申請(qǐng)第三類(lèi)醫(yī)療器械臨床試驗(yàn)審批需要注意哪些問(wèn)題？

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　　根據(jù)醫(yī)療器械相關(guān)法律的規(guī)定，申請(qǐng)第三類(lèi)醫(yī)療器械注冊(cè)，列入需進(jìn)行臨床試驗(yàn)審批目錄的，應(yīng)當(dāng)先獲得國(guó)家食品藥品監(jiān)督管理總局的批準(zhǔn)。那么，申請(qǐng)第三類(lèi)醫(yī)療器械臨床試驗(yàn)審批需要注意哪些問(wèn)題呢？

　　一、申請(qǐng)人應(yīng)當(dāng)按照相關(guān)要求向國(guó)家食品藥品監(jiān)督管理總局報(bào)送申報(bào)資料。一般來(lái)說(shuō)，臨床試驗(yàn)審批是指國(guó)家食品藥品監(jiān)督管理總局根據(jù)申請(qǐng)人的申請(qǐng)，對(duì)擬開(kāi)展臨床試驗(yàn)的醫(yī)療器械的風(fēng)險(xiǎn)程度、臨床試驗(yàn)方案、臨床受益與風(fēng)險(xiǎn)對(duì)比分析報(bào)告等進(jìn)行綜合分析，以決定是否同意開(kāi)展臨床試驗(yàn)的過(guò)程。

　　二、在醫(yī)療器械技術(shù)審評(píng)過(guò)程中需要申請(qǐng)人補(bǔ)正資料的，申請(qǐng)人應(yīng)當(dāng)在一年內(nèi)按照補(bǔ)正通知的要求一次提供補(bǔ)充資料。申請(qǐng)人逾期未提交補(bǔ)充資料的，國(guó)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(yàn)應(yīng)當(dāng)在批準(zhǔn)后3年內(nèi)實(shí)施，逾期未實(shí)施的，原批準(zhǔn)文件自行廢止，仍需進(jìn)行臨床試驗(yàn)的，應(yīng)當(dāng)重新申請(qǐng)。

　　此外，對(duì)于臨床試驗(yàn)申報(bào)資料虛假或已有最新研究證實(shí)原批準(zhǔn)的臨床試驗(yàn)倫理性和科學(xué)性存在問(wèn)題的，國(guó)家食品藥品監(jiān)督管理總局會(huì)撤銷(xiāo)已獲得的醫(yī)療器械臨床試驗(yàn)批準(zhǔn)文件。

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