皇冠篮球比分网

临床研究
医疗器械临床试验机构条件和备案管理办法

皇冠篮球比分网GUOJIASHIPINYAOPINJIANDUGUANLIZONGJU GUOJIAWEISHENGHEJIHUASHENGYUWEIYUANHUIGUANYUFABUYILIAOQIXIELINCHUANGSHIYANJIGOUTIAOJIANHEBEIANGUANLIBANFADEGONGGAO(2017NIANDI145HAO)

  GENJU《ZHONGGONGZHONGYANGBANGONGTING、GUOWUYUANBANGONGTINGYINFA〈GUANYUSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN〉DETONGZHI》(TINGZI〔2017〕42HAO)HE《GUOWUYUANGUANYUXIUGAI〈YILIAOQIXIEJIANDUGUANLITIAOLI〉DEJUEDING》(ZHONGHUARENMINGONGHEGUOGUOWUYUANLINGDI680HAO)GUIDING,YILIAOQIXIELINCHUANGSHIYANJIGOUYOUZIZHIRENDINGGAIWEIBEIANGUANLI。GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUHUITONGGUOJIAWEISHENGHEJIHUASHENGYUWEIYUANHUIZHIDINGLE《YILIAOQIXIELINCHUANGSHIYANJIGOUTIAOJIANHEBEIANGUANLIBANFA》,XIANYUFABU,ZI2018NIAN1YUE1RIQISHIXING。



皇冠篮球比分网SHIPINYAOPINJIANGUANZONGJU GUOJIAWEISHENGJISHENGWEI

2017NIAN11YUE15RI





医疗器械临床试验机构条件和备案管理办法



DIYIZHANG ZONG ZE



皇冠篮球比分网  DIYITIAO WEILEJIAQIANGHEGUIFANYILIAOQIXIELINCHUANGSHIYANJIGOUGUANLI,GENJU《YILIAOQIXIEJIANDUGUANLITIAOLI》DEGUIDING,ZHIDINGBENBANFA。



皇冠篮球比分网  DIERTIAO BENBANFASUOZHIDEYILIAOQIXIELINCHUANGSHIYANJIGOUBEIAN,SHIZHIYILIAOQIXIELINCHUANGSHIYANJIGOUANZHAOBENBANFAGUIDINGDETIAOJIANHEYAOQIU,JIANGJIGOUGAIKUANG、ZHUANYEJISHUSHUIPING、ZUZHIGUANLINENGLI、LUNLISHENCHANENGLIDENGXINXITIJIAOSHIPINYAOPINJIANDUGUANLIBUMENJINXINGCUNDANG、BEICHADEGUOCHENG。



  DISANTIAO BENBANFASHIYONGYUZAIZHONGHUARENMINGONGHEGUOJINGNEIKAIZHANYILIAOQIXIELINCHUANGSHIYANDEJIGOUBEIANGUANLIGONGZUO。



DIERZHANG BEIANTIAOJIAN



皇冠篮球比分网  DISITIAO YILIAOQIXIELINCHUANGSHIYANJIGOUYINGDANGFUHEYILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLIGUIFANDEYAOQIU,JUBEIKAIZHANYILIAOQIXIELINCHUANGSHIYANXIANGYINGDEZHUANYEJISHUSHUIPING、ZUZHIGUANLINENGLI、LUNLISHENCHANENGLIDENGYIXIATIAOJIAN:

皇冠篮球比分网  (YI)JUYOUYILIAOJIGOUZHIYEZIGE;

  (ER)JUYOUERJIJIADENGYISHANGZIZHI;

  (SAN)CHENGDANXUJINXINGLINCHUANGSHIYANSHENPIDEDISANLEIYILIAOQIXIELINCHUANGSHIYANDE,YINGWEISANJIJIADENGYILIAOJIGOU;

皇冠篮球比分网  (SI)JUYOUYILIAOQIXIELINCHUANGSHIYANGUANLIBUMEN,PEIBEISHIYIDEGUANLIRENYUAN、BANGONGTIAOJIAN,BINGJUYOUDUIYILIAOQIXIELINCHUANGSHIYANDEZUZHIGUANLIHEZHILIANGKONGZHINENGLI;

  (WU)JUYOUFUHEYILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLIGUIFANYAOQIUDELUNLIWEIYUANHUI;

皇冠篮球比分网  (LIU)JUYOUYILIAOQIXIELINCHUANGSHIYANGUANLIZHIDUHEBIAOZHUNCAOZUOGUICHENG;

皇冠篮球比分网  (QI)JUYOUYUKAIZHANXIANGGUANYILIAOQIXIELINCHUANGSHIYANXIANGSHIYINGDEZHENLIAOKEMU,QIEYINGYUYILIAOJIGOUZHIYEXUKEZHENLIAOKEMUYIZHI;

  (BA)JUYOUNENGGOUCHENGDANYILIAOQIXIELINCHUANGSHIYANDERENYUAN,YILIAOQIXIELINCHUANGSHIYANZHUYAOYANJIUZHEYINGDANGJUYOUGAOJIZHICHENG,QIZHONGKAIZHANCHUANGXINYILIAOQIXIECHANPINHUOXUJINXINGLINCHUANGSHIYANSHENPIDEDISANLEIYILIAOQIXIECHANPINLINCHUANGSHIYANDEZHUYAOYANJIUZHEYINGCANJIAGUO3GEYISHANGYILIAOQIXIEHUOYAOWULINCHUANGSHIYAN;

  (JIU)YIKAIZHANXIANGGUANYILIAOYEWU,NENGGOUMANZUYILIAOQIXIELINCHUANGSHIYANSUOXUDESHOUSHIRENQUNYAOQIUDENG;

  (SHI)JUYOUFANGFANHECHULIYILIAOQIXIELINCHUANGSHIYANZHONGTUFASHIJIANHEYANZHONGBULIANGSHIJIANDEYINGJIJIZHIHECHUZHINENGLI;

皇冠篮球比分网  (SHIYI)GUOJIASHIPINYAOPINJIANDUGUANLIZONGJU、GUOJIAWEISHENGHEJIHUASHENGYUWEIYUANHUIGUIDINGDEQITATIAOJIAN。



皇冠篮球比分网  DIWUTIAO CHUFUHEBENBANFADISITIAOTIAOJIANDEYILIAOJIGOUWAI,QITACHENGDANTIWAIZHENDUANSHIJILINCHUANGSHIYANDEXUEYEZHONGXINHEZHONGXINXUEZHAN、SHEQUDESHIJIYISHANGJIBINGYUFANGKONGZHIJIGOU、JIEDUZHONGXINDENGFEIYILIAOJIGOUKAIZHANANYILIAOQIXIEGUANLIDETIWAIZHENDUANSHIJILINCHUANGSHIYAN,QIYINGDANGJUBEIYIXIATIAOJIAN:

皇冠篮球比分网  (YI)JUYOUXIANGYINGYEWUZHUGUANBUMENFAFANGDEJIGOUZIZHIZHENGMINGWENJIAN;

  (ER)JUYOUTIWAIZHENDUANSHIJILINCHUANGSHIYANDEGUANLIBUMEN,PEIBEIXIANGYINGRENYUAN、BANGONGTIAOJIAN,BINGJUYOUDUITIWAIZHENDUANSHIJILINCHUANGSHIYANDEZUZHIGUANLIHEZHILIANGKONGZHINENGLI;

皇冠篮球比分网  (SAN)NENGGOUKAIZHANLUNLISHENCHAGONGZUO;

  (SI)JUYOUTIWAIZHENDUANSHIJILINCHUANGSHIYANGUANLIZHIDUHEBIAOZHUNCAOZUOGUICHENG;

  (WU)JUYOUYUKAIZHANTIWAIZHENDUANSHIJILINCHUANGSHIYANXIANGSHIYINGDEZHENLIAOKEMU,QIEYINGYUBENJIGOUYEWUFANWEIYIZHI;

皇冠篮球比分网  (LIU)JUYOUNENGGOUCHENGDANLINCHUANGSHIYANDERENYUAN,LINCHUANGSHIYANZHUYAOYANJIUZHEYINGDANGJUYOUGAOJIZHICHENG;

皇冠篮球比分网  (QI)YIKAIZHANXIANGGUANYEWU,NENGGOUMANZUTIWAIZHENDUANSHIJILINCHUANGSHIYANSUOXUDESHOUSHIRENQUNYAOQIUDENG;

  (BA)JUYOUFANGFANHECHULIYILIAOQIXIELINCHUANGSHIYANZHONGTUFASHIJIANHEYANZHONGBULIANGSHIJIANDEYINGJIJIZHIHECHUZHINENGLI;

  (JIU)GUOJIASHIPINYAOPINJIANDUGUANLIZONGJU、GUOJIAWEISHENGHEJIHUASHENGYUWEIYUANHUIGUIDINGDEQITATIAOJIAN。



DISANZHANG BEIANCHENGXU



  DILIUTIAO GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUZUZHIJIANLIYILIAOQIXIELINCHUANGSHIYANJIGOUBEIANGUANLIXINXIXITONG(YIXIAJIANCHENGBEIANXITONG),YONGYUKAIZHANYILIAOQIXIELINCHUANGSHIYANJIGOUBEIANGUANLIGONGZUO。



皇冠篮球比分网  DIQITIAO YILIAOQIXIELINCHUANGSHIYANJIGOUYINGDANGGENJUBENBANFADEYAOQIUDUIBENDANWEISHIFOUJUBEIYILIAOQIXIELINCHUANGSHIYANTIAOJIANHENENGLIJINXINGPINGGU,BINGZIXINGZAIBEIANXITONGZHONGBEIAN。



皇冠篮球比分网  DIBATIAO YILIAOQIXIELINCHUANGSHIYANJIGOUYINGDANGANZHAOYAOQIU,ZAIBEIANXITONGZHONGRUSHITIANXIEYIXIANEIRONG:

  (YI)JIGOUMINGCHENG、JIGOUXINGZHI、DIZHI、LIANXIFANGSHI。

皇冠篮球比分网  (ER)JIGOUJIBIE、GUIMOGAIKUANG,BAOKUOCHUANGWEI、RENYUANPEIBEI、JIANZHUMIANJI、YILIAOSHEBEIDENG。

  (SAN)NIKAIZHANYILIAOQIXIELINCHUANGSHIYANDEZHUANYEJIZHUYAOYANJIUZHEGAIKUANG。

皇冠篮球比分网  (SI)YILIAOQIXIELINCHUANGSHIYANGUANLIBUMENFUZERENHELIANXIFANGSHI。

皇冠篮球比分网  (WU)TIJIAOBAOHANRUXIANEIRONGDEZICHABAOGAO:

皇冠篮球比分网  1.LINCHUANGSHIYANGUANLIBUMENGAIKUANG、RENYUANJIESHAO、GUANLIZHIDU、BIAOZHUNCAOZUOGUICHENGDENG;

皇冠篮球比分网  2.LUNLIWEIYUANHUIHUOLUNLISHENCHAGONGZUOGAIKUANG,BAOKUORENYUAN、ZHIDUDENG;

  3.YILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLITIXIJIANLIYUNXINGGAIKUANG;

  4.LINCHUANGSHIYANGUANLIBUMENRENYUAN、YANJIUZHEDEYILIAOQIXIELINCHUANGSHIYANXIANGGUANFAGUIHEZHUANYEZHISHIPEIXUNQINGKUANG;

  5.FANGFANHECHULIYILIAOQIXIELINCHUANGSHIYANZHONGTUFASHIJIAN、YANZHONGBULIANGSHIJIANDEYINGJIJIZHIHECHUZHINENGLIQINGKUANG;

皇冠篮球比分网  6.JIWANGKAIZHANYILIAOQIXIELINCHUANGSHIYANDEQINGKUANG;

皇冠篮球比分网  7.QITAXUYAOSHUOMINGDEQINGKUANG。



  DIJIUTIAO YILIAOQIXIELINCHUANGSHIYANJIGOUYINGANZHAOBEIANXITONGYAOQIU,SHANGCHUANYILIAOJIGOUZHIYEZIGEXUKEZHENGZHAO、YILIAOJIGOUJIBIEZHENGMINGWENJIAN、QITAJIGOUZIZHIZHENGMINGWENJIANHEZILIAOFUHEXINGSHENGMINGDENGCAILIAO。



  DISHITIAO YILIAOQIXIELINCHUANGSHIYANJIGOUBANLIBEIANHUODEBEIANHAOHOUKEYICHENGDANYILIAOQIXIELINCHUANGSHIYAN。

YIBEIANDEYILIAOQIXIELINCHUANGSHIYANJIGOUMINGCHENG、DIZHI、LIANXIREN、LIANXIFANGSHIHEZHUYAOYANJIUZHEDENGYOUGUANBEIANXINXIKEZAIBEIANXITONGZHONGCHAXUN。



  DISHIYITIAO YILIAOQIXIELINCHUANGSHIYANJIGOUMINGCHENG、JIGOUJIBIE、JIGOUFUZERENYUAN、DIZHI、LUNLIWEIYUANHUI、YILIAOQIXIELINCHUANGSHIYANZHUANYEHEZHUYAOYANJIUZHEBEIANXINXIFASHENGBIANHUASHI,YILIAOQIXIELINCHUANGSHIYANJIGOUYINGDANGDENGLUBEIANXITONG,ZAIXIANTIANXIEXIANGGUANXINXIBIANGENGQINGKUANG。



皇冠篮球比分网  DISHIERTIAO YILIAOQIXIELINCHUANGSHIYANJIGOUYINGDANGZAIMEINIAN1YUE31RIQIANZAIXIANTIJIAOSHANGYINIANDUKAIZHANYILIAOQIXIELINCHUANGSHIYANGONGZUOZONGJIEBAOGAO。



皇冠篮球比分网  DISHISANTIAO YILIAOQIXIELINCHUANGSHIYANJIGOUJUEDINGBUZAIKAIZHANYILIAOQIXIELINCHUANGSHIYANDE,YINGDENGLUBEIANXITONG,QUXIAOBEIAN。



DISIZHANG JIANDUGUANLI



  DISHISITIAO SHENGJIYISHANGSHIPINYAOPINJIANDUGUANLIBUMENYINGDANGMEINIANDINGQIJIANGBENXINGZHENGQUYUYILIAOQIXIELINCHUANGSHIYANJIGOUBEIANDEXIANGGUANXINXITONGBAOTONGJIWEISHENGJISHENGXINGZHENGBUMEN。



皇冠篮球比分网  DISHIWUTIAO SHENGJISHIPINYAOPINJIANDUGUANLIBUMEN、WEISHENGJISHENGXINGZHENGBUMENYINGANZHAOGEZIJIANGUANZHIZE,JIAQIANGDUIBENXINGZHENGQUYUYILIAOQIXIELINCHUANGSHIYANJIGOUDEJIANDUGUANLIHEXINXITONGBAO。DUIFAXIANDEWEIFAWEIGUIXINGWEI,ANZHAO《YILIAOQIXIEJIANDUGUANLITIAOLI》JIQITAXIANGGUANFAGUIGUIDINGZUZHICHACHU。



  DISHILIUTIAO YINMANYOUGUANQINGKUANGHUOZHETIGONGXUJIACAILIAOBANLILINCHUANGSHIYANJIGOUBEIANDE,HUOZHECUNZAIQUEXIAN、BUSHIYIJIXUCHENGDANLINCHUANGSHIYANDELINCHUANGSHIYANJIGOU,SHENGJIYISHANGSHIPINYAOPINJIANDUGUANLIBUMENANZHAO《YILIAOQIXIEJIANDUGUANLITIAOLI》DEGUIDINGJINXINGCHULI。GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUQUXIAOQIJIGOUHUOXIANGGUANZHUANYEDEBEIANXINXI,TONGBAOGUOJIAWEISHENGHEJIHUASHENGYUWEIYUANHUI,BINGJINXINGGONGGAO。



  DISHIQITIAO YILIAOQIXIELINCHUANGSHIYANJIGOUDEBEIANXINXISHEJIGUOJIAJIMI、SHANGYEMIMIHUOZHEGERENYINSIDE,YINGDANGFUHE《ZHONGHUARENMINGONGHEGUOBAOSHOUGUOJIAMIMIFA》JIQITAXIANGGUANFALVFAGUIDEGUIDING。



DIWUZHANG FU ZE



皇冠篮球比分网  DISHIBATIAO YILIAOQIXIELINCHUANGSHIYANJIGOUBEIANHAOGESHIWEI:XIELINJIGOUBEI+4WEINIANDAIHAO+5WEISHUNXUBIANHAO。



  DISHIJIUTIAO SHIPINYAOPINJIANDUGUANLIBUMENSHISHILINCHUANGSHIYANJIGOUBEIANHEJIANDUGUANLI,BUDESHOUQURENHEFEIYONG。



  DIERSHITIAO BENBANFAZI2018NIAN1YUE1RIQISHIXING。

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