Consultation on Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)

The Medical Devices Branch (MDB) has released a draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) for stakeholders’ consultation. This document draws reference from the international Medical Device Regulators Forum (IMDRF)’s guidance on Software as a Medical Device (SaMD) to provide an internationally harmonised approach to determining the risk classification of a Standalone Medical Mobile Application (SaMD).

In addition, the guidelines provide better clarity on qualification of Clinical Decision Support Software (CDSS) as medical devices  as well as the regulatory approach for such software. We would like to invite our stakeholders to provide feedback on this document:

[For Consult] SaMD Risk Class-CDSS Guidelines212 KB

The Consultation period for this document is from 19 July 2021 to 19 August 2021. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 19 August 2021. Please indicate " Regulatory Guidelines for SaMD Classification and Qualification of CDSS" in the email subject header.

guidance-feedback--form14 KB

Published: 19 Jul 2021

Regulatory Updates