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Health Sciences Authority
Regulatory Updates

Consultation on Guidance on Change Management Program (CMP) for SaMD

Audiences

Industry member

Product type

Medical devices

26 August 2024

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The Medical Devices Cluster (MDC) has released a draft of Guidance on Change Management Program (CMP) for SaMD for stakeholders' consultation. The document describes the regulatory requirements and procedures for CMP submission. 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.

We would like to invite our stakeholders to provide feedback on the Guidance on Change Management Program (CMP) for SaMD:

Guidance on Change Management Program for SaMD_For consultation [PDF, 558 KB] (opens in new tab)

The Consultation period for this document is from 26 August 2024 to 21 October 2024. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 21 October 2024 and with "Feedback on Guidance on CMP for SaMD" in the email subject header.

Consultation feedback form - Guidance on CMP for SaMD [XLSX, 10 KB] (opens in new tab)

Briefing webinar slides: Industry Briefing on CMP for SaMD_slides [PDF, 363 KB] (opens in new tab)