Singapore: GL-04 Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach (Revision 4) January 20, 2026
Singapore: GN-02 Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices (Revision 7) November 5, 2025
Singapore: GN-17 and GN-18 Guidance on Preparation of Product Registration Submissions using the ASEAN CSDT (Revision 4) November 5, 2025
Singapore: HSA–SMF Partnership Enhances MedTech Regulatory Support and Market Access October 28, 2025
Singapore: GL-08 Regulatory Guidelines for Laboratory Developed Tests (LDTs) Revision 2 September 23, 2025
Singapore: GN-21 – Guidance on Change Notification for Registered Medical Devices Revised July 18, 2025
Singapore: HSA and MFDS Publish Guiding Principles for Clinical Trials of Machine Learning-enabled Medical Devices (MLMD) June 11, 2025
Singapore: HSA Public Consultation Re: Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for AI-SaMD in Public Healthcare June 11, 2025
Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity March 17, 2025
