哪些醫(yī)療器械可以不進(jìn)行臨床試驗(yàn)？

test4 · 發(fā)表于 2018-8-1 10:20:03

　　眾所周知，辦理醫(yī)療器械注冊或者備案事務(wù)的人員需要具有相應(yīng)的專業(yè)知識，熟悉醫(yī)療器械注冊或者備案管理的法律、法規(guī)、規(guī)章和技術(shù)要求，不然醫(yī)療器械產(chǎn)品需要不需要進(jìn)行臨床試驗(yàn)都不清楚。那么，哪些醫(yī)療器械可以不進(jìn)行臨床試驗(yàn)?zāi)兀?/font>

　　根據(jù)醫(yī)療器械監(jiān)督管理?xiàng)l例的相關(guān)規(guī)定，第一類醫(yī)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(yàn)；由于第二類醫(yī)療器械具有中度風(fēng)險，第三類醫(yī)療器械具有較高風(fēng)險，國家對這兩類醫(yī)療器械實(shí)行產(chǎn)品注冊管理，所以申請這兩類醫(yī)療器械產(chǎn)品注冊通常需要進(jìn)行臨床試驗(yàn)。

　　不過，有些醫(yī)療器械也是可以免于進(jìn)行臨床試驗(yàn)的，具體目錄由國務(wù)院食品藥品監(jiān)督管理部門制定、調(diào)整并公布。一般來說，滿足下列情形之一的，可以免于進(jìn)行臨床試驗(yàn)：

　　一、工作機(jī)理明確、設(shè)計(jì)定型，生產(chǎn)工藝成熟，已上市的同品種醫(yī)療器械臨床應(yīng)用多年且無嚴(yán)重不良事件記錄，不改變常規(guī)用途的；

　　二、通過非臨床評價能夠證明該醫(yī)療器械安全、有效的；

　　三、通過對同品種醫(yī)療器械臨床試驗(yàn)或者臨床使用獲得的數(shù)據(jù)進(jìn)行分析評價，能夠證明該醫(yī)療器械安全、有效的。

gvgwe · 發(fā)表于 2019-1-24 22:14:12

頂．支持，路過！

oiokd · 發(fā)表于 2019-1-23 14:22:10

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香港社區(qū)網(wǎng) · 發(fā)表于 2018-12-17 19:20:17

鑒定完畢！

澳門生活網(wǎng)b · 發(fā)表于 2018-12-17 18:18:54

此貼有意思~

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