guidelines on risk classification of standalone medical mobile applications and qualification of clinical decision support software

Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software

The Health Sciences Authority Singapore published a new guidance document titled ‘Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS). It was published in April 2022. This final version overrides an earlier draft that was sent for industry feedback in 2021. 

Standalone Medical Mobile Application (SaMD)

The risk classification framework for SaMD is built upon: 

  • The significance of the information provided by SaMD whether to 1. treat or diagnose 2. drive clinical management or 3. Inform clinical management
  • The patient’s state of health whether 1. critical 2. serious or 3. non-serious
  • Rules-based risk classification in existing GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (pub Sep 2018).

Clinical Decision Support Software (CDSS)

Qualification

The qualification on whether Clinical Decision Support Software (CDSS) constitutes a medical device is built upon the intended purpose of CDSS. Generally, a CDSS with an intended medical purpose qualifies as a medical device.

Risk Classification

A CDSS is considered a Class A Medical Device if and only if ALL 4 conditions are satisfied: 

  1. Intended to analyse patient’s medical information and other general medical information.
  2. Not intended to obtain, process (excluding conversion of medical image to compatible format for information transfer), or analyse medical images, signals, or patterns from other medical devices or signal acquisition system.
  3. Intended to only support Healthcare Professional (HCP)’s decision-making process on patient’s state of health.
  4. Not intended to replace the clinical judgment of HCP. HCP could verify software’s recommendation independently.

To determine the appropriate risk classification of other CDSS medical devices, refer to risk classification framework for SaMD.

For details and various classification examples of SaMD, Non-MD CDSS, Class A CDSS, and Other CDSS, please refer to [1]. If you have any questions regarding medical device registration and representation in Singapore, please contact us at sales@andamanmed.com

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