Regulatory updates Archives - Page 2 of 16

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

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

January 6, 2026

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

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

December 29, 2025

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,

Regulatory Updates

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

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

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

Countries

Categories

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

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!