國家藥品監督管理局辦公室公開征求《醫療器械臨床試驗檢查要點及判定原則（征求意見稿）》意見
為強化對醫療器械臨床試驗過程的監督管理，有效開展醫療器械臨床試驗監督檢查，國家藥品監督管理局按照《醫療器械臨床試驗質量管理規范》《體外診斷試劑臨床試驗技術指導原則》的要求，組織起草了《醫療器械臨床試驗檢查要點及判定原則（征求意見稿）》，現公開征求意見。
請將意見建議于2018年6月30日前以電子郵件形式反饋至國家食品藥品監督管理總局食品藥品審核查驗中心。
聯系人：周失、程錦
電 話：010-68441563、010-88331453
電子郵箱：zhous@cfdi.org.cn
附件：醫療器械臨床試驗檢查要點及判定原則（征求意見稿）（下載）
國家藥品監督管理局辦公室
2018年5月31日
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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