On 22 September 2025 , the Medical Device Authority (MDA) led a key stakeholder engagement session with the Association of Malaysian Medical Industries (AMMI) in Penang , held at the Iconic Marjorie Hotel. The session, attended by 51 industry participants, focused on strategic discussions regarding regulatory sandboxes for high-tech medical devices, particularly AI-enabled medical devices, and the Medical Device Single Audit Program (MDSAP). These focus areas reflect MDA’s

In the ever-evolving world of medical device regulation, staying ahead of the curve is crucial, especially when entering rapidly growing markets like Malaysia. The newly released Second Edition of MDA/GD/0070 from Malaysia’s Medical Device Authority (MDA) brings clarity and structure to the registration process, especially for manufacturers and authorised representatives who opt for conformity assessment by way of the verification route. Here’s what you need to know and how t

31 October 2025 – Cyberjaya, Malaysia The Medical Device Authority (MDA), under the Ministry of Health (MOH), has issued a media statement to reinforce regulatory control and monitoring of influenza test kits currently available in the Malaysian market. The announcement clarifies that all influenza test kits are classified as In Vitro Diagnostic (IVD) Medical Devices intended strictly for use by trained healthcare professionals. This means these test kits are not approved for

The Medical Device Authority (MDA) of Malaysia has released the first edition draft guidance document titled “𝘈𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘊𝘰𝘯𝘧𝘪𝘳𝘮𝘢𝘵𝘪𝘰𝘯 𝘚𝘵𝘢𝘵𝘶𝘴 𝘰𝘧 𝘖𝘳𝘱𝘩𝘢𝘯𝘦𝘥 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦”. It is inviting industry stakeholders to provide feedback. This document is a significant step toward managing legacy medical devices that remain in healthcare facilities without active manufacturer or Authorised Representative (AR) oversight, ensur

In a powerful display of commitment to global harmonization and regulatory efficiency, Malaysia’s Medical Device Authority (MDA) has...

On 17 September 2025 , the National Pharmaceutical Regulatory Agency (NPRA) released a safety signal alert concerning the anticonvulsant...

22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the...

In a landmark move for international medical device regulation, the Medical Device Authority (MDA) and National Medical Products...

In a continued effort to strengthen the quality and efficiency of regulatory assessments, the National Pharmaceutical Regulatory Agency...

In a world where healthcare innovation often outpaces regulations, one country is stepping forward to bridge that gap with confidence,...

The Medical Device Authority (MDA) has released an official statement reinforcing a strict prohibition on the online sale of optical...

The World Health Organization (WHO) released a notification regarding the performance of certain malaria diagnostic test kits , which has...

In a move to enhance the regulation and traceability of medical device imports, the Medical Device Authority (MDA) has officially...

The Medical Device Authority (MDA) has announced a key regulatory update that impacts all stakeholders within the medical device and...

Starting 1 May 2025 , the Medical Device Authority (MDA) is pleased to announce that all product classification applications must be...

To provide clarity and streamline compliance with the Medical Device Act 2012 (Act 737), on the 13 March 2025, the Medical Device...

The Medical Device Authority (MDA) is set to enhance its application process by transitioning to a fully online system for advertisement...

The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of...

The National Pharmaceutical Regulatory Agency (NPRA) has introduced a progressive initiative to improve the regulatory process for...

Effective 19 November 2024 , the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the...