HSA consults on regulatory guideline for classification of Standalone Medical Mobile Applications and qualification of Clinical Decision Support Software

The Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) Singapore, has recently released a draft regulatory guideline for the classification of Standalone Medical mobile applications (commonly referred to as Software as a Medical Device (SaMD)) and Qualification of Clinical Decision Support Software (CDSS), for stakeholder consultation.

The guideline 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).

The guideline also provides better clarity on qualification of Clinical Decision Support Software (CDSS) as medical devices  as well as the current regulatory approach for such software that are regulated by the HSA.

Unusually, the guideline has been published as a presentation. Essentially, the latter is divided into two sections as follows:

  • A section on the risk classification framework of standalone mobile applications, including
    • a risk classification framework
    • a risk classification table
    • examples
  • A section on Clinical Decision Support Software (CDSS) which includes:
    • Background
    • Intended use
    • qualification
    • Non-Medical Device Support Software with examples
    • Class A CDSS software with examples
    • Other CDSS

Some of the definitions in the document are provided below:

Standalone Mobile Application (commonly referred to as Software as a Medical Device (SaMD)

A software and/or mobile application that is intended to function by itself and is not intended for use to control or affect the operation of other hardware medical devices (as defined in the Health Products (Medical Devices Regulations).

Clinical Decision Support Software (CDSS)

Clinical Decision Support Software (CDSS) is standalone software (including mobile applications, cloud based and web based software) that can perform a wide range of functions for healthcare professionals, patients and caregivers to support clinical practice, clinical and patient management.

CDSS classified as a medical device

CDSS intended for medical purposes such as investigation, detection, diagnosis, prevention, monitoring, treatment or management of any medical condition, disease, anatomy or
physiological process; will be classified as a medical device subject to regulatory controls by HSA.

CDSS not regulated as a medical device

CDSS will not be regulated as a medical device if the intended use does not meet the definition of a medical device in the First Schedule of the Health Products Act (HPA)


the CDSS is intended solely for the display or printing of medical information* about a patient or other medical information (such as demographic information, drug labelling, clinical guidelines, studies or recommendations).

*Does not include real time patient information or data

What are the consultation start and end dates?

Start date: 19 July 2021

End Date: 19 August 2021

Where can you provide feedback?

You can provide feedback by downloading the guidance feedback form on this page.

Source: HSA Singapore