超凡电竞

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  • 信息名称

    GUANYUYINFA《SHANXISHENGDIERLEICHUANGXINYILIAOQIXIETEBIESHENCHACHENGXU》DETONGZHI

  • 索引号

    yjj/2020-00115

  • 文号

    超凡电竞SHANYAOJIANFA〔2020〕86HAO

  • 状态

    YOUXIAO

  • 发布时间

    2020NIAN07YUE30RI 16:29

关于印发《陕西省第二类创新医疗器械特别审查程序》的通知
陕药监发〔2020〕86号
发布时间 : 2020年07月30日 16:29    点击量:

JUJIGUANGECHUSHI、XIANGGUANZHISHUDANWEI:

超凡电竞《SHANXISHENGDIERLEICHUANGXINYILIAOQIXIETEBIESHENCHACHENGXU》YIJING2020NIAN7YUE27RIJUWUHUIYISHENYITONGGUO,XIANYINFAJINIMEN,QINGRENZHENANZHAOZHIXING。

                                                                                                         SHANXISHENGYAOPINJIANDUGUANLIJU

                                                                                                              2020NIAN7YUE29RI

(GONGKAISHUXING: ZHUDONGGONGKAI)

 

陕西省第二类创新医疗器械特别审查程序

(试行)

DIYITIAO WEILEBAOZHANGYILIAOQIXIEDEANQUAN、YOUXIAO,GULIYILIAOQIXIEDEYANJIUYUCHUANGXIN,CUJINYILIAOQIXIEXINJISHUDETUIGUANGHEYINGYONG,TUIDONGBENSHENGYILIAOQIXIECHANYECHUANGXINFAZHAN,GENJU《GUANYUSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN》《YILIAOQIXIEJIANDUGUANLITIAOLI》《YILIAOQIXIEZHUCEGUANLIBANFA》《TIWAIZHENDUANSHIJIZHUCEGUANLIBANFA》、GUOJIAYAOPINJIANDUGUANLIJU(YIXIAJIANCHENG“GUOJIAJU”)《CHUANGXINYILIAOQIXIETEBIESHENCHACHENGXU》YIJISHANXISHENGRENMINZHENGFU《GUANYUSHENHUAXINGZHENGSHENPIZHIDUGAIGETUIJINJIANZHENGFANGQUANGONGZUODESHISHIYIJIAN》DENGFAGUI、GUIZHANGHEGUIFANXINGWENJIAN,ZHIDINGBENCHENGXU。

DIERTIAODIERLEICHUANGXINYILIAOQIXIETEBIESHENCHACHENGXU(YIXIAJIANCHENG“CHUANGXINTEBIESHENCHA”)SHIGENJUSHENQINGRENDESHENQING,DUIFUHEBENCHENGXUDISANTIAOQINGXINGDEDIERLEIYILIAOQIXIECHANPIN,ZAIZHUCESHENQINGQIANJISHENPINGGUOCHENGZHONG,DUIXIANGGUANJIANCE、HECHAJIANCHA、JISHUSHENPING、GOUTONGCHAOFANDIANJINGDENGSHELITEBIETONGDAO、YOUXIANCHAOFANDIANJINGDETEBIECHENGXU。

DISANTIAOBENCHENGXUSHIYONGYUFUHEXIALIEQINGXINGDENIZAIBENSHENGSHENQINGZHUCEDEDIERLEIYILIAOQIXIE:

超凡电竞(YI)CHANPINZHUYAOGONGZUOYUANLIHUOZHEZUOYONGJILIWEIGUONEISHOUCHUANG,CHANPINXINGNENGHUOZHEANQUANXINGYUTONGLEICHANPINBIJIAOYOUGENBENXINGGAIJIN,JISHUSHANGCHUYUGUONEILINGXIANSHUIPING,QIEJUYOUXIANZHUDELINCHUANGYINGYONGJIAZHI。

(ER)SHENQINGRENYIWANCHENGCHANPINDEQIANQIYANJIUBINGJUYOUJIBENDINGXINGCHANPIN,YANJIUGUOCHENGZHENSHIHESHOUKONG,YANJIUSHUJUWANZHENGHEKESUYUAN。

(SAN)SHENQINGRENTONGGUOQIZHUDAODEJISHUCHUANGXINHUODONG,ZAIZHONGGUOYIFAYONGYOUCHANPINHEXINJISHUFAMINGZHUANLIQUAN,HUOZHEYIFATONGGUOSHOURANGQUDEZAIZHONGGUOFAMINGZHUANLIQUANHUOQISHIYONGQUAN,CHUANGXINTEBIESHENCHASHENQINGSHIJIANJUZHUANLISHOUQUANGONGGAORIBUCHAOGUO5NIAN;HUOZHEHEXINJISHUFAMINGZHUANLIDESHENQINGYIYOUGUOWUYUANZHUANLIXINGZHENGBUMENGONGKAI,BINGYOUGUOJIAZHISHICHANQUANJUZHUANLIJIANSUOZIXUNZHONGXINCHUJUJIANSUOBAOGAO,BAOGAOZAIMINGCHANPINHEXINJISHUFANGANJUBEIXINYINGXINGHECHUANGZAOXING;HUOZHECHANPINJISHUGUONEILINGXIAN,KETIANBUBENSHENGGAIPINZHONGYILIAOQIXIEDEKONGBAI。

超凡电竞DISITIAOSHANXISHENGYAOPINJIANDUGUANLIJU(YIXIAJIANCHENG“SHENGJU”)JIXIANGGUANJISHUJIGOU,GENJUGEZIZHIZEHEBENCHENGXUGUIDING,ANZHAOZAOQIJIERU、ZHUANRENFUZE、KEXUESHENCHADEYUANZE,ZAIBIAOZHUNBUJIANGDI、CHENGXUBUJIANSHAODEQIANTIXIA,DUICHUANGXINYILIAOQIXIEYUYIYOUXIANBANLI,BINGFAHUISHANXISHENGYILIAOQIXIECHUANGXINZHUANHUAZHONGXINDEGONGNENG,JIAQIANGYUSHENQINGRENDEGOUTONGCHAOFANDIANJING。

超凡电竞DIWUTIAO SHENGJUSHELICHUANGXINSHENCHACHAOFANDIANJINGBANGONGSHI,BANGONGSHISHEZAISHENGJUYILIAOQIXIEJIANGUANCHU,FUZEXIEDIAOBUSHU、ZUZHIXIANGGUANBUMENHUISHANG、YIYICHULIDENGGONGZUO。SHENGXINYAOSHENPINGZHONGXINFUZEDUICHUANGXINTEBIESHENCHASHENQINGDESHENCHA、ZUZHIZHUANJIASHENCHADENGJUTIGONGZUO。

超凡电竞DILIUTIAODUIYUFUHEBENCHENGXUDISANTIAOGUIDINGQINGXING,XUYAOJINRUCHUANGXINTEBIESHENCHADE,SHENQINGRENYINGZAIDIERLEIYILIAOQIXIESHOUCIZHUCESHENQINGQIAN,XIANGSHENGJUTICHUCHUANGXINTEBIESHENCHADESHENQING。

DIQITIAOSHENQINGRENSHENQINGSHIYINGDANGTIANXIE《DIERLEICHUANGXINYILIAOQIXIETEBIESHENCHASHENQINGBIAO》(FUJIAN1),BINGXIANGSHENGJUXINGZHENGSHOULIBUMENTIJIAOFUHEBENCHENGXUDISANTIAOYAOQIUDEZILIAO。ZILIAOYINGDANGBAOKUO:

超凡电竞(YI)SHENQINGRENQIYEZIZHIZHENGMINGWENJIAN。

超凡电竞(ER)CHANPINZHISHICHANQUANQINGKUANGJIZHENGMINGWENJIAN。

超凡电竞(SAN)CHANPINYANFAGUOCHENGJIJIEGUOZONGSHU。

超凡电竞(SI)CHANPINJISHUWENJIAN,ZHISHAOYINGDANGBAOKUO:

超凡电竞1.CHANPINDESHIYONGFANWEIHUOZHEYUQIYONGTU;

超凡电竞2.CHANPINGONGZUOYUANLIHUOZHEZUOYONGJILI;

3.CHANPINZHUYAOJISHUZHIBIAOJIQUEDINGYIJU,ZHUYAOYUANCAILIAO、GUANJIANYUANQIJIANDEZHIBIAOYAOQIU,ZHUYAOSHENGCHANGONGYIGUOCHENGJILIUCHENGTU,ZHUYAOJISHUZHIBIAODEJIANYANFANGFA。

(WU)CHANPINCHUANGXINDEZHENGMINGXINGWENJIAN,ZHISHAOYINGDANGBAOKUO:

1.HEXINKANWUGONGKAIFABIAODENENGGOUCHONGFENSHUOMINGCHANPINLINCHUANGYINGYONGJIAZHIDEXUESHULUNWEN、ZHUANZHUJIWENJIANZONGSHU;

超凡电竞2.GUONEIWAIYISHANGSHITONGLEICHANPINYINGYONGQINGKUANGDEFENXIJIDUIBI(RUYOU);

超凡电竞3.CHANPINDECHUANGXINNEIRONGJIZAILINCHUANGYINGYONGDEXIANZHUJIAZHI。

超凡电竞(LIU)CHANPINFENGXIANFENXIZILIAO。

(QI)CHANPINSHUOMINGSHU(YANGGAO)。

(BA)QITAZHENGMINGCHANPINFUHEBENCHENGXUDISANTIAODEZILIAO。

(JIU)SUOTIJIAOZILIAOZHENSHIXINGDEZICHAOFANDIANJINGBAOZHENGSHENGMING。

SHENBAOZILIAOYINGDANGSHIYONGZHONGWEN。YUANWENWEIWAIWENDE,YINGDANGYOUZHONGWENYIBEN。

DIBATIAO SHENGJUXINGZHENGSHOULIBUMENYU5GEGONGZUORINEIWANCHENGDUICHUANGXINTEBIESHENCHASHENQINGZILIAODEXINGSHISHENCHA。DUIFUHEBENCHENGXUDIQITIAOGUIDINGDEXINGSHIYAOQIUDEYUYISHOULI,BINGJIYUSHOULIBIANHAO,BIANPAIFANGSHIWEI: SHANXIEXIN××××1×××2,QIZHONG××××1WEISHENQINGDENIANFEN;×××2WEILIUSHUIHAO。

超凡电竞DUIYUYISHOULIDECHUANGXINTEBIESHENCHASHENQING,SHENQINGRENKEYIZAISHENCHAJUEDINGZUOCHUQIAN,SHENQINGCHEHUICHUANGXINTEBIESHENCHASHENQINGJIXIANGGUANZILIAO,BINGSHUOMINGLIYOU。

DIJIUTIAO DUINIJINXINGCHUANGXINTEBIESHENCHADESHENQINGXIANGMU,JINGSHENGJUHEZHUNHOU,ZAIJUZHENGWUWANGZHANGONGSHISHENQINGREN、CHANPINMINGCHENGHEGUIGEXINGHAO,GONGSHISHIJIANYINGBUSHAOYU10GEGONGZUORI。

DUIGONGSHIYOUYIYIDE,YIYIFANGYINGDANGZAIGONGSHIQINEITIJIAOSHUMIANYIJIANBINGSHUOMINGLIYOU(FUJIAN2)。SHENGJUZAIGONGSHIJIESHUHOU,DUIXIANGGUANYIJIANJINXINGYANJIU,BINGZUOCHUZUIZHONGSHENCHAJUEDING。

DISHITIAO SHENQINGZILIAOCUNZAIYIXIAQINGXINGZHIYIDE,SHENGJUKEYIBUZUZHIZHUANJIAJINXINGSHENCHA:

(YI)SHENQINGZILIAOXUJIADE。

(ER)SHENQINGZILIAONEIRONGHUNLUAN、MAODUNDE。

(SAN)SHENQINGZILIAODENEIRONGYUSHENBAOXIANGMUMINGXIANBUFUDE。

(SI)SHENQINGZILIAOZHONGCHANPINZHISHICHANQUANZHENGMINGWENJIANBUWANZHENG、ZHUANLIQUANBUQINGXIDE。

(WU)QIANCISHENCHAYIJIANYIMINGQUEZHICHUCHANPINZHUYAOGONGZUOYUANLIHUOZHEZUOYONGJILIFEIGUONEISHOUCHUANG,QIEZAICISHENQINGSHICHANPINSHEJIWEIFASHENGGAIBIANDE。

DISHIYITIAO DUISHENQINGCHUANGXINTEBIESHENCHADEYILIAOQIXIEDEGUANLISHUXINGCUNZAIYIWENDE,SHENGJUYINGDANGGAOZHISHENQINGRENXIANXIANGGUOJIAJUTICHUCHANPINFENLEIJIEDINGSHENQING。

JINGGUOJIAJUSHENCHAJIEDING,CHANPINANZHAODIERLEIYILIAOQIXIEGUANLIDE,SHENQINGRENANZHAOBENCHENGXUTICHUCHUANGXINTEBIESHENCHASHENQING。

DISHIERTIAO SHENGJUYINGZAI60GEGONGZUORINEIZUOCHUSHENCHAJUEDINGBINGJIANGJIEGUOGAOZHISHENQINGREN,GONGSHIJIYIYICHULISHIJIANCHUWAI。

超凡电竞JINGSHENCHA,DUIBUYUJINXINGCHUANGXINTEBIESHENCHADESHENQINGXIANGMU,YINGDANGJIANGYANJIUYIJIANHELIYOUGAOZHISHENQINGREN,CIJIEGUOBUYINGXIANGSHENQINGRENANZHAOZHENGCHANGCHENGXUSHENQINGDIERLEIYILIAOQIXIEZHUCE。

JINGSHENCHA,TONGYIANBENCHENGXUSHENCHADEDIERLEICHUANGXINYILIAOQIXIE,SHENCHAJIEGUOGAOZHIHOU5NIANNEI,WEISHENBAOZHUCEYILIAOQIXIEDE,BUZAIANZHAOBENCHENGXUSHISHITEBIESHENCHA。5NIANHOU,SHENQINGRENKEANZHAOBENCHENGXUZHONGXINSHENQINGCHUANGXINTEBIESHENCHA。

超凡电竞DISHISANTIAODUIDIERLEICHUANGXINYILIAOQIXIE,SHENGJUXUJIJIZHUDONGYUSHENQINGRENLIANXI,ZAICHANPINZHUCESHENQINGSHOULIQIANYIJISHENPINGSHENPIGUOCHENGZHONG,ANPAIZHUANRENYUSHENQINGRENJIUZHONGDAJISHUWENTI、ZHONGDAANQUANXINGWENTI、LINCHUANGSHIYANFANGANHEJIEDUANXINGLINCHUANGSHIYANJIEGUODEZONGJIEYUPINGJIADENGFANGMIAN,KAIZHANJIJIYOUXIAODEGOUTONGCHAOFANDIANJING,JIAQIANGLINCHUANGSHIYANZHIDAO,BIYAOSHIZUZHIZHUANJIAJIYUJISHUZHIDAO。GOUTONGCHAOFANDIANJINGYINGDANGXINGCHENGJILU,ZUOWEICHANPINHOUXUYANJIUJISHENPINGGONGZUODECANKAO。

超凡电竞DISHISITIAO SHANXISHENGYILIAOQIXIEZHILIANGJIANDUJIANYANYUANYOUXIANANPAIDIERLEICHUANGXINYILIAOQIXIEKAIZHANZHUCEJIANYAN、CHANPINJISHUYAOQIUYUPINGJIA,JIAQIANGJISHUCHAOFANDIANJINGHEZHIDAO。SHENGJUXINGZHENGSHOULIBUMENYINGDANGYOUXIANSHOULI,BINGJIANGGAIZHUCESHENQINGXIANGMUBIAOJIWEI“CHUANGXINYILIAOQIXIE”,JISHIJINXINGZHUCESHENBAOZILIAOLIUZHUAN。

DISHIWUTIAO SHUYUXIALIEQINGXINGZHIYIDE,SHENGJUKEZHONGZHIBENCHENGXUBINGGAOZHISHENQINGREN:

超凡电竞(YI)SHENQINGRENZHUDONGYAOQIUZHONGZHIDE。

超凡电竞(ER)SHENQINGRENWEIANGUIDINGDESHIJIANJIYAOQIULVXINGXIANGYINGYIWUDE。

(SAN)SHENQINGRENTIGONGWEIZAOHEXUJIAZILIAODE。

超凡电竞(SI)QUANBUHEXINJISHUFAMINGZHUANLISHENQINGBEIBOHUIHUOSHIWEICHEHUIDE。

超凡电竞(WU)SHIQUCHANPINQUANBUHEXINJISHUFAMINGZHUANLIZHUANLIQUANHUOZHESHIYONGQUAN。

超凡电竞(LIU)SHENQINGCHANPINBUZAIZUOWEIDIERLEIYILIAOQIXIEGUANLIDE。

超凡电竞(QI)JINGZHUANJIASHENCHAHUIYITAOLUNQUEDINGBUYIZAIANZHAOBENCHENGXUGUANLIDE。

DISHILIUTIAO SHENGJUZAISHISHIBENCHENGXUGUOCHENGZHONG,YINGDANGJIAQIANGYUYOUGUANBUMENDEGOUTONGHECHAOFANDIANJING,JISHILEJIECHUANGXINYILIAOQIXIEDEYANFAJINZHAN。

DISHIQITIAO DANGDIERLEICHUANGXINYILIAOQIXIELINCHUANGYANJIUGONGZUOXUZHONGDABIANGENGDE,RULINCHUANGSHIYANFANGANXIUDING,SHIYONGFANGFA、GUIGEXINGHAO、YUQIYONGTU、SHIYONGFANWEIHUORENQUNDEDIAOZHENGDENG,SHENQINGRENYINGDANGPINGGUBIANGENGDUIYILIAOQIXIEANQUANXING、YOUXIAOXINGHEZHILIANGKEKONGXINGDEYINGXIANG。CHANPINZHUYAOGONGZUOYUANLIHUOZHEZUOYONGJILI、YUQIYONGTUFASHENGBIANHUADE,YINGDANGANZHAOBENCHENGXUZHONGXINSHENQING。

DISHIBATIAOBENCHENGXUDUIDIERLEICHUANGXINYILIAOQIXIEZHUCEGUANLIWEIZUOGUIDINGDE,ANZHAO《YILIAOQIXIEZHUCEGUANLIBANFA》《TIWAIZHENDUANSHIJIZHUCEGUANLIBANFA》DENGXIANGGUANGUIDINGZHIXING。

超凡电竞DISHIJIUTIAOJINGGUOJIAJUSHENCHARENDINGDECHUANGXINYILIAOQIXIE,QIEQIGUANLILEIBIEJINGJIEDINGWEIDIERLEIYILIAOQIXIEDE,SHENGJUKECANZHAOBENCHENGXUYUYIYOUXIANCHAOFANDIANJING。

超凡电竞DIERSHITIAOXUYAOGUOJIAJURENDINGDECHUANGXINYILIAOQIXIE,SHENGJUANZHAOGUOJIAJU《CHUANGXINYILIAOQIXIETEBIESHENCHACHENGXU》BAOGUOJIAJUSHENCHA。

DIERSHIYITIAO SHENGJUDUIPIZHUNWEIDIERLEICHUANGXINYILIAOQIXIEDECHANPIN,ZAIZHUCEGUOCHENGZHONGYUYIYOUXIANSHENPING、YOUXIANANPAITIXIHECHA、YOUXIANSHENPI。DUIDIERLEICHUANGXINYILIAOQIXIEDEXUKESHIXIANGBIANGENGSHENQING,YUYIYOUXIANBANLI。

DIERSHIERTIAOBENCHENGXUZI2020NIAN8YUE28RIQISHISHI,YOUXIAOQI5NIAN。

FUBIAO: 1.DIERLEICHUANGXINYILIAOQIXIETEBIESHENCHASHENQINGBIAO

          2.DIERLEICHUANGXINYILIAOQIXIETEBIESHENCHAYIYIBIAO

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