Dive into Regulations in Singapore, Malaysia & Thailand
02 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives into a critical question for manufacturers of low-risk devices: Is the full ASEAN Common Submission Dossi...
Navigating Singapore's HSA: A Pure Global Guide to Class A Medical Device Registration and Fast-Tracking Your ASEAN Market Access
01 Sep 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights demystifies the common misconception surrounding Class A medical device registration in Singapore. We uncover w...
Navigating MedTech in Malaysia: A Deep Dive into Post-Market Surveillance and Vigilance Requirements with Pure Global's ASEAN Insights
31 Aug 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the essential post-market surveillance and vigilance requirements for medical devices in Malaysi...
ASEAN MedTech Insights by Pure Global: Navigating Clinical Trial Requirements for Medical Devices in Indonesia, Thailand, and Vietnam
30 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights tackles a crucial question for global manufacturers: Are local clinical trials required to register your medica...
Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy
29 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We ex...
MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia
28 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk ...
Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.
27 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's st...
Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN
26 Aug 2025
Contributed by Lukas
Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Repr...
Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand
25 Aug 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fa...
Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success
24 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device ...
ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways
23 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (H...
Unlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.
22 Aug 2025
Contributed by Lukas
In this episode of ASEAN MedTech Insights, we explore the ASEAN Common Submission Dossier Template (CSDT). Designed to unify medical device registrati...
Unlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech Firms
20 Aug 2025
Contributed by Lukas
This episode of ASEAN MedTech Insights dives deep into the strategic process of medical device registration in Singapore with the Health Sciences Auth...