The National Medical Products Administration (NMPA) in China has issued a notification confirming the establishment of two new standards related to medical devices utilizing Brain-Computer Interface (BCI) technology. The first standard, titled “Terminology and Definitions for Medical Devices Using Brain Computer Interface (BCI) Technology,” aims to provide a clear framework for the terminology and definitions used in the field. The second standard, “Testing Methods for Perception and Response Performance of Implantable Neural Stimulators with Closed Loop Function for Medical Devices Using Brain Computer Interface Technology,” outlines the testing methods for evaluating the performance of implantable neural stimulators with closed-loop functionality.
The responsibility for these standards falls on the Standardization Administration of the People’s Republic of China Technical Committee 10 (SAC/TC10) and SAC/TC110/SC4, respectively. These standards are expected to play a crucial role in guiding the development, manufacturing, and evaluation of BCI medical devices, ensuring safety and efficacy.- Flcube.com
