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
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
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
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,
The Food and Drug Administration (FDA) of the Philippines has issued updated guidelines for applying for a Compassionate Special Permit (CSP), enabling access to pharmaceutical products and medical devices that are not registered in the Philippines but are necessary for restricted, compassionate use. This Order aims to facilitate access to
The Medical Device Authority (MDA) has published the draft for comments of the First Edition Guidance Document titled “CHANGE MANAGEMENT FOR REGISTERED MEDICAL DEVICES”. This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples. Read the full announcement to
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