February 2026

How AI is Shaping the In Vitro Diagnostics (IVD) Market in Asia Pacific

Artificial intelligence (AI) is emerging as a powerful driver in the Asia Pacific IVD market. By improving diagnostic accuracy and speeding up decision-making, AI is helping laboratories and healthcare providers detect diseases earlier and design more personalized treatment plans. Its integration into molecular diagnostics and point-of-care testing is especially impactful in remote or underserved regions, […]

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Thailand: Criteria, Procedures, and Conditions for Record Keeping and Reporting of the Manufacture, Importation, or Sale of Medical Devices (B.E. 2568)

The Ministry of Public Health has issued a new Announcement to update and modernize the requirements for record keeping and regulatory reporting related to the manufacture, importation, and sale of medical devices in Thailand under the Medical Device Act B.E. 2551 (2008), as amended. The objective of this Announcement is to strengthen regulatory oversight, ensure

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Thailand: Criteria, Methods, and Conditions for Business Termination, Remaining Quantity, and Storage Facility of Medical Devices after Business Cessation, Non Renewal or Revocation of Business Establishment License, Medical Device License, Notified Certificate, or Listed Certificates of Medical Device B.E.2568 (2025)

The secretary of the Food and Drug Administration has issued a new Announcement to regulate the management, declaration, and reporting of remaining quantities and storage facilities of medical devices following: Business termination Non-renewal or refusal of renewal of Business establishment license, medical device licenses, notified certificates and listed certificates This announcement repeals and replaces the

Thailand: Criteria, Methods, and Conditions for Business Termination, Remaining Quantity, and Storage Facility of Medical Devices after Business Cessation, Non Renewal or Revocation of Business Establishment License, Medical Device License, Notified Certificate, or Listed Certificates of Medical Device B.E.2568 (2025) Read More »

Thailand: Draft Criteria, Procedures, and Conditions for the Use of Medical Devices in Clinical Investigations B.E. xxxx

The Ministry of Public Health has issued a draft Notification to revise and replace the existing regulation on the use of medical devices in clinical investigations (B.E. 2545 (2002). The proposed revision aims to modernize Thailand’s clinical investigation framework and align with current international standards. Read the full draft here: กองควบคุมเครื่องมือแพทย์ Purpose of the Draft

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Malaysia: Malaysia MDA – Thai FDA Pilot Project under Regulatory Reliance Framework

The Thai Food and Drug Administration (Thai FDA), in collaboration with the Medical Device Authority (MDA) of Malaysia, has launched a pilot project to facilitate medical device registration in Thailand under the Regulatory Reliance framework, based on Good Reliance Practices. Under this pilot initiative, the Thai FDA may rely on the assessment outcomes from Malaysia

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Andaman Medical at HKPC: Supporting MedTech Companies in Navigating ASEAN Medical Device Compliance

On 2 February 2026, Andaman Medical co-organised a focused industry seminar together with Nord Pacific Medical and Hong Kong Productivity Council (HKPC), bringing together companies looking for practical guidance on ASEAN medical device compliance. As more MedTech companies look toward Southeast Asia for growth, many are seeking clearer direction on regulatory pathways, documentation requirements, and

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Malaysia: New Requirements for Procurement of Medical Devices by Healthcare Facility Institutions

The Medical Device Authority (MDA) has issued Circular Letter No. 1/2026, introducing new requirements under Act 737 governing the procurement of medical devices by healthcare facility institutions in Malaysia. These requirements take effect from 28 January 2026. The Circular clarifies the regulatory obligations applicable to companies participating in medical device tenders and sets out mandatory

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Vietnam: New Radiation Safety Requirements for Medical Devices

The Minister of Science and Technology has issued Circular No. 59/2025/TT-BKHCN, regulating radiation safety and preparedness and response to radiation and nuclear incidents. The Circular introduces comprehensive requirements on radiation safety in healthcare, with specific obligations applicable to radiation-related medical devices. Read the full circular here in Vietnamese: [PDF] (English translation not available). Purpose of

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Rising Demand for IVD Tests Creates Opportunities in Southeast Asia

The in vitro diagnostics (IVD) market in Southeast Asia is forecast to grow steadily, with projections showing a 7% CAGR from 2025 to 2032 and an expected value of 4.11 billion US dollars by 2032. IVD tests, including PCR, ELISA, and next-generation sequencing, are becoming central to healthcare delivery by supporting early disease detection, chronic

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