Regulatory updates Archives - Page 4 of 17

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,

Vietnam: MoH Releases New Circular on Medical Device Management and Regulatory Documentation Requirements

November 28, 2025

Overview of the New Circular On 22 November 2025, the Vietnam Ministry of Health (MoH) issued a new Circular detailing updated administrative procedures and regulatory requirements for medical device management. The Circular provides: Specific assignments of authority to the Infrastructure and Medical Device Administration (IMDA) Updated requirements for documentation and

Malaysia: Implementation of Validity Period for Product Classification Letters

November 25, 2025

The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025. To read the full announcement: Implementation of Validity Period for Product Classification Letter [link] Key Updates 1. Introduction

Regulatory Updates

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

Vietnam: MoH Releases New Circular on Medical Device Management and Regulatory Documentation Requirements

Malaysia: Implementation of Validity Period for Product Classification Letters

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