Regulatory Updates

The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, for public comment.  This document is intended to replace the previous edition, MDA/GD/0043 May 2020: Special Access – Notification – General

On 25 March 2025, the Medical Device Authority (MDA) of Malaysia issued a press release announcing a prohibition on the online sale of optical devices and contact lenses. These products are designated as prescribed medical devices under the Medical Device Act 2012 (Act 737) and the Opticians Act 1991 (Act

On 26 March 2025, the Medical Device Authority (MDA) of Malaysia officially announced the implementation of a Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. This new regulation mandates that importers obtain an Import Permit for bringing medical devices into Malaysia. The MDA has

On April 8, 2025, the Medical Device Authority (MDA) of Malaysia released two important regulatory updates to enhance efficiency, strengthen compliance, and improve the overall submission process for product classification. These updates are effective starting May 1, 2025. The first update mandates the full transition to online submission for product