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,” which became effective on 4th December 2024.
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.
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For inquiries or assistance, contact us at sales@andamanmed.com or click the button below to contact us.
