LIVE — Last crawled: 2026-11-14 07:06 JST
Vol.1 — November 15, 2026
MSC Portal ›Regulatory Watch› All Entries (4)
Standards, Guidance & Notices
Showing 1–4 of 4
NIST
SP
SP 800-161 Rev. 1
Cybersecurity Supply Chain Risk Management Practices for Systems and Organizations
PUBLISHED SBOM / Vulnerability
Organizations are concerned about the risks associated with products and services that may potentially contain malicious functionality, are counterfeit, or are vulnerable due to poor manufacturing and development practices within the supply chain. These risks are associated with an enterprise’s decreased visibility into and understanding of how the technology they acquire is developed, integrated, and deployed or the processes, procedures, standards, and practices used to ensure the security, resilience, reliability, safety, integrity, and quality of the products and services. This publication provides guidance to organizations on identifying, assessing, and mitigating cybersecurity risks throughout the supply chain at all levels of their organizations. The publication integrates cybersecurity supply chain risk management (C-SCRM) into risk management activities by applying a multilevel, C-SCRM-specific approach, including guidance on the development of C-SCRM strategy implementation
Published: 2024-11-01
MHLW
Notice
MHLW-PFSB-MDED-0328-No.1
Guidance on Vulnerability Management to Ensure Cybersecurity of Medical Devices
PUBLISHED SBOM / Vulnerability
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.
Published: 2024-03-28
NIST
SP
SP 800-82 Rev. 3
Guide to Operational Technology (OT) Security
PUBLISHED SBOM / Vulnerability
This document provides guidance on how to secure operational technology (OT) while addressing their unique performance, reliability, and safety requirements. OT encompasses a broad range of programmable systems and devices that interact with the physical environment (or manage devices that interact with the physical environment). These systems and devices detect or cause a direct change through the monitoring and/or control of devices, processes, and events. Examples include industrial control systems, building automation systems, transportation systems, physical access control systems, physical environment monitoring systems, and physical environment measurement systems. The document provides an overview of OT and typical system topologies, identifies common threats and vulnerabilities to these systems, and provides recommended security countermeasures to mitigate the associated risks.
Published: 2023-09-28
IMDRF
IMDRF/CYBER WG/N73 FINAL:2023
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity
PUBLISHED SBOM / Vulnerability
Final document of the IMDRF Medical Device Cybersecurity Working Group on the Software Bill of Materials (SBOM), complementing the medical device cybersecurity principles set out in IMDRF N60. It provides recommendations for medical device manufacturers on creating, maintaining, and distributing SBOMs, and for healthcare providers on receiving and managing them. It also describes how both manufacturers and healthcare providers can use SBOMs in risk management, vulnerability management, and incident response across the total product life cycle.
Published: 2023-04-13