The Center for Medical Device Evaluation (CMDE) of the China National Medical Products Administration (NMPA) recently published a "Guidance for the Registration Review of Human Factors Design in Medical Devices" in March 2024. In 2020, NMPA once consulted public opinion on a draft version of usability; however, that draft was never implemented and has now been replaced by the current release version.
This blog, written by Stephanie Huang outlines the key differences between China's and the EU/FDA's expectations for preparing usability documents to support product registration in China. The guidance focuses on Class II and III medical devices (excluding IVD reagents). It provides authority's current thinking on the application of human factors (also known as usability), to medical devices (both domestic and imported) to be registered in China. Due to China's ever-growing consideration of the possible impact on medical device safety and effectiveness originating from cultural, users and users' environmental differences, the Chinese authority believes that usability compliance to other markets, such as the EU or USA, may not be sufficient enough to meet China's latest requirements such as the Chinese use environment.
The key differences between China's and the EU/FDA's expectations:
From the regulatory management perspective, the FDA has a longer establishment history and has published several human factors guidance since 1996. Applying Human Factors and Usability Engineering to Medical Devices in 2016, Content of Human Factors Information in Medical Device Marketing Submissions in 2022, Guidance for Human Factors for Home Use Products, and Application of Human Factors Engineering Principles for Combination Products Q&A 2023 are some significant documents to refer to for US submission preparation.
The European Union does not publish guidelines but relies on the standards compliance to IEC 62366 series and IEC60601-1-6 to regulate the usability's design, development, and validation process. China adopts both ways to release a guidance document and convert IEC standards (IEC 62366：2007, although expired, are adopted to YY/T 1474—2016, while IEC 60601-1-6：2013 is converted to YY/T 9706.106—2021 with modification) to set up its usability requirements.
User focus
The underlying principle of usability across countries is all about risk management. The common goal is to improve the design of the devices to minimize the potential use errors or harm and to ensure the products' intended safety and effectiveness. Although usability's definition, key elements, and continuous improvement in the device's life cycle are the same, the applied guidance scope in China is narrowed down to focus on users only and excludes transportation, installation, maintenance, repair, and disposal parties for now.
Validation process
The validation process for registration purposes is also slightly different. China's usability submission file content is managed based on product risk levels, while the US submission is based on the presence of critical tasks. The European Union relies on the standard's applicability. China also introduced a new term called "high use-related risk" to manage devices by risk better. Only high-use-related risk devices contain critical tasks, while medium and low-use-related risk devices do not. If the medical device has high use-related risks (NMPA lists 19 categories of class III devices to define the applicable scope), the applicant would be required to conduct a comprehensive analysis and validation testing reports when applicable. Otherwise, user error assessment reports would be sufficient.
For foreign devices, differences exist between the Chinese and foreign human factors designs with regard to the users, task scopes, critical task definitions, validation test participants, etc. For devices with high use-related risks and identified acceptable risks, a comparison analysis is required, plus existing validation documents used for submission out of China and use analysis of similar products' post-market reports. Additional local re-validation testing (based on Chinese users, use conditions, and registration requirements) shall also be performed if the assessed risks are deemed unacceptable. User error assessment reports and usability study research documents prepared in the device's original country would be sufficient for devices with medium and low use-related risks.
The minimum sample size is also specified in the China user interface verification and validation (V&V) tests. While IEC62366-1 does not specify the sample sizes, and the FDA mentions that manufacturers shall determine the necessary number of test participants, in general, the minimum number of participants should be 15 in Appendix B of the guidance document. During the China verification study design, a minimum of 5-8 participants per group is deemed necessary, and a minimum of 15 participants are required in the summary validation testing with justification for the total number of selected participants. These V&V processes shall be documented in test plans and reports with details.
The implementation date is approaching. NMPA requires the initial registration submission to include a usability study from October 8th, 2024. The product change submission needs to consider whether any substantial changes (usually involving the change to the intended scope, structure, PTR, etc.) happened to the users, use conditions, and interface and then decide if a research study or validation testing is applicable. The registration renewal submission does not need to provide a usability study for the time being.
How can we help you?
Our consultants can help perform gap assessments of existing files and draft summary reports to ensure that foreign manufacturers comply with NMPA's expectations. If you have any questions related to the China usability study, feel free to contact Qserve for more information.
Ready to Navigate Chinese Medical Device Regulations?
Download our whitepaper, Chinese Medical Device Regulations NMPA, and get answers to the most common questions about market access in China.
References:
Usability guidance
Usability application note