醫(yī)療器械臨床試驗(yàn)需要符合哪些要求？

test4

　　眾所周知，國家對醫(yī)療器械按照風(fēng)險(xiǎn)程度實(shí)行分類管理，第一類醫(yī)療器械實(shí)行產(chǎn)品備案管理，第二類、第三類醫(yī)療器械實(shí)行產(chǎn)品注冊管理。根據(jù)醫(yī)療器械注冊管理辦法的相關(guān)規(guī)定，辦理第一類醫(yī)療器械備案，不需進(jìn)行臨床試驗(yàn)，而申請第二類、第三類醫(yī)療器械注冊，則應(yīng)當(dāng)進(jìn)行臨床試驗(yàn)。不過，進(jìn)行醫(yī)療器械臨床試驗(yàn)需要符合下列要求：

　　一、申請第二類、第三類醫(yī)療器械注冊，需要按照醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范的要求，在取得資質(zhì)的臨床試驗(yàn)機(jī)構(gòu)內(nèi)進(jìn)行醫(yī)療器械臨床試驗(yàn)，臨床試驗(yàn)樣品的生產(chǎn)必須符合醫(yī)療器械質(zhì)量管理體系的相關(guān)要求，而且提交的臨床評價(jià)資料必須包括臨床試驗(yàn)方案和臨床試驗(yàn)報(bào)告。

　　二、由于有些第三類醫(yī)療器械進(jìn)行臨床試驗(yàn)對人體具有較高風(fēng)險(xiǎn)的，所以這些醫(yī)療器械需要經(jīng)國家食品藥品監(jiān)督管理總局批準(zhǔn)后才能進(jìn)行臨床試驗(yàn)。而且需進(jìn)行臨床試驗(yàn)審批的第三類醫(yī)療器械目錄由國家食品藥品監(jiān)督管理總局制定、調(diào)整并公布。

　　三、對于需進(jìn)行醫(yī)療器械臨床試驗(yàn)審批的，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(bào)送申報(bào)資料。

　　四、在國家食品藥品監(jiān)督管理總局將申報(bào)資料轉(zhuǎn)交醫(yī)療器械技術(shù)審評機(jī)構(gòu)技術(shù)審評過程中，需要申請人補(bǔ)正資料的，申請人必須在一年內(nèi)按照補(bǔ)正通知的要求一次提供補(bǔ)充資料，逾期未提交補(bǔ)充資料的將被終止技術(shù)審評，不予批準(zhǔn)。

　　五、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)性存在問題的，將會(huì)被撤銷已獲得的醫(yī)療器械臨床試驗(yàn)批準(zhǔn)文件。

　　六、醫(yī)療器械臨床試驗(yàn)應(yīng)當(dāng)在批準(zhǔn)后三年內(nèi)實(shí)施，逾期未實(shí)施的，原批準(zhǔn)文件自行廢止，如果仍需進(jìn)行臨床試驗(yàn)的，則需要重新申請。

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