December 2025

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

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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, including official forms and implementation […]

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Philippines: Administrative Order No. 2025-0024 – Guidelines in Availing Compassionate Special Permit for the Restricted Use of Covered Pharmaceutical Products and Medical Devices for Human Use

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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 critical therapeutic interventions in urgent

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Asia’s Ageing Population Drives MedTech Expansion

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Asia is home to 60% of the world’s population, and by 2030, one in four people in the region will be aged over 60. This demographic shift will significantly increase the need for diagnosis, treatment, and management of chronic conditions such as cardiovascular disease, diabetes, cancer, and neurodegenerative disorders. The impact on healthcare systems will

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Malaysia: Draft for Comments – First Edition Guidance Document on Change Management for Registered Medical Devices

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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 learn more: https://portal.mda.gov.my/index.php/announcement/1729-announcement-public-comment-first-edition-guidance-document-change-management-for-registered-medical-devices Purpose of

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Malaysia: Draft for Comments – Second Edition Guidance Document on the Definitions of Medical Devices

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The Medical Device Authority (MDA) has published a draft of the Second Edition Guidance Document titled “Definitions of Medical Devices” for public comment. This guidance document defines accessories, components, and spare parts of medical devices, and provides examples to enhance clarity. Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1730-announcement-public-comment-first-edition-guidance-document-definitions-of-medical-devices Purpose of the Guidance Document To

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Malaysia and Thailand Launch Regulatory Reliance Pilot to Accelerate Medical Device Market Access

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The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) have signed a Confidentiality Agreement to strengthen regulatory collaboration and launch a pilot program to accelerate medical device market access. As part of this agreement, both authorities officially launched a three-month pilot of the Medical Device Regulatory Reliance Programme.

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Malaysia: MDA Postpones Mandatory Enforcement of Medical Device Import Permit (IP)

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On 1 December 2025, the Medical Device Authority (MDA) issued an important update regarding the enforcement timeline for the Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. The update provides: A revised enforcement date for the mandatory Import Permit requirement Continued application of existing import procedures during the transition

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Thailand: Thai FDA Clarifies That All Types of Contact Lenses Are Classified as Medical Devices

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The Thai FDA has issued a clarification and reminder that all types of contact lenses whether used for medical or aesthetic purposes are classified as medical devices in Thailand. This announcement aims to promote consumer safety by preventing improper use, ensuring that only high quality and compliant products reach customers, and reinforcing proper regulation in

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