Standards, Guidance & Notices
Showing 11–20 of 29
MHLW
Notice
Notice
Admin-Notice-2023-07-20
Q&A on Application of Essential Principles Article 12(3) for Medical Devices
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.
Published: 2023-07-20
MHLW
Notice
Notice
MHLW-PSEHB-MDED-0523-No.1
Conformance Assessment Procedures for Essential Principles Article 12(3) of Medical Devices
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.
Published: 2023-05-23
IMDRF
IMDRF/CYBER WG/N70FINAL:2023
Principles and Practices for Cybersecurity of Legacy Medical Devices (FINAL 2023)
This document provides IMDRF guidance on managing cybersecurity risks in legacy medical devices that are end-of-life (EOL) or difficult to maintain. It clarifies responsibilities and practical mitigation strategies for both manufacturers and healthcare facilities. The document establishes frameworks for EOL management planning, identifying alternative solutions, and making informed risk acceptance decisions. As a complementary document to N60, it addresses the specific challenges posed by legacy systems that cannot be readily updated with security patches or improvements. Manufacturers and healthcare organizations should use this guidance to systematically assess legacy device risks and implement appropriate risk mitigation measures aligned with current cybersecurity standards.
Published: 2023-04-01
MHLW
Notice
Notice
医政参発0331-No.1
Guideline for Ensuring Cybersecurity of Medical Devices in Healthcare Facilities
MHLW notification of Cybersecurity Guideline for healthcare facility administrators and staff. Presents practical procedures for information collection from manufacturers, risk assessment, pre-implementation verification, vulnerability response during operation, and EOL management. Positioned as healthcare facility version of manufacturer guideline (薬生機審発0331第11号), structured to promote coordination between both parties.
Published: 2023-03-31
MHLW
Notice
Notice
MHLW-PSEHB-MDED-0331-No.11
Revision of Cybersecurity Implementation Guideline for Medical Devices
MHLW notification of revised Cybersecurity Guideline for Medical Device Manufacturers (2nd Edition). Updated to align with Essential Principles Article 12(3) implementation. Provides practical procedures for security requirements identification, architecture design, SBOM, PSIRT establishment, and vulnerability disclosure. Functions as specific guidance for JIS T 81001-5-1 application.
Published: 2023-03-31
MHLW
Notice
Notice
MHLW-PSEHB-MDED-0331-No.8
Notice on Application of Essential Principles Article 12(3) for Medical Devices
Interpretation notice accompanying April 1, 2023 enforcement of Essential Principles Article 12(3) cybersecurity requirements. Mandates three elements for network-connected medical devices: lifecycle cybersecurity planning, risk reduction design, and minimum operational environment specifications. Recognizes JIS T 81001-5-1 conformance as equivalent to Article 12(3) compliance. Provides transition period until March 31, 2024.
Published: 2023-03-31
JIS
Std
Std
JIST810015-1
JIS T 81001-5-1:2023 Health software and health IT system safety, efficacy and security - Part 5-1: Security - Activities in the product lifecycle (equivalent to IEC 81001-5-1:2021)
This JIS standard specifies cybersecurity activities that medical device manufacturers must implement in addition to the software lifecycle processes defined in JIS T 2304, corresponding to IEC 81001-5-1:2021. The document establishes requirements for managing security risks throughout the product lifecycle, addressing threats related to unauthorized access, data integrity, and system availability. Enacted on February 25, 2023, and effective from April 1, 2024, this standard was developed by JEITA (Japan Electronics and Information Technology Industries Association) as a draft originator. The standard is positioned as a conformance specification for Article 12, Paragraph 3 of Japan's Medical Device Basic Requirements Standards (Yakuhin Kikai Kihon Youken Kijun). Manufacturers should integrate the cybersecurity activities outlined herein with their existing software development processes to ensure comprehensive protection against evolving security threats throughout the device lifecycle.
Published: 2023-02-25
NIST
FIPS
FIPS
FIPS 186-5
Digital Signature Standard (DSS)
This standard specifies a suite of algorithms that can be used to generate a digital signature. Digital signatures are used to detect unauthorized modifications to data and to authenticate the identity of the signatory. In addition, the recipient of signed data can use a digital signature as evidence in demonstrating to a third party that the signature was, in fact, generated by the claimed signatory. This is known as non-repudiation since the signatory cannot easily repudiate the signature at a later time.
Published: 2023-02-03
AAMI
TIR
TIR
AAMI TIR97:2019/(R)2023
Principles for medical device security — Postmarket risk management for device manufacturers
Technical information report providing guidance on postmarket security risk management for medical devices within the ISO 14971 safety risk management process. Designed for use with AAMI TIR57:2016. Covers PSIRT establishment, vulnerability disclosure policy, and coordinated vulnerability disclosure (CVD) frameworks. Closely aligned with FDA postmarket cybersecurity guidance. Published 2019, reaffirmed 2023.
Published: 2023-01-31
AAMI
TIR
TIR
AAMI TIR57:2016/(R)2023
Principles for medical device security — Risk management
Technical information report providing guidance on information security risk management for medical devices within the ISO 14971 safety risk management process. Incorporates expanded risk management concepts from IEC 62443, presenting practical methods for threat modeling and security risk assessment. Directly referenced by FDA's 2023 final cybersecurity guidance. Complementary to IEC 81001-5-1. Originally published 2016, reaffirmed 2023.
Published: 2023-01-13