秒速赛车控制器

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醫療器械
藥監局:醫療器械注冊人制度試點進一步擴大,增至21地
發布時間: 2019-08-05     來源: 藥監局

8YUE1RI,GUOJIAYAOJIANJUGUANWANGFABUGUANYUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODETONGZHI,MINGQUE21GESHENG、ZIZHIQU、ZHIXIASHICANJIABENCIYILIAOQIXIEZHUCERENZHIDUSHIDIAN。

秒速赛车控制器WEISHENRUGUANCHELUOSHIZHONGGONGZHONGYANGBANGONGTING、GUOWUYUANBANGONGTING《GUANYUSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN》(TINGZI〔2017〕42HAO)JINGSHEN,JIAKUAITUIJINYILIAOQIXIECHANYECHUANGXINFAZHAN,ZAIQIANQISHANGHAI、GUANGDONG、TIANJINZIMAOQUKAIZHANYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODEJICHUSHANG,JINRI,GUOJIAYAOPINJIANDUGUANLIJU(YIXIAJIANCHENGGUOJIAJU)FABU《GUANYUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODETONGZHI》(GUOYAOJIANXIEZHU〔2019〕33HAO,YIXIAJIANCHENG《TONGZHI》),JINYIBUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIAN,WEIQUANMIANSHISHIYILIAOQIXIEZHUCERENZHIDUJINYIBUJILEIJINGYAN。

《TONGZHI》MINGQUE,BEIJING、TIANJIN、HEBEI、LIAONING、HEILONGJIANG、SHANGHAI、JIANGSU、ZHEJIANG、ANHUI、FUJIAN、SHANDONG、HENAN、HUBEI、HUNAN、GUANGDONG、GUANGXI、HAINAN、ZHONGQING、SICHUAN、YUNNAN、SHANXIDENG21GESHENG、ZIZHIQU、ZHIXIASHICANJIABENCIYILIAOQIXIEZHUCERENZHIDUSHIDIAN。

秒速赛车控制器《TONGZHI》DUICANYUSHIDIANGONGZUODEZHUCERENHESHOUTUOSHENGCHANQIYEFENBIEGUIDINGLEXIANGYINGDETIAOJIANHEYIWUZEREN,MINGQUESHUANGFANGYINGDANGQIANDINGWEITUOHETONGHEZHILIANGXIEYI,BINGDUICHANPINZHUCE、BIANGENGHESHENGCHANQIYEXUKEZHENGBANLICHENGXUJINXINGLEGUIDING,TONGSHIQIANGDIAOGEJIYAOPINJIANGUANBUMENYINGDANGJIAQIANGDUIZHUCERENLVXINGBAOZHENGYILIAOQIXIEZHILIANG、SHANGSHIXIAOSHOUYUFUWU、YILIAOQIXIEBULIANGSHIJIANJIANCEYUPINGJIA、YILIAOQIXIEZHAOHUIDENGYIWUQINGKUANGDEJIANDUGUANLI。DUIWEITUOSHENGCHANSHEJIKUAQUYUDE,XIANGGUANSHENGJIYAOPINJIANGUANBUMENYAOZAIXIEDIAOYIZHIDEJICHUSHANG,QUEDINGKUAQUYUJIANGUANGEFANGZHIZEHUAFEN,LUOSHIRICHANGJIANGUANZERENZHUTI,QUEBAODUIYILIAOQIXIEQUANSHENGMINGZHOUQIQUANLIANTIAOJIANGUANWUFENGXIWUSIJIAO。

GUOJIAJUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUO,QIMUDEZAIYUJINYIBUTANSUOJIANLIYILIAOQIXIEZHUCERENZHIDUYIJIWEITUOSHENGCHANGUANLIZHIDU,YOUHUAZIYUANPEIZHI,LUOSHIZHUTIZEREN;TANSUOJIANLIWANSHANDEZHUCERENYILIAOQIXIEZHILIANGGUANLITIXI,MINGQUEYILIAOQIXIEZHUCEREN、SHOUTUORENDENGZHUTIZHIJIANDEFALVGUANXI,ZAIZERENQINGXI、FENGXIANKEKONGDEJICHUSHANG,GOUJIANZHUCERENQUANSHENGMINGZHOUQIZHILIANGGUANLIZHIDUHETIXI;TANSUOCHUANGXINYILIAOQIXIEJIANGUANFANGSHI,YOUXIAOLUOSHI“JIANGUANGONGZUOYIDINGYAOGENSHANG”DEYAOQIU,JINYIBUSHIFANGCHANYEHUOLI,TUIDONGYILIAOQIXIECHANYEGAOZHILIANGFAZHAN,MANZURENMINQUNZHONGSHIYONGGAOSHUIPINGYILIAOQIXIEXUQIU。 

秒速赛车控制器GUOJIAYAOJIANJUGUANYUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODETONGZHI

(GUOYAOJIANXIEZHU〔2019〕33HAO)

BEIJING、TIANJIN、HEBEI、LIAONING、HEILONGJIANG、SHANGHAI、JIANGSU、ZHEJIANG、ANHUI、FUJIAN、SHANDONG、HENAN、HUBEI、HUNAN、GUANGDONG、GUANGXI、HAINAN、ZHONGQING、SICHUAN、YUNNAN、SHANXISHENG(ZIZHIQU、ZHIXIASHI)YAOPINJIANDUGUANLIJU:

WEISHENRUGUANCHELUOSHIZHONGGONGZHONGYANGBANGONGTING、GUOWUYUANBANGONGTINGYINFADE《GUANYUSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN》(TINGZI〔2017〕42HAO),JIAKUAITUIJINYILIAOQIXIECHANYECHUANGXINFAZHAN,WEIQUANMIANSHISHIYILIAOQIXIEZHUCERENZHIDUJINYIBUJILEIJINGYAN,ZAISHANGHAI、GUANGDONG、TIANJINZIMAOQUKAIZHANYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODEJICHUSHANG,GUOJIAYAOPINJIANDUGUANLIJU(YIXIAJIANCHENGGUOJIAJU)JUEDINGJINYIBUKUODAYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUO,XIANJIANGYOUGUANSHIXIANGTONGZHIRUXIA:

一、試點范圍

BEIJING、TIANJIN、HEBEI、LIAONING、HEILONGJIANG、SHANGHAI、JIANGSU、ZHEJIANG、ANHUI、FUJIAN、SHANDONG、HENAN、HUBEI、HUNAN、GUANGDONG、GUANGXI、HAINAN、ZHONGQING、SICHUAN、YUNNAN、SHANXISHENG(ZIZHIQU、ZHIXIASHI)。

二、試點內容和目標

秒速赛车控制器(YI)TANSUOJIANLIYILIAOQIXIEWEITUOSHENGCHANGUANLIZHIDU,YOUHUAZIYUANPEIZHI,LUOSHIZHUTIZEREN。YILIAOQIXIEZHUCESHENQINGREN(YIXIAJIANCHENG“SHENQINGREN”)SHENQINGBINGQUDEYILIAOQIXIEZHUCEZHENGDE,CHENGWEIYILIAOQIXIEZHUCEREN(YIXIAJIANCHENG“ZHUCEREN”)。SHENQINGRENKEYIWEITUOJUBEIXIANGYINGSHENGCHANNENGLIDEQIYESHENGCHANYANGPIN,ZHUCERENKEYIJIANGYIHUOZHENGCHANPINWEITUOGEIJUBEISHENGCHANNENGLIDEYIJIAHUOZHEDUOJIAQIYESHENGCHANCHANPIN。GULIJITUANGONGSITONGGUOZHUCERENZHIDUSHIDIANJINYIBUZHENGHE、YOUHUAZIYUANPEIZHI,LUOSHIYILIAOQIXIEZHUCERENZHUTIZEREN。

秒速赛车控制器(ER)TANSUOJIANLIWANSHANDEZHUCERENYILIAOQIXIEZHILIANGGUANLITIXI,MINGQUEYILIAOQIXIEZHUCEREN、SHOUTUORENDENGZHUTIZHIJIANDEFALVGUANXI,ZAIZERENQINGXI、FENGXIANKEKONGDEJICHUSHANG,GOUJIANZHUCERENQUANSHENGMINGZHOUQIZHILIANGGUANLIZHIDUHETIXI。

(SAN)TANSUOCHUANGXINYILIAOQIXIEJIANGUANFANGSHI,YOUXIAOLUOSHI“JIANGUANGONGZUOYIDINGYAOGENSHANG”DEYAOQIU,WANSHANSHIZHONGSHIHOUJIANGUANTIXI,LIQINGKUAQUYUJIANGUANZEREN,XINGCHENGWANSHANDEKUAQUYUXIETONGJIANGUANJIZHI,ZENGQIANGJIANGUANHELI,TISHENGJIANGUANXIAONENG。

秒速赛车控制器(SI)TANSUOSHIFANGYILIAOQIXIEZHUCERENZHIDUHONGLI,GULIYILIAOQIXIECHUANGXIN,TUIDONGYILIAOQIXIECHANYEGAOZHILIANGFAZHAN。

秒速赛车控制器(WU)JILEIYILIAOQIXIEZHUCERENZHIDUSHIDIANJINGYAN,WEIQUANMIANTUIJINSHISHIYILIAOQIXIEZHUCERENGUANLIZHIDUTIGONGZHONGYAOZHICHENG。

SHUYUYUANGUOJIASHIPINYAOPINJIANDUGUANLIZONGJUFABUDEJINZHIWEITUOSHENGCHANYILIAOQIXIEMULUDECHANPIN,ZANBULIERUSHIDIAN。

三、注冊人條件和義務責任

(YI)ZHUCERENTIAOJIAN

1.ZHUSUOHUOZHESHENGCHANDIZHIWEIYUCANYUSHIDIANDESHENG、ZIZHIQUHEZHIXIASHINEIDEQIYE、KEYANJIGOU。

2.JUBEIZHUANZHIDEFAGUISHIWU、ZHILIANGGUANLI、SHANGSHIHOUSHIWUDENGGONGZUOXIANGGUANDEJISHUYUGUANLIRENYUAN,JUYOUYILIAOQIXIEJIANGUANFAGUIHEBIAOZHUNXIANGGUANZHISHIHEJINGYAN。

秒速赛车控制器3.JIANLIYUCHANPINXIANGSHIYINGDEZHILIANGGUANLITIXIBINGBAOCHIYOUXIAOYUNXING,YOUDUIZHILIANGGUANLITIXIDULIJINXINGPINGGU、SHENHEHEJIANDUDERENYUAN。

4.JUBEICHENGDANYILIAOQIXIEZHILIANGANQUANZERENDENENGLI。 

(ER)ZHUCERENDEYIWUZEREN

1.YIFACHENGDANYILIAOQIXIESHEJIKAIFA、LINCHUANGSHIYAN、SHENGCHANZHIZAO、XIAOSHOUPEISONG、SHOUHOUFUWU、CHANPINZHAOHUI、BULIANGSHIJIANBAOGAODENGHUANJIEZHONGDEXIANGYINGFALVZEREN。

2.YUSHOUTUOSHENGCHANQIYEQIANDINGWEITUOHETONGHEZHILIANGXIEYI,MINGQUEWEITUOSHENGCHANZHONGJISHUYAOQIU、ZHILIANGBAOZHENG、ZERENHUAFEN、FANGXINGYAOQIUDENGZEREN,MINGQUESHENGCHANFANGXINGYAOQIUHECHANPINSHANGSHIFANGXINGFANGSHI。 

秒速赛车控制器3.JIAQIANGDUISHOUTUOSHENGCHANQIYEDEJIANDUGUANLI,DUISHOUTUOSHENGCHANQIYEDEZHILIANGGUANLINENGLIJINXINGPINGGU,DINGQIDUISHOUTUOSHENGCHANQIYEKAIZHANZHILIANGGUANLITIXIPINGGUHESHENHE。 

秒速赛车控制器4.JIAQIANGBULIANGSHIJIANJIANCE,GENJUFENGXIANDENGJIJIANLIYILIAOQIXIEXIANGYINGDEZHUISUGUANLIZHIDU,QUEBAOYILIAOQIXIECHANPINKEMANZUQUANCHENGZHUISUDEYAOQIU。 

5.KEYIZIXINGXIAOSHOUYILIAOQIXIE,YEKEYIWEITUOJUYOUXIANGGUANZIZHIDEYILIAOQIXIEJINGYINGQIYEXIAOSHOU。ZIXINGXIAOSHOUDEZHUCERENYINGDANGJUBEIGUIDINGDEYILIAOQIXIEJINGYINGNENGLIHETIAOJIAN;WEITUOXIAOSHOUDE,YINGDANGQIANDINGWEITUOHETONG,MINGQUEGEFANGQUANLIYIWU。

6.TONGGUOXINXIHUASHOUDUAN,DUIYANFA、SHENGCHAN、XIAOSHOUHEBULIANGSHIJIANJIANCEQINGKUANGJINXINGQUANLIUCHENGZHUISU、JIANKONG。

7.QUEBAOTIJIAODEYANJIUZILIAOHELINCHUANGSHIYANSHUJUZHENSHIKEKAO、XITONGWANZHENG、KEZHUISU。

四、受托生產企業條件和義務責任

秒速赛车控制器(YI)SHOUTUOSHENGCHANQIYETIAOJIAN

秒速赛车控制器1.ZHUSUOHUOZHESHENGCHANDIZHIWEIYUCANYUSHIDIANDESHENG、ZIZHIQUHEZHIXIASHINEIDEQIYE。

2.JUBEIYUSHOUTUOSHENGCHANYILIAOQIXIEXIANGSHIYINGDEZHILIANGGUANLITIXIHESHENGCHANNENGLI。

秒速赛车控制器(ER)SHOUTUOSHENGCHANQIYEYIWUZEREN

1.CHENGDAN《YILIAOQIXIEJIANDUGUANLITIAOLI》、YIJIQITAXIANGGUANFALVFAGUIYIJIWEITUOHETONG、ZHILIANGXIEYIGUIDINGDEYIWU,BINGCHENGDANXIANGYINGDEFALVZEREN。

2.ANZHAOYILIAOQIXIEXIANGGUANFAGUIGUIDINGYIJIWEITUOHETONG、ZHILIANGXIEYIYUEDINGDEYAOQIUZUZHISHENGCHAN,DUIZHUCERENFUXIANGYINGZHILIANGZEREN。

秒速赛车控制器3.FAXIANSHANGSHIHOUYILIAOQIXIEFASHENGZHONGDAZHILIANGSHIGUDE,YINGDANGJISHIBAOGAOSUOZAIDISHENGJIYAOPINJIANGUANBUMEN。

秒速赛车控制器4.SHOUTUOSHENGCHANZHONGZHISHI,SHOUTUOSHENGCHANQIYEYINGDANGXIANGSUOZAIDISHENGJIYAOPINJIANGUANBUMENSHENQINGJIANSHAOYILIAOQIXIESHENGCHANXUKESUOFUSHENGCHANCHANPINDENGJIBIAOZHONGDENGZAIDESHOUTUOCHANPINXINXI。

秒速赛车控制器5.SHOUTUOSHENGCHANQIYEBUDEZAICIZHUANTUO。

五、辦理程序

秒速赛车控制器(YI)ZHUCESHENQING。ZHUCESHENQINGRENTIJIAOYILIAOQIXIEZHUCESHENQINGDE,XIANGXIANGYINGYAOPINJIANGUANBUMENTIJIAOZHUCESHENQINGZILIAO,JINGSHENCHAFUHEYAOQIUDE,HEFAYILIAOQIXIEZHUCEZHENG,YILIAOQIXIEZHUCEZHENGZHONGDENGZAIDESHENGCHANDIZHIWEISHOUTUOSHENGCHANDIZHIDE,BEIZHULANBIAOZHUSHOUTUOQIYEMINGCHENG。

(ER)SHENGCHANXUKEBANLI。SHOUTUOSHENGCHANQIYEBUJUBEIXIANGYINGSHENGCHANZIZHIDE,KETIJIAOZHUCERENDEYILIAOQIXIEZHUCEZHENGSHENQINGSHENGCHANXUKEHUOZHESHENQINGSHENGCHANXUKEBIANGENG,KUAQUYUSHIDIANDEXIANGSHOUTUOSHENGCHANQIYESUOZAIDISHENGJIYAOPINJIANGUANBUMENTIJIAO。

(SAN)SHENGCHANDIZHIDENGJISHIXIANGBIANGENGBANLI。DUIYUZHUCERENNITONGGUOWEITUOSHENGCHANFANGSHIBIANGENGZHUCEZHENGSHENGCHANDIZHIDE,YOUSHOUTUOSHENGCHANQIYESUOZAIDISHENGJIYAOPINJIANGUANBUMENHUITONGZHUCERENSUOZAIDISHENGJIYAOPINJIANGUANBUMENKAIZHANXIANCHANGHECHA,BINGYOUSHOUTUOSHENGCHANQIYESUOZAIDISHENGJIYAOPINJIANGUANBUMENBIANGENG《YILIAOQIXIESHENGCHANXUKEZHENG》。ZHUCERENTIJIAOSHOUTUOSHENGCHANQIYEBIANGENGHOU《YILIAOQIXIESHENGCHANXUKEZHENG》HEWEITUOXIEYIXIANGXIANGYINGYAOPINJIANGUANBUMENBANLIDENGJISHIXIANGBIANGENG。

(SI)SHOUTUOBEIAN。SHOUTUOSHENGCHANQIYEYINGDANGXIANGSUOZAIDISHENGJIYAOPINJIANGUANBUMENBEIAN,BEIANSHIYINGDANGTIJIAOWEITUOHETONG、ZHILIANGXIEYIDENGZILIAO。

六、工作要求

秒速赛车控制器(YI)JIAQIANGZUZHIXIEDIAO。GUOJIAJUFUZEZUZHIQUANGUOYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUO。GESHIDIANSHENGJIYAOPINJIANGUANBUMENYAOCHENGLIYOUFENGUANJULINGDAODANRENZUCHANGDESHIDIANGONGZUOZU,YANJIUNIDINGSHIDIANGONGZUOSHISHIFANGANHEXIANGGUANGUANLIZHIDU,WANSHANGONGZUOJIZHI,JIAQIANGLILIANGTOURU,JIAQIANGZHIYEHUA、ZHUANYEHUAJIANCHAYUANDUIWUJIANSHE,ZHASHITUIJINSHIDIANGONGZUOKAIZHAN。GESHIDIANSHENGJIYAOPINJIANGUANBUMENJIEHEBENDIYILIAOQIXIECHANYEHEJIANGUANQINGKUANG,ZAICHONGFENDIAOYANLUNZHENGDEJICHUSHANGJINKUAIZHIDINGSHIDIANGONGZUOFANGAN,JISHISHANGBAOGUOJIAJU。

秒速赛车控制器(ER)QIANGHUAJIANDUGUANLI。GEJIYAOPINJIANGUANBUMENYINGDANGJIAQIANGDUIZHUCERENLVXINGBAOZHENGYILIAOQIXIEZHILIANG、SHANGSHIXIAOSHOUYUFUWU、YILIAOQIXIEBULIANGSHIJIANJIANCEYUPINGJIA、YILIAOQIXIEZHAOHUIDENGYIWUQINGKUANGDEJIANDUGUANLI。SHEJIKUAQUYUSHIDIANDE,GESHENGJIYAOPINJIANGUANBUMENYAOZAIXIEDIAOYIZHIDEJICHUSHANG,QUEDINGKUAQUYUJIANGUANGEFANGZHIZEHUAFEN,LUOSHIRICHANGJIANGUANZERENZHUTI,QUEBAODUIYILIAOQIXIEQUANSHENGMINGZHOUQIQUANLIANTIAOJIANGUANWUFENGXIWUSIJIAO。YAOJIANLIXIETONGGUANLI、XINXIGONGXIANGYUJIEGUOHURENJIZHI。DUIWEIYILIAOQIXIEYANZHI、SHENGCHAN、JINGYING、SHIYONGDENGHUODONGTIGONGCHANPINHUOZHEFUWUDEQITAXIANGGUANDANWEI,YAOPINJIANGUANBUMENKEYIJINXINGYANSHENJIANCHA。

(SAN)GULISHEHUICANYU。GESHIDIANSHENGJIYAOPINJIANGUANBUMENYAOCHONGFENFAHUIXINGYEXIEHUIDEZUOYONG,TONGGUOXINGYEXIEHUICHONGFENTINGQUQIYEYIJIANHEJIANYI;ZUZHIFALVZHUANJIAYANJIUQICAOWEITUOXIEYIFANBEN;GULISHEHUILILIANGYISHIDANGXINGSHIJIJICANYUQIYEZHILIANGZERENBAOZHENGNENGLIJIANSHE。 

(SI)TUIDONGXINXIGONGXIANG。GESHIDIANSHENGJIYAOPINJIANGUANBUMENYINGDANGANGUIDINGZHUDONGGONGKAIBINGJISHIXIANGGUOJIAJUBAOSONGSHIDIANGONGZUOJINZHANHEZUIXINQINGKUANG。

(WU)JISHIZONGJIEJINGYAN。GESHIDIANSHENGJIYAOPINJIANGUANBUMENYAOQUANCHENGGUANZHUGENZONGSHIDIANQINGKUANG,JISHIZONGJIE,DUIQUDECHENGXIAOHEMIANLINWENTIJINXINGFENXI,BINGXINGCHENGJIEJUEJIANYI,JISHISHANGBAOGUOJIAJU。

GUOJIAYAOJIANJU

2019NIAN8YUE1RI