This technical report provides practical guidance on developing, implementing, and maintaining medical device risk management systems in accordance with JIS T 14971:2020 and its parent standard ISO 14971:2019. Published concurrently with JIS T 14971:2020 on October 1, 2020, the document offers detailed explanations and examples to support manufacturers in applying risk management principles effectively. The guidance clarifies the relationship between ISO 14971 requirements and other standards such as IEC 62304 and IEC 62366-1, demonstrating how risk management integrates with software lifecycle and usability engineering processes. Manufacturers should consult this technical report to understand implementation best practices, including hazard analysis methodologies, risk estimation approaches, risk control strategies, and residual risk evaluation techniques. The document addresses sector-specific considerations applicable to various medical device types and provides case studies demonstrating risk management in practice. This non-normative guidance helps organizations establish robust risk management culture and documentation while ensuring compliance with both Japanese regulatory requirements and international standards.

This JIS standard specifies terminology, principles, and processes for applying risk management to medical devices, including Software as a Medical Device (SaMD) and In Vitro Diagnostic devices (IVD), corresponding to ISO 14971:2019. The 2020 revision strengthens provisions for addressing security risks and aligns terminology with JIS T 0063:2020 (vocabulary for medical device risk management). Manufacturers must establish and maintain a risk management system that identifies hazards, estimates risks, implements controls, and verifies their effectiveness throughout the device lifecycle. The standard provides a structured approach to ensure patient safety by reducing risks to acceptable levels. As the foundational risk management framework under Japanese medical device regulations, this standard works in conjunction with other lifecycle standards such as JIS T 2304 and JIS T 62366-1. The document replaced JIS T 14971:2003 and represents Japan's adoption of evolving international risk management best practices.