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Health Sciences Authority
Regulatory Updates

Updates to GN-21

Audiences

Industry member

Product type

Medical devices

4 July 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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:

Thank you.
MEDICAL DEVICES CLUSTER
HEALTH SCIENCES AUTHORITY
SINGAPORE

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