Stakeholder responses and support for the AISaMD sandbox
HSA invited stakeholders to provide feedback from 19 May 2025 to 19 June 2025 on a proposed exemption from manufacturer's licensing and product registration requirements for AI-SaMD developed by selected public healthcare institutions for use in public healthcare settings. Responses were generally positive and supported the AI-SaMD sandbox, with suggestions to strengthen controls and potentially expand the scope.
Criteria for participation and device requirements
The sandbox is restricted to AISaMDs that pose lower potential patient risks, including Class A and Class B devices, and that manage only noncritical medical conditions. Eligible devices must be developed by public healthcare institutions and overseen by a clinician holding the position of Consultant or above. Developers must conduct annual quality management system selfattestations aligned with ISO 13485 to ensure a robust QMS. Each AISaMD must be endorsed by the institution's Chairman of the Medical Board or Chief Executive Officer and notified to HSA prior to deployment. Patients must be informed when AISaMDs are used, and adverse event reporting obligations remain.
Safeguards, obligations, and enforcement mechanisms
The sandbox expands existing exceptions under the Health Products Act but does not remove oversight regulatory oversight and retains equivalent safeguards. Key safeguards such as post-market obligations and accountability are retained. HSA will continue to enforce adverse event reporting and holds the authority to impose fines or imprisonment for non-compliance. The framework was designed to strike a balance between ensuring appropriate regulatory oversight and fostering healthcare innovation.
Future direction and expansion of AIenabled healthcare innovation
HSA views the sandbox as a strategic first step toward broader adoption of AI-enabled medical devices across Singapore's healthcare ecosystem. Starting with the public healthcare sector allows regulators to gather implementation insights before considering potential expansion beyond the public healthcare sector. Outcomes from the sandbox will inform whether controls should be calibrated and the scope widened to support safe and effective AI innovation in healthcare.
Timeline
| Period | Activity | Comments |
| 19 May 2025 – 19 Jun 2025 | Public consultation on proposed AISaMD sandbox | HSA invited stakeholders to provide feedback on exempting lowrisk AISaMDs developed by public healthcare institutions from manufacturer licensing and product registration requirements. |
| 13 Feb 2026 | HSA publishes response to consultation | HSA released its response summarising public feedback and outlining regulatory controls for the AISaMD sandbox, including eligibility criteria, clinical oversight, QMS requirements and notification obligations. |
| Following Post February 2026 | Sandbox implementation and evaluation | Selected public healthcare institutions deploy eligible AISaMD under the sandbox. HSA will evaluate outcomes to determine whether to expand the framework beyond the public sector. |
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