On 19 July 2021, the Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) published its draft “Regulatory Guidelines on Risk Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)” for comments.
The consultation period is from 19 July 2021 to 19 August 2021.
In more detail
On 19 July 2021, the MDB of the HSA published its draft “Regulatory Guidelines on Risk Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)” for comments.
The guidelines outline the approach toward determining the risk classification of standalone mobile applications that are considered to be medical devices. The clarified approach takes into account the HSA’s existing GN-13 Guidance on Risk Classification, in addition to the significance of the information communicated by the SaMD to healthcare decisions, as well as the state of the patient’s healthcare situation or condition.
The guidelines also shed light on the regulatory approach toward the medical device and risk classification of CDSS. CDSS are typically standalone software that may be used to support clinical practice and management. Given the potentially wide range of functions these software can support, not all CDSS are medical devices, and the classification of such software may prove tricky in practice.
In this regard, a key feature of the regulatory guidelines that might prove especially helpful for dealers in the medical device space is the inclusion of several examples for the various risk classes, as well as the types of products that may or may not qualify as a medical device.
The guidelines were based on the guidance note on SaMDs published by the International Medical Device Regulators Forum and aim to ensure greater harmonization with international approaches for classifying the risk level of a SaMD.
Details of the proposed guidelines may be accessed here.
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