MHLW notice establishing witness inspection procedures for registered conformity assessment bodies and revising on-site inspection implementation standards to ensure compliance and quality oversight.

Practical worked examples of application forms and supporting documentation for IDATEN change control plan confirmation applications specific to SaMD. Illustrates how to describe proposed changes, set acceptance criteria, and prepare draft revised approval documents. Issued concurrently with the consolidated Q&A revision.

Consolidated revision of Q&A guidance on the IDATEN change control plan confirmation system, integrating three previously separate documents. Adds provisions specific to AI/ML-enabled medical devices and SaMD, requiring submission of procedures for developing and implementing the change control plan and materials for appropriate AI technology management. Reflects startup company needs and accumulated regulatory experience since the system's 2020 launch.