From 19 May 2025 to 19 June 2025, the Health Sciences Authority (“HSA“) conducted a public consultation exercise to seek feedback on exempting artificial intelligence (“AI“)-software as a medical device (“SaMD“) developed in public healthcare from manufacturer’s licensing and product registration requirements under the Health Products Act 2007 (“HPA“).
Current Regulatory Framework
Currently, under regulations 3 and 6 of the Health Products (Medical Services) Regulations 2010 (“Regulations“), specified healthcare service licensees developing AI-SaMDs for in-house use (i.e. for their own patients) are exempt from manufacturer’s licensing and product registration requirements. This is to minimise the regulatory burden on licensees to allow them to address the clinical needs of their patients promptly.
HSA has highlighted that MOH Office for Healthcare Transformation Pte Ltd (“MOHT“), Synapxe Pte Ltd (“Synapxe“), and public healthcare clusters are increasingly using technology to develop AI-SaMDs tailored for Singapore’s public healthcare institutions to enhance the provision of patient care. While they are all part of the of public healthcare ecosystem, they span multiple healthcare service licensees. As a result, AI-SaMDs developed within public healthcare currently do not fall under regulations 3 and 6 of the Regulations, making it challenging to deploy such AI-SaMDs across the public healthcare sector.
Need to Expand AI Implementation Across Public Healthcare Sector
AI-SaMDs that are developed by public healthcare should be deployed not just in a single healthcare institution but across multiple institutions. This is to maximise the benefits of these customised AI-SaMDs and to avoid duplicative development costs. It is against this background that HSA has proposed the licensing and registration requirements exemption under the HPA.
The aim of the proposed exemption is to run a regulatory sandbox that allows public healthcare to deploy and test AI-SaMDs developed for public healthcare. This seeks to further evaluate the use of AI to deliver public healthcare services safely and effectively.
The proposed exemption will extend the current exception under regulations 3 and 6 of the Regulations to AI-SaMDs that are:
- developed by MOHT, Synapxe and public healthcare clusters and institutions;
- classified as class A (low risk) or class B (moderately low risk) under the Third Schedule to the Regulations;
- developed under the supervision and oversight of a clinician employed in public healthcare institution holding the position of Consultant or higher;
- only for in-house use by public healthcare licensees; and
- notified to HSA at the point of deployment.
Non-compliance with these conditions constitutes infringement of the HPA, which can attract a fine of up to S$50,000 or imprisonment of up to two years, or both.
Proposed Safeguards and Controls
HSA proposes additional safeguards and controls for MOHT, Synapxe and public healthcare clusters and institutions developing these AI-SaMDs. These include annual self-attestation to a quality management system (ISO 13485), and verification against an internal product control checklist. The existing internal governance measures for public healthcare institutions, including cyber and data security requirements, will remain in effect. Additionally, AI-SaMDs for public healthcare should be endorsed by the Chairman Medical Board or Chief Executive Officer of the public healthcare licensee before use.
Post-market controls, including adverse event reporting to HSA, will continue to apply with enforcement actions for breaches.
Monitoring of Proposed Exemption
HSA will monitor the proposed exemption over the course of 12 months, with possible extension for a more thorough assessment.
Click on the following link for more information:
- Public Consultation on the Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for Artificial Intelligence – Software as a Medical Device Developed by Selected Public Healthcare Entities for Use in Public Healthcare (available on the HSA website at hsa.gov.sg)
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