China's NMPA Releases New Guidelines for Usability Engineering in Medical Device Registration
Beijing, March 19, 2024 – In a significant move to further regulate the usability aspects of medical devices, the Center for Medical Device Evaluation under the National Medical Products Administration (NMPA) has officially released the "Guidelines for Usability Engineering in Medical Device Registration" along with its application notes. This announcement, marked as Notice No. 13 of 2024, aims to streamline the management and evaluation of medical device usability engineering, a critical factor in ensuring device safety and effectiveness.
The guidelines are intended to assist registrants in establishing a usability engineering process and preparing the necessary documentation for medical device registration. They emphasize the importance of user interface design in facilitating safe and effective device use, requiring that usability engineering considerations be integrated into the design and development stages of medical devices. The guidelines specify that these principles apply primarily to Class II and Class III medical devices, excluding in vitro diagnostic reagents.
Underlining the significance of human-machine interaction, the NMPA stresses that usability is an integral part of a medical device's safety and effectiveness. Manufacturers are encouraged to analyze expected use, scenarios, and core functionalities to mitigate usage risks and design user interfaces that cater to both the users and the usage environments. The guidelines advocate for a lifecycle approach to usability engineering, advising manufacturers to identify foreseeable usage risks before market entry and to refine usability post-market based on feedback and incident reports, thereby enhancing the overall safety and effectiveness of the medical devices.
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