SINGAPORE: HSA Announced Draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) – August, 2021

• 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

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