源興醫療

標題: 哪些醫療器械可以不進(jìn)行臨床試驗？ [打印本頁(yè)]

作者: test4 時(shí)間: 2018-8-1 10:20
標題: 哪些醫療器械可以不進(jìn)行臨床試驗？
　　眾所周知，辦理醫療器械注冊或者備案事務(wù)的人員需要具有相應的專(zhuān)業(yè)知識，熟悉醫療器械注冊或者備案管理的法律、法規、規章和技術(shù)要求，不然醫療器械產(chǎn)品需要不需要進(jìn)行臨床試驗都不清楚。那么，哪些醫療器械可以不進(jìn)行臨床試驗呢？

　　根據醫療器械監督管理條例的相關(guān)規定，第一類(lèi)醫療器械風(fēng)險程度低，國家實(shí)行產(chǎn)品備案管理，不需要進(jìn)行臨床試驗；由于第二類(lèi)醫療器械具有中度風(fēng)險，第三類(lèi)醫療器械具有較高風(fēng)險，國家對這兩類(lèi)醫療器械實(shí)行產(chǎn)品注冊管理，所以申請這兩類(lèi)醫療器械產(chǎn)品注冊通常需要進(jìn)行臨床試驗。

　　不過(guò)，有些醫療器械也是可以免于進(jìn)行臨床試驗的，具體目錄由國務(wù)院食品藥品監督管理部門(mén)制定、調整并公布。一般來(lái)說(shuō)，滿(mǎn)足下列情形之一的，可以免于進(jìn)行臨床試驗：

　　一、工作機理明確、設計定型，生產(chǎn)工藝成熟，已上市的同品種醫療器械臨床應用多年且無(wú)嚴重不良事件記錄，不改變常規用途的；

　　二、通過(guò)非臨床評價(jià)能夠證明該醫療器械安全、有效的；

　　三、通過(guò)對同品種醫療器械臨床試驗或者臨床使用獲得的數據進(jìn)行分析評價(jià)，能夠證明該醫療器械安全、有效的。

作者: 小想人158 時(shí)間: 2018-8-6 02:57
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作者: oiokd 時(shí)間: 2019-1-23 14:22
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作者: gvgwe 時(shí)間: 2019-1-24 22:14
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