The Shanghai Food and Drug Safety Commission issued the “Shanghai Fifteenth Five-Year Plan to Ensure Drug Safety and Promote High-Quality Development of the Pharmaceutical Industry”, which proposes to strengthen the service and supervision of the whole chain of brain-computer-connected medical devices. Improve the pre-marketing supervision system for brain-computer interface medical devices, improve the special standard system for brain-computer interface medical devices, and develop evaluation methods and test and evaluation tools for new functions and characteristics of micro-nano neural electrodes. Establish and improve a “research, inspection and supervision” linkage mechanism, explore the linkage between review and approval, inspection and post-marketing risk monitoring, and accelerate product launch and application.

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