申請第三類(lèi)醫療器械臨床試驗審批需要注意哪些問(wèn)題？

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　　根據醫療器械相關(guān)法律的規定，申請第三類(lèi)醫療器械注冊，列入需進(jìn)行臨床試驗審批目錄的，應當先獲得國家食品藥品監督管理總局的批準。那么，申請第三類(lèi)醫療器械臨床試驗審批需要注意哪些問(wèn)題呢？

　　一、申請人應當按照相關(guān)要求向國家食品藥品監督管理總局報送申報資料。一般來(lái)說(shuō)，臨床試驗審批是指國家食品藥品監督管理總局根據申請人的申請，對擬開(kāi)展臨床試驗的醫療器械的風(fēng)險程度、臨床試驗方案、臨床受益與風(fēng)險對比分析報告等進(jìn)行綜合分析，以決定是否同意開(kāi)展臨床試驗的過(guò)程。

　　二、在醫療器械技術(shù)審評過(guò)程中需要申請人補正資料的，申請人應當在一年內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，國家食品藥品監督管理總局核準后作出不予批準的決定。

　　三、醫療器械臨床試驗應當在批準后3年內實(shí)施，逾期未實(shí)施的，原批準文件自行廢止，仍需進(jìn)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(shí)原批準的臨床試驗倫理性和科學(xué)性存在問(wèn)題的，國家食品藥品監督管理總局會(huì )撤銷(xiāo)已獲得的醫療器械臨床試驗批準文件。

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