Singapore HSA has updated GN-21: Guidance on Change Notification for Registered Medical Devices, effective 14th July 2025.
Key Updates to GN-21 include:
– 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 updated guidance GN-21 can be accessed at the following link: