申請第三類醫(yī)療器械臨床試驗審批需要注意哪些問題？

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　　根據(jù)醫(yī)療器械相關法律的規(guī)定，申請第三類醫(yī)療器械注冊，列入需進行臨床試驗審批目錄的，應當先獲得國家食品藥品監(jiān)督管理總局的批準。那么，申請第三類醫(yī)療器械臨床試驗審批需要注意哪些問題呢？

　　一、申請人應當按照相關要求向國家食品藥品監(jiān)督管理總局報送申報資料。一般來說，臨床試驗審批是指國家食品藥品監(jiān)督管理總局根據(jù)申請人的申請，對擬開展臨床試驗的醫(yī)療器械的風險程度、臨床試驗方案、臨床受益與風險對比分析報告等進行綜合分析，以決定是否同意開展臨床試驗的過程。

　　二、在醫(yī)療器械技術審評過程中需要申請人補正資料的，申請人應當在一年內(nèi)按照補正通知的要求一次提供補充資料。申請人逾期未提交補充資料的，國家食品藥品監(jiān)督管理總局核準后作出不予批準的決定。

　　三、醫(yī)療器械臨床試驗應當在批準后3年內(nèi)實施，逾期未實施的，原批準文件自行廢止，仍需進行臨床試驗的，應當重新申請。

　　此外，對于臨床試驗申報資料虛假或已有最新研究證實原批準的臨床試驗倫理性和科學性存在問題的，國家食品藥品監(jiān)督管理總局會撤銷已獲得的醫(yī)療器械臨床試驗批準文件。

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