On July 2025, a new revision to the existing guidance GN-21: Guidance on Change Notification for Registered Medical Devices was released. This guidance outlines the requirements for Change Notifications for Medical Devices registered on the Singapore Medical Device Register (SMDR).
To view the official guidance, refer to: GN-21: Guidance on Change Notification for Registered Medical Devices
Key Highlights
Expanded Exemptions
- Expanded the list of changes which do not require Change Notification application to be submitted.
- This includes details on certain label changes and material supplier changes.
New MLMD Flowchart
- 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.
- This flowchart shows various scenarios for MLMDs applicable to Notification, Review, and Technical changes.
Labelling Clarification
- Editorial changes made to Flowchart 5: Changes to Labelling to clarify labelling changes to indications of use, warnings, precautions, and/or adverse events that fall under the Notification route.
New Change Type 6E
- Addition of Change Type 6E – Submit UDI data elements for registered devices that do not have their UDIDI established at the point of submission.
Marketing History Requirement Removed
- Removal of marketing history requirement under 6Ai: Addition of models.
Exemption for Class A Devices
- Change Notification application will not be required for Class A medical devices.
Implications to Clients
Authorized Representatives (ARs) for Medical Devices products who are required to submit Change Notifications to the authority will need to keep up to date with the latest changes to ensure continued compliance.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
