Revised Guidance for Software Medical Devices (GL‑04)
HSA introduced the revised GL‑04 guidance, which provides a comprehensive, reader‑friendly reference covering the entire software life cycle. It aligns definitions with international standards, clarifies cybersecurity and machine‑learning requirements and introduces a Change Management Program (CMP) to streamline pre‑approved software updates.
Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0)
AIHGle 2.0 was published on 10 March 2026 to ensure patient safety while supporting innovation. Key updates include clearer accountability across the ecosystem, stronger transparency and explainability requirements, enhanced risk‑based validation and monitoring tools, and new guidance for generative AI.
Audit Report Submission Requirement
From 1 April 2026, medical device dealer license applicants must submit their latest audit reports together with QMS certificates to enhance detection of systemic issues and early safety signals through audits and post‑market data.
Regulatory Reliance with Malaysia's MDA
HSA announced a regulatory reliance arrangement with Malaysia's Medical Device Authority for Class B, C and D devices that have undergone full conformity assessment and registration with MDA. Devices must have identical labelled use for Singapore and Malaysia, while devices incorporating therapeutic or medicinal products are excluded.
Reclassification of COVID‑19 IVDs
With COVID‑19 transitioning to endemic status, HSA will reclassify COVID‑19 in vitro diagnostic devices from Class D to Class C effective 2 June 2026. The reclassification reflects reduced propagation risk while maintaining appropriate controls for vulnerable populations and aligns requirements with other Class C infectious disease IVDs.
IVD Cluster Grouping Restructuring
HSA plans to obsolete the "IVD cluster" grouping in GN‑12‑1 from 2 June 2026. Specific grouping criteria with regulatory value will be retained and expanded in GN‑12‑2. HSA will gather industry feedback to propose new categories and update GN‑12‑2 accordingly.
Registration Support Initiative for Unregistered Medical Devices Supplied via Special Access Route (SAR)
To encourage registration of unregistered medical devices supplied via Special Access Route (SAR), HSA will waive evaluation fees for essential life‑saving devices or legacy devices without registered alternatives. Devices must be proposed by healthcare institutions and endorsed by the Chairman of the Medical Board or the Academy of Medicine Singapore.
Implications and Significance
These regulatory updates demonstrate HSA's emphasis on adapting to technological advances, improving guidance on software and AI, strengthening post‑market oversight, collaborating with regional authorities through regulatory reliance, and right‑sizing controls for COVID‑19 diagnostics. The restructuring of IVD groupings and registration support initiative aim to streamline processes and encourage timely registration of essential and legacy devices.
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