Regulatory updates Archives - Page 3 of 16

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

December 24, 2025

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

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

December 12, 2025

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

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

December 12, 2025

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

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

December 9, 2025

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

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

December 8, 2025

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

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

December 8, 2025

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,

Regulatory Updates

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

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

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

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

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

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

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