On 21.05.2020, the NMPA (National Medical Products Administration) issued a draft guidance document (Official Chinese Version / Unofficial English Translation by Cisema) seeking input on whether to include human factors/usability engineering (HFE) in China NMPA registration of Class II and Class III medical devices. HFE focuses on the interactions between people and devices, ensuring the hardware and software are safe if used as intended. Applying HFE during product registration would be one method to verify the user interface is safe and effective.
Considering the ethnic differences between China and foreign countries, the draft guidance suggests to conduct HFE tests in China on imported medical devices for confirmation, unless sufficient information can be provided to prove that the differences will have no significant impact. The draft guidance suggests that in most circumstances, clinical trials are insufficient to substitute HFE tests.
The document provides that the following information would need to be submitted in the HFE research report (that would be submitted as part of the NMPA application dossier):
- Basic information (Device name, model number / spec., intended use and target users)
- Risk level (High, medium, or low) and supporting materials for justification
- Core elements (Users, usage scenarios, and user interfaces)
- HFE design process (Flow chart, detailed content and requirements), and checklist of relevant process standards if any
- Documentation of user interface requirements or product requirements
- Risk management and risk control measures to ensure all known errors and residual risks are reduced to acceptable levels
- Evaluation report based on different HFE methods
- HFE relationship table (User interface requirements, design, risk management, etc.) for tracing analysis
- Summary report to determine if the user requirements (safety use and effectiveness) have been met
Please share your opinions with us before the consultation period ends on 26th June, so that we can together submit a strong proposal to the Chinese authorities.
Contact us for our translation of the draft guidance document.
By Jacky Li. Contact Cisema to learn more.