New Requirements
Starting from October 8, 2024, usability engineering documents need to be submitted for medical device applications in accordance with the new guideline, “Registration Review Guideline for Medical Device Usability Engineering (2024, NO.13)”, published in Mar 2024. A risk-based approach is adopted when determining what human factors information to include in a marketing submission.
Classification of Devices Based on Use-Related Risk
The devices are regulated under two categories: those with high use-related risk and those with medium or low use-related risk.
High Use-Related Risk Devices
If your product is considered a medical device with high use-related risk, a usability engineering research report should be submitted. If equivalent devices are available on the market, the usability engineering documents of the equivalent device can be used as alternatives. Depending on whether there are differences between the equivalent device and the product to be registered or whether new risks are introduced, additional usability testing may be required.
If no equivalent devices are available, summative usability testing should be performed and included in the usability engineering research report. Such testing should be conducted in China unless the applicant can provide sufficient supporting materials to prove that the differences between China and foreign countries have no significant impact on user interface validation.
NMPA published the “Catalog of Products with High Use-related Risks”, which includes 19 types of medical devices. To request the catalog, please send the email to: info@chinamedevice.com.
Medium or Low Use-Related Risk Devices
For products with medium or low use-related risk, the relevant quality control can be based on the risk management process. Generally, the applicant only needs to submit a product use error evaluation report instead of a usability engineering research report.
Risk-Based Approach for Usability Documents Submission
The flowchart below illustrates the risk-based approach to determine the usability documents to be submitted to China NMPA.
Next Steps
It is recommended to evaluate your current usability documents against China’s requirements as soon as possible to avoid potential delays if you are planning a submission in China. China Med Device can help you to assess if your current documents are sufficient to meet China’s requirements or if a summative usability test in China is needed for your submission. Please send the email to info@chinameddevice.com for more information.
