Updates to GN-21
Dear Medical Device Stakeholders
The Medical Devices Cluster (MDC) has updated GN-21: Guidance on Change Notification for Registered Medical Devices.
Key Updates to GN-21
- Expanded the list of changes which do not require Change notification application to be submitted
- Added Flowchart 2.5 Changes to Machine Learning-enabled Medical Device (MLMD) to provide further clarity on Change Notification routes applicable to changes made to MLMDs
- Editorial changes to Flowchart 5 Changes to Labelling to provide clarity on labelling changes to indications of use, warnings, precautions and/ or adverse events that will fall under Notifications route.
- Addition of Change type 6E - Submit UDI data elements for registered devices
- Removal of marketing history requirement under 6Ai Addition of models
- Change notification application will not be required for Class A medical devices
The finalised version can be accessed here and will be effective 14 July 2025:
- GN-21: Guidance on Change Notification for Registered Medical Device
Thank you.
MEDICAL DEVICES CLUSTER
HEALTH SCIENCES AUTHORITY
SINGAPORE
Industry member, Medical devices
Published:
Regulatory Updates