醫療器械臨床試驗前需要做好哪些準備？

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　　醫療器械臨床試驗的目的是評價(jià)受試產(chǎn)品是否具有預期的安全性和有效性，依據相關(guān)規定，醫療器械臨床試驗應當在兩個(gè)或者兩個(gè)以上醫療器械臨床試驗機構中進(jìn)行，所選擇的試驗機構應當是經(jīng)資質(zhì)認定的醫療器械臨床試驗機構，且設施和條件應當滿(mǎn)足安全有效地進(jìn)行臨床試驗的需要。研究者應當具備承擔該項臨床試驗的專(zhuān)業(yè)特長(cháng)、資格和能力，并經(jīng)過(guò)培訓。

　　由于臨床試驗應當獲得醫療器械臨床試驗機構倫理委員會(huì )的同意，列入需進(jìn)行臨床試驗審批的第三類(lèi)醫療器械目錄的，還應當獲得國家食品藥品監督管理總局的批準，而且進(jìn)行醫療器械臨床試驗應當有充分的科學(xué)依據和明確的試驗目的，并權衡對受試者和公眾健康預期的受益以及風(fēng)險，預期的受益應當超過(guò)可能出現的損害。因此，醫療器械臨床試驗前需要做好相關(guān)的準備。

　　一、臨床試驗前，申辦者應當向所在地省、自治區、直轄市食品藥品監督管理部門(mén)備案。

　　二、臨床試驗前，申辦者應當完成試驗用醫療器械的臨床前研究，包括產(chǎn)品設計(結構組成、工作原理和作用機理、預期用途以及適用范圍、適用的技術(shù)要求)和質(zhì)量檢驗、動(dòng)物試驗以及風(fēng)險分析等，且結果應當能夠支持該項臨床試驗。質(zhì)量檢驗結果包括自檢報告和具有資質(zhì)的檢驗機構出具的一年內的產(chǎn)品注冊檢驗合格報告。

　　三、臨床試驗前，申辦者應當準備充足的試驗用醫療器械，而且試驗用醫療器械的研制應當符合適用的醫療器械質(zhì)量管理體系相關(guān)要求。

　　四、臨床試驗前，申辦者與臨床試驗機構和研究者應當就試驗設計、試驗質(zhì)量控制、試驗中的職責分工、申辦者承擔的臨床試驗相關(guān)費用以及試驗中可能發(fā)生的傷害處理原則等達成書(shū)面協(xié)議。

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