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On 21 July 2025, the Health Sciences Authority (HSA) revised its guidelines on the risk classification of software as a medical device (SaMD) and the qualification of clinical decision support software (CDSS).
The revised guidelines incorporate changes to improve online searchability and international alignment on terminology, provide better clarity on the classification of SaMDs under Class B and include additional criterion to determine whether or not a CDSS is considered a medical device.
The following are the notable changes to the guidelines:
HSA’s continuous updates to its guidelines in relation to SaMDs, especially to bring better alignment with international standards, illustrate that HSA is closely monitoring digital health related developments and will ensure that its guidelines evolve in tandem with advancements in the medical technology space.
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