Singapore’s revised GN-21 guidance streamlines medical device change notification by expanding exemptions, clarifying pathways for machine learning-enabled devices, and introducing new UDI data requirements. These updates reduce regulatory burden while reinforcing oversight of post-market changes.
Singapore’s Health Sciences Authority (HSA) released a revised version of GN-21: Guidance on Change Notifications. The updated document expands the list of changes that don’t require submission, clarifies reporting pathways for machine learning-enabled medical devices (MLMDs), and introduces a new requirement for UDI data submission. These revisions aim to simplify compliance while ensuring continued oversight of post-market device changes.
Expanded List of Changes That Don’t Require Notification: More types of device modifications are now exempt from formal change notification, reducing the administrative load for manufacturers and registrants.
New Flowchart for Machine Learning-Enabled Devices: Flowchart 2.5 has been added to address regulatory routes for MLMDs. It helps determine whether model updates, algorithm changes, or retraining activities require notification.
Clarified Labelling Rules: Flowchart 5 has been edited to better define when labelling updates—such as changes to indications for use, warnings, or adverse events—fall under the notification pathway.
New Change Type 6E: UDI Data Submission: A new category under GN-21, Change Type 6E, now requires companies to submit Unique Device Identifier (UDI) data elements for already registered devices.
Removed Requirement for Marketing History: For additions of new models under Change Type 6Ai, the requirement to include prior marketing history has been removed, streamlining documentation requirements.
No Notification for Class A Devices: Class A medical devices are no longer subject to change notification applications, further aligning with risk-based regulatory principles.
These updates signal HSA’s commitment to aligning regulation with evolving technologies and practical industry needs. Manufacturers operating in Singapore should ensure full alignment with GN-21 to maintain compliance, avoid unnecessary delays, and support efficient product lifecycle management.
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