ASEAN MedTech Insights

Pure Global: Malaysia's New Diplomatic Wall for MedTech Imports

07 May 2026

Contributed by Lukas

This week, we dive into a critical regulatory update from Malaysia's Medical Device Authority (MDA) that has immediate implications for global MedTech...

Singapore's AI MedTech Rules: Pure Global Decodes the HSA's Hidden SaMD Challenges.

06 May 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) just raised the bar for AI-powered medical devices. In this episode, we break down the critical updates fr...

Pure Global: Singapore & Malaysia's MedTech Shortcut - The New Reliance Playbook

05 May 2026

Contributed by Lukas

This week, we dissect the game-changing regulatory reliance pilot program between Malaysia’s MDA and Singapore’s HSA. This collaboration is creati...

Pure Global: Singapore & Malaysia's MedTech Reliance—An Untapped Loophole?

04 May 2026

Contributed by Lukas

Singapore and Malaysia have just launched a groundbreaking pilot program for regulatory reliance, promising a faster path to market for medical device...

Jakarta's Halal Mandate: Pure Global on MedTech's Unseen Compliance Crisis

03 May 2026

Contributed by Lukas

This week, we dive deep into a pressing issue for MedTech manufacturers in Indonesia: the fast-approaching deadline for mandatory Halal certification....

Pure Global: Thailand's AI MedTech Gambit - Fast-Track Pitfalls.

01 May 2026

Contributed by Lukas

Thailand's FDA has launched an accelerated approval pathway for AI-based medical software, aiming to cement its position as a digital health leader in...

Malaysia-Thailand MedTech's New Backdoor: Pure Global on Fast-Track Regulatory Reliance Strategies.

30 Apr 2026

Contributed by Lukas

This week, we dissect the new regulatory reliance program between Malaysia and Thailand. This groundbreaking pilot promises a faster, streamlined path...

Pure Global: Malaysia's AI MedTech Ambition & The Hidden Regulatory Hurdle

29 Apr 2026

Contributed by Lukas

Malaysia is making a bold play to dominate high-tech medical device manufacturing in ASEAN. But what happens when cutting-edge factory AI, designed to...

Pure Global: Malaysia-Thailand's Fast-Track A Golden Handshake?

28 Apr 2026

Contributed by Lukas

This week, we dissect the groundbreaking regulatory reliance program just launched between Malaysia and Thailand. This pilot promises a faster route t...

Pure Global: The Malaysia-Thailand Fast-Track & The Closing Window for Device Approval

27 Apr 2026

Contributed by Lukas

This week, we dissect the Malaysia-Thailand Medical Device Regulatory Reliance Pilot, a game-changing program in its final days. This initiative offer...

Malaysia's MedTech Shuffle: Pure Global on The New Market Access Paradox

26 Apr 2026

Contributed by Lukas

This week, we dissect a major shift in the ASEAN MedTech landscape. Malaysia's Medical Device Authority has just rolled out a dual-edged policy: a fas...

Jakarta's AI Sandbox: Pure Global on Indonesia's Risky New MedTech Fast-Track.

25 Apr 2026

Contributed by Lukas

This week, we dissect the groundbreaking launch of Indonesia's "Digital Health Sandbox." This new fast-track initiative offers a provisional approval ...

Pure Global: Malaysia's AI MedTech Sandbox, An Insider's Playbook for Rapid ASEAN Entry.

24 Apr 2026

Contributed by Lukas

This week, we dissect Malaysia's game-changing new Digital Health Sandbox. This initiative creates a new fast-track regulatory pathway for AI and soft...

Thailand's MedTech Shift: Pure Global on the New Change-Notification Landmines.

23 Apr 2026

Contributed by Lukas

This week, we dive into a sudden regulatory shift from Thailand's FDA. A new guideline on medical device change notifications was issued on April 16th...

Pure Global: Malaysia & Thailand's MedTech Fast-Track. The Secret Reliance Strategy.

22 Apr 2026

Contributed by Lukas

This week, we dive into a game-changing development in the ASEAN MedTech corridor. Malaysia's MDA and Thailand's FDA have launched a pilot regulatory ...

Pure Global: Malaysia-Thailand's MedTech Fast-Track - Beyond The Red Tape.

21 Apr 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the groundbreaking regulatory reliance pilot program launched by Malaysia's MDA and Thailand's Thai FD...

Pure Global: Malaysia's MedTech Fast-Track & The Hidden Harmonization Hurdles for Device Approval

20 Apr 2026

Contributed by Lukas

This week, we dissect the breaking news from Malaysia: a new "fast-track" device registration system for products already approved in Singapore. This ...

Pure Global: Singapore's New MedTech Domino - Unlocking Hong Kong via a Hidden Regulatory Shortcut

19 Apr 2026

Contributed by Lukas

This week, we dive into a major regulatory shift in Asia. Hong Kong's medical device authority has announced it will now recognize approvals from Sing...

Pure Global: Singapore's New Fast-Track to Hong Kong MedTech Market.

18 Apr 2026

Contributed by Lukas

This week, we dive into a major policy shift that just created a new, high-speed corridor between two of Asia's most important MedTech markets. Hong K...

Pure Global: Malaysia's AI MedTech Rules & The Hidden Data Compliance Trap

17 Apr 2026

Contributed by Lukas

This week, we dissect the breaking news from Malaysia. The Medical Device Authority (MDA) has just unveiled a new, comprehensive regulatory framework ...

Pure Global: The Malaysia-Thailand MedTech Shortcut - Beyond the Reliance Pilot.

16 Apr 2026

Contributed by Lukas

This episode dives deep into the final, critical phase of the Malaysia-Thailand Medical Device Regulatory Reliance Pilot. We explore how this program ...

Pure Global: Singapore's New AI Device Rules - Decoding The Hidden Regulatory Hurdles.

15 Apr 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just launched a new, more stringent regulatory framework for AI-powered medical devices. This move com...

Pure Global: Malaysia's New MedTech Shortcut - Cracking the Singapore-KL Regulatory Corridor.

14 Apr 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect a game-changing regulatory update from Malaysia. The Medical Device Authority (MDA) has just launched ...

Pure Global: Malaysia's AI MedTech Fast-Track, Unpacking Hidden Regulatory Hurdles.

13 Apr 2026

Contributed by Lukas

This week, we dissect the big news out of Malaysia. The Medical Device Authority (MDA) has just clarified its "fast-track" conditional registration pa...

Pure Global: Vietnam's MedTech Market Unlocked? Navigating the Registration Logjam.

12 Apr 2026

Contributed by Lukas

This episode of ASEAN MedTech Insights dives into a major development in Vietnam's medical device market. After a prolonged period of delays and uncer...

Pure Global: Indonesia's MedTech Halal Hurdle - The Unseen Compliance Challenge

11 Apr 2026

Contributed by Lukas

This week, we dive into a sudden regulatory shift in ASEAN's largest market. Indonesia has just mandated Halal certification for a wide range of medic...

Pure Global: Singapore's AI MedTech Sandbox, Cracking the New HSA Code.

10 Apr 2026

Contributed by Lukas

This week, we dive deep into the breaking news from Singapore as the Health Sciences Authority (HSA) rolls out a landmark new regulatory framework for...

Pure Global: Malaysia's AI MedTech Sandbox—The New Shortcut to Market Access?

09 Apr 2026

Contributed by Lukas

Malaysia's Medical Device Authority (MDA) has launched its first regulatory sandbox, creating a controlled, live-market environment for innovative AI-...

Pure Global: Singapore-Malaysia MedTech Shortcut - A New 'Two-for-One' Market Access Play.

08 Apr 2026

Contributed by Lukas

This week, ASEAN MedTech Insights unpacks a game-changing development from March 2026: Malaysia's permanent adoption of a regulatory reliance route wi...

Pure Global: Singapore's Digital & Halal Compliance - ASEAN's Unwritten Rules

07 Apr 2026

Contributed by Lukas

This week, we dissect the new ASEAN regulatory guidance that's shaking up the MedTech landscape. While the dream of a single, harmonized market is clo...

Malaysia's Singapore Shortcut: Pure Global on the New MedTech Regulatory Fast-Track.

06 Apr 2026

Contributed by Lukas

In this episode of ASEAN MedTech Insights, we dissect the groundbreaking new regulatory reliance program launched by Malaysia's Medical Device Authori...

Singapore's Regulatory Backdoor: Pure Global on Hacking MedTech Access into Malaysia & Beyond.

05 Apr 2026

Contributed by Lukas

This week, we dive into the most significant shift in ASEAN's MedTech regulatory landscape: the rise of reliance pathways. Discover how new pilot prog...

Vietnam's MedTech Shift: Pure Global on Navigating Sudden Import & Regulatory Hurdles.

04 Apr 2026

Contributed by Lukas

This week, we dive into the sudden and complex changes in Vietnam's medical device import regulations. A new set of decrees and circulars from the Min...

Pure Global: Singapore's AI MedTech Rule Change & The New ASEAN Domino Effect

03 Apr 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect a pivotal regulatory update from Singapore's Health Sciences Authority (HSA). We explore their newly r...

SG-MY MedTech Corridor: Pure Global on Unlocking the New Fast-Track Approval Secret.

02 Apr 2026

Contributed by Lukas

This week, we dive into a game-changing regulatory shift in Southeast Asia. Singapore's HSA and Malaysia's MDA have just formalized a fast-track appro...

Pure Global: Malaysia & Thailand's MedTech Dossier - The Hidden Hurdles.

01 Apr 2026

Contributed by Lukas

This week, we dive into the new "Med-Tech Unity Dossier," a pilot program launched by Malaysia and Thailand to streamline medical device registration....

Thailand's AI MedTech Green Lane: Pure Global on Dodging the Data Sovereignty Trap.

31 Mar 2026

Contributed by Lukas

Thailand just opened a regulatory fast-track for AI medical devices, promising rapid market entry. But this "Green Lane" comes with a hidden trap that...

Pure Global: The Malaysia-Thailand MedTech Corridor - Your Borderless Strategy's Hidden Traps.

30 Mar 2026

Contributed by Lukas

This week, we unpack the groundbreaking new medical device regulatory reliance pilot program launched between Malaysia and Thailand. This collaboratio...

Pure Global: Malaysia's Home-Use Devices & The Digital Dilemma of E-Labelling

29 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dive into a major regulatory update from Malaysia. The Medical Device Authority (MDA) has just greenlit e-labe...

Pure Global: Vietnam's Regulatory Shift & The MedTech Domino Effect in ASEAN

28 Mar 2026

Contributed by Lukas

This week, we dive into the landmark announcement from Vietnam's Ministry of Health: the full and immediate implementation of the ASEAN Medical Device...

Pure Global: Malaysia's AI MedTech Maze - Navigating Last Week's Unseen Regulatory Shifts.

27 Mar 2026

Contributed by Lukas

Malaysia's Medical Device Authority (MDA) has just unveiled a new, comprehensive regulatory framework for AI-powered medical devices, fundamentally ch...

Singapore's New AI Device Rules: Pure Global on Hidden Hurdles Beyond the Official Guidelines.

26 Mar 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just released a landmark new regulatory framework for AI-powered medical devices. This move solidifies...

Malaysia-Thailand's Regulatory Shortcut: Pure Global on a New Borderless MedTech Strategy.

25 Mar 2026

Contributed by Lukas

Last week, Malaysia and Thailand launched a pivotal pilot program for medical device registration, creating a new fast-track pathway for market access...

Pure Global: Singapore's AI MedTech Shake-up - Cracking the New HSA Software Rules

24 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the major regulatory shift in Singapore. The Health Sciences Authority (HSA) has just released updated...

Pure Global: Malaysia's Digital Shift - Unlocking MedTech Approval Secrets

23 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we delve into the sudden and mandatory switch to Malaysia's new digital medical device registration portal, MeDC@...

Singapore's AI MedTech Gambit: Pure Global on the New HSA Registration Shortcut

22 Mar 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just launched a new fast-track approval pathway for AI-powered medical devices. This game-changing mov...

Pure Global: Singapore-Malaysia's MedTech 'Backdoor'? Unpacking the New Joint Registration Pilot.

21 Mar 2026

Contributed by Lukas

This week, we dive into the groundbreaking MedTech registration pilot program just launched between Singapore and Malaysia. This collaboration promise...

Pure Global: Jakarta's AMDD Update - Cracking the Code of ASEAN's High-Risk Device Maze.

20 Mar 2026

Contributed by Lukas

This week, we dissect the groundbreaking new draft guidelines from the ASEAN Medical Device Committee meeting in Jakarta. A unified market for high-ri...

Pure Global: Singapore's AI MedTech Rules - Beyond the Official Playbook.

19 Mar 2026

Contributed by Lukas

This week, we dive deep into Singapore's groundbreaking new regulatory updates for AI-powered medical devices. Singapore's Health Sciences Authority (...

Kuala Lumpur MedTech Gridlock: Pure Global Unpacks the MDA Portal's Hidden Challenge

18 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we delve into the critical challenges emerging from Malaysia's new digital medical device registration portal, Me...

Malaysia's AI Gatekeeper: Pure Global on Navigating New SaMD Hurdles.

17 Mar 2026

Contributed by Lukas

This week, we dive into a major development from Malaysia's Medical Device Authority (MDA). The launch of their new AI-powered submission platform and...

Pure Global: Singapore AI MedTech - Navigating HSA's New High-Stakes Regulatory Maze.

16 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the groundbreaking new guidelines from Singapore's Health Sciences Authority (HSA) for AI-powered medi...

Pure Global: Malaysia's MedTech Fast-Track & The Singapore Reliance Trap.

15 Mar 2026

Contributed by Lukas

This week, we explore Malaysia's game-changing decision to fast-track medical device approvals for products already cleared by Singapore's Health Scie...

Pure Global: Singapore's AI MedTech Leap—Navigating Hidden HSA Compliance Traps.

14 Mar 2026

Contributed by Lukas

Last week, Singapore's Health Sciences Authority (HSA) launched a new, stringent regulatory framework for AI-enabled medical devices, setting a new be...

Bangkok's AI MedTech Play: Pure Global on the Singapore-Thai Secret Regulatory Shortcut.

13 Mar 2026

Contributed by Lukas

Last week, Thailand's FDA unveiled a game-changing 90-day fast-track registration for high-risk AI diagnostic software already approved in Singapore. ...

Pure Global: Malaysia's AI Sandbox - The Secret Rules for Fast-Track MedTech Approval.

12 Mar 2026

Contributed by Lukas

This week, we dive into a major development from Malaysia's Medical Device Authority (MDA): the launch of a new AI Regulatory Sandbox. This initiative...

KL-Bangkok MedTech Corridor: Pure Global on The Secret To Slashing Your Device Registration Time.

11 Mar 2026

Contributed by Lukas

This week, we dive into a game-changing development in ASEAN's regulatory landscape: the new Malaysia-Thailand Medical Device Regulatory Reliance Pilo...

Pure Global: Malaysia's MedTech Gambit - Cracking the New Fast-Track for Cardio Devices.

10 Mar 2026

Contributed by Lukas

In this episode, we dissect the groundbreaking news from Malaysia's Medical Device Authority (MDA), which has just launched a pilot program to slash a...

Pure Global | Malaysia's New MedTech Fortress: A Backdoor Strategy for ASEAN Market Dominance?

09 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect Malaysia's bold new regulatory policy that tightens import and export controls for medical devices. We...

Kuala Lumpur AI MedTech: Pure Global on Cracking Malaysia's New Regulatory Code.

08 Mar 2026

Contributed by Lukas

This week, we dissect Malaysia's bold new regulatory framework for AI-powered medical devices. The government has introduced an accelerated pathway to...

Pure Global: Thai-Malay MedTech's New Playbook - Beyond the Rivalry

07 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we explore a game-changing shift in the region's landscape. For years, Thailand and Malaysia have been viewed as ...

Kuala Lumpur's New Data Pact: Pure Global on ASEAN's Hidden MedTech Compliance Web.

06 Mar 2026

Contributed by Lukas

This week, we dissect a major regulatory shift from Malaysia's Medical Device Authority (MDA) that has immediate implications for MedTech firms across...

Pure Global: Singapore's AI SaMD Update - The New Pre-Market Compliance Hurdle

05 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we delve into a major regulatory shift from Singapore's Health Sciences Authority (HSA). A new, mandatory Change ...

Pure Global: Singapore's AI MedTech Scene - Inside the HSA's New Fast-Track Sandbox

04 Mar 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just launched a new fast-track regulatory sandbox for AI-powered medical devices. This pivotal move is...

Pure Global: Hanoi's New AI Regulation - Navigating the Data Trap.

03 Mar 2026

Contributed by Lukas

This week, we dissect the sudden and impactful regulatory earthquake in Vietnam's MedTech sector. The Ministry of Health has released a new circular t...

Pure Global: Kuala Lumpur's MedTech Export Surge & The Hidden Regulatory Maze

01 Mar 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we delve into Malaysia's aggressive new strategy to dominate the global medical device market. Beyond its traditi...

Pure Global: Malaysia's MedTech Shift & The New Geopolitical Hurdles for Device Imports.

28 Feb 2026

Contributed by Lukas

This week, we dissect Malaysia's recent and abrupt regulatory shifts. The Medical Device Authority (MDA) has cancelled a key circular and simultaneous...

Malaysia-Thai MedTech Corridor: Pure Global on the New Reliance Program's Hidden Traps.

27 Feb 2026

Contributed by Lukas

This week, we dive into the newly launched medical device regulatory reliance program between Malaysia and Thailand. This landmark initiative promises...

Pure Global: Malaysia's AI MedTech Gambit - The 90-Day Approval Trap

26 Feb 2026

Contributed by Lukas

This week, we dissect Malaysia's bold new regulatory initiative launched last week. The Medical Device Authority (MDA) has rolled out an aggressive 90...

Pure Global: Singapore-Malaysia's Regulatory Fast-Track - A Hidden Market Backdoor?

25 Feb 2026

Contributed by Lukas

In this episode of ASEAN MedTech Insights, we dissect the groundbreaking new regulatory reliance pilot program launched between Singapore's HSA and Ma...

Pure Global: Malaysia's MedTech Maze & Cracking the New Borderline Device Code

24 Feb 2026

Contributed by Lukas

This week, ASEAN MedTech Insights unpacks the latest regulatory shift in Malaysia. We explore the new guidance from the Medical Device Authority (MDA)...

Kuala Lumpur AI MedTech: Pure Global on Malaysia's New Post-Market Surveillance Maze.

23 Feb 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the major regulatory shift in Malaysia. The Medical Device Authority (MDA) has just launched an aggres...

Kuala Lumpur's AI MedTech: Pure Global on Decoding Malaysia's New Regulatory Playbook

22 Feb 2026

Contributed by Lukas

This week, ASEAN MedTech Insights dives into a game-changing regulatory update from Malaysia. The Medical Device Authority (MDA) has just released its...

Singapore's AI MedTech Fast-Track: Pure Global on the Hidden Compliance Trap.

21 Feb 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the groundbreaking 'AI-Accelerate' pathway just launched by Singapore's Health Sciences Authority. Thi...

Pure Global: Malaysia's AI Gatekeepers - Surviving MedTech's New Robotic Reviewers.

20 Feb 2026

Contributed by Lukas

This week, we dive into a sudden and disruptive shift in Malaysia's MedTech landscape. The Medical Device Authority (MDA) has activated a mandatory AI...

Pure Global: Kuala Lumpur's AI MedTech Fast-Track or a Hidden Compliance Trap?

19 Feb 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we dissect the big news out of Malaysia: a new "fast-track" registration pathway for AI-powered medical software....

Jakarta's MedTech Gamble: Pure Global on Indonesia's Hidden Regulatory Traps.

18 Feb 2026

Contributed by Lukas

Indonesia's groundbreaking Omnibus Health Law is reshaping the MedTech landscape. With strong incentives for local manufacturing and R&D, the law pres...

Pure Global: Singapore's AI MedTech Rules & The ASEAN Compliance Domino Effect.

17 Feb 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just mandated a new, stringent cybersecurity requirement for all high-risk software and AI-enabled med...

Pure Global: Singapore's AI MedTech Fast-Track - Beyond the Hype, The Real Entry Hurdles

15 Feb 2026

Contributed by Lukas

Singapore has just launched an accelerated approval pathway for AI-powered medical devices, positioning itself as a top ASEAN hub for digital health. ...

Malaysia's MedTech Minefield: Pure Global on Borderline Product Classification Risks

14 Feb 2026

Contributed by Lukas

This week, we dive into a crucial regulatory shift in Malaysia. The Medical Device Authority (MDA) has released new, stricter guidance on classifying ...

Hanoi's MedTech Gambit: Pure Global on Vietnam's New Half-Price Window for Device Registration.

13 Feb 2026

Contributed by Lukas

This week, we dive into Vietnam's surprising and aggressive new strategy to attract global MedTech investment. The Ministry of Health has slashed medi...

Pure Global | Kuala Lumpur's AI MedTech Gambit: Navigating the New Fast-Track Maze.

12 Feb 2026

Contributed by Lukas

In this episode, we dissect the groundbreaking announcement from Malaysia's Medical Device Authority (MDA): a new fast-track approval pathway for AI-p...

Pure Global: Singapore-Malaysia's New MedTech 'Twin-Market' Shortcut

11 Feb 2026

Contributed by Lukas

This week, we dive into the groundbreaking news from Singapore and Malaysia. The two nations have launched a joint MedTech registration pilot, creatin...

Singapore-Malaysia MedTech Corridor: Unpacking the New Regulatory Shortcut with Pure Global.

10 Feb 2026

Contributed by Lukas

This week, we dive into the groundbreaking new regulatory pilot program launched between Singapore and Malaysia. This collaboration promises a faster,...

Pure Global: Malaysia & Thailand's New Fast-Track--A Unified Market or a Hidden Trap?

08 Feb 2026

Contributed by Lukas

This week, we dive into a major regulatory shift that just launched in ASEAN. On February 1st, Malaysia and Thailand kicked off a groundbreaking pilot...

Pure Global: Singapore's New AI Sandbox - The MedTech Fast-Track or a Hidden Trap?

07 Feb 2026

Contributed by Lukas

Singapore's Health Sciences Authority (HSA) has just unveiled a new "Regulatory Sandbox" for AI-powered medical software. This program promises a fast...

Pure Global: Malaysia's MedTech Gambit - The Race Against ASEAN Harmonization.

06 Feb 2026

Contributed by Lukas

Last week, Malaysia’s Medical Device Authority (MDA) unveiled a game-changing fast-track registration pathway for breakthrough medical technologies....

Pure Global: Malaysia-Thailand MedTech's New Fastlane—A Hidden Shortcut?

05 Feb 2026

Contributed by Lukas

In this episode, we dissect the groundbreaking regulatory reliance pilot program launched by Malaysia's MDA and Thailand's FDA. This initiative create...

Pure Global: Malaysia's MedTech Compliance Shockwave - Navigating New Registration Hurdles

03 Feb 2026

Contributed by Lukas

In this episode, we dissect the breaking news from Malaysia as its Medical Device Authority begins full enforcement of a new, stricter device classifi...

Pure Global: Malaysia-Thailand's MedTech Fast Track - Unlocking The New Reliance Loophole.

02 Feb 2026

Contributed by Lukas

This week, we dive into the landmark regulatory reliance pilot program launched between Malaysia and Thailand. This new initiative creates a fast-trac...

Pure Global: Singapore's AI MedTech Shockwave & The New ASEAN Rulebook.

01 Feb 2026

Contributed by Lukas

This week, we dissect the groundbreaking announcement from Singapore and Malaysia that is sending shockwaves through the ASEAN MedTech scene. Regulato...

Malaysia's AI MedTech Rules: Pure Global on The New Data Localization Trap.

31 Jan 2026

Contributed by Lukas

This week, we dissect the surprise regulatory shake-up in Malaysia's MedTech scene. The Medical Device Authority (MDA) just dropped new, stricter draf...

Pure Global: Malaysia's AI MedTech Regulations, Cracking the New Digital Code.

30 Jan 2026

Contributed by Lukas

Malaysia just dropped a bombshell on the MedTech world. A brand-new regulatory framework for AI-powered medical devices has been rolled out, effective...

Vietnam's IVD Crackdown: Pure Global on Surviving the New Regulatory Gauntlet.

29 Jan 2026

Contributed by Lukas

This week on ASEAN MedTech Insights, we're diving into the urgent regulatory crisis hitting the in-vitro diagnostics sector in Vietnam. A new governme...

Pure Global: Singapore's New AI MedTech Rules & The Market Entry Trap

28 Jan 2026

Contributed by Lukas

Last week, Singapore's Health Sciences Authority (HSA) issued a critical update to its guidance for Software as a Medical Device (SaMD), with major im...

Pure Global: Malaysia-Thailand MedTech Shortcut & Its Hidden Traps

27 Jan 2026

Contributed by Lukas

This episode unpacks the groundbreaking new regulatory reliance pilot program announced by Malaysia and Thailand. We explore how this collaboration cr...

Pure Global: ASEAN's MedTech Harmonization Myth & The AMDD Reality Check

26 Jan 2026

Contributed by Lukas

This week, we dissect the complex reality of the ASEAN Medical Device Directive (AMDD). While the vision is a single, harmonized market, MedTech compa...

Bangkok's New Playbook: Pure Global on Cracking ASEAN's MedTech Harmonization Code.

25 Jan 2026

Contributed by Lukas

This week, we dive into the most significant announcement from the International Healthcare Week in Bangkok: the launch of the 'ASEAN Device Accord'. ...

Indonesia's Halal Mandate: Pure Global on the MedTech Compliance Blind Spot.

24 Jan 2026

Contributed by Lukas

This week, we dissect a critical, and often overlooked, market access barrier in Indonesia: the mandatory Halal certification for medical devices. Thi...

Pure Global: The Malaysia-Thailand MedTech Shortcut - Hacking the New Regulatory Alliance.

23 Jan 2026

Contributed by Lukas

In this episode, we dive into the most significant ASEAN regulatory news of the year: the launch of the Malaysia-Thailand Medical Device Regulatory Re...