January 2026

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

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

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

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)

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)

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)

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

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) Read More »

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”

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

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

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

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

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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