申請第三類醫(yī)療器械臨床試驗審批需要注意哪些問題？

test4

　　根據(jù)醫(yī)療器械相關(guān)法律的規(guī)定，申請第三類醫(yī)療器械注冊，列入需進(jìn)行臨床試驗審批目錄的，應(yīng)當(dāng)先獲得國家食品藥品監(jiān)督管理總局的批準(zhǔn)。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(yīng)當(dāng)按照相關(guān)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(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，以決定是否同意開展臨床試驗的過程。

　　二、在醫(yī)療器械技術(shù)審評過程中需要申請人補正資料的，申請人應(yīng)當(dāng)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(zhǔn)后作出不予批準(zhǔn)的決定。

　　三、醫(yī)療器械臨床試驗應(yīng)當(dāng)在批準(zhǔn)后3年內(nèi)實施，逾期未實施的，原批準(zhǔn)文件自行廢止，仍需進(jìn)行臨床試驗的，應(yīng)當(dāng)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(zhǔn)的臨床試驗倫理性和科學(xué)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(zhǔn)文件。

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