秒速赛车控制器

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國家藥監局發布《醫療器械臨床試驗檢查要點及判定原則》
發布時間: 2018-11-30     來源: 藥監局

 

為加強醫療器械臨床試驗過程的監督管理,指導監管部門開展醫療器械臨床試驗監督檢查工作,根據《醫療器械注冊管理辦法》和《醫療器械臨床試驗質量管理規范》要求,近日國家藥品監督管理局組織制定了《醫療器械臨床試驗檢查要點及判定原則》。

GENJU《YILIAOQIXIEZHUCEGUANLIBANFA》HE《YILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLIGUIFAN》DENGYAOQIUZHIDINGBENJIANCHAYAODIANJIPANDINGYUANZE,YONGYUZHIDAOYILIAOQIXIELINCHUANGSHIYANXIANCHANGJIANCHAGONGZUO。

一、檢查要點

 

二、判定原則

GENJUJIANCHAFAXIANDEWENTI,JIANCHAJIEGUOANYIXIAYUANZEPANDING:

(YI)YOUYIXIAQINGXINGZHIYIDE,PANDINGWEICUNZAIZHENSHIXINGWENTI:

1.BIANZAOSHOUSHIZHEXINXI、ZHUYAOSHIYANGUOCHENGJILU、YANJIUSHUJU、JIANCESHUJUDENGLINCHUANGSHIYANSHUJU,YINGXIANGYILIAOQIXIEANQUANXING、YOUXIAOXINGPINGJIAJIEGUODE;

2.LINCHUANGSHIYANSHUJU,RURUXUANPAICHUBIAOZHUN、ZHUYAOLIAOXIAOZHIBIAO、ZHONGYAODEANQUANXINGZHIBIAODENGBUNENGSUYUANDE;

3.SHIYANYONGYILIAOQIXIEBUZHENSHI,RUYIDUIZHAOYONGYILIAOQIXIETIDAISHIYANYONGYILIAOQIXIE、YISHIYANYONGYILIAOQIXIETIDAIDUIZHAOYONGYILIAOQIXIE,YIJIYIQITAFANGSHISHIYONGXUJIASHIYANYONGYILIAOQIXIEDE;

4.MANBAOYULINCHUANGSHIYANYONGYILIAOQIXIEXIANGGUANDEYANZHONGBULIANGSHIJIANHEKENENGDAOZHIYANZHONGBULIANGSHIJIANDEYILIAOQIXIEQUEXIAN、SHIYONGFANGANJINYONGDEHEBINGYONGYAOHUOYILIAOQIXIEDE;

秒速赛车控制器5.ZHUCESHENQINGDELINCHUANGSHIYANBAOGAOZHONGSHUJUYULINCHUANGSHIYANJIGOUBAOCUNDELINCHUANGSHIYANBAOGAOZHONGDESHUJUBUYIZHI,YINGXIANGYILIAOQIXIEANQUANXING、YOUXIAOXINGPINGJIAJIEGUODE;

6.ZHUCESHENQINGDELINCHUANGSHIYANTONGJIFENXIBAOGAOZHONGSHUJUYULINCHUANGSHIYANTONGJISHUJUKUZHONGSHUJUHUOFENZHONGXINLINCHUANGSHIYANXIAOJIEZHONGSHUJUBUYIZHI,YINGXIANGYILIAOQIXIEANQUANXING、YOUXIAOXINGPINGJIAJIEGUODE;

秒速赛车控制器7.QITAGUYIPOHUAIYILIAOQIXIELINCHUANGSHIYANSHUJUZHENSHIXINGDEQINGXING。

(ER)WEIFAXIANZHENSHIXINGWENTIDE,DANLINCHUANGSHIYANGUOCHENGBUFUHEYILIAOQIXIELINCHUANGSHIYANXIANGGUANGUIDINGYAOQIUDE,PANDINGWEICUNZAIHEGUIXINGWENTI。

秒速赛车控制器(SAN)WEIFAXIANSHANGSHUWENTIDE,PANDINGWEIFUHEYAOQIU。