As more MedTech manufacturers look beyond China and explore Southeast Asia as their next growth market, many are seeking clearer guidance on how to navigate ASEAN regulatory pathways, market access requirements, and local commercial strategies. With this growing demand in mind, Andaman Medical returned to the 93rd China International Medical Equipment Fair (CMEF) in Shanghai […]
Asia Pacific is rapidly becoming one of the most transformative regions for In Vitro Diagnostics (IVD), driven by fast-advancing technologies and growing demand for high-precision, accessible diagnostic solutions. As healthcare systems across the region invest in modernization and digital health, innovation in diagnostics is playing a critical role in reshaping clinical workflows and elevating standards
2026 Trend: Technological Innovation Accelerating IVD Growth in Asia Pacific Read More »
Asia is rapidly emerging as a strategic hub for innovation, manufacturing, and commercial expansion in the global MedTech landscape. No longer viewed solely as an end market, the region is becoming a core base where leading companies build capabilities to meet diverse and fast-growing healthcare needs. Insights shared from last year’s LSI USA Emerging MedTech
Why Global MedTech Leaders Are Increasing Investment in Asia Read More »
On January 23, 2026, the Vietnamese Government issued Decree No. 37/2026/ND-CP, detailing provisions and measures for the implementation of the Law on Product and Goods Quality. The Decree establishes a comprehensive regulatory framework consisting of 8 chapters and 99 articles governing the quality management of products and goods circulating in Vietnam, with a strong emphasis
Vietnam: New Decree on Product and Goods Quality Management Issued Read More »
On March 9, 2026, the Medical Device Authority (MDA), Ministry of Health Malaysia, announced the implementation of the Innovative Medical Device Review Pathway to support the development and regulatory readiness of innovative medical devices in Malaysia. The initiative aligns with the New Industrial Master Plan (NIMP) 2030 and aims to foster collaboration between government, academia,
Malaysia: MDA Launches Innovative Medical Device Review Pathway Read More »
Administrative Order (AO) 2025-0030 was issued by the Philippines Department of Health to formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). The AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued safety, performance and quality following
The Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0274 announcing the designation of an Officer of the Day (OOD) at the Food and Drug Action Center (FDAC). This initiative aims to ensure the continuous, efficient, and timely handling of urgent regulatory concerns, public inquiries, and emergency cases within the Food and Drug Administration
Philippines: Designation of Officer of the Day at the Food and Drug Action Center (FDAC) Read More »
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,
How AI is Shaping the In Vitro Diagnostics (IVD) Market in Asia Pacific Read More »
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
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
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
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
Malaysia: Malaysia MDA – Thai FDA Pilot Project under Regulatory Reliance Framework Read More »
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
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
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
Vietnam: New Radiation Safety Requirements for Medical Devices Read More »
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
Rising Demand for IVD Tests Creates Opportunities in Southeast Asia Read More »
On January 27, 2026, the Medical Device Authority (MDA) of Malaysia hosted the “Shaping What’s Next 2026” ceremony in Putrajaya. The Chief Executive presented a comprehensive review of 2025 achievements and outlined the strategic roadmap for 2026. 2025 Performance Review: Global Leadership in Efficiency MDA demonstrated world-class regulatory efficiency in 2025, maintaining a 95% adherence
The Thai Ministry of Public Health has issued a new Notification titled Principles, Methods, and Conditions for Displaying Labels and Medical Device Package Inserts, B.E. 2568 (2025). This Notification replaces the previous 2020 regulation and introduces streamlined labeling rules, harmonized package insert requirements for home-use and professional-use devices, updated provisions for software and special device
The Government of Vietnam has issued Decree No. 342/2025/NĐ-CP, providing detailed guidance on the implementation of the Law on Advertising. The Decree consists of 5 chapters and 32 articles, establishing comprehensive rules governing advertising activities across multiple platforms and product categories. Read the full decree here: See attached Vietnamese document (English translation not available). Purpose
Vietnam: Vietnam MoH Issues New Decree Detailing Guidance on Advertising Regulations Read More »
The Ministry of Health has issued Circular No. 59/2025/TT-BYT amending Circular No. 05/2022/TT-BYT, which provides guidance on the implementation of certain provisions of Government Decree No. 98/2021/NĐ-CP on the management of medical devices. The amendment specifically updates Article 8, which outlines the roadmap for safety and technical performance testing of medical devices listed in Article
On December 31, 2025, the Minister of Health issued Circular No. 57/2025/TT-BYT, providing guidance on the classification of medical devices by technical and quality standards pursuant to Point (d), Clause 2, Article 146 of Government Decree No. 214/2025/NĐ-CP, which details the implementation of the Law on Bidding with respect to contractor selection. The Circular establishes
Vietnam: New Circular on Medical Device Categorization by Standards and Quality Read More »
The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Designated Medical Devices) Order 2026, introducing enhanced regulatory oversight for selected medical devices used in aesthetic and cosmetic treatments. The Order aims to strengthen patient safety, ensure device quality, and promote responsible use of medical technologies in Malaysia. Read the full announcement:
The Singapore Health Sciences Authority (HSA) has published Revision 4 of GL-04: Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach. This updated guideline introduces significant enhancements reflecting HSA’s strengthened focus on lifecycle governance, cybersecurity expectations, and oversight of machine learning technologies within Software as a Medical Device
The Food and Drug Administration (FDA) of the Philippines has issued FDA Circular No. 2025-007, providing detailed guidance on the submission of initial Certificate of Medical Device Notification (CMDN) applications, monitoring application status, and downloading approved CMDNs via the FDA eServices Portal System. This Circular formalizes the transition of CMDN initial application processing from the
The Philippine Department of Health (DOH) has issued Department Circular (DC) No. 2025-0574, further extending the suspension of the implementation of Administrative Order (AO) No. 2024-0016, which outlines the revised schedule of fees and charges of the Food and Drug Administration (FDA). The newly released circular continues the temporary halt on the implementation of the
The Philippine Food and Drug Administration (FDA) has issued FDA Circular No. 2025-006, announcing the implementation of an Online User Account Registration and Renewal System within the FDA eServices Platform. This circular establishes a centralized and automated system for the creation, activation, renewal, and management of user accounts across all FDA online portals. The circular
Philippines: FDA Circular No. 2025-006 on Online User Account Registration and Renewal Read More »
The Nuclear Energy Regulatory Agency of the Republic of Indonesia (BAPETEN) has issued Regulation Number 1 of 2025 concerning the Conformity Assessment of X-ray Equipment for Diagnostic and Interventional Radiology. This regulation establishes the requirements and procedures to ensure X-ray equipment complies with applicable national and/or international safety standards. The regulation applies to both locally
Indonesia: New Indonesian Regulation on Conformity Assessment of X-ray Equipment Read More »
The Ministry of Public Health has released a draft Notification for public consultation proposing amendments to the fees collected in the medical device product authorization process. The draft was published on 11 December 2025 through official platforms of the Thai Food and Drug Administration and outlines proposed fee exemptions applicable to specific categories of applicants.
The Food and Drug Administration (FDA) has published a draft circular for comments outlining the proposed Operational Procedures and Requirements for the Application of a Sales Promotion Permit for FDA-regulated health products. The draft aims to establish a streamlined and harmonized application process for sales promotion campaigns and is currently open for public comment. Read
On December 11, 2025, the Vietnam Ministry of Health (MoH) issued Decision No. 3830, establishing internal and electronic procedures for handling administrative procedures related to medical devices under the MoH’s authority. Read the full announcement: PDF link Clients are advised to review the original Vietnamese version for complete procedural details, including official forms and implementation
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