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
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
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
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
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
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
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