Pilot run: Change Management Program (CMP) for SaMD, including Machine learning-enabled SaMD

Dear Medical Device Stakeholders,

As part of HSA"s ongoing initiative to improve regulatory efficiency, the Medical Devices Cluster (MDC) is rolling out our Pilot run of Change Management Program (CMP) for SaMD, including Machine learning-enabled SaMD.

CMP is a new optional regulatory pathway specifically for SaMD that is incorporated into HSA's Premarket Product Registration and Change Notification (CN) processes, which also introduces the concept of Pre-specified changes.

With effect from 4th December 2024, please follow these 2-steps if you would like to enrol into the Program:

Step 1: Upload all required documents on MEDICS when submitting product registration / CN application. For CN application, applicant may select the following change types:
- Class B SaMD: Other Notification Changes (Verified by HSA prior to submission)
- Class C SaMD: Other Technical (Verified by HSA prior to submission)
Please upload the email blast circulated on 4th December 2024 as supporting document under "HSA email" section

Step 2: Drop us an email at HSA_MD_Info@hsa.gov.sg to inform us the intention to enrol into CMP, with the following information.
Email subject header: CMP enrolment
- MEDICS job reference number
- Company name
- Submission date
- Device name

We also wish to take this opportunity to thank our stakeholders for your feedback during the consultation of the Change Management Program (CMP) for SaMD, including Machine learning-enabled SaMD guidance document. The Guidance has been updated based on the various feedback and comments received during consultation. We look forward to your continued support and engagement.

The finalised version can be accessed here:

GN-37-R1 Guidance on Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD

Thank you.

MEDICAL DEVICES CLUSTER
HEALTH PRODUCTS REGULATION GROUP
HEALTH SCIENCES AUTHORITY
SINGAPORE

Published: 4 Dec 2024

Regulatory Updates