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Vietnam: New Radiation Safety Requirements for Medical Devices

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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

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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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MDA Chief Executive’s New Year Message 2026

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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

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Thailand: Principles, Methods, and Conditions for Displaying Labels and Medical Device Package Inserts, B.E. 2568 (2025)

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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

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Vietnam: Vietnam MoH Issues New Decree Detailing Guidance on Advertising Regulations

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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

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Vietnam: Updated Roadmap for Safety and Technical Performance Testing of Medical Devices in Vietnam

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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

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Vietnam: New Circular on Medical Device Categorization by Standards and Quality

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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

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Malaysia: Malaysia Introduces Enhanced Regulatory Control for Aesthetic and Cosmetic Medical Devices (Medical Device Order 2026)

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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:

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Singapore: GL-04 Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach (Revision 4)

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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

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Philippines: FDA Circular 2025-007 | Guidelines on the Use of the Food and Drug Administration eServices Portal System for the Initial Application of a Certificate of Medical Device Notification (CMDN)

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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

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Philippines: Further Extension of the Suspension Period Under Department Circular No. 2025-0240 and Its Subsequent Extension, Pertaining to the Implementation of Administrative Order No. 2024-0016 Entitled, “Implementation Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration”

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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

Philippines: Further Extension of the Suspension Period Under Department Circular No. 2025-0240 and Its Subsequent Extension, Pertaining to the Implementation of Administrative Order No. 2024-0016 Entitled, “Implementation Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration” Read More »

Philippines: FDA Circular No. 2025-006 on Online User Account Registration and Renewal

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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

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Indonesia: New Indonesian Regulation on Conformity Assessment of X-ray Equipment

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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

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Thailand: Draft for Comments – Proposed Fee Exemptions in Medical Device Product Authorization Process

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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.

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Philippines: Draft for Comments – Operational Procedures on the Application for Sales Promotion Permit

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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

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Vietnam: Ministry of Health Issues Decision No. 3830 Establishing Internal and Electronic Procedures for Medical Device Administration

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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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Philippines: Administrative Order No. 2025-0024 – Guidelines in Availing Compassionate Special Permit for the Restricted Use of Covered Pharmaceutical Products and Medical Devices for Human Use

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The Food and Drug Administration (FDA) of the Philippines has issued updated guidelines for applying for a Compassionate Special Permit (CSP), enabling access to pharmaceutical products and medical devices that are not registered in the Philippines but are necessary for restricted, compassionate use. This Order aims to facilitate access to critical therapeutic interventions in urgent

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Asia’s Ageing Population Drives MedTech Expansion

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Asia is home to 60% of the world’s population, and by 2030, one in four people in the region will be aged over 60. This demographic shift will significantly increase the need for diagnosis, treatment, and management of chronic conditions such as cardiovascular disease, diabetes, cancer, and neurodegenerative disorders. The impact on healthcare systems will

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Malaysia: Draft for Comments – First Edition Guidance Document on Change Management for Registered Medical Devices

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The Medical Device Authority (MDA) has published the draft for comments of the First Edition Guidance Document titled “CHANGE MANAGEMENT FOR REGISTERED MEDICAL DEVICES”. This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples. Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1729-announcement-public-comment-first-edition-guidance-document-change-management-for-registered-medical-devices Purpose of

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Malaysia: Draft for Comments – Second Edition Guidance Document on the Definitions of Medical Devices

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The Medical Device Authority (MDA) has published a draft of the Second Edition Guidance Document titled “Definitions of Medical Devices” for public comment. This guidance document defines accessories, components, and spare parts of medical devices, and provides examples to enhance clarity. Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1730-announcement-public-comment-first-edition-guidance-document-definitions-of-medical-devices Purpose of the Guidance Document To

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Malaysia and Thailand Launch Regulatory Reliance Pilot to Accelerate Medical Device Market Access

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The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) have signed a Confidentiality Agreement to strengthen regulatory collaboration and launch a pilot program to accelerate medical device market access. As part of this agreement, both authorities officially launched a three-month pilot of the Medical Device Regulatory Reliance Programme.

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Malaysia: MDA Postpones Mandatory Enforcement of Medical Device Import Permit (IP)

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On 1 December 2025, the Medical Device Authority (MDA) issued an important update regarding the enforcement timeline for the Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. The update provides: A revised enforcement date for the mandatory Import Permit requirement Continued application of existing import procedures during the transition

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Thailand: Thai FDA Clarifies That All Types of Contact Lenses Are Classified as Medical Devices

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The Thai FDA has issued a clarification and reminder that all types of contact lenses whether used for medical or aesthetic purposes are classified as medical devices in Thailand. This announcement aims to promote consumer safety by preventing improper use, ensuring that only high quality and compliant products reach customers, and reinforcing proper regulation in

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Vietnam: MoH Releases New Circular on Medical Device Management and Regulatory Documentation Requirements

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Overview of the New Circular On 22 November 2025, the Vietnam Ministry of Health (MoH) issued a new Circular detailing updated administrative procedures and regulatory requirements for medical device management. The Circular provides: Specific assignments of authority to the Infrastructure and Medical Device Administration (IMDA) Updated requirements for documentation and reporting New and revised templates

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Andaman Medical at the TIER Business Matching Event 2025: Supporting Taiwanese Innovators Entering Malaysia’s Healthcare Market

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The Taiwan Economic Development (TIER) Business Matching Event has steadily developed into a significant platform for strengthening regional cooperation and advancing healthcare innovation. From the 25th to the 26th September 2025, Andaman Medical was pleased to participate in this year’s event together with Nord Pacific Medical, engaging directly with manufacturers and innovators interested in expanding

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Andaman Medical at CMEF Guangzhou 2025: Empowering Chinese Manufacturers Expanding Into Southeast Asia

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Andaman Medical was proud to participate in the China International Medical Equipment Fair (CMEF) Autumn Edition 2025, held from 26 to 29 September 2025 at the China Import and Export Fair Complex in Guangzhou. As one of the largest and most influential exhibitions in the global MedTech calendar, CMEF brought together thousands of medical device

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Malaysia: Implementation of Validity Period for Product Classification Letters

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The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025. To read the full announcement: Implementation of Validity Period for Product Classification Letter [link] Key Updates 1. Introduction of Validity Period As stated

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Malaysia–United States Agreement on Reciprocal Trade

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The Medical Device Authority (MDA) of Malaysia has announced the successful conclusion of the Malaysia–United States Agreement on Reciprocal Trade, marking a landmark achievement for the nation’s medical device industry. The announcement coincides with the ASEAN Summit 2025, underscoring Malaysia’s commitment to advancing international trade and regulatory cooperation in the healthcare sector. Scope Summary of

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Indonesia: Regulation of the Minister of Health No. 11 Year 2025 — Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector

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The Ministry of Health of the Republic of Indonesia has issued Regulation of the Minister of Health No. 11 of 2025 (“the Regulation”) concerning Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector. The Regulation comprises 40 articles and 1 appendix and introduces updated requirements for licensing within the health sub-sector, covering the

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Indonesia: Procedures for the Registration of Foreign Halal Certificates (BPJPH Decree No. 221 Year 2025)

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The Halal Product Assurance Agency (BPJPH) has issued Decree No. 221 Year 2025 (“the Decree”) titled Procedures for the Registration of Foreign Halal Certificates. This regulation revokes the Decree of the Head of the Halal Product Assurance Agency (BPJPH) No. 90 of 2023. The Decree was promulgated on 15 September 2025 and governs the registration

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