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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[QT Analysis] Singapore: Gateway to ASEAN Healthcare Opportunities – September, 2020

• 2020-09-15 06:44:21

Singapore remains one of the most important medical device hubs in the Asian region, growing to be on par with developed first world nations. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a MedTech Giant in Asia and how you shouldn’t miss out on the great business opportunities it offers.

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SINGAPORE: HSA consults healthcare professionals and industry members on revised draft guidance documents for change notification and IVD analyzers - January, 2020

• 2020-02-21 07:07:01

For both GN-21 and GN-34, HSA added guidance regarding notification of software changes in In Vitro Devices (IVD) .

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