Pilot Run – Change Management Program (CMP) for SaMD, Including Machine Learning-enabled SaMD

The Medical Devices Cluster is launching a Pilot Change Management Program (CMP) for Software as a Medical Device (SaMD), including machine learning-enabled SaMD, aimed at enhancing regulatory efficiency.

Program Details

• Launch Date: 04-Dec-2024.
• Eligibility: Applicants submitting product registration or CN applications for:
  • Class B SaMD: Other Notification Changes (Verified by HSA before submission).
  • Class C SaMD: Other Technical Changes (Verified by HSA before submission).
• Enrollment Process:
  • Upload the required documents on MEDICS during application submission.
  • Send an email to HSA_MD_Info@hsa.gov.sg to confirm enrollment.

Guidance and Stakeholder Engagement

• Stakeholder feedback during the consultation phase was key to shaping the CMP for SaMD, including the Machine Learning-enabled SaMD Guidance Document.
• The finalized guidance document, GN-37-R1, is available for reference.

This pilot program reflects the Medical Devices Cluster’s commitment to fostering innovation while streamlining regulatory processes for SaMD and machine learning-enabled medical devices.

Region: Singapore

Source: https://www.hsa.gov.sg/announcements/regulatory-updates/pilot-run–change-management-program-(cmp)-for-samd–including-machine-learning-enabled-samd