Amendment to medical device adverse event reporting requirements, updating procedures for manufacturers and importers to report defects, malfunctions, and serious incidents to PMDA and MHLW in a timely manner.

Notice on post-market vulnerability management framework. Requires manufacturers/distributors to integrate vulnerability monitoring, evaluation, response, and disclosure processes (including SBOM utilization) into quality management systems. Mandates establishment of PSIRT structure, clear vulnerability notification policies to customers, and practical end-of-life support management procedures.

Expanded Q&A set on application and conformance assessment of Essential Principles Article 12(3). Provides guidance on system architecture diagram formats, post-transition application handling, third-party testing utilization, SBOM documentation scope, and legacy product compliance strategies based on practical implementation experience.

Notice clarifying handling of cybersecurity events in adverse event/serious adverse event reporting systems. Addresses reporting applicability for patient harm from cyber attacks or vulnerability exploitation, decision-making flowcharts, and manufacturer response procedures. Serves as foundational regulatory documentation for post-market cybersecurity management.

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.

Q&A addressing application and conformance assessment of Essential Principles Article 12(3). Covers transition period marketing approval application handling, submission documentation methods, third-party agency utilization for JIS T 81001-5-1 conformance, and reliability document review scope. References related MHLW regulatory notices issued in March and May 2023.

Practical guidance on expedited regulatory approval for SaMD including two-stage approval processes. Clarifies early marketing approval application handling across different development stages while maintaining consistent pre- and post-market safety/effectiveness assurance. Developed through public-private-academic collaboration as part of DASH for SaMD strategy, applicable to AI/ML-enabled SaMD.

Notice specifying concrete compliance assessment considerations for Essential Principles Article 12(3). Details additional verification items against JIS T 81001-5-1 provisions (general requirements, maintenance processes, configuration management). Requires demonstration of intended use environment through system/network architecture diagrams and integration of vulnerability notification activities into quality management systems.

Revision of 2021 SaMD classification guideline (2023 version). Clarifies and refines classification criteria based on accumulated consultation cases. Adds judgment criteria for AI/ML-enabled software, cloud-based programs, and wellness applications. Maintains alignment with IMDRF N10 and N12. Updates judgment flow based on intended use and risk.