Skip to main content
A Singapore Government Agency Website How to identify
Official website links end with .gov.sg
Government agencies communicate via .gov.sg websites (e.g. go.gov.sg/open). Trusted websites
Secure websites use HTTPS
Look for a lock () or https:// as an added precaution. Share sensitive information only on official, secure websites.

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

Call the 24/7 ScamShield Helpline at 1799 if you are unsure if something is a scam.

Health Sciences Authority
Public Consultations

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

Audiences

Consumer

Healthcare professional

Industry member

Product type

Medical devices

19 May 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Introduction

The Health Sciences Authority (HSA), a statutory board of the Ministry of Health (MOH), invites public feedback on the proposed exemption under the Health Products Act 2007. The consultation period will be from 19 May 2025 to 19 June 2025.

Current regulatory framework

2      Under Regulation 3 and 6 of the Health Products (Medical Devices) Regulations 2010 (the Regulations), specified healthcare service licensees that develop an Artificial Intelligence (AI) - Software as a Medical Device (SaMD) for in-house use (i.e. for their own patients) are not subject to the requirements for a manufacturer’s license and product registration. This exception is designed to minimise the regulatory burden on licensees, so that they can address the clinical needs of their patients more quickly. Healthcare service licensees operate within a regulated healthcare setting, subject to existing clinical governance frameworks, safety protocols, and oversight in the use of the SaMDs.

3      The MOH Office for Healthcare Transformation Pte Ltd (MOHT), Synapxe Pte Ltd (Synapxe), and public healthcare clusters are increasingly leveraging technology to develop AI-SaMDs customised for our public healthcare institutions, to facilitate and improve their provision of patient care. While they are all part of public healthcare, they span multiple healthcare service licensees. Thus, the AI-SaMDs developed in public healthcare currently fall outside the scope of regulations 3 and 6 of the Regulations, and cannot be easily deployed across public healthcare. 

Need for scaling of AI in public healthcare sector

4      Yet, AI-SaMDs that are developed by public healthcare for the purpose of public healthcare should be deployed not just in a single public healthcare institution, but across multiple institutions. This is so that public healthcare as a whole can reap the benefits of these customised AI-SaMDs, and also avoid duplicative costs if each institution has to develop its own AI-SaMD to perform the same function.

Proposed exemption under the Health Products Act 2007

5      The objective of the proposed exemption under the Health Products Act 2007 is to run a regulatory sandbox for the deployment of AI-SaMDs developed by public healthcare for public healthcare, to assess the use of AI to provide public healthcare in an effective and safe manner.

6      Specifically, the proposed exemption will expand the current exception in regulations 3 and 6 of the Regulations to include AI-SaMDs that are:

  1. developed by MOHT, Synapxe and public healthcare clusters and institutions;

  2. classified as class A (low risk) or class B (moderately low risk) under the Third Schedule to the Regulations;

  3. developed under the supervision and oversight of a clinician employed in a public healthcare institution holding the position of Consultant or higher;

  4. only for in-house use by public healthcare licensees; and

  5. notified to HSA at the point of deployment.

Non-compliance with these conditions will amount to breaches of the Health Products Act, which are offences punishable by a fine of up to $50,000 or imprisonment of up to 2 years, or both.

Proposed additional safeguards and controls

7      MOHT, Synapxe and public healthcare clusters and institutions developing these AI-SaMDs must self-attest annually to a quality management system (ISO 13485), and check against an internal product control checklist. The internal governance controls for public healthcare institutions, including cyber and data security requirements, will also continue to apply. The AI-SaMDs should be endorsed by the Chairman Medical Board or Chief Executive Officer of the public healthcare licensee before use.

8     Post-market controls, including the requirement to report any adverse effect to HSA, will continue to apply, and breaches can be subject to HSA enforcement actions, which include fines of up to $20,000 or imprisonment up to 12 months, or both.

9      HSA will monitor the proposed exemption over the course of 12 months to assess the regulatory sandbox. This 12-month duration may be extended to allow for a more robust assessment if there are insufficient indicators or AI-SaMDs developed during the initial sandbox period.

Views sought

10     HSA welcomes feedback on the proposed exemption. Please provide your feedback using the following online form between 19 May 2025 and 19 June 2025. Please provide your name, name of the organisation you represent, contact number and email address. We may contact you to clarify your feedback if necessary.

11     Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence and not be published, if the information is proprietary, confidential, or sensitive. HSA will respond to you, if needed, in confidence.

https://go.gov.sg/aisamdsandbox

HEALTH SCIENCES AUTHORITY

SINGAPORE

19 MAY 2025

Back to top