Singapore HSA Publishes Updated Guidelines on Software Medical Devices

The Health Sciences Authority (HSA) Singapore has published an updated version of the guidelines for software medical devices (MD) in April 2022. 

One of the updates is under the pre-market product registration requirements, where there are additional requirements for cybersecurity. Proof of verification for the security and usability of security controls for connected medical devices should be provided for product registration. 

Requirements on software with multiple functions has been incorporated. Submission of information on non-MD functions may or may not be required, depending on the impact of these functions on the safety and performance of the device. 

More details can be found in “Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach, Revision 2.0, April 2022”:—a-life-cycle-approach_r2-(2022-apr)-pub.pdf  

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