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地址:南阳路岗杜北街中亨本色
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一类医疗器械需要的备案资料

文章编辑:【郑州汇达医疗器械企业服务中心】发布日期:2015-06-10 10:43:06

第一类医疗器械是指,通过常规管理足以保证其安全性、有效性的医疗器械。《医疗器械监督管理条例》(国务院令第650号)自2014年6月1日起施行。根据条例,第一类医疗器械实行产品备案管理。今天郑州医疗器械资质办理开心棋牌公司汇达就和您聊聊:一类医疗器械需要的备案资料。

 

YI、BEIANZILIAO

 

开心棋牌(YI)DIYILEIYILIAOQIXIEBEIANBIAO

 

(ER)ANQUANFENGXIANFENXIBAOGAO

 

YILIAOQIXIEYINGANZHAOYY 0316《YILIAOQIXIEFENGXIANGUANLIDUIYILIAOQIXIEDEYINGYONG》DEYOUGUANYAOQIUBIANZHI,ZHUYAOBAOKUOYILIAOQIXIEYUQIYONGTUHEYUANQUANXINGYOUGUANTEZHENGDEPANDING、WEIHAIDEPANDING、GUJI MEIGEWEIHAICHUJINGDEFENGXIAN;DUIMEIGEYIPANDINGDEWEIHAICHUJING,PINGJIAHEJUEDINGSHIFOUXUYAOJIANGDIFENGXIAN;FENGXIANKONGZHICUOSHIDESHISHIHEYANZHENGJIEGUO,BIYAOSHIYINGYINYONGJIANCEHEPINGJIAXINGBAOGAO;RENHEYIGEHUODUO GESHENGYUFENGXIANDEKEJIESHOUXINGPINGDINGDENG,XINGCHENGFENGXIANGUANLIBAOGAO。

 

TIWAIZHENDUANSHIJIYINGDUICHANPINSHOUMINGZHOUQIDEGEGEHUANJIE,CONGYUQIYONGTU、KENENGDESHIYONGCUOWU、YUANQUANXINGYOUGUANDETEZHENG、YIZHIHEKEYUJIANDEWEIHAIDENGFANGMIANDEPANDINGJIDUIHUANZHEFENGXIANDEGUJIJINXINGFENGXIANFENXI、FENGXIANPINGJIAJIXIANGYINGDEFENGXIANKONGZHIDEJICHUSHANG,XINGCHENGFENGXIANGUANLIBAOGAO。

 

(SAN)CHANPINJISHUYAOQIU

 

CHANPINJISHUYAOQIUYINGANZHAO《YILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZE》BIANZHI。

 

(SI)CHANPINJIANYANBAOGAO

 

开心棋牌CHANPINJIANYANBAOGAOYINGWEICHANPINQUANXINGNENGZIJIANBAOGAOHUOWEITUOJIANYANBAOGAO,JIANYANDECHANPINYINGDANGJUYOUDIANXINGXING。

 

(WU)LINCHUANGPINGJIAZILIAO

 

1. XIANGSHUCHANPINYUQIYONGTU,BAOKUOCHANPINSUOTIGONGDEGONGNENG,BINGKEMIAOSHUQISHIYONGDEYILIAOJIEDUAN(RUZHILIAOHOUDEJIANCE、KANGFUDENG),MUBIAOYONGHUJIQICAOZUOGAICHANPINYINGJUBEIDEJINENG/ZHISHI/PEIXUN;YUQIYUQIZUHESHIYONGDEQIXIE。

 

2. XIANGSHUCHANPINYUQISHIYONGHUANJING,BAOKUOGAICHANPINYUQISHIYONGDEDIDIANRUYIYUAN、YILIAO/LINCHUANGSHIYANSHI、JIUHUCHE、JIATINGDENG,YIJIKENENGHUIYINGXIANGQIANQUANXINGHEYOUXIAOXINGDEHUANJINGTIAOJIAN(RUWENDU、SHIDU、GONGLV、YALI、YIDONGDENG)。

 

3. XIANGSHUCHANPINSHIYONGRENQUN,BAOKUOMUBIAOHUANZHERENQUNDEXINXI(RUCHENGREN、ERTONGHUOXINSHENGER),HUANZHEXUANZEBIAOZHUNDEXINXI,YIJISHIYONGGUOCHENGZHONGXUYAOJIANCEDECANSHU、KAOLVDEYINSU。

 

4. XIANGSHUCHANPINJINJIZHENG,RUSHIYONG,YINGMINGQUESHUOMINGGAIQIXIEJINZHISHIYONGDEJIBINGHUOQINGKUANG。

 

开心棋牌5. YISHANGSHITONGLEICHANPINLINCHUANGSHIYONGQINGKUANGDEBIDUISHUOMING。

 

开心棋牌6. TONGLEICHANPINBULIANGSHIJIANQINGKUANGSHUOMING。

 

开心棋牌(LIU)CHANPINSHUOMINGSHUJIZUIXIAOXIAOSHOUDANYUANBIAOQIANSHEJIYANGGAO

 

YILIAOQIXIEYINGFUHEXIANGYINGFAGUIGUIDING。JINKOUYILIAOQIXIECHANPINYINGTIJIAOJINGWAIZHENGFUZHUGUANBUMENPIZHUNHUOZHERENKEDESHUOMINGSHUYUANWENJIQIZHONGWENYIBEN。

 

TIWAIZHENDUANSHIJICHANPINYINGANZHAO《TIWAIZHENDUANSHIJISHUOMINGSHUBIANXIEZHIDAOYUANZE》DEYOUGUANYAOQIU,BINGCANKAOYOUGUANJISHUZHIDAOYUANZEBIANXIECHANPINSHUOMINGSHU。JINKOUTIWAIZHENDUANSHIJICHANPINYINGTIJIAOJINGWAIZHENGFUZHUGUANBUMENPIZHUNHUOZHERENKEDESHUOMINGSHUYUANWENJIQIZHONGWENYIBEN。

 

(QI)SHENGCHANZHIZAOXINXI

 

DUI SHENGCHANGUOCHENGXIANGGUANQINGKUANGDEGAISHU。WUYUANYILIAOQIXIEYINGMINGQUECHANPINSHENGCHANJIAGONGGONGYI,ZHUMINGGUANJIANGONGYIHETESHUGONGYI。YOUYUANYILIAOQIXIEYINGTIGONGCHANPINSHENGCHANGONGYIGUOCHENGDEMIAOSHUXINGZILIAO,KECAIYONGLIUCHENGTU DEXINGSHI,SHISHENGCHANGUOCHENGDEGAISHU。TIWAIZHENDUANSHIJIYINGGAISHUZHUYAOSHENGCHANGONGYI,BAOKUO:GUXIANGZAITI、XIANSEXITONGDENGDEMIAOSHUJIQUEDINGYIJU,FANYINGTIXIBAOKUOYANGBENCAIJIJICHULI、YANGBENYAOQIU、YANGBEN YONGLIANG、SHIJIYONGLIANG、FANYINGTIAOJIAN、XIAOZHUNFANGFA(RUGUOXUYAO)、ZHIKONGFANGFADENG。

 

开心棋牌YINGGAISHUYANZHI、SHENGCHANCHANGDIDESHIJIQINGKUANG。

 

(BA)ZHENGMINGXINGWENJIAN

 

1.JINGNEIBEIANRENTIGONG:QIYEYINGYEZHIZHAOFUYINJIAN、ZUZHIJIGOUDAIMAZHENGFUYINJIAN。

 

2.JINGWAIBEIANRENTIGONG:

 

开心棋牌(1)JINGWAIBEIANRENQIYEZIGEZHENGMINGWENJIAN。

 

(2) JINGWAIBEIANRENZHUCEDIHUOSHENGCHANDIZHISUOZAIGUOJIA(DIQU)YILIAOQIXIEZHUGUANBUMENCHUJUDEYUNXUCHANPINSHANGSHIXIAOSHOUDEZHENGMINGWENJIAN。BEIANRENZHUCEDIHUOSHENGCHANDIZHISUOZAIGUOJIA(DIQU)BUBAGAICHANPINZUOWEI YILIAOQIXIEGUANLIDE,BEIANRENXUTIGONGXIANGGUANZHENGMINGWENJIAN,BAOKUOBEIANRENZHUCEDIHUOSHENGCHANDIZHISUOZAIGUOJIA(DIQU)ZHUNXUGAICHANPINHEFASHANGSHIXIAOSHOUDEZHENGMINGWENJIAN。RUGAIZHENGMINGWENJIANWEIFUYINJIAN,YINGJING DANGDIGONGZHENGJIGUANGONGZHENG。

 

(3)JINGWAIBEIANRENZAIZHONGGUOJINGNEIZHIDINGDAILIRENDEWEITUOSHU、DAILIRENCHENGNUOSHUJIYINGYEZHIZHAOFUBENFUYINJIANHUOZHEJIGOUDENGJIZHENGMINGFUYINJIAN。

 

(JIU)FUHEXINGSHENGMING

 

1. SHENGMINGFUHEYILIAOQIXIEBEIANXIANGGUANYAOQIU;

 

2. SHENGMINGBENCHANPINFUHEDIYILEIYILIAOQIXIECHANPINMULUHUOXIANGYINGTIWAIZHENDUANSHIJIFENLEIZIMULUDEYOUGUANNEIRONG;

 

3. SHENGMINGBENCHANPINFUHEXIANXINGGUOJIABIAOZHUN、XINGYEBIAOZHUNBINGTIGONGFUHEBIAOZHUNDEQINGDAN;

 

4. SHENGMINGSUOTIJIAOBEIANZILIAODEZHENSHIXING。

 

ER、BIANGENGBEIANZILIAO

开心棋牌(YI)BIANHUAQINGKUANGSHUOMINGJIXIANGGUANZHENGMINGWENJIAN

 

开心棋牌BIANHUAQINGKUANGSHUOMINGYINGFUBEIANXINXIBIAOBIANHUANEIRONGBIDUILIEBIAO。

 

SHEJICHANPINJISHUYAOQIUBIANHUADE,YINGTIGONGCHANPINJISHUYAOQIUBIANHUANEIRONGBIDUIBIAO。

 

开心棋牌BIANGENGCHANPINMINGCHENG(TIWAIZHENDUANSHIJIWEICHANPINFENLEIMINGCHENG,YIXIATONG)、CHANPINMIAOSHU、YUQIYONGTUDE,BIANGENGHOUDENEIRONGYINGYUDIYILEIYILIAOQIXIECHANPINMULUHEXIANGYINGTIWAIZHENDUANSHIJIZIMULUXIANGYINGNEIRONGYIZHI。QIZHONG,CHANPINMINGCHENGYINGDANGYUMULUSUOLIENEIRONGXIANGTONG;CHANPINMIAOSHU、YUQIYONGTU,YINGDANGYUMULUSUOLIENEIRONGXIANGTONGHUOZHESHAOYUMULUNEIRONG。

 

开心棋牌XIANGYINGZHENGMINGWENJIANYINGXIANGSHI、QUANMIAN、ZHUNQUE。

 

(ER)ZHENGMINGXINGWENJIAN

 

开心棋牌1.JINGNEIBEIANRENTIGONG:QIYEYINGYEZHIZHAOFUBENFUYINJIAN、ZUZHIJIGOUDAIMAZHENGFUBENFUYINJIAN。

 

2.JINGWAIBEIANRENTIGONG:

 

(1)RUBIANGENGSHIXIANGZAIJINGWAIBEIANRENZHUCEDIHUOSHENGCHANDIZHISUOZAIGUOJIA(DIQU)YINGDANGHUODEXINDEYILIAOQIXIEZHUGUANBUMENCHUJUDEYUNXUCHANPINSHANGSHIXIAOSHOUZHENGMINGWENJIANDE,YINGTIJIAOXINDESHANGSHIZHENGMINGWENJIAN。RUGAIZHENGMINGWENJIANWEIFUYINJIAN,YINGJINGDANGDIGONGZHENGJIGUANGONGZHENG。

 

开心棋牌(2)JINGWAIBEIANRENZAIZHONGGUOJINGNEIZHIDINGDAILIRENDEWEITUOSHU、DAILIRENCHENGNUOSHUJIYINGYEZHIZHAOFUBENFUYINJIANHUOZHEJIGOUDENGJIZHENGMINGFUYINJIAN。

 

(SAN)FUHEXINGSHENGMING

 

1. SHENGMINGFUHEYILIAOQIXIEBEIANXIANGGUANYAOQIU;

 

2. SHENGMINGBENCHANPINFUHEDIYILEIYILIAOQIXIECHANPINMULUHEXIANGYINGTIWAIZHENDUANSHIJIFENLEIZIMULUDEYOUGUANNEIRONG;

 

3. SHENGMINGBENCHANPINFUHEXIANXINGGUOJIABIAOZHUN、XINGYEBIAOZHUNBINGTIGONGFUHEBIAOZHUNDEQINGDAN;

 

4. SHENGMINGSUOTIJIAOBEIANZILIAODEZHENSHIXING。

 

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联系人:张老师 电话:0371-63968301 地址:郑州市南阳路岗杜北街中亨本色
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