PFDA issued a circular draft for comments regarding the guidelines on the use of the eServices portal system for the initial application of Certificate of Medical Device Notification (CMDN) in line with the PFDA’s goal of delivering efficient government services. Currently, CMDN applications are transacted via the ePortal System. Migrating
On November 20, 2023, the Health Sciences Authority (HSA) Singapore revised the guidance document on Change Notification applications due to EU MDR and IVDR-related changes to registered medical devices. The identified changes clarified in this update are the following: Changes to IFU related to clarification of existing content and addition
On 14 November 2023, the Vietnam Ministry of Health released Circular 20/2023/TT-BYT repealing some legal regulations issued by the Ministry of Health. By January 1, 2024, the following regulations will be completely revoked: Regulation Regulation Date Provision Directive No. 06/2008/CT-BYT June 27, 2008 The enhancement of the quality of healthcare
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
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