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The Medical Device Authority (MDA) has issued the Third Edition of the Guidance Document MDA/GD/0062: Harmonised Classification of Medical Devices in ASEAN. This document supersedes previous editions and provides an updated list of harmonised risk classifications for general and in-vitro diagnostic (IVD) medical devices, as agreed by the ASEAN Medical Device Committee (AMDC). The classification […]

The Medical Device Authority (MDA) has published the Third Edition of MDA/GD/0063: Harmonised Borderline Products in ASEAN, which outlines product categories that fall within or outside the scope of medical device regulation across ASEAN member states. This guidance serves as a key reference to determine whether a product is regulated as a medical device or

The Medical Device Authority (MDA) has announced a new enhanced process to facilitate the resolution of classification risk disputes between Establishments and Conformity Assessment Bodies (CABs). This initiative aligns with the Medical Device Act 2012 (Act 737) and aims to improve consistency and clarity in determining the appropriate classification for both General Medical Devices (GMD)

The Medical Device Authority (MDA) has issued an updated regulatory approach regarding the use of expired EC Certificates for the new registration of medical devices in Malaysia. This revision is in response to ongoing challenges associated with the transition to the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The Medical Device Authority (MDA) reminds all licensed establishments of the official requirements for re-registering medical devices in Malaysia, in accordance with the latest Guidance Document MDA/GD/0070 titled “Guide for Medical Device Establishment Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St.” Under this guidance, re-registration must be conducted via

On 3 June 2025, the Medical Device Authority (MDA) issued a media statement highlighting its ongoing efforts to ensure that online advertisements of medical devices comply with regulatory requirements under the Medical Device Act 2012 (Act 737). The objective is to safeguard public health and safety by preventing the sale and advertisement of unregistered medical

On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits. In this regard, the Medical

On 26 March 2025, the Medical Device Authority (MDA) announced the implementation of Circular Letter No. 1/2025, which supersedes Circular Letter No. 2/2014 regarding conformity assessment procedures for medical devices approved by recognised foreign regulatory authorities. This new circular was approved by the MDA Board and Top Management and took effect on 11 March 2025.

The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0051 April 2025: Medical Device for the Purpose of Export Only, for public comment. This document is intended to replace the previous edition MDA/GD/0051 April 2019: Notification of Export Only Medical Device. The revised guidance provides comprehensive guidance on the procedures and

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 Requirements. The revised guidance provides

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 469). Only registered opticians or

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 been designated as the responsible

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 classification applications. The second introduces