Guideline compiled under the FY2025 Medical Device Cybersecurity Promotion Project and circulated to industry by MHLW notice for reference. It covers all software contained in a medical device and sets out a stepwise adoption path according to organizational maturity: Stage 1 establishes the capability to create, update and change-manage SBOMs based on the NTIA minimum elements; Stage 2 integrates SBOMs into existing QMS and post-market safety processes, including vulnerability, license and EOL/EOS management, for lifecycle risk management. SPDX 2.2 or later and CycloneDX 1.6 or later are recommended for new adoption; where SWID is already in use, parallel use or conversion may be considered. As the disclosure baseline set by the guideline, manufacturers should be able to provide SBOMs to healthcare facilities, mainly at installation and upon significant software changes, and present them on request at least throughout the product support period. Intended readers span software development, quality assurance, regulatory affairs, PSIRT/information security and field service, as a shared cross-functional reference. Article 12(3) of the Essential Principles and FD&C Act Section 524B are cited as regulatory background.

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.