The Revision 2 provides updated regulatory guidance for in vitro diagnostic (IVD) analysers and their associated accessories. It focuses on risk classification, grouping, SMDR (Singapore Medical Device Register) listing options, and change notification requirements. Scope Summary of the updated GN-34 Guidance Document for IVD Analysers (Revision 2) issued by the
The Revision 7 introduces several structural and procedural updates to streamline medical device regulatory submissions. The most significant change is the platform migration from MEDICS to SHARE, marking a complete transition across all application processes. Scope Summary of the updated GN-02 Guidance Document (Revision 7) issued by the Health Sciences
Key Highlights Revision 4 reminded applicants that the online submission platform has transited from MEDICS to SHARE. The inclusion of a dedicated Machine Learning documentation section establishes robust expectations for ML-enabled devices, covering model design, training validation protocols, and risk management and others per GL-04 guidelines. Additionally, the new ISO
The Medical Device Authority (MDA) has announced the approval of a minor amendment to Circular Letter No. 1 Year 2025. The revised document is now designated as Circular Letter No. 2 Year 2025 (“the Circular”) and took effect on 30 September 2025. Scope Summary of the latest update issued
The Medical Device Authority (MDA) has released the draft Seventh Edition of the Guidance Document titled “Requirements for Labelling of Medical Devices” for public consultation. The draft introduces key amendments to the existing labelling framework, including the proposed implementation of electronic labelling (e-labelling) for home-use medical devices, aligning Malaysia’s regulatory
The Medical Device Authority (MDA) has published the draft First Edition Guidance Document (PDF) titled “Application for Confirmation Status of Obsolete and Discontinued Medical Device” for public comment. The guidance outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments in managing obsolete and discontinued medical devices.
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