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06醫用成像器械
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【CMDE】國家藥監局器審中心關于發布電子內窺鏡同品種臨床評價注冊審查指導原則的通告（2023年第35號）
為進一步規范電子內窺鏡醫療器械的管理，國家藥監局器審中心組織制定了《電子內窺鏡同品種臨床評價注冊審查指導原則》
【CMDE】國家藥監局器審中心關于發布電子內窺鏡同品種臨床評價注冊審查指導原則的通告（2023年第35號）
【CMDE】國家藥監局器審中心關于發布正電子發射/X射線計算機斷層成像系統同品種臨床評價注冊審查指導原則的通告（2023年第31號）
為進一步規范正電子發射/X射線計算機斷層成像系統的管理，國家藥監局器審中心組織制定了《正電子發射/X射線計算機斷層成像系統同品種臨床評價注冊審查指導原則》并發布
【CMDE】國家藥監局器審中心關于發布正電子發射/X射線計算機斷層成像系統同品種臨床評價注冊審查指導原則的通告（2023年第31號）
關于公開征求《X射線計算機體層攝影設備同品種臨床評價技術指導原則（征求意見稿）》意見的通知
本指導原則為《醫療器械分類目錄》中06醫用成像器械，分類編碼為06-02-01的第三類醫療器械指導原則。
關于公開征求《X射線計算機體層攝影設備同品種臨床評價技術指導原則（征求意見稿）》意見的通知
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