Japan’s MHLW/PMDA Mandate Compliance with New HFE/UE Standard for Medical Devices

Key Takeaways:

• Regulatory Compliance: As of April 1, 2024, Japan’s Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Products Agency (PMDA) require compliance with JIS T 62366-1:2022, Japan’s national Human Factors Engineering (HFE) and Usability Engineering (UE) standard for medical devices.
• HFE/UE Standards: The Japanese standard, based on IEC 62366-1:2015+AMD1:2020, outlines specific activities for applying HFE/UE to medical devices. While manufacturers can use internationally recognized standards, they must understand the differences between IEC 62366-1:2015 and JIS T 62366-1:2022.
• Local Adaptations: Manufacturers are advised to assess the impact of local use conditions in Japan and consider whether additional HF validation tests are necessary for compliance.

Japan’s regulatory authorities—the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Products Agency (PMDA)—will require all medical device manufacturers to comply with JIS T 62366-1:2022, the national Human Factors Engineering (HFE) and Usability Engineering (UE) standard. This new mandate signals a significant shift in Japan’s regulatory landscape, particularly for companies looking to market medical devices in the country. Understanding the implications of this requirement is crucial for ensuring successful regulatory approval and market entry in Japan.

Historically, Japanese regulators did not enforce strict guidelines related to HFE/UE in medical device development. However, with the release of JIS T 62366-1:2022, there is now a formalized expectation for incorporating HFE/UE principles into the design and development of medical devices. This standard is closely aligned with IEC 62366-1:2015+AMD1:2020, an international standard, but with specific adaptations that reflect Japan’s regulatory environment.

In 2022, following the release of JIS T 62366-1:2022, Japanese regulators issued several key documents that outlined the expectations for compliance. These include a notification on the handling of amendments to the Japanese Industrial Standards (JIS) for usability engineering and a supplemental Q&A document addressing frequently asked questions about the new requirements. Together, these documents emphasize the importance of updating standard operating procedures (SOPs) related to medical device design, development, and risk management to align with JIS T 62366-1:2022.

Key Considerations for Compliance

Manufacturers must carefully review and potentially update their SOPs to ensure they meet the requirements set forth in JIS T 62366-1:2022. This review should extend to all processes related to risk management, usability testing, and design controls. The Japanese regulators have made it clear that adherence to these updated standards is not optional; it is a critical component of the regulatory approval process in Japan.

One notable aspect of the new standard is its approach to the user interface of unknown provenance (UOUP). While IEC 62366-1:2015 identifies devices commercialized before February 24, 2015, as UOUP, JIS T 62366-1:2022 extends this date to October 1, 2019. Moreover, devices released before April 1, 2024, may also be treated as UOUP under certain conditions. This flexibility provides manufacturers with additional time to comply with the full requirements of the HFE/UE standard, but it also necessitates a thorough understanding of the differences between the international and Japanese standards.

Navigating HFE/UE Compliance for Medical Devices in Japan: Key Considerations for HF Validation Test Data and Regulatory Alignment

A common question among manufacturers is whether Japanese regulators will accept Human Factors (HF) validation test data collected outside of Japan as part of their compliance submissions. While JIS T 62366-1:2022 does not explicitly require that such data be collected within Japan, it is important to consider the potential differences in user profiles and use environments between Japan and other countries.Before deciding to use HF validation test data collected elsewhere, manufacturers should undertake several key activities.Developing detailed user profiles that reflect the characteristics and needs of the intended Japanese users. This step is crucial for identifying any differences that could affect how the device is used in Japan.

Evaluating the intended use environments in Japan and compare them with those where the HF validation tests were conducted. Any significant differences should be analyzed for their impact on the device’s usability.Revisiting the use-related risk analysis (URRA) to determine if the differences in users or use environments introduce new risks or alter the critical tasks associated with the device. Once the labeling is translated into Japanese, assess whether the translation impacts the validity of the HF validation test data. Depending on the outcomes of these activities, it may be beneficial to conduct a supplemental HF validation test within Japan to ensure that the device can be safely and effectively used by Japanese users in their specific environments.

The Japanese regulatory landscape is evolving, with a growing emphasis on HFE/UE compliance. Manufacturers aiming to bring medical devices to the Japanese market must align their development processes with JIS T 62366-1:2022. While the standards share similarities with IEC 62366-1:2015, there are important differences, particularly regarding UOUP criteria and HF validation testing.By thoroughly understanding these requirements and conducting the necessary analyses, manufacturers can ensure that their devices meet the stringent expectations of Japanese regulators, thereby facilitating a smoother path to market approval. For those needing additional support, local expertise, such as that offered by Emergo’s Japan-based team, can provide valuable guidance throughout the regulatory process.

Resource: Emergo by UL, August 29, 2024

Elham Talatghoushchi