Regulatory updates Archives - Page 6 of 17

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

January 20, 2026

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

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)

January 20, 2026

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

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”

January 20, 2026

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

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

January 12, 2026

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

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

January 7, 2026

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

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

January 7, 2026

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

Regulatory Updates

Regulatory Updates

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

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)

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

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

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

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Regulatory Updates

Regulatory Updates

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

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)

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

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

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

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

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Main Pages

Address

E-mail Address

Phone Number

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