SINGAPORE: HSA responds to consultation on proposed AI-SaMD licensing and registration exemption for selected public healthcare entities – February/March 2026

• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

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Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity – April/May 2025

• 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.

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SINGAPORE: Announcement on Public Consultation for the Proposed Framework and Implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] – February/March 2023

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

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