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
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