Singapore HSA Updates Guidelines on Software Medical Devices (GL-04)
The revised guideline includes several key changes: Document title has been updated to include machine learning-enabled medical devices. New and …
Singapore HSA Publishes New Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) is pleased to inform of the publication of new Guidelines on Prohibited and Restricted …
Singapore HSA Updates Multiple Medical Device Guidances
In July 2025, HSA launched the new online platform SHARE (Singapore Health Product Access and Regulatory E-System) for Medical Devices …
Singapore HSA Signs Memorandum Of Understanding With Hong Kong DoH To Enhance Healthcare Regulatory Cooperation
Singapore’s Health Sciences Authority (HSA) and the Department of Health (DoH), Hong Kong Special Administrative Region (HKSAR) signed a Memorandum …
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore’s Health Sciences Authority (HSA) ongoing initiative to improve regulatory efficiency and enhance clarity in Therapeutic Products’ …
Singapore HSA Updates Guidelines on Risk Classification of SaMD and Qualification of CDSS
Singapore HSA Medical Devices Cluster has updated Guidelines on Risk Classification of Software as a Medical Device (SaMD) and Qualification …
Singapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10
Singapore Health Sciences Authority (HSA) revises guidance documents related to Medical Device Field Safety Corrective Action (FSCA). Detail of the …
Singapore HSA Updates Medical Device Guidance on Change Notification
Singapore HSA has updated GN-21: Guidance on Change Notification for Registered Medical Devices, effective 14th July 2025. Key Updates to …
Singapore HSA Updates Guidance Documents for CTGTP
In September/October 2024, HSA has re-organized and updated Cell, Tissue or Gene Therapy Product (CTGTP) guidance on Product Notification, Product …
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