top of page
Search

Singapore: HSA Updates GN-21, Now with Smarter Change Notifications for Medical Devices (effective from 14 July 2025)

The Health Sciences Authority (HSA) has announced the implementation of revised GN-21, which is set to take effect on 14 July 2025. This latest revision introduces pivotal enhancements to Singapore’s medical device regulatory framework, particularly in how registrants manage and notify changes to registered devices. With clearer guidance for AI/ML-enabled technologies, new exemptions, and streamlined pathways, the latest revision reflects a stronger alignment with global best practices, ensuring both innovation and safety continue to move forward together.


Here are the most significant additions and clarifications now in effect:


  1. New Guidance for ML-enabled Devices (MLMDs)

Flowchart 2.5 has been introduced specifically for Machine Learning-enabled Medical Devices, distinguishing between changes that require notification vs new submissions.

  • Change Type 2Aiii: Notification required for modifications to ML outputs using the same input type

  • Change Type 5C or Pre-market: Required for changes that affect the indication for use or bypass healthcare provider review

  • New Definition: MLMD is now officially recognized using IMDRF terminology

 

  1. Standalone Software (SaMD) & Continuous Learning AI

The latest revision, GN-21, recognizes Standalone Medical Mobile Applications (SaMD) and continuous learning algorithms.

  • Registrants for such software should refer to GN-37, the new CMP guidance

  • Continuous learning boundaries or baseline performance changes must be declared

 

  1. More Changes Now Do Not Require Notification

Certain low-risk changes are now exempt from notification, including:

  • Label changes that don’t add new safety info

  • Change of material suppliers that do not affect device specs (non-biologic, non-drug components)

  • Addition of barcodes, UDI, or distributors without affecting listing info.


These exemptions reduce paperwork for companies while maintaining oversight.


  1. Class A Devices Fully Exempt from Change Notifications

All change notifications for Class A medical devices (lowest-risk) are no longer required, including:

  • Addition or removal of Class A models

  • Identifier changes


These devices must now be listed in a separate Class A database, as explained in GN-22.

 

  1. Clearer Pathways for Labelling Changes (Flowchart 5)

Updates distinguish between:

  • Technical or Review notifications

  • Notification-only changes (example: Formatting updates, new clinical statements within scope)


Flowchart 5 is expected to help in determining the right route based on type, impact, and data requirements.

 

  1. New Change Type 6E: Submission of UDI Data

Manufacturers must now submit Unique Device Identifier (UDI) data elements for registered devices via Change Type 6E, enhancing device traceability.

This aligns Singapore with global UDI regulations from IMDRF, FDA, and EU MDR.

 

  1. No More Marketing History for 6Ai

Previously, adding new models under Change Type 6Ai required proof of overseas marketing. In the latest revision, this condition has been removed to speed up the local introduction of updated models.

 

  1. Bundled Notification Restrictions for AI & Safety Events

Registrants cannot bundle certain notifications, including:

  • AI/MLMDs with continuous learning or generative AI

  • Changes linked to Field Safety Corrective Actions (FSCAs) or Adverse Events (AEs)


These must be submitted separately and approved before implementation.

 

Stakeholders’ Attention

To prepare for the implementation of the latest GN-21, registrants should start by thoroughly reviewing the updated guidance to determine which changes impact their registered medical devices. internal standard operating procedures (SOPs) should be updated accordingly, especially concerning the revised flowcharts and change categories.

It is also essential to train regulatory and quality assurance teams on the new notification routes, particularly for machine learning-enabled or software-based devices. Where required, Unique Device Identifier (UDI) data must be submitted via SHARE using Change Type 6E. Lastly, accurate classification is critical; misclassified submissions may be rejected by HSA.


Summary

Revision 6 GN-21 is not just a regulatory update; it is a smarter and forward-looking framework for a rapidly evolving MedTech landscape. By recognizing AI tools, streamlining low-risk changes, and empowering digital traceability, HSA helps manufacturers stay compliant, innovative, and efficient.

 

Comments

bottom of page