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為滿足監管急需，助推采用腦機接口技術的醫療器械高質量發展，經研究，國家藥監局批準《采用腦機接口技術的醫療器械 術語及定義》和《采用腦機接口技術的醫療器械 具備閉環功能的植入式神經刺激器 感知與響應性能測試方法》2項醫療器械行業標準制修訂項目立項。
請按照《醫療器械標準制修訂工作管理規范》有關要求，采用快速程序開展標準制訂，做好標準的起草、驗證、征求意見和技術審查等工作，保證標準質量和水平。
附件：醫療器械行業標準制修訂項目
國家藥監局綜合司
2024年9月30日
國家藥監局綜合司關于《采用腦機接口技術的醫療器械 術語及定義》等2項醫療器械行業標準立項的通知 藥監綜械注函〔2024〕503號
掃描下方的二維碼訂閱“CIRS醫械合規動態”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
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