Singapore: HSA Opens Consultation on AI-SaMD Regulatory Sandbox

ARQon
Jun 4
2 min read

The Health Sciences Authority (HSA) launched a public consultation on a pivotal proposal that could significantly reshape the landscape of AI in public healthcare. From 19 May to 19 June 2025, stakeholders are invited to share their feedback on the proposed exemption from manufacturers’ licensing and product registration requirements for specific AI-based Software as a Medical Device (AI-SaMD) solutions.

Why This Matters

Artificial Intelligence continues transforming healthcare, with public entities like the MOH Office for Healthcare Transformation (MOHT), Synapxe, and public healthcare clusters developing AI-SaMDs tailored for internal use. However, current regulations limit their deployment to individual institutions due to licensing constraints.

This proposal aims to expand access to AI tools across Singapore’s public healthcare network, enhancing patient care, reducing redundant development costs, and accelerating the safe and effective adoption of healthcare technology.

What’s Changing?

Under the current Health Products (Medical Devices) Regulations 2010, AI-SaMDs developed in-house by a healthcare licensee are exempt from licensing and registration, but only for single-institution use.

The proposed exemption will:

Enable AI-SaMDs developed by MOHT, Synapxe, and public healthcare institutions to be used across multiple institutions.
Apply only to low to moderate-risk devices (Class A and B)
Require oversight by a clinician holding Consultant rank or higher
Mandate notification to HSA at the point of deployment

Non-compliance will lead to penalties and fines.

Safeguards and Oversight

To ensure safety and accountability, the following conditions will apply:

Annual self-attestation to ISO 13485 quality management standards
Use of internal product control checklists
Ongoing cybersecurity and data governance protocol
Mandatory endorsement by senior medical leadership (Chaiman Medical Board or CEO)
Adverse events must be reported to HSA, with post-market enforcement mechanisms in place

A Regulatory Sandbox Approach

The exemption will function as a regulatory sandbox – a 12-month trial monitored by HSA to assess its viability. This period may be extended if more data or case studies are needed to evaluate the framework effectively.

Your Feedback Seed the Future

Stakeholders – including healthcare professionals, AI developers, patients, and institutions – are encouraged to contribute their views during the consultation window. Your feedback can shape the future of AI adoption in public healthcare.

Consultation Period: 19 May – 19 June 2025

Submit your feedback here: https://form.gov.sg/681db02e08ec7d1313dd8b18

Source: Health Sciences Authority (HSA)