Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance

By Yvonne Limpens and Julee Henry 

On March 19th, 2024, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) released a final version of its guidance pertaining to the application of human factors engineering (HFE) / usability engineering (UE) to medical device development. Compliance to the Guideline of usability engineering review for medical devices and the supplemental document Application notes on the “Guideline of usability engineering review for medical devices” is required starting in October 2024.   

Emergo will host a webinar on April 10, 2024, covering NMPA’s HFE expectations in greater detail. Below, we outline changes and updates from the draft guidelines for public comment, released October 2023. 

• A new decision flow chart (figure 4) clarifies the expected HFE activities, in-country validation testing and documentation requirements. This decision depends on level of use-risk (low, medium, or high), product novelty, equivalent devices and comparative evaluation outcome. Consistent with the prior draft guidance, a “use error assessment report” is required for low and medium-use-risk devices, whereas a “usability engineering research report” is required for all high-use risk devices.  

• A high-use-risk (note: not synonymous with high-risk) device is defined as one listed in the catalog of high-use risk products OR high-risk devices that “adopt a new way of use, have a long learning curve, are used by non-professional users, and have high operational complexity,” clarifying previous ambiguity.  

• The pass/fail criteria for validation now align with the U.S. Food and Drug Administration's (FDA) expectations and regulators upholding (a national variant of) IEC 62366. Rather than requiring validation testing to have clear pass/fail criteria, validation test findings should be analyzed according to residual risk to determine a “pass.” 

• While previously mentioned explicitly, there is no training program and plan requirement for high use-risk medical devices.   

• The finalized guidance document includes detailed expectations for the scope and content of a comparative evaluation, validation report and the “use error assessment report.”  

• The introduction of a supplementary document (Application notes on the "Guidelines for the Registration Review of Medical Device Usability Engineering) defines the catalogue of high-risk devices and provides a high-level overview of the HFE requirements for product registration. In theory, this could allow the catalogue of high-use risk devices to be updated more frequently, making it a key component of the NMPA guidance to monitor. 

In conclusion, the final guidance provides further clarity and details about NMPA’s expectations for HFE activities and documentation. While the HFE approach and process are similar to other standards and guidance documents, NMPA’s approach to determining how to scope HFE activities is unique and should be followed carefully when seeking market access to China.  

Navigate China NMPA’s HFE expectations with Emergo by UL 

Please reach out if we can help you consider how this new guidance, and/or other existing HFE guidance documents, impacts the HFE work needed for your particular product. We remain eager to help our customers plan global HFE efforts in a compliant and efficient manner. The NMPA HFE guidance states that stakeholders (e.g., applicant’s staff members) cannot serve as participants or evaluators of the summative usability test, and the evaluators must have knowledge and experience in usability engineering. Emergo by UL is staffed with human factors expertise locally in China, and a partnership with a state-owned test facility, the Shanghai Center for Medical Testing and Inspection (CMTC), where we currently conduct usability testing. Let us know how we can help!  

Want to learn more about NMPA’s HFE expectations? Register for our April 10, 2024 webinar here.

Yvonne Limpens is a Managing Human Factors Specialist at Emergo by UL.  

Julee Henry is a Lead Human Factors Specialist at Emergo by UL.