The Singapore Health Sciences Authority (HSA) has published updated guidance for its Change Management Program (CMP) Pilot for Software as a Medical Device (SaMD). This program aims to make the regulatory pathways for post-market changes to SaMD more efficient, balancing patient safety with the need for innovation in medical software.
Notably, the revised guidance explicitly includes SaMD with machine learning (ML) features. The change reflects that HSA recognizes both the complications of repetitive updates in AI-driven software and the need for a strong framework to ensure that these changes are managed appropriately. The revised guidance establishes a risk-based approach to change management. Under the revised guidance, manufacturers must classify the changes based on their potential impact on safety and performance. The documentation requirements for minor changes will be simplified. In addition, HSA has provided clear criteria for distinguishing between minor and major changes, with faster review timelines for low-risk updates.
Another key point of the CMP pilot is the encouragement of engagement between the manufacturers and the HSA before submission. This engagement will help clarify regulatory requirements, enable changes to be implemented more smoothly, and help to foster a collaborative environment.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.