On November 16, 2023, the Medical Device Authority of Malaysia (MDA) published an infographicrelated to the medical device registration for In-Vitro Diagnostic (IVD) Medical Devices, where theMDA illustrated the possible ways to register an IVD Analyzer.Based on the infographic, the approaches below can be applied to register an IVD Analyzer:1)

On 8th November 2023, the Medical Device Authority of Malaysia (MDA) published an announcement related with medical device advertisement applications. Commencing December 1st, 2023, the medical device advertisement applications can only be submitted to the MDA via email at advertisement@mda.gov.my. Any hard copies applications will not be processed by MDA.

Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted

On 26th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023. With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by