The Health Sciences Authority (HSA) has released Revision 4 of the GL-04 guidelines, introducing updated regulatory expectations for software medical devices and machine learning technologies.

• Machine Learning: The scope now explicitly includes machine learning-enabled medical devices (MLMD), clarifying oversight for AI-based algorithms.
• Lifecycle Governance: Updated requirements focus on cybersecurity management, post-market monitoring, and “End of Support” (EOS) communication for software.
• Effective Date: The finalised guidelines became effective on 31 December 2025, aligning local definitions with international standards.

This summary is based on updates issued by the Health Sciences Authority.