HSA introduces exemption from manufacturer’s licensing and product registration requirements for AI-SaMD developed by public healthcare entities for use in public healthcare

27 March 2026

On 13 February 2026, the Health Products (AI Standalone Mobile Application - Exemption) Order 2026 (“Order”) took effect. The Order exempts Artificial Intelligence - Software as a Medical Device (“SaMD”) developed by selected public healthcare entities for use in public healthcare (“AI-SaMD sandbox”) from manufacturer’s licensing and product registration requirements, subject to safeguards.

The implementation of the exemption follows a public consultation conducted by the Health Sciences Authority (“HSA”) from 19 May 2025 to 19 June 2025. More details on the consultation are set out in our article “HSA consults on proposed exemption from manufacturer’s licensing and product registration requirements for AI-SaMD”.

In its response published on 13 February 2026, HSA reported that the responses received were generally positive and supported the proposed AI-SaMD sandbox. HSA received:

  • suggestions to strengthen the controls on AI-SaMDs in the sandbox including by imposing additional International Organisation for Standardisation (“ISO”), International Electrotechnical Commission, and cybersecurity requirements, and for the AI-SaMDs in the sandbox to be eventually registered with HSA; and
  • suggestions to expand the scope of the AI-SaMD sandbox, including allowing other healthcare professionals (apart from registered medical practitioners) to provide oversight over the development of the AI-SaMDs, and extending participation to other parties beyond the public healthcare sector, such as private healthcare institutions and software developers.

HSA explains that the proposed sandbox seeks to strike a balance between ensuring appropriate regulatory oversight and fostering healthcare innovation. The controls for the sandbox have been developed taking into consideration the existing cyber and data security safeguards that all public healthcare entities are already required to comply with, and the prevailing regulatory requirements in the Health Products Act 2007 and the Healthcare Services Act 2020. HSA has scoped the sandbox to only AI-SaMDs that pose lower potential patient risks, i.e. only Class A and Class B AI-SaMDs, which aim to diagnose and/or drive clinical patient management for only non-critical medical conditions.

In addition, HSA has introduced a requirement that:

  • a clinician employed in a public healthcare institution (“PHI”) and holding the position of consultant or higher oversee the AI-SaMD’s design, validation, and output, ensuring that the AI-SaMD is manufactured under the supervision of a qualified medical practitioner;
  • public healthcare developers conduct yearly quality management system (“QMS”) self-attestations to confirm that they meet the ISO 13485 standards, similar to the approach for Class A SaMDs under the Health Products Act 2007, to ensure that they maintain a robust QMS;
  • the AI-SaMDs be endorsed by the Chairman of Medical Board or Chief Executive Officer of the PHI or cluster for deployment, ensuring that senior leadership is accountable and aware of the AI-SaMDs deployed in their PHI or cluster;
  • the PHI or cluster notify HSA of the AI-SaMDs before deployment for use in patients; and
  • deployers inform patients when AI-SaMDs developed under the proposed sandbox will be used in their medical care.

HSA will engage public healthcare developers on HSA product registration upon wider deployment of AI-SaMDs across public healthcare.

As the sandbox is an expansion of the current exceptions within the Health Products Act 2007, key safeguards, such as post-market obligations and accountability, will continue to be mandated by HSA to ensure equivalent oversight, without compromising patient safety. The requirement to report any
adverse effect to HSA, for example, will continue to apply, and breaches can be subject to enforcement actions, which include fines of up to S$20,000 or imprisonment for up to 12 months, or both.

Reference materials

The following materials are available on the HSA website www.hsa.gov.sg and the Government Gazette website www.egazette.gov.sg: