This resource is the guideline on review of human factors (usability) design of medical devices issued by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA).
About this document
Human factors design focuses on use errors that may occur when users interact with a device, and the associated risks. The guideline sets out the requirements for human factors study documentation in registration submissions, including user, use environment and user interface analysis, identification of critical tasks, and formative and summative evaluation (usability testing), consistent with the approach of IEC 62366-1.
Applicable products and users
- Medical devices with complex operation or a higher risk of use error, such as active devices, home-use devices and injection and infusion devices
- Companies applying for Class II or Class III medical device registration in China
Main contents
- Scope of human factors study documentation
- Critical tasks and use error risk analysis
- Requirements for formative and summative evaluation (usability testing)
- Format for preparing the submission documents
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Related articles
- Latest NMPA Guidelines for Registration Review of Human Factors (Usability) Design of Medical Devices
- China Medical Device Registration (NMPA) Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.