On February 13, 2026, the Health Sciences Authority (HSA) released the outcome of its public consultation on a proposed “regulatory sandbox” for AI software as a medical device (AI-SaMD). The sandbox would exempt certain AI-SaMDs developed by public healthcare institutions from product registration under the Health Products Act.
The HSA confirmed that the sandbox will apply only to lower-risk AI-SaMDs. This includes Class A and Class B products for non-critical conditions. Each AI-SaMD product must be overseen by a senior clinician employed by a public healthcare institution. Developers must conduct annual quality management system self-attestations aligned with ISO 13485. Senior leadership approval will be required before deployment, and institutions must notify the HSA before use. Patients must also be informed when these AI tools are involved in their care.
The HSA stated that the sandbox builds on existing statutory exemptions but maintains core safeguards. These include post-market obligations and accountability requirements. The authority will monitor outcomes closely. Product registration may be required if tools are deployed more broadly.
The sandbox supports Singapore’s efforts to promote responsible AI use in healthcare. Companies should monitor further developments, as the results may influence future regulatory controls for AI-SaMDs.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.