Singapore: HSA Introduces Change Management Program (CMP) for SaMD, Including Machine-Learning Enabled SaMD

The Health Sciences Authority (HSA) of Singapore has issued a new guidance document, GN-37-R1 Change Management Program (CMP) for SaMD, Including Machine-Learning Enabled SaMD, effective December 4, 2024. This guidance introduces an optional regulatory pathway designed to streamline regulatory processes for software as a medical device (SaMD) manufacturers, particularly those incorporating machine learning.

Key Highlights of GN-37-R1

Introduction of the Change Management Program (CMP)

  • The CMP provides a framework for “pre-specified changes” that SaMD manufacturers can implement without requiring a formal Change Notification submission.
  • “Pre-specified changes” must align with the SaMD’s original intended use and indication for use to qualify under CMP.

Assessment of Changes

  • Changes approved within a CMP must still be assessed in accordance with GN-37 to ensure compliance.
  • Any changes outside the scope of CMP-approved modifications must adhere to:
    • GN-21 Guidance on Change Notification for Registered Medical Devices
    • Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach (specific to ML-SaMD).

Benefits of CMP for SaMD Manufacturers

The CMP program offers several advantages:

  • Greater Efficiency: Streamlines the implementation of software updates while maintaining compliance with regulatory requirements.
  • Regulatory Clarity: Provides clear pathways for managing changes, especially for machine-learning-enabled SaMDs.
  • Operational Flexibility: Reduces administrative burden by eliminating the need for Change Notifications for pre-approved changes.

Next Steps for SaMD Manufacturers

  • Review GN-37-R1 Guidance: Ensure a thorough understanding of CMP criteria and the scope of “pre-specified changes”.
  • Evaluate Current Change Processes: Align internal processes with the CMP framework to leverage its benefits.
  • Plan Compliance Measures: Identify changes that qualify for CMP and establish protocols for non-CMP changes per GN-21 or relevant guidelines.

Further Information

For additional details, consult the official guidance document: HSA: Medical Device Guidance.

For inquiries or assistance, contact us at sales@andamanmed.com or click the button below to contact us.

Sign up for our regulatory roundup delivered once a month to your inbox



Scroll to Top

Stay Ahead in Southeast Asia's Medical Device Market!

Subscribe to our Newsletter

Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!

Contact Us