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.

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.