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The Shanghai Food and Drug Safety Committee has issued the "15th Five-Year Plan for Ensuring Drug Safety and Promoting High-Quality Development of the Pharmaceutical Industry in Shanghai," which proposes strengthening full-chain services and regulation of brain-computer interface medical devices. The plan calls for improving the pre-market regulatory system, refining the specialized standards system, and developing evaluation methods and testing and assessment tooling for the new functions and characteristics of micro-nano neural electrodes. It also calls for establishing a "research-inspection-review-supervision" linkage mechanism and exploring linkages among review and approval, inspection and testing, and post-market risk monitoring, so as to accelerate product market entry and application.
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