Regulatory Guidelines for Software Medical Devices
The Health Sciences Authority Singapore has revised a guidance document to strengthen regulatory oversight on cybersecurity as well as facilitate pre-market and/or change application’s required documentation for high-risk SaMDs.
The document is titled ‘Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach Revision 2.0’. It is effective from 29 April 2022. The latest guidance document:
- Requires registrant to provide additional proof to demonstrate device’s security or successful device’s security controls as part of cybersecurity documentation during pre-market and/or change application.
- Clarifies that for other non-medical-purpose functions of SaMD e.g. transferring patient data, general patient education, such information and validation reports are not required to be submitted at the point of pre-market application. However, it is expected of the manufacturer to assess the risks of such functions with regards to overall device safety and performance, mitigate risks (if applicable) to acceptable levels, demonstrate effective risk controls and document these actions as part of manufacturer’s QMS.
- Updates the Change Flowchart for Registered AI-MD, incorporating either locked or continuous learning algorithm, to align various changes to the identified Change Type Categories stipulated in GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9. It is important to note that Flowcharts 2.3 and 2.4 in GN-21 remain applicable, for change assessment.
These updates strengthen regulatory oversight on cybersecurity as well as facilitate pre-market and/or change application’s required documentation for high-risk SaMDs.
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