NMPA has released draft of a new Guidance Document of Human Factors in Medical Devices in May (hereinafter referred to as "Guidance"), and has solicited public comments.
Human factors design (also known as Usability) refers to the comprehensive use of human factors knowledge about human anatomy, physiology, psychology, behavior and other capabilities and limitations to design and develop medical devices to enhance the usability of medical devices. Usability means the expected safe and effective use of medical devices when the user normally uses the medical device under the indication of use.
After future implementation, this Guidance will be applicable to Class II and Class III medical devices. Registrant needs to submit “Human Factor Design Research Report” in initial application and major change application. If the product has higher risk on usage, the user risk assessment report would be requested.
For imported medical devices, in general, usability confirmation tests should be carried out in China, unless detailed supporting data can be provided to confirm that the differences between China and foreign countries have no significant impact on human factor design.
This Guidance clearly lists the framework and requirements of the "Human Factor Design Research Report", and explains the basic elements of human factor design, such as the use environment, software control interface, user manuals, labels , etc.
Qualtech interpretation: Manufacturers can refer to IEC60601-1-6 or IEC 62366-1, but should pay close attention to whether Chinese users are included in the participants scope. If yes, manufacturers should provide relevant evidences to explain and evaluate the usage behavior of Chinese users for their device.