Cyberjaya, 26 January 2026 – The Medical Device Authority (MDA) successfully convened the MDA–Industry Collaborative Committee (MICC) Bil. 1/2026, marking the first engagement session with industry stakeholders for the year 2026. The meeting served as a strategic platform to strengthen collaboration between the regulator and the medical device industry in advancing a progressive and responsive regulatory ecosystem.

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The meeting was chaired by the Chief Executive of MDA, Dr. Muralitharan Paramasua, and attended by MDA officials as well as representatives from key industry associations, namely the Association of Malaysian Medical Industries (AMMI), Malaysia Medical Device Association (MMDA), Malaysia Dental Industry Association (MDIA), Malaysian Rubber Glove Manufacturers Association (MARGMA), and Persatuan Pengilang-Pengilang Peranti Perubatan Malaysia (PERANTIM).

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During the session, the Chairman provided updates on several key strategic initiatives undertaken by MDA, including the implementation of the Designated Medical Devices regulation, the introduction of the AI Regulatory Sandbox to support emerging technologies, and updates to the circular on Conformity Assessment by Verification, which now incorporates reliance on existing regulatory approvals. The meeting also highlighted the ongoing development of the Medc@st 3.0 system, with core modules targeted for launch in Quarter 2 and Quarter 3 of 2026.

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In addition, updates were presented on the implementation of the Unique Device Identification (UDI) framework and related data requirements. The draft UDI guidance document is expected to be circulated for public comment in May 2026 and subsequently published in July 2026, in conjunction with the launch of the Medc@st 3.0 system.

In his closing remarks, the Chairman emphasised that continuous engagement with industry stakeholders through the MICC platform remains essential in ensuring effective dissemination of regulatory information related to medical device implementation. The platform also plays a vital role in gathering constructive feedback from industry players on planned and implemented, further supporting MDA’s commitment to a transparent, collaborative, and future-ready regulatory environment.