In brief
On 13 February 2026, the Health Sciences Authority (HSA) published the findings of its public consultation on the proposed exemption from manufacturer’s licensing and product registration requirements for artificial intelligence software as a medical device (AI-SaMD) developed by selected public healthcare entities for use in public healthcare (AI‑SaMD sandbox).
The public consultation was held from 19 May 2025 to 19 June 2025, and the HSA announced that the feedback was generally supportive of the proposed AI-SaMD sandbox. The HSA also published a summary of the suggestions provided.
In more detail
As covered in our May 2025 alert, the HSA invited the public to provide feedback on the proposed AI-SaMD sandbox from 19 May 2025 to 19 June 2025.
The respondents generally expressed support for the proposal and provided constructive suggestions, which broadly fell into the following categories:
- Suggestions to strengthen controls within the sandbox, such as imposing additional International Organisation for Standardisation (ISO), International Electrotechnical Commission and cybersecurity requirements, and for the AI-SaMDs in the sandbox to eventually be registered with HSA
- Suggestions to expand the scope of the AI-SaMD sandbox to allow other healthcare professionals, apart from registered medical practitioners, to provide oversight over the development of these AI-SaMDs, and extending participation beyond the public healthcare sector, such as to private healthcare institutions and software developers
The HSA emphasised that the proposed sandbox is intended to ensure appropriate regulatory oversight, while at the same time fostering healthcare innovation. Therefore, the HSA has to consider the existing cybersecurity and data security safeguards that public healthcare entities have to comply with, as well as the prevailing requirements under the Health Products Act and the Healthcare Services Act.
Taking into account the above considerations, the HSA will undertake the following:
- Scope the sandbox only to AI-SaMDs that pose lower potential patient risks, i.e., Class A and Class B AI‑SaMDs, which only aim to diagnose and/or drive clinical patient management for non-critical medical conditions (For more information on the risk classification of AI-SaMDs, see our previous alert.)
- Require a clinician employed in a public healthcare institution, and holding the position of consultant or higher, to oversee the AI-SaMD’s design, validation and output, and to ensure that the AI-SaMD is manufactured under the supervision of a qualified medical practitioner
- Require public healthcare developers to conduct yearly quality management system self‑attestations to confirm compliance with ISO 13485 standards
- Require AI-SaMDs to be endorsed by the chair of the medical board or the CEO of the public healthcare institution for deployment, ensuring that senior leadership is aware of and accountable for the AI-SaMDs being deployed in their public healthcare institution or cluster
- Require that the public healthcare institution or cluster notify the HSA of the AI-SaMDs before deploying them for use in patients
- Require that deployers inform patients when AI-SaMDs developed under the proposed sandbox will be used in their medical care
- Engage with public healthcare developers on the HSA product registration upon the wider deployment of the AI-SaMD across public healthcare
The HSA reiterated that the sandbox is an expansion of the exceptions within the Health Products Act, and the HSA will continue to uphold the key safeguards, such as post-market obligations and accountability, to ensure regulatory oversight and patient safety.
Key takeaways
The HSA has been embracing and encouraging the adoption and use of AI within the Singapore healthcare system, along with providing regulatory guidance to ensure patient safety. This AI-SaMD sandbox is one such measure that facilitates broader AI adoption and scaling up across the Singapore healthcare ecosystem, and the HSA has confirmed that it will be considering extending the scope to beyond public healthcare.
The HSA will closely monitor the outcomes of the sandbox to evaluate and determine the next steps, including the calibration of controls, and to create a comprehensive framework to support AI innovation while ensuring the safe and effective use of AI in healthcare.
Companies should continue to monitor how the HSA calibrates its controls toward AI-SaMDs in Singapore, as the outcomes of the sandbox may have knock-on effects on wider controls and guidance for AI-SaMDs.
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