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源興醫(yī)療

標題: 哪些醫(yī)療器械可以不進行臨床試驗？ [打印本頁]
作者: test4    時間: 2018-8-1 10:20
標題: 哪些醫(yī)療器械可以不進行臨床試驗？
　　眾所周知，辦理醫(yī)療器械注冊或者備案事務的人員需要具有相應的專業(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)章和技術要求，不然醫(yī)療器械產(chǎn)品需要不需要進行臨床試驗都不清楚。那么，哪些醫(yī)療器械可以不進行臨床試驗呢？

　　根據(jù)醫(yī)療器械監(jiān)督管理條例的相關規(guī)定，第一類醫(yī)療器械風險程度低，國家實行產(chǎn)品備案管理，不需要進行臨床試驗；由于第二類醫(yī)療器械具有中度風險，第三類醫(yī)療器械具有較高風險，國家對這兩類醫(yī)療器械實行產(chǎn)品注冊管理，所以申請這兩類醫(yī)療器械產(chǎn)品注冊通常需要進行臨床試驗。

　　不過，有些醫(yī)療器械也是可以免于進行臨床試驗的，具體目錄由國務院食品藥品監(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(yī)療器械臨床應用多年且無嚴重不良事件記錄，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)療器械臨床試驗或者臨床使用獲得的數(shù)據(jù)進行分析評價，能夠證明該醫(yī)療器械安全、有效的。
作者: 小想人158    時間: 2018-8-6 02:57
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作者: oiokd    時間: 2019-1-23 14:22
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作者: gvgwe    時間: 2019-1-24 22:14
頂．支持，路過！



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