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.

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 regulatory notices 薬生機審発0331第8号 and 0523第1号.

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.