Singapore HSA consultation Software as a Medical Device

Singapore HSA consultation on Software as a Medical Device Classification

The Singapore Health Sciences Authority (HSA) has issued draft regulatory guidelines on the Classification of Software as a Medical Device that are open for consultation by stakeholders. Comments may be submitted until 19 August 2021.

The draft guidelines cover the classification of non-IVD standalone mobile medical device applications commonly known as Software as a Medical Device or SaMD and draws on guidance issued by the International Medical Device Regulators Forum (IMDRF) and Health Canada. The draft guidelines also cover the qualification of Clinical Decision Support Software (CDSS) as medical devices. Throughout the document numerous examples are presented to show the regulatory approach expected to be taken by the HSA in classifying the risk category of such devices.

The proposed risk classification framework for SaMD will take into account the following:

  • The significance of the information provided by the SaMD to the healthcare decision:
    • Does the information provided help to treat or diagnose a patient?
    • Or does the information drive clinical/patient management?
    • Or does the information inform clinical/patient management?
  • The state of the patient’s healthcare situation or condition and whether it is considered:
    • critical,
    • serious,
    • or non-serious.
  • Existing GN-13 Guidance on Risk Classification of General Medical Devices and their corresponding risk classification rules.

Risk classification table for Software as a Medical Device:

State of healthcare situation or condition

Significance of information provided by SaMD to healthcare decisions

 

Treat or diagnoseDrive clinical/patient managementInform clinical/patient management
CriticalCCB
SeriousCBA
Non-seriousBA*A

*Software as a Medical Device will be classified as Class B if intended to image, measure or monitor a physiological process to drive clinical/patient management.

How to submit your comments:

All comments can be sent directly to HSA_MD_INFO@hsa.gov.sg indicating ” Regulatory Guidelines for SaMD Classification and Qualification of CDSS” in the email subject header. The deadline for the submission of comments is 19 August 2021 using the prescribed feedback form which is available on the dedicated HSA website page – click here.

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