Change Management Program (CMP) Guidance for SaMD

The updated guidance outlines the regulatory requirements for submitting a Change Management Program (CMP) during the registration or change notification of Software as a Medical Device (SaMD) in Singapore. The aim is to streamline the process while ensuring timely and safe software updates.

The document covers key areas like post-market data analysis, change management, and procedures for implementing anticipated changes that do not affect the intended use. It also details the verification protocols to ensure that updates meet both new and existing specifications.

Specific protocols are outlined for SaMD with machine learning components, ensuring quality assurance and risk mitigation. Post-implementation impact analysis is emphasized to assess the overall effects of any changes.

The public consultation period is open from 26 August 2024 to 21 October 2024. Once approved, changes under the CMP can be implemented without further notification but remain under post-market regulatory oversight.

Resource:https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/guidance-on-change-management-program-for-samd_for-consultation.pdf?sfvrsn=45a3e6a2_1##~https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd

Region: Singapore