Medical devices that contain software must follow GN-23: Guidance on Labelling for Medical Devices and include additional information about software versioning and traceability. If the device is supplied in physical form (through a DVD or CD), a label must be present on the device and include the software version number and the product owner’s information. If the software is supplied without any physical form, in the case of software downloaded from the internet and web-based software, the ‘splash screen’ must contain information about the elements of identification, including the software version number.
Versioning and Traceability
Clear versioning is essential for post-market surveillance and follow-up in the case of Field Safety Corrective Actions. Versioning and traceability information must be provided to the HSA as a part of the registration application process. Software versioning information must detail changes to the software/interface, including changes to graphic interface, functionality and bug fixes.
Changes to Registered Software
The HSA has different change review pathways for medical device software depending on the differing risk and complexity of the device. Significant changes, such as technical and review changes, require a more in-depth review than non-significant changes, known as Notification Changes.
Post Market Surveillance of Software
Manufacturers, importers, wholesalers and registrants are responsible for the post market surveillance of software devices and must report things like FSCA and Adverse Events to the HSA without “undue delay”.
Software medical devices should be registered with a cybersecurity plan detailing:
Secure device design
Customer security documentation
Cyber risk management
Verification and validation testing
Plan for surveillance and timely detection of emerging threats
Artificial Intelligence (AI) Medical Devices
Medical Devices that include AI must comply with healthcare requirements under the Personal Data Protection Act, Human Biomedical Research Act and Private Hospitals and Medical Clinics Act. From a regulatory perspective, AI-MD must comply with the regulatory principles for software medical devices in addition to considerations about continuous learning capabilities, level of human intervention, training of models and retraining. All AI-MDs registered in Singapore must monitor real-world performance post-deployment and submit post-market reports to the HSA periodically.
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