Tag Archive for: HSA

Artificial Intelligence (AI) Software Registration in Singapore

In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.

Singapore’s HSA Removes Classification and Grouping Inquiry Option

Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.

Singapore Releases New Guidance of Medical Device Software

Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.