On 4 July 2025, Singapore’s Health Sciences Authority (HSA) issued a regulatory update to GN-21 Guidance on Change Notification for Registered Medical Devices. These changes aim to streamline industry compliance and better accommodate emerging technologies like machine learning-enabled devices.
The updated guidance will take effect from 14 July 2025.
Key Changes in the Revised GN-21
- Expanded scope of changes that no longer require a Change Notification application
- New Flowchart 2.5 added for Machine Learning-enabled Medical Devices (MLMDs) to guide applicable notification routes
- Editorial updates to Flowchart 5 to clarify labelling-related changes affecting indications of use, warnings, precautions, and/or adverse events that will fall under Notification route
- New Change Type 6E: Submission of UDI data elements for registered devices
- Marketing history requirement removed under 6Ai Addition of Models
- Change Notification application will not be required for Class A medical devices
These revisions reflect HSA’s continued effort to enhance regulatory clarity and reduce unnecessary submission burdens. Access the updated guidance:
Official Source: Updates to GN-21
Published by HSA on 4 July 2025
