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新聞資訊
最新公司動態 海量行業資訊
醫療器械監督管理條例
2021-03-18

(2000nian1yue4rizhonghuarenmingongheguoguowuyuanlingdi276haogongbu 2014nian2yue12riguowuyuandi39cichangwuhuiyixiudingtongguo wenzhanglaiyuan: xinhuashe

genju2017nian5yue4ri《guowuyuanguanyuxiugai〈yiliaoqixiejianduguanlitiaoli〉dejueding》xiuding 2020nian12yue21riguowuyuandi119cichangwuhuiyixiudingtongguo)

  第一章 總則

  diyitiao weilebaozhengyiliaoqixiedeanquan、youxiao,baozhangrentijiankangheshengminganquan,cujinyiliaoqixiechanyefazhan,zhidingbentiaoli。

  diertiao zaizhonghuarenmingongheguojingneicongshiyiliaoqixiedeyanzhi、shengchan、jingying、shiyonghuodongjiqijianduguanli,shiyongbentiaoli。

  disantiao guowuyuanyaopinjianduguanlibumenfuzequanguoyiliaoqixiejianduguanligongzuo。

  guowuyuanyouguanbumenzaigezidezhizefanweineifuzeyuyiliaoqixieyouguandejianduguanligongzuo。

  disitiao xianjiyishangdifangrenminzhengfuyingdangjiaqiangduibenxingzhengquyudeyiliaoqixiejianduguanligongzuodelingdao,zuzhixiediaobenxingzhengquyuneideyiliaoqixiejianduguanligongzuoyijitufashijianyingduigongzuo,jiaqiangyiliaoqixiejianduguanlinenglijianshe,weiyiliaoqixieanquangongzuotigongbaozhang。

  xianjiyishangdifangrenminzhengfufuzeyaopinjianduguanlidebumenfuzebenxingzhengquyudeyiliaoqixiejianduguanligongzuo。xianjiyishangdifangrenminzhengfuyouguanbumenzaigezidezhizefanweineifuzeyuyiliaoqixieyouguandejianduguanligongzuo。

  diwutiao yiliaoqixiejianduguanlizunxunfengxianguanli、quanchengguankong、kexuejianguan、shehuigongzhideyuanze。

  diliutiao guojiaduiyiliaoqixieanzhaofengxianchengdushixingfenleiguanli。

  diyileishifengxianchengdudi,shixingchangguiguanlikeyibaozhengqianquan、youxiaodeyiliaoqixie。

  dierleishijuyouzhongdufengxian,xuyaoyangekongzhiguanliyibaozhengqianquan、youxiaodeyiliaoqixie。

  disanleishijuyoujiaogaofengxian,xuyaocaiqutebiecuoshiyangekongzhiguanliyibaozhengqianquan、youxiaodeyiliaoqixie。

  pingjiayiliaoqixiefengxianchengdu,yingdangkaolvyiliaoqixiedeyuqimude、jiegoutezheng、shiyongfangfadengyinsu。

  guowuyuanyaopinjianduguanlibumenfuzezhidingyiliaoqixiedefenleiguizehefenleimulu,binggenjuyiliaoqixieshengchan、jingying、shiyongqingkuang,jishiduiyiliaoqixiedefengxianbianhuajinxingfenxi、pingjia,duifenleiguizehefenleimulujinxingdiaozheng。zhiding、diaozhengfenleiguizehefenleimulu,yingdangchongfentingquyiliaoqixiezhuceren、beianren、shengchanjingyingqiyeyijishiyongdanwei、xingyezuzhideyijian,bingcankaoguojiyiliaoqixiefenleishijian。yiliaoqixiefenleiguizehefenleimuluyingdangxiangshehuigongbu。

  diqitiao yiliaoqixiechanpinyingdangfuheyiliaoqixieqiangzhixingguojiabiaozhun;shangwuqiangzhixingguojiabiaozhunde,yingdangfuheyiliaoqixieqiangzhixingxingyebiaozhun。

  dibatiao guojiazhidingyiliaoqixiechanyeguihuahezhengce,jiangyiliaoqixiechuangxinnarufazhanzhongdian,duichuangxinyiliaoqixieyuyiyouxianshenpingshenpi,zhichichuangxinyiliaoqixielinchuangtuiguangheshiyong,tuidongyiliaoqixiechanyegaozhiliangfazhan。guowuyuanyaopinjianduguanlibumenyingdangpeiheguowuyuanyouguanbumen,guancheshishiguojiayiliaoqixiechanyeguihuaheyindaozhengce。

  dijiutiao guojiawanshanyiliaoqixiechuangxintixi,zhichiyiliaoqixiedejichuyanjiuheyingyongyanjiu,cujinyiliaoqixiexinjishudetuiguangheyingyong,zaikejilixiang、rongzi、xindai、zhaobiaocaigou、yiliaobaoxiandengfangmianyuyizhichi。zhichiqiyeshelihuozhelianhezujianyanzhijigou,guliqiyeyugaodengxuexiao、keyanyuansuo、yiliaojigoudenghezuokaizhanyiliaoqixiedeyanjiuyuchuangxin,jiaqiangyiliaoqixiezhishichanquanbaohu,tigaoyiliaoqixiezizhuchuangxinnengli。

  dishitiao guojiajiaqiangyiliaoqixiejianduguanlixinxihuajianshe,tigaozaixianzhengwufuwushuiping,weiyiliaoqixiexingzhengxuke、beiandengtigongbianli。

  dishiyitiao yiliaoqixiexingyezuzhiyingdangjiaqiangxingyezilv,tuijinchengxintixijianshe,ducuqiyeyifakaizhanshengchanjingyinghuodong,yindaoqiyechengshishouxin。

  dishiertiao duizaiyiliaoqixiedeyanjiuyuchuangxinfangmianzuochutuchugongxiandedanweihegeren,anzhaoguojiayouguanguidinggeiyubiaozhangjiangli。

  第二章 醫療器械產品注冊與備案

  dishisantiao diyileiyiliaoqixieshixingchanpinbeianguanli,dierlei、disanleiyiliaoqixieshixingchanpinzhuceguanli。

  yiliaoqixiezhuceren、beianrenyingdangjiaqiangyiliaoqixiequanshengmingzhouqizhiliangguanli,duiyanzhi、shengchan、jingying、shiyongquanguochengzhongyiliaoqixiedeanquanxing、youxiaoxingyifachengdanzeren。

  dishisitiao diyileiyiliaoqixiechanpinbeianheshenqingdierlei、disanleiyiliaoqixiechanpinzhuce,yingdangtijiaoxialieziliao:

  (yi)chanpinfengxianfenxiziliao;

  (er)chanpinjishuyaoqiu;

  (san)chanpinjianyanbaogao;

  (si)linchuangpingjiaziliao;

  (wu)chanpinshuomingshuyijibiaoqianyanggao;

  (liu)yuchanpinyanzhi、shengchanyouguandezhiliangguanlitixiwenjian;

  (qi)zhengmingchanpinanquan、youxiaosuoxudeqitaziliao。

  chanpinjianyanbaogaoyingdangfuheguowuyuanyaopinjianduguanlibumendeyaoqiu,keyishiyiliaoqixiezhuceshenqingren、beianrendezijianbaogao,yekeyishiweituoyouzizhideyiliaoqixiejianyanjigouchujudejianyanbaogao。

  fuhebentiaolidiershisitiaoguidingdemianyujinxinglinchuangpingjiaqingxingde,keyimianyutijiaolinchuangpingjiaziliao。

  yiliaoqixiezhuceshenqingren、beianrenyingdangquebaotijiaodeziliaohefa、zhenshi、zhunque、wanzhenghekezhuisu。

  dishiwutiao diyileiyiliaoqixiechanpinbeian,youbeianrenxiangsuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumentijiaobeianziliao。

  xiangwoguojingneichukoudiyileiyiliaoqixiedejingwaibeianren,youqizhidingdewoguojingneiqiyefarenxiangguowuyuanyaopinjianduguanlibumentijiaobeianziliaohebeianrensuozaiguo(diqu)zhuguanbumenzhunxugaiyiliaoqixieshangshixiaoshoudezhengmingwenjian。weizaijingwaishangshidechuangxinyiliaoqixie,keyibutijiaobeianrensuozaiguo(diqu)zhuguanbumenzhunxugaiyiliaoqixieshangshixiaoshoudezhengmingwenjian。

  beianrenxiangfuzeyaopinjianduguanlidebumentijiaofuhebentiaoliguidingdebeianziliaohoujiwanchengbeian。fuzeyaopinjianduguanlidebumenyingdangzishoudaobeianziliaozhiriqi5gegongzuorinei,tongguoguowuyuanyaopinjianduguanlibumenzaixianzhengwufuwupingtaixiangshehuigongbubeianyouguanxinxi。

  beianziliaozaimingdeshixiangfashengbianhuade,yingdangxiangyuanbeianbumenbiangengbeian。

  dishiliutiao shenqingdierleiyiliaoqixiechanpinzhuce,zhuceshenqingrenyingdangxiangsuozaidisheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumentijiaozhuceshenqingziliao。shenqingdisanleiyiliaoqixiechanpinzhuce,zhuceshenqingrenyingdangxiangguowuyuanyaopinjianduguanlibumentijiaozhuceshenqingziliao。

  xiangwoguojingneichukoudierlei、disanleiyiliaoqixiedejingwaizhuceshenqingren,youqizhidingdewoguojingneiqiyefarenxiangguowuyuanyaopinjianduguanlibumentijiaozhuceshenqingziliaohezhuceshenqingrensuozaiguo(diqu)zhuguanbumenzhunxugaiyiliaoqixieshangshixiaoshoudezhengmingwenjian。weizaijingwaishangshidechuangxinyiliaoqixie,keyibutijiaozhuceshenqingrensuozaiguo(diqu)zhuguanbumenzhunxugaiyiliaoqixieshangshixiaoshoudezhengmingwenjian。

  guowuyuanyaopinjianduguanlibumenyingdangduiyiliaoqixiezhuceshenchachengxuheyaoqiuzuochuguiding,bingjiaqiangduisheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumenzhuceshenchagongzuodejianduzhidao。

  dishiqitiao shoulizhuceshenqingdeyaopinjianduguanlibumenyingdangduiyiliaoqixiedeanquanxing、youxiaoxingyijizhuceshenqingrenbaozhengyiliaoqixieanquan、youxiaodezhiliangguanlinenglidengjinxingshencha。

  shoulizhuceshenqingdeyaopinjianduguanlibumenyingdangzishoulizhuceshenqingzhiriqi3gegongzuorineijiangzhuceshenqingziliaozhuanjiaojishushenpingjigou。jishushenpingjigouyingdangzaiwanchengjishushenpinghou,jiangshenpingyijiantijiaoshoulizhuceshenqingdeyaopinjianduguanlibumenzuoweishenpideyiju。

  shoulizhuceshenqingdeyaopinjianduguanlibumenzaizuzhiduiyiliaoqixiedejishushenpingshirenweiyoubiyaoduizhiliangguanlitixijinxinghechade,yingdangzuzhikaizhanzhiliangguanlitixihecha。

  dishibatiao shoulizhuceshenqingdeyaopinjianduguanlibumenyingdangzishoudaoshenpingyijianzhiriqi20gegongzuorineizuochujueding。duifuhetiaojiande,zhunyuzhucebingfageiyiliaoqixiezhucezheng;duibufuhetiaojiande,buyuzhucebingshumianshuomingliyou。

  shoulizhuceshenqingdeyaopinjianduguanlibumenyingdangziyiliaoqixiezhunyuzhucezhiriqi5gegongzuorinei,tongguoguowuyuanyaopinjianduguanlibumenzaixianzhengwufuwupingtaixiangshehuigongbuzhuceyouguanxinxi。

  dishijiutiao duiyongyuzhiliaohanjianjibing、yanzhongweijishengmingqieshangwuyouxiaozhiliaoshouduandejibingheyingduigonggongweishengshijiandengjixudeyiliaoqixie,shoulizhuceshenqingdeyaopinjianduguanlibumenkeyizuochufutiaojianpizhunjueding,bingzaiyiliaoqixiezhucezhengzhongzaimingxiangguanshixiang。

  chuxiantebiezhongdatufagonggongweishengshijianhuozheqitayanzhongweixiegongzhongjiankangdejinjishijian,guowuyuanweishengzhuguanbumengenjuyufang、kongzhishijiandexuyaotichujinjishiyongyiliaoqixiedejianyi,jingguowuyuanyaopinjianduguanlibumenzuzhilunzhengtongyihoukeyizaiyidingfanweiheqixianneijinjishiyong。

  diershitiao yiliaoqixiezhuceren、beianrenyingdanglvxingxialieyiwu:

  (yi)jianliyuchanpinxiangshiyingdezhiliangguanlitixibingbaochiyouxiaoyunxing;

  (er)zhidingshangshihouyanjiuhefengxianguankongjihuabingbaozhengyouxiaoshishi;

  (san)yifakaizhanbuliangshijianjiancehezaipingjia;

  (si)jianlibingzhixingchanpinzhuisuhezhaohuizhidu;

  (wu)guowuyuanyaopinjianduguanlibumenguidingdeqitayiwu。

  jingwaiyiliaoqixiezhuceren、beianrenzhidingdewoguojingneiqiyefarenyingdangxiezhuzhuceren、beianrenlvxingqiankuanguidingdeyiwu。

  diershiyitiao yizhucededierlei、disanleiyiliaoqixiechanpin,qisheji、yuancailiao、shengchangongyi、shiyongfanwei、shiyongfangfadengfashengshizhixingbianhua,youkenengyingxianggaiyiliaoqixieanquan、youxiaode,zhucerenyingdangxiangyuanzhucebumenshenqingbanlibiangengzhuceshouxu;fashengqitabianhuade,yingdanganzhaoguowuyuanyaopinjianduguanlibumendeguidingbeianhuozhebaogao。

  diershiertiao yiliaoqixiezhucezhengyouxiaoqiwei5nian。youxiaoqijiemanxuyaoyanxuzhucede,yingdangzaiyouxiaoqijieman6geyueqianxiangyuanzhucebumentichuyanxuzhucedeshenqing。

  chuyoubentiaodisankuanguidingqingxingwai,jiedaoyanxuzhuceshenqingdeyaopinjianduguanlibumenyingdangzaiyiliaoqixiezhucezhengyouxiaoqijiemanqianzuochuzhunyuyanxudejueding。yuqiweizuojuedingde,shiweizhunyuyanxu。

  youxialieqingxingzhiyide,buyuyanxuzhuce:

  (yi)weizaiguidingqixianneitichuyanxuzhuceshenqing;

  (er)yiliaoqixieqiangzhixingbiaozhunyijingxiuding,shenqingyanxuzhucedeyiliaoqixiebunengdadaoxinyaoqiu;

  (san)futiaojianpizhundeyiliaoqixie,weizaiguidingqixianneiwanchengyiliaoqixiezhucezhengzaimingshixiang。

  diershisantiao duixinyanzhideshangweilierufenleimuludeyiliaoqixie,shenqingrenkeyiyizhaobentiaoliyouguandisanleiyiliaoqixiechanpinzhucedeguidingzhijieshenqingchanpinzhuce,yekeyiyijufenleiguizepanduanchanpinleibiebingxiangguowuyuanyaopinjianduguanlibumenshenqingleibiequerenhouyizhaobentiaolideguidingshenqingchanpinzhucehuozhejinxingchanpinbeian。

  zhijieshenqingdisanleiyiliaoqixiechanpinzhucede,guowuyuanyaopinjianduguanlibumenyingdanganzhaofengxianchengduquedingleibie,duizhunyuzhucedeyiliaoqixiejishinarufenleimulu。shenqingleibiequerende,guowuyuanyaopinjianduguanlibumenyingdangzishoulishenqingzhiriqi20gegongzuorineiduigaiyiliaoqixiedeleibiejinxingpandingbinggaozhishenqingren。

  diershisitiao yiliaoqixiechanpinzhuce、beian,yingdangjinxinglinchuangpingjia;danshifuhexialieqingxingzhiyi,keyimianyujinxinglinchuangpingjia:

  (yi)gongzuojilimingque、shejidingxing,shengchangongyichengshu,yishangshidetongpinzhongyiliaoqixielinchuangyingyongduonianqiewuyanzhongbuliangshijianjilu,bugaibianchangguiyongtude;

  (er)qitatongguofeilinchuangpingjianenggouzhengminggaiyiliaoqixieanquan、youxiaode。

  guowuyuanyaopinjianduguanlibumenyingdangzhidingyiliaoqixielinchuangpingjiazhinan。

  diershiwutiao jinxingyiliaoqixielinchuangpingjia,keyigenjuchanpintezheng、linchuangfengxian、yiyoulinchuangshujudengqingxing,tongguokaizhanlinchuangshiyan,huozhetongguoduitongpinzhongyiliaoqixielinchuangwenxianziliao、linchuangshujujinxingfenxipingjia,zhengmingyiliaoqixieanquan、youxiao。

  anzhaoguowuyuanyaopinjianduguanlibumendeguiding,jinxingyiliaoqixielinchuangpingjiashi,yiyoulinchuangwenxianziliao、linchuangshujubuzuyiquerenchanpinanquan、youxiaodeyiliaoqixie,yingdangkaizhanlinchuangshiyan。

  diershiliutiao kaizhanyiliaoqixielinchuangshiyan,yingdanganzhaoyiliaoqixielinchuangshiyanzhiliangguanliguifandeyaoqiu,zaijubeixiangyingtiaojiandelinchuangshiyanjigoujinxing,bingxianglinchuangshiyanshenbanzhesuozaidisheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumenbeian。jieshoulinchuangshiyanbeiandeyaopinjianduguanlibumenyingdangjiangbeianqingkuangtongbaolinchuangshiyanjigousuozaiditongjiyaopinjianduguanlibumenheweishengzhuguanbumen。

  yiliaoqixielinchuangshiyanjigoushixingbeianguanli。yiliaoqixielinchuangshiyanjigouyingdangjubeidetiaojianyijibeianguanlibanfahelinchuangshiyanzhiliangguanliguifan,youguowuyuanyaopinjianduguanlibumenhuitongguowuyuanweishengzhuguanbumenzhidingbinggongbu。

  guojiazhichiyiliaojigoukaizhanlinchuangshiyan,jianglinchuangshiyantiaojianhenenglipingjianaruyiliaojigoudengjipingshen,guliyiliaojigoukaizhanchuangxinyiliaoqixielinchuangshiyan。

  diershiqitiao disanleiyiliaoqixielinchuangshiyanduirentijuyoujiaogaofengxiande,yingdangjingguowuyuanyaopinjianduguanlibumenpizhun。guowuyuanyaopinjianduguanlibumenshenpilinchuangshiyan,yingdangduinichengdanyiliaoqixielinchuangshiyandejigoudeshebei、zhuanyerenyuandengtiaojian,gaiyiliaoqixiedefengxianchengdu,linchuangshiyanshishifangan,linchuangshouyiyufengxianduibifenxibaogaodengjinxingzonghefenxi,bingzishoulishenqingzhiriqi60gegongzuorineizuochujuedingbingtongzhilinchuangshiyanshenbanzhe。yuqiweitongzhide,shiweitongyi。zhunyukaizhanlinchuangshiyande,yingdangtongbaolinchuangshiyanjigousuozaidisheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumenheweishengzhuguanbumen。

  linchuangshiyanduirentijuyoujiaogaofengxiandedisanleiyiliaoqixiemuluyouguowuyuanyaopinjianduguanlibumenzhiding、diaozhengbinggongbu。

  diershibatiao kaizhanyiliaoqixielinchuangshiyan,yingdanganzhaoguidingjinxinglunlishencha,xiangshoushizhegaozhishiyanmude、yongtuhekenengchanshengdefengxiandengxiangxiqingkuang,huodeshoushizhedeshumianzhiqingtongyi;shoushizheweiwuminshixingweinenglirenhuozhexianzhiminshixingweinenglirende,yingdangyifahuodeqijianhurendeshumianzhiqingtongyi。

  kaizhanlinchuangshiyan,budeyirenhexingshixiangshoushizheshouquyulinchuangshiyanyouguandefeiyong。

  diershijiutiao duizhengzaikaizhanlinchuangshiyandeyongyuzhiliaoyanzhongweijishengmingqieshangwuyouxiaozhiliaoshouduandejibingdeyiliaoqixie,jingyixueguanchakenengshihuanzhehuoyi,jinglunlishencha、zhiqingtongyihou,keyizaikaizhanyiliaoqixielinchuangshiyandejigouneimianfeiyongyuqitabingqingxiangtongdehuanzhe,qianquanxingshujukeyiyongyuyiliaoqixiezhuceshenqing。

  第三章 醫療器械生產

  disanshitiao congshiyiliaoqixieshengchanhuodong,yingdangjubeixialietiaojian:

  (yi)youyushengchandeyiliaoqixiexiangshiyingdeshengchanchangdi、huanjingtiaojian、shengchanshebeiyijizhuanyejishurenyuan;

  (er)younengduishengchandeyiliaoqixiejinxingzhiliangjianyandejigouhuozhezhuanzhijianyanrenyuanyijijianyanshebei;

  (san)youbaozhengyiliaoqixiezhiliangdeguanlizhidu;

  (si)youyushengchandeyiliaoqixiexiangshiyingdeshouhoufuwunengli;

  (wu)fuhechanpinyanzhi、shengchangongyiwenjianguidingdeyaoqiu。

  disanshiyitiao congshidiyileiyiliaoqixieshengchande,yingdangxiangsuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumenbeian,zaitijiaofuhebentiaolidisanshitiaoguidingtiaojiandeyouguanziliaohoujiwanchengbeian。

  yiliaoqixiebeianrenzixingshengchandiyileiyiliaoqixiede,keyizaiyizhaobentiaolidishiwutiaoguidingjinxingchanpinbeianshiyibingtijiaofuhebentiaolidisanshitiaoguidingtiaojiandeyouguanziliao,jiwanchengshengchanbeian。

  disanshiertiao congshidierlei、disanleiyiliaoqixieshengchande,yingdangxiangsuozaidisheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumenshenqingshengchanxukebingtijiaoqifuhebentiaolidisanshitiaoguidingtiaojiandeyouguanziliaoyijisuoshengchanyiliaoqixiedezhucezheng。

  shoulishengchanxukeshenqingdeyaopinjianduguanlibumenyingdangduishenqingziliaojinxingshenhe,anzhaoguowuyuanyaopinjianduguanlibumenzhidingdeyiliaoqixieshengchanzhiliangguanliguifandeyaoqiujinxinghecha,bingzishoulishenqingzhiriqi20gegongzuorineizuochujueding。duifuheguidingtiaojiande,zhunyuxukebingfageiyiliaoqixieshengchanxukezheng;duibufuheguidingtiaojiande,buyuxukebingshumianshuomingliyou。

  yiliaoqixieshengchanxukezhengyouxiaoqiwei5nian。youxiaoqijiemanxuyaoyanxude,yizhaoyouguanxingzhengxukedefalvguidingbanliyanxushouxu。

  disanshisantiao yiliaoqixieshengchanzhiliangguanliguifanyingdangduiyiliaoqixiedeshejikaifa、shengchanshebeitiaojian、yuancailiaocaigou、shengchanguochengkongzhi、chanpinfangxing、qiyedejigoushezhiherenyuanpeibeidengyingxiangyiliaoqixieanquan、youxiaodeshixiangzuochumingqueguiding。

  disanshisitiao yiliaoqixiezhuceren、beianrenkeyizixingshengchanyiliaoqixie,yekeyiweituofuhebentiaoliguiding、jubeixiangyingtiaojiandeqiyeshengchanyiliaoqixie。

  weituoshengchanyiliaoqixiede,yiliaoqixiezhuceren、beianrenyingdangduisuoweituoshengchandeyiliaoqixiezhiliangfuze,bingjiaqiangduishoutuoshengchanqiyeshengchanxingweideguanli,baozhengqianzhaofadingyaoqiujinxingshengchan。yiliaoqixiezhuceren、beianrenyingdangyushoutuoshengchanqiyeqiandingweituoxieyi,mingqueshuangfangquanli、yiwuhezeren。shoutuoshengchanqiyeyingdangyizhaofalvfagui、yiliaoqixieshengchanzhiliangguanliguifan、qiangzhixingbiaozhun、chanpinjishuyaoqiuheweituoxieyizuzhishengchan,duishengchanxingweifuze,bingjieshouweituofangdejiandu。

  juyougaofengxiandezhiruxingyiliaoqixiebudeweituoshengchan,jutimuluyouguowuyuanyaopinjianduguanlibumenzhiding、diaozhengbinggongbu。

  disanshiwutiao yiliaoqixiezhuceren、beianren、shoutuoshengchanqiyeyingdanganzhaoyiliaoqixieshengchanzhiliangguanliguifan,jianlijianquanyusuoshengchanyiliaoqixiexiangshiyingdezhiliangguanlitixibingbaozhengqiyouxiaoyunxing;yangeanzhaojingzhucehuozhebeiandechanpinjishuyaoqiuzuzhishengchan,baozhengchuchangdeyiliaoqixiefuheqiangzhixingbiaozhunyijijingzhucehuozhebeiandechanpinjishuyaoqiu。

  yiliaoqixiezhuceren、beianren、shoutuoshengchanqiyeyingdangdingqiduizhiliangguanlitixideyunxingqingkuangjinxingzicha,binganzhaoguowuyuanyaopinjianduguanlibumendeguidingtijiaozichabaogao。

  disanshiliutiao yiliaoqixiedeshengchantiaojianfashengbianhua,buzaifuheyiliaoqixiezhiliangguanlitixiyaoqiude,yiliaoqixiezhuceren、beianren、shoutuoshengchanqiyeyingdanglijicaiquzhenggaicuoshi;kenengyingxiangyiliaoqixieanquan、youxiaode,yingdanglijitingzhishengchanhuodong,bingxiangyuanshengchanxukehuozheshengchanbeianbumenbaogao。

  disanshiqitiao yiliaoqixieyingdangshiyongtongyongmingcheng。tongyongmingchengyingdangfuheguowuyuanyaopinjianduguanlibumenzhidingdeyiliaoqixiemingmingguize。

  disanshibatiao guojiagenjuyiliaoqixiechanpinleibie,fenbushishiyiliaoqixieweiyibiaoshizhidu,shixianyiliaoqixiekezhuisu,jutibanfayouguowuyuanyaopinjianduguanlibumenhuitongguowuyuanyouguanbumenzhiding。

  disanshijiutiao yiliaoqixieyingdangyoushuomingshu、biaoqian。shuomingshu、biaoqiandeneirongyingdangyujingzhucehuozhebeiandexiangguanneirongyizhi,quebaozhenshi、zhunque。

  yiliaoqixiedeshuomingshu、biaoqianyingdangbiaomingxialieshixiang:

  (yi)tongyongmingcheng、xinghao、guige;

  (er)yiliaoqixiezhuceren、beianren、shoutuoshengchanqiyedemingcheng、dizhiyijilianxifangshi;

  (san)shengchanriqi,shiyongqixianhuozheshixiaoriqi;

  (si)chanpinxingneng、zhuyaojiegou、shiyongfanwei;

  (wu)jinji、zhuyishixiangyijiqitaxuyaojingshihuozhetishideneirong;

  (liu)anzhuangheshiyongshuominghuozhetushi;

  (qi)weihuhebaoyangfangfa,teshuyunshu、zhucundetiaojian、fangfa;

  (ba)chanpinjishuyaoqiuguidingyingdangbiaomingdeqitaneirong。

  dierlei、disanleiyiliaoqixiehuanyingdangbiaomingyiliaoqixiezhucezhengbianhao。

  youxiaofeizhegerenzixingshiyongdeyiliaoqixiehuanyingdangjuyouanquanshiyongdetebieshuoming。

  第四章 醫療器械經營與使用

  disishitiao congshiyiliaoqixiejingyinghuodong,yingdangyouyujingyingguimohejingyingfanweixiangshiyingdejingyingchangsuohezhucuntiaojian,yijiyujingyingdeyiliaoqixiexiangshiyingdezhiliangguanlizhiduhezhiliangguanlijigouhuozherenyuan。

  disishiyitiao congshidierleiyiliaoqixiejingyingde,youjingyingqiyexiangsuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumenbeianbingtijiaofuhebentiaolidisishitiaoguidingtiaojiandeyouguanziliao。

  anzhaoguowuyuanyaopinjianduguanlibumendeguiding,duichanpinanquanxing、youxiaoxingbushouliutongguochengyingxiangdedierleiyiliaoqixie,keyimianyujingyingbeian。

  disishiertiao congshidisanleiyiliaoqixiejingyingde,jingyingqiyeyingdangxiangsuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumenshenqingjingyingxukebingtijiaofuhebentiaolidisishitiaoguidingtiaojiandeyouguanziliao。

  shoulijingyingxukeshenqingdefuzeyaopinjianduguanlidebumenyingdangduishenqingziliaojinxingshencha,biyaoshizuzhihecha,bingzishoulishenqingzhiriqi20gegongzuorineizuochujueding。duifuheguidingtiaojiande,zhunyuxukebingfageiyiliaoqixiejingyingxukezheng;duibufuheguidingtiaojiande,buyuxukebingshumianshuomingliyou。

  yiliaoqixiejingyingxukezhengyouxiaoqiwei5nian。youxiaoqijiemanxuyaoyanxude,yizhaoyouguanxingzhengxukedefalvguidingbanliyanxushouxu。

  disishisantiao yiliaoqixiezhuceren、beianrenjingyingqizhuce、beiandeyiliaoqixie,wuxubanliyiliaoqixiejingyingxukehuozhebeian,danyingdangfuhebentiaoliguidingdejingyingtiaojian。

  disishisitiao congshiyiliaoqixiejingying,yingdangyizhaofalvfaguiheguowuyuanyaopinjianduguanlibumenzhidingdeyiliaoqixiejingyingzhiliangguanliguifandeyaoqiu,jianlijianquanyusuojingyingyiliaoqixiexiangshiyingdezhiliangguanlitixibingbaozhengqiyouxiaoyunxing。

  disishiwutiao yiliaoqixiejingyingqiye、shiyongdanweiyingdangcongjubeihefazizhideyiliaoqixiezhuceren、beianren、shengchanjingyingqiyegoujinyiliaoqixie。goujinyiliaoqixieshi,yingdangchayangonghuozhedezizhiheyiliaoqixiedehegezhengmingwenjian,jianlijinhuochayanjiluzhidu。congshidierlei、disanleiyiliaoqixiepifayewuyijidisanleiyiliaoqixielingshouyewudejingyingqiye,huanyingdangjianlixiaoshoujiluzhidu。

  jilushixiangbaokuo:

  (yi)yiliaoqixiedemingcheng、xinghao、guige、shuliang;

  (er)yiliaoqixiedeshengchanpihao、shiyongqixianhuozheshixiaoriqi、xiaoshouriqi;

  (san)yiliaoqixiezhuceren、beianrenheshoutuoshengchanqiyedemingcheng;

  (si)gonghuozhehuozhegouhuozhedemingcheng、dizhiyijilianxifangshi;

  (wu)xiangguanxukezhengmingwenjianbianhaodeng。

  jinhuochayanjiluhexiaoshoujiluyingdangzhenshi、zhunque、wanzhenghekezhuisu,binganzhaoguowuyuanyaopinjianduguanlibumenguidingdeqixianyuyibaocun。guojiagulicaiyongxianjinjishushouduanjinxingjilu。

  disishiliutiao congshiyiliaoqixiewangluoxiaoshoude,yingdangshiyiliaoqixiezhuceren、beianrenhuozheyiliaoqixiejingyingqiye。congshiyiliaoqixiewangluoxiaoshoudejingyingzhe,yingdangjiangcongshiyiliaoqixiewangluoxiaoshoudexiangguanxinxigaozhisuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumen,jingyingdiyileiyiliaoqixiehebentiaolidisishiyitiaodierkuanguidingdedierleiyiliaoqixiedechuwai。

  weiyiliaoqixiewangluojiaoyitigongfuwudedianzishangwupingtaijingyingzheyingdangduiruwangyiliaoqixiejingyingzhejinxingshimingdengji,shenchaqijingyingxuke、beianqingkuanghesuojingyingyiliaoqixiechanpinzhuce、beianqingkuang,bingduiqijingyingxingweijinxingguanli。dianzishangwupingtaijingyingzhefaxianruwangyiliaoqixiejingyingzheyouweifanbentiaoliguidingxingweide,yingdangjishizhizhibinglijibaogaoyiliaoqixiejingyingzhesuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumen;faxianyanzhongweifaxingweide,yingdanglijitingzhitigongwangluojiaoyipingtaifuwu。

  disishiqitiao yunshu、zhucunyiliaoqixie,yingdangfuheyiliaoqixieshuomingshuhebiaoqianbiaoshideyaoqiu;duiwendu、shidudenghuanjingtiaojianyouteshuyaoqiude,yingdangcaiquxiangyingcuoshi,baozhengyiliaoqixiedeanquan、youxiao。

  disishibatiao yiliaoqixieshiyongdanweiyingdangyouyuzaiyongyiliaoqixiepinzhong、shuliangxiangshiyingdezhucunchangsuohetiaojian。yiliaoqixieshiyongdanweiyingdangjiaqiangduigongzuorenyuandejishupeixun,anzhaochanpinshuomingshu、jishucaozuoguifandengyaoqiushiyongyiliaoqixie。

  yiliaoqixieshiyongdanweipeizhidaxingyiyongshebei,yingdangfuheguowuyuanweishengzhuguanbumenzhidingdedaxingyiyongshebeipeizhiguihua,yuqigongnengdingwei、linchuangfuwuxuqiuxiangshiying,juyouxiangyingdejishutiaojian、peitaosheshihejubeixiangyingzizhi、nenglidezhuanyejishurenyuan,bingjingshengjiyishangrenminzhengfuweishengzhuguanbumenpizhun,qudedaxingyiyongshebeipeizhixukezheng。

  daxingyiyongshebeipeizhiguanlibanfayouguowuyuanweishengzhuguanbumenhuitongguowuyuanyouguanbumenzhiding。daxingyiyongshebeimuluyouguowuyuanweishengzhuguanbumenshangguowuyuanyouguanbumentichu,baoguowuyuanpizhunhouzhixing。

  disishijiutiao yiliaoqixieshiyongdanweiduizhongfushiyongdeyiliaoqixie,yingdanganzhaoguowuyuanweishengzhuguanbumenzhidingdexiaoduheguanlideguidingjinxingchuli。

  yicixingshiyongdeyiliaoqixiebudezhongfushiyong,duishiyongguodeyingdanganzhaoguojiayouguanguidingxiaohuibingjilu。yicixingshiyongdeyiliaoqixiemuluyouguowuyuanyaopinjianduguanlibumenhuitongguowuyuanweishengzhuguanbumenzhiding、diaozhengbinggongbu。lieruyicixingshiyongdeyiliaoqixiemulu,yingdangjuyouchongzudewufazhongfushiyongdezhengjuliyou。zhongfushiyongkeyibaozhenganquan、youxiaodeyiliaoqixie,bulieruyicixingshiyongdeyiliaoqixiemulu。duiyinsheji、shengchangongyi、xiaodumiejunjishudenggaijinhouzhongfushiyongkeyibaozhenganquan、youxiaodeyiliaoqixie,yingdangdiaozhengchuyicixingshiyongdeyiliaoqixiemulu,yunxuzhongfushiyong。

  diwushitiao yiliaoqixieshiyongdanweiduixuyaodingqijiancha、jianyan、xiaozhun、baoyang、weihudeyiliaoqixie,yingdanganzhaochanpinshuomingshudeyaoqiujinxingjiancha、jianyan、xiaozhun、baoyang、weihubingyuyijilu,jishijinxingfenxi、pinggu,quebaoyiliaoqixiechuyulianghaozhuangtai,baozhangshiyongzhiliang;duishiyongqixianchangdedaxingyiliaoqixie,yingdangzhutaijianlishiyongdangan,jiluqishiyong、weihu、zhuanrang、shijishiyongshijiandengshixiang。jilubaocunqixianbudeshaoyuyiliaoqixieguidingshiyongqixianzhongzhihou5nian。

  diwushiyitiao yiliaoqixieshiyongdanweiyingdangtuoshanbaocungourudisanleiyiliaoqixiedeyuanshiziliao,bingquebaoxinxijuyoukezhuisuxing。

  shiyongdaxingyiliaoqixieyijizhiruhejieruleiyiliaoqixiede,yingdangjiangyiliaoqixiedemingcheng、guanjianxingjishucanshudengxinxiyijiyushiyongzhilianganquanmiqiexiangguandebiyaoxinxijizaidaobinglidengxiangguanjiluzhong。

  diwushiertiao faxianshiyongdeyiliaoqixiecunzaianquanyinhuande,yiliaoqixieshiyongdanweiyingdanglijitingzhishiyong,bingtongzhiyiliaoqixiezhuceren、beianrenhuozheqitafuzechanpinzhiliangdejigoujinxingjianxiu;jingjianxiurengbunengdadaoshiyonganquanbiaozhundeyiliaoqixie,budejixushiyong。

  diwushisantiao duiguoneishangwutongpinzhongchanpinshangshidetiwaizhenduanshiji,fuhetiaojiandeyiliaojigougenjubendanweidelinchuangxuyao,keyizixingyanzhi,zaizhiyeyishizhidaoxiazaibendanweineishiyong。jutiguanlibanfayouguowuyuanyaopinjianduguanlibumenhuitongguowuyuanweishengzhuguanbumenzhiding。

  diwushisitiao fuzeyaopinjianduguanlidebumenheweishengzhuguanbumenyijugezizhize,fenbieduishiyonghuanjiedeyiliaoqixiezhiliangheyiliaoqixieshiyongxingweijinxingjianduguanli。

  diwushiwutiao yiliaoqixiejingyingqiye、shiyongdanweibudejingying、shiyongweiyifazhucehuozhebeian、wuhegezhengmingwenjianyijiguoqi、shixiao、taotaideyiliaoqixie。

  diwushiliutiao yiliaoqixieshiyongdanweizhijianzhuanrangzaiyongyiliaoqixie,zhuanrangfangyingdangquebaosuozhuanrangdeyiliaoqixieanquan、youxiao,budezhuanrangguoqi、shixiao、taotaiyijijianyanbuhegedeyiliaoqixie。

  diwushiqitiao jinkoudeyiliaoqixieyingdangshiyizhaobentiaolidierzhangdeguidingyizhucehuozheyibeiandeyiliaoqixie。

  jinkoudeyiliaoqixieyingdangyouzhongwenshuomingshu、zhongwenbiaoqian。shuomingshu、biaoqianyingdangfuhebentiaoliguidingyijixiangguanqiangzhixingbiaozhundeyaoqiu,bingzaishuomingshuzhongzaimingyiliaoqixiedeyuanchandiyijijingwaiyiliaoqixiezhuceren、beianrenzhidingdewoguojingneiqiyefarendemingcheng、dizhi、lianxifangshi。meiyouzhongwenshuomingshu、zhongwenbiaoqianhuozheshuomingshu、biaoqianbufuhebentiaoguidingde,budejinkou。

  yiliaojigouyinlinchuangjixujinkoushaoliangdierlei、disanleiyiliaoqixiede,jingguowuyuanyaopinjianduguanlibumenhuozheguowuyuanshouquandesheng、zizhiqu、zhixiashirenminzhengfupizhun,keyijinkou。jinkoudeyiliaoqixieyingdangzaizhidingyiliaojigouneiyongyutedingyiliaomude。

  jinzhijinkouguoqi、shixiao、taotaidengyishiyongguodeyiliaoqixie。

  diwushibatiao churujingjianyanjianyijigouyifaduijinkoudeyiliaoqixieshishijianyan;jianyanbuhegede,budejinkou。

  guowuyuanyaopinjianduguanlibumenyingdangjishixiangguojiachurujingjianyanjianyibumentongbaojinkouyiliaoqixiedezhucehebeianqingkuang。jinkoukouansuozaidichurujingjianyanjianyijigouyingdangjishixiangsuozaidishequdeshijirenminzhengfufuzeyaopinjianduguanlidebumentongbaojinkouyiliaoqixiedetongguanqingkuang。

  diwushijiutiao chukouyiliaoqixiedeqiyeyingdangbaozhengqichukoudeyiliaoqixiefuhejinkouguo(diqu)deyaoqiu。

  diliushitiao yiliaoqixieguanggaodeneirongyingdangzhenshihefa,yijingfuzeyaopinjianduguanlidebumenzhucehuozhebeiandeyiliaoqixieshuomingshuweizhun,budehanyouxujia、kuada、wudaoxingdeneirong。

  fabuyiliaoqixieguanggao,yingdangzaifabuqianyousheng、zizhiqu、zhixiashirenminzhengfuquedingdeguanggaoshenchajiguanduiguanggaoneirongjinxingshencha,bingqudeyiliaoqixieguanggaopizhunwenhao;weijingshencha,budefabu。

  shengjiyishangrenminzhengfuyaopinjianduguanlibumenzelingzantingshengchan、jinkou、jingyingheshiyongdeyiliaoqixie,zaizantingqijianbudefabushejigaiyiliaoqixiedeguanggao。

  yiliaoqixieguanggaodeshenchabanfayouguowuyuanshichangjianduguanlibumenzhiding。

  第五章 不良事件的處理與醫療器械的召回

  diliushiyitiao guojiajianliyiliaoqixiebuliangshijianjiancezhidu,duiyiliaoqixiebuliangshijianjishijinxingshouji、fenxi、pingjia、kongzhi。

  diliushiertiao yiliaoqixiezhuceren、beianrenyingdangjianliyiliaoqixiebuliangshijianjiancetixi,peibeiyuqichanpinxiangshiyingdebuliangshijianjiancejigouherenyuan,duiqichanpinzhudongkaizhanbuliangshijianjiance,binganzhaoguowuyuanyaopinjianduguanlibumendeguiding,xiangyiliaoqixiebuliangshijianjiancejishujigoubaogaodiaocha、fenxi、pingjia、chanpinfengxiankongzhidengqingkuang。

  yiliaoqixieshengchanjingyingqiye、shiyongdanweiyingdangxiezhuyiliaoqixiezhuceren、beianrenduisuoshengchanjingyinghuozheshiyongdeyiliaoqixiekaizhanbuliangshijianjiance;faxianyiliaoqixiebuliangshijianhuozhekeyibuliangshijian,yingdanganzhaoguowuyuanyaopinjianduguanlibumendeguiding,xiangyiliaoqixiebuliangshijianjiancejishujigoubaogao。

  qitadanweihegerenfaxianyiliaoqixiebuliangshijianhuozhekeyibuliangshijian,youquanxiangfuzeyaopinjianduguanlidebumenhuozheyiliaoqixiebuliangshijianjiancejishujigoubaogao。

  diliushisantiao guowuyuanyaopinjianduguanlibumenyingdangjiaqiangyiliaoqixiebuliangshijianjiancexinxiwangluojianshe。

  yiliaoqixiebuliangshijianjiancejishujigouyingdangjiaqiangyiliaoqixiebuliangshijianxinxijiance,zhudongshoujibuliangshijianxinxi;faxianbuliangshijianhuozhejiedaobuliangshijianbaogaode,yingdangjishijinxingheshi,biyaoshijinxingdiaocha、fenxi、pinggu,xiangfuzeyaopinjianduguanlidebumenheweishengzhuguanbumenbaogaobingtichuchulijianyi。

  yiliaoqixiebuliangshijianjiancejishujigouyingdanggongbulianxifangshi,fangbianyiliaoqixiezhuceren、beianren、shengchanjingyingqiye、shiyongdanweidengbaogaoyiliaoqixiebuliangshijian。

  diliushisitiao fuzeyaopinjianduguanlidebumenyingdanggenjuyiliaoqixiebuliangshijianpinggujieguojishicaiqufabujingshixinxiyijizelingzantingshengchan、jinkou、jingyingheshiyongdengkongzhicuoshi。

  shengjiyishangrenminzhengfuyaopinjianduguanlibumenyingdanghuitongtongjiweishengzhuguanbumenhexiangguanbumenzuzhiduiyinqitufa、qunfadeyanzhongshanghaihuozhesiwangdeyiliaoqixiebuliangshijianjishijinxingdiaochahechuli,bingzuzhiduitongleiyiliaoqixiejiaqiangjiance。

  fuzeyaopinjianduguanlidebumenyingdangjishixiangtongjiweishengzhuguanbumentongbaoyiliaoqixieshiyongdanweidebuliangshijianjianceyouguanqingkuang。

  diliushiwutiao yiliaoqixiezhuceren、beianren、shengchanjingyingqiye、shiyongdanweiyingdangduiyiliaoqixiebuliangshijianjiancejishujigou、fuzeyaopinjianduguanlidebumen、weishengzhuguanbumenkaizhandeyiliaoqixiebuliangshijiandiaochayuyipeihe。

  diliushiliutiao youxialieqingxingzhiyide,yiliaoqixiezhuceren、beianrenyingdangzhudongkaizhanyishangshiyiliaoqixiezaipingjia:

  (yi)genjukexueyanjiudefazhan,duiyiliaoqixiedeanquan、youxiaoyourenshishangdegaibian;

  (er)yiliaoqixiebuliangshijianjiance、pinggujieguobiaomingyiliaoqixiekenengcunzaiquexian;

  (san)guowuyuanyaopinjianduguanlibumenguidingdeqitaqingxing。

  yiliaoqixiezhuceren、beianrenyingdanggenjuzaipingjiajieguo,caiquxiangyingkongzhicuoshi,duiyishangshiyiliaoqixiejinxinggaijin,binganzhaoguidingjinxingzhucebiangenghuozhebeianbiangeng。zaipingjiajieguobiaomingyishangshiyiliaoqixiebunengbaozhenganquan、youxiaode,yiliaoqixiezhuceren、beianrenyingdangzhudongshenqingzhuxiaoyiliaoqixiezhucezhenghuozhequxiaobeian;yiliaoqixiezhuceren、beianrenweishenqingzhuxiaoyiliaoqixiezhucezhenghuozhequxiaobeiande,youfuzeyaopinjianduguanlidebumenzhuxiaoyiliaoqixiezhucezhenghuozhequxiaobeian。

  shengjiyishangrenminzhengfuyaopinjianduguanlibumengenjuyiliaoqixiebuliangshijianjiance、pinggudengqingkuang,duiyishangshiyiliaoqixiekaizhanzaipingjia。zaipingjiajieguobiaomingyishangshiyiliaoqixiebunengbaozhenganquan、youxiaode,yingdangzhuxiaoyiliaoqixiezhucezhenghuozhequxiaobeian。

  fuzeyaopinjianduguanlidebumenyingdangxiangshehuijishigongbuzhuxiaoyiliaoqixiezhucezhenghequxiaobeianqingkuang。beizhuxiaoyiliaoqixiezhucezhenghuozhequxiaobeiandeyiliaoqixiebudejixushengchan、jinkou、jingying、shiyong。

  diliushiqitiao yiliaoqixiezhuceren、beianrenfaxianshengchandeyiliaoqixiebufuheqiangzhixingbiaozhun、jingzhucehuozhebeiandechanpinjishuyaoqiu,huozhecunzaiqitaquexiande,yingdanglijitingzhishengchan,tongzhixiangguanjingyingqiye、shiyongdanweihexiaofeizhetingzhijingyingheshiyong,zhaohuiyijingshangshixiaoshoudeyiliaoqixie,caiqubujiu、xiaohuidengcuoshi,jiluxiangguanqingkuang,fabuxiangguanxinxi,bingjiangyiliaoqixiezhaohuihechuliqingkuangxiangfuzeyaopinjianduguanlidebumenheweishengzhuguanbumenbaogao。

  yiliaoqixieshoutuoshengchanqiye、jingyingqiyefaxianshengchan、jingyingdeyiliaoqixiecunzaiqiankuanguidingqingxingde,yingdanglijitingzhishengchan、jingying,tongzhiyiliaoqixiezhuceren、beianren,bingjilutingzhishengchan、jingyinghetongzhiqingkuang。yiliaoqixiezhuceren、beianrenrenweishuyuyizhaoqiankuanguidingxuyaozhaohuideyiliaoqixie,yingdanglijizhaohui。

  yiliaoqixiezhuceren、beianren、shoutuoshengchanqiye、jingyingqiyeweiyizhaobentiaoguidingshishizhaohuihuozhetingzhishengchan、jingyingde,fuzeyaopinjianduguanlidebumenkeyizelingqizhaohuihuozhetingzhishengchan、jingying。

  第六章 監督檢查

  diliushibatiao guojiajianlizhiyehuazhuanyehuajianchayuanzhidu,jiaqiangduiyiliaoqixiedejiandujiancha。

  diliushijiutiao fuzeyaopinjianduguanlidebumenyingdangduiyiliaoqixiedeyanzhi、shengchan、jingyinghuodongyijishiyonghuanjiedeyiliaoqixiezhiliangjiaqiangjiandujiancha,bingduixialieshixiangjinxingzhongdianjiandujiancha:

  (yi)shifouanzhaojingzhucehuozhebeiandechanpinjishuyaoqiuzuzhishengchan;

  (er)zhiliangguanlitixishifoubaochiyouxiaoyunxing;

  (san)shengchanjingyingtiaojianshifouchixufuhefadingyaoqiu。

  biyaoshi,fuzeyaopinjianduguanlidebumenkeyiduiweiyiliaoqixieyanzhi、shengchan、jingying、shiyongdenghuodongtigongchanpinhuozhefuwudeqitaxiangguandanweihegerenjinxingyanshenjiancha。

  diqishitiao fuzeyaopinjianduguanlidebumenzaijiandujianchazhongyouxialiezhiquan:

  (yi)jinruxianchangshishijiancha、chouquyangpin;

  (er)chayue、fuzhi、chafeng、kouyayouguanhetong、piaoju、zhangbuyijiqitayouguanziliao;

  (san)chafeng、kouyabufuhefadingyaoqiudeyiliaoqixie,weifashiyongdelingpeijian、yuancailiaoyijiyongyuweifashengchanjingyingyiliaoqixiedegongju、shebei;

  (si)chafengweifanbentiaoliguidingcongshiyiliaoqixieshengchanjingyinghuodongdechangsuo。

  jinxingjiandujiancha,yingdangchushizhifazhengjian,baoshoubeijianchadanweideshangyemimi。

  youguandanweihegerenyingdangduijiandujianchayuyipeihe,tigongxiangguanwenjianheziliao,budeyinman、jujue、zunao。

  diqishiyitiao weishengzhuguanbumenyingdangduiyiliaojigoudeyiliaoqixieshiyongxingweijiaqiangjiandujiancha。shishijiandujianchashi,keyijinruyiliaojigou,chayue、fuzhiyouguandangan、jiluyijiqitayouguanziliao。

  diqishiertiao yiliaoqixieshengchanjingyingguochengzhongcunzaichanpinzhilianganquanyinhuan,weijishicaiqucuoshixiaochude,fuzeyaopinjianduguanlidebumenkeyicaiqugaojie、zerenyuetan、zelingxianqizhenggaidengcuoshi。

  duirentizaochengshanghaihuozheyouzhengjuzhengmingkenengweihairentijiankangdeyiliaoqixie,fuzeyaopinjianduguanlidebumenkeyicaiquzelingzantingshengchan、jinkou、jingying、shiyongdejinjikongzhicuoshi,bingfabuanquanjingshixinxi。

  diqishisantiao fuzeyaopinjianduguanlidebumenyingdangjiaqiangduiyiliaoqixiezhuceren、beianren、shengchanjingyingqiyeheshiyongdanweishengchan、jingying、shiyongdeyiliaoqixiedechouchajianyan。chouchajianyanbudeshouqujianyanfeiheqitarenhefeiyong,suoxufeiyongnarubenjizhengfuyusuan。shengjiyishangrenminzhengfuyaopinjianduguanlibumenyingdanggenjuchouchajianyanjielunjishifabuyiliaoqixiezhilianggonggao。

  weishengzhuguanbumenyingdangduidaxingyiyongshebeideshiyongzhuangkuangjinxingjianduhepinggu;faxianweiguishiyongyijiyudaxingyiyongshebeixiangguandeguodujiancha、guoduzhiliaodengqingxingde,yingdanglijijiuzheng,yifayuyichuli。

  diqishisitiao fuzeyaopinjianduguanlidebumenweijishifaxianyiliaoqixieanquanxitongxingfengxian,weijishixiaochujianduguanliquyuneiyiliaoqixieanquanyinhuande,benjirenminzhengfuhuozheshangjirenminzhengfufuzeyaopinjianduguanlidebumenyingdangduiqizhuyaofuzerenjinxingyuetan。

  difangrenminzhengfuweilvxingyiliaoqixieanquanzhize,weijishixiaochuquyuxingzhongdayiliaoqixieanquanyinhuande,shangjirenminzhengfuhuozheshangjirenminzhengfufuzeyaopinjianduguanlidebumenyingdangduiqizhuyaofuzerenjinxingyuetan。

  beiyuetandebumenhedifangrenminzhengfuyingdanglijicaiqucuoshi,duiyiliaoqixiejianduguanligongzuojinxingzhenggai。

  diqishiwutiao yiliaoqixiejianyanjigouzizhirendinggongzuoanzhaoguojiayouguanguidingshixingtongyiguanli。jingguowuyuanrenzhengrenkejianduguanlibumenhuitongguowuyuanyaopinjianduguanlibumenrendingdejianyanjigou,fangkeduiyiliaoqixieshishijianyan。

  fuzeyaopinjianduguanlidebumenzaizhifagongzuozhongxuyaoduiyiliaoqixiejinxingjianyande,yingdangweituoyouzizhideyiliaoqixiejianyanjigoujinxing,bingzhifuxiangguanfeiyong。

  dangshirenduijianyanjielunyouyiyide,keyizishoudaojianyanjielunzhiriqi7gegongzuorineixiangshishichouyangjianyandebumenhuozheqishangyijifuzeyaopinjianduguanlidebumentichufujianshenqing,youshoulifujianshenqingdebumenzaifujianjigoumingluzhongsuijiquedingfujianjigoujinxingfujian。chengdanfujiangongzuodeyiliaoqixiejianyanjigouyingdangzaiguowuyuanyaopinjianduguanlibumenguidingdeshijianneizuochufujianjielun。fujianjielunweizuizhongjianyanjielun。fujianjigouyuchujianjigoubudeweitongyijigou;xiangguanjianyanxiangmuzhiyouyijiayouzizhidejianyanjigoude,fujianshiyingdangbiangengchengbanbumenhuozherenyuan。fujianjigoumingluyouguowuyuanyaopinjianduguanlibumengongbu。

  diqishiliutiao duikenengcunzaiyouhaiwuzhihuozheshanzigaibianyiliaoqixiesheji、yuancailiaoheshengchangongyibingcunzaianquanyinhuandeyiliaoqixie,anzhaoyiliaoqixieguojiabiaozhun、xingyebiaozhunguidingdejianyanxiangmuhejianyanfangfawufajianyande,yiliaoqixiejianyanjigoukeyishiyongguowuyuanyaopinjianduguanlibumenpizhundebuchongjianyanxiangmuhejianyanfangfajinxingjianyan;shiyongbuchongjianyanxiangmu、jianyanfangfadechudejianyanjielun,keyizuoweifuzeyaopinjianduguanlidebumenrendingyiliaoqixiezhiliangdeyiju。

  diqishiqitiao shichangjianduguanlibumenyingdangyizhaoyouguanguanggaoguanlidefalv、xingzhengfaguideguiding,duiyiliaoqixieguanggaojinxingjiandujiancha,chachuweifaxingwei。

  diqishibatiao fuzeyaopinjianduguanlidebumenyingdangtongguoguowuyuanyaopinjianduguanlibumenzaixianzhengwufuwupingtaiyifajishigongbuyiliaoqixiexuke、beian、chouchajianyan、weifaxingweichachudengrichangjianduguanlixinxi。danshi,budexieludangshirendeshangyemimi。

  fuzeyaopinjianduguanlidebumenjianliyiliaoqixiezhuceren、beianren、shengchanjingyingqiye、shiyongdanweixinyongdangan,duiyoubuliangxinyongjiludezengjiajiandujianchapinci,yifajiaqiangshixinchengjie。

  diqishijiutiao fuzeyaopinjianduguanlidebumendengbumenyingdanggongbubendanweidelianxifangshi,jieshouzixun、tousu、jubao。fuzeyaopinjianduguanlidebumendengbumenjiedaoyuyiliaoqixiejianduguanliyouguandezixun,yingdangjishidafu;jiedaotousu、jubao,yingdangjishiheshi、chuli、dafu。duizixun、tousu、jubaoqingkuangjiqidafu、heshi、chuliqingkuang,yingdangyuyijilu、baocun。

  youguanyiliaoqixieyanzhi、shengchan、jingying、shiyongxingweidejubaojingdiaochashushide,fuzeyaopinjianduguanlidebumendengbumenduijubaorenyingdanggeiyujiangli。youguanbumenyingdangweijubaorenbaomi。

  dibashitiao guowuyuanyaopinjianduguanlibumenzhiding、diaozheng、xiugaibentiaoliguidingdemuluyijiyuyiliaoqixiejianduguanliyouguandeguifan,yingdanggongkaizhengqiuyijian;caiqutingzhenghui、lunzhenghuidengxingshi,tingquzhuanjia、yiliaoqixiezhuceren、beianren、shengchanjingyingqiye、shiyongdanwei、xiaofeizhe、xingyexiehuiyijixiangguanzuzhidengfangmiandeyijian。

  第七章 法律責任

  dibashiyitiao youxialieqingxingzhiyide,youfuzeyaopinjianduguanlidebumenmeishouweifasuode、weifashengchanjingyingdeyiliaoqixieheyongyuweifashengchanjingyingdegongju、shebei、yuancailiaodengwupin;weifashengchanjingyingdeyiliaoqixiehuozhijinebuzu1wanyuande,bingchu5wanyuanyishang15wanyuanyixiafakuan;huozhijine1wanyuanyishangde,bingchuhuozhijine15beiyishang30beiyixiafakuan;qingjieyanzhongde,zelingtingchantingye,10nianneibushoulixiangguanzerenrenyijidanweitichudeyiliaoqixiexukeshenqing,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,zhongshenjinzhiqicongshiyiliaoqixieshengchanjingyinghuodong:

  (yi)shengchan、jingyingweiqudeyiliaoqixiezhucezhengdedierlei、disanleiyiliaoqixie;

  (er)weijingxukecongshidierlei、disanleiyiliaoqixieshengchanhuodong;

  (san)weijingxukecongshidisanleiyiliaoqixiejingyinghuodong。

  youqiankuandiyixiangqingxing、qingjieyanzhongde,youyuanfazhengbumendiaoxiaoyiliaoqixieshengchanxukezhenghuozheyiliaoqixiejingyingxukezheng。

  dibashiertiao weijingxukeshanzipeizhishiyongdaxingyiyongshebeide,youxianjiyishangrenminzhengfuweishengzhuguanbumenzelingtingzhishiyong,geiyujinggao,meishouweifasuode;weifasuodebuzu1wanyuande,bingchu5wanyuanyishang10wanyuanyixiafakuan;weifasuode1wanyuanyishangde,bingchuweifasuode10beiyishang30beiyixiafakuan;qingjieyanzhongde,5nianneibushoulixiangguanzerenrenyijidanweitichudedaxingyiyongshebeipeizhixukeshenqing,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen。

  dibashisantiao zaishenqingyiliaoqixiexingzhengxukeshitigongxujiaziliaohuozhecaiquqitaqipianshouduande,buyuxingzhengxuke,yijingqudexingzhengxukede,youzuochuxingzhengxukejuedingdebumenchexiaoxingzhengxuke,meishouweifasuode、weifashengchanjingyingshiyongdeyiliaoqixie,10nianneibushoulixiangguanzerenrenyijidanweitichudeyiliaoqixiexukeshenqing;weifashengchanjingyingshiyongdeyiliaoqixiehuozhijinebuzu1wanyuande,bingchu5wanyuanyishang15wanyuanyixiafakuan;huozhijine1wanyuanyishangde,bingchuhuozhijine15beiyishang30beiyixiafakuan;qingjieyanzhongde,zelingtingchantingye,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,zhongshenjinzhiqicongshiyiliaoqixieshengchanjingyinghuodong。

  weizao、bianzao、maimai、chuzu、chujiexiangguanyiliaoqixiexukezhengjiande,youyuanfazhengbumenyuyishoujiaohuozhediaoxiao,meishouweifasuode;weifasuodebuzu1wanyuande,bingchu5wanyuanyishang10wanyuanyixiafakuan;weifasuode1wanyuanyishangde,bingchuweifasuode10beiyishang20beiyixiafakuan;gouchengweifanzhianguanlixingweide,yougonganjiguanyifayuyizhianguanlichufa。

  dibashisitiao youxialieqingxingzhiyide,youfuzeyaopinjianduguanlidebumenxiangshehuigonggaodanweihechanpinmingcheng,zelingxianqigaizheng;yuqibugaizhengde,meishouweifasuode、weifashengchanjingyingdeyiliaoqixie;weifashengchanjingyingdeyiliaoqixiehuozhijinebuzu1wanyuande,bingchu1wanyuanyishang5wanyuanyixiafakuan;huozhijine1wanyuanyishangde,bingchuhuozhijine5beiyishang20beiyixiafakuan;qingjieyanzhongde,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang2beiyixiafakuan,5nianneijinzhiqicongshiyiliaoqixieshengchanjingyinghuodong:

  (yi)shengchan、jingyingweijingbeiandediyileiyiliaoqixie;

  (er)weijingbeiancongshidiyileiyiliaoqixieshengchan;

  (san)jingyingdierleiyiliaoqixie,yingdangbeiandanweibeian;

  (si)yijingbeiandeziliaobufuheyaoqiu。

  dibashiwutiao beianshitigongxujiaziliaode,youfuzeyaopinjianduguanlidebumenxiangshehuigonggaobeiandanweihechanpinmingcheng,meishouweifasuode、weifashengchanjingyingdeyiliaoqixie;weifashengchanjingyingdeyiliaoqixiehuozhijinebuzu1wanyuande,bingchu2wanyuanyishang5wanyuanyixiafakuan;huozhijine1wanyuanyishangde,bingchuhuozhijine5beiyishang20beiyixiafakuan;qingjieyanzhongde,zelingtingchantingye,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,10nianneijinzhiqicongshiyiliaoqixieshengchanjingyinghuodong。

  dibashiliutiao youxialieqingxingzhiyide,youfuzeyaopinjianduguanlidebumenzelinggaizheng,meishouweifashengchanjingyingshiyongdeyiliaoqixie;weifashengchanjingyingshiyongdeyiliaoqixiehuozhijinebuzu1wanyuande,bingchu2wanyuanyishang5wanyuanyixiafakuan;huozhijine1wanyuanyishangde,bingchuhuozhijine5beiyishang20beiyixiafakuan;qingjieyanzhongde,zelingtingchantingye,zhizhiyouyuanfazhengbumendiaoxiaoyiliaoqixiezhucezheng、yiliaoqixieshengchanxukezheng、yiliaoqixiejingyingxukezheng,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,10nianneijinzhiqicongshiyiliaoqixieshengchanjingyinghuodong:

  (yi)shengchan、jingying、shiyongbufuheqiangzhixingbiaozhunhuozhebufuhejingzhucehuozhebeiandechanpinjishuyaoqiudeyiliaoqixie;

  (er)weianzhaojingzhucehuozhebeiandechanpinjishuyaoqiuzuzhishengchan,huozheweiyizhaobentiaoliguidingjianlizhiliangguanlitixibingbaochiyouxiaoyunxing,yingxiangchanpinanquan、youxiao;

  (san)jingying、shiyongwuhegezhengmingwenjian、guoqi、shixiao、taotaideyiliaoqixie,huozheshiyongweiyifazhucedeyiliaoqixie;

  (si)zaifuzeyaopinjianduguanlidebumenzelingzhaohuihourengjubuzhaohui,huozhezaifuzeyaopinjianduguanlidebumenzelingtingzhihuozhezantingshengchan、jinkou、jingyinghou,rengjubutingzhishengchan、jinkou、jingyingyiliaoqixie;

  (wu)weituobujubeibentiaoliguidingtiaojiandeqiyeshengchanyiliaoqixie,huozheweiduishoutuoshengchanqiyedeshengchanxingweijinxingguanli;

  (liu)jinkouguoqi、shixiao、taotaidengyishiyongguodeyiliaoqixie。

  dibashiqitiao yiliaoqixiejingyingqiye、shiyongdanweilvxinglebentiaoliguidingdejinhuochayandengyiwu,youchongfenzhengjuzhengmingqibuzhidaosuojingying、shiyongdeyiliaoqixieweibentiaolidibashiyitiaodiyikuandiyixiang、dibashisitiaodiyixiang、dibashiliutiaodiyixianghedisanxiangguidingqingxingdeyiliaoqixie,bingnengrushishuomingqijinhuolaiyuande,shoujiaoqijingying、shiyongdebufuhefadingyaoqiudeyiliaoqixie,keyimianchuxingzhengchufa。

  dibashibatiao youxialieqingxingzhiyide,youfuzeyaopinjianduguanlidebumenzelinggaizheng,chu1wanyuanyishang5wanyuanyixiafakuan;jubugaizhengde,chu5wanyuanyishang10wanyuanyixiafakuan;qingjieyanzhongde,zelingtingchantingye,zhizhiyouyuanfazhengbumendiaoxiaoyiliaoqixieshengchanxukezheng、yiliaoqixiejingyingxukezheng,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang2beiyixiafakuan,5nianneijinzhiqicongshiyiliaoqixieshengchanjingyinghuodong:

  (yi)shengchantiaojianfashengbianhua、buzaifuheyiliaoqixiezhiliangguanlitixiyaoqiu,weiyizhaobentiaoliguidingzhenggai、tingzhishengchan、baogao;

  (er)shengchan、jingyingshuomingshu、biaoqianbufuhebentiaoliguidingdeyiliaoqixie;

  (san)weianzhaoyiliaoqixieshuomingshuhebiaoqianbiaoshiyaoqiuyunshu、zhucunyiliaoqixie;

  (si)zhuanrangguoqi、shixiao、taotaihuozhejianyanbuhegedezaiyongyiliaoqixie。

  dibashijiutiao youxialieqingxingzhiyide,youfuzeyaopinjianduguanlidebumenheweishengzhuguanbumenyijugezizhizezelinggaizheng,geiyujinggao;jubugaizhengde,chu1wanyuanyishang10wanyuanyixiafakuan;qingjieyanzhongde,zelingtingchantingye,zhizhiyouyuanfazhengbumendiaoxiaoyiliaoqixiezhucezheng、yiliaoqixieshengchanxukezheng、yiliaoqixiejingyingxukezheng,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuanchu1wanyuanyishang3wanyuanyixiafakuan:

  (yi)weianzhaoyaoqiutijiaozhiliangguanlitixizichabaogao;

  (er)congbujubeihefazizhidegonghuozhegoujinyiliaoqixie;

  (san)yiliaoqixiejingyingqiye、shiyongdanweiweiyizhaobentiaoliguidingjianlibingzhixingyiliaoqixiejinhuochayanjiluzhidu;

  (si)congshidierlei、disanleiyiliaoqixiepifayewuyijidisanleiyiliaoqixielingshouyewudejingyingqiyeweiyizhaobentiaoliguidingjianlibingzhixingxiaoshoujiluzhidu;

  (wu)yiliaoqixiezhuceren、beianren、shengchanjingyingqiye、shiyongdanweiweiyizhaobentiaoliguidingkaizhanyiliaoqixiebuliangshijianjiance,weianzhaoyaoqiubaogaobuliangshijian,huozheduiyiliaoqixiebuliangshijianjiancejishujigou、fuzeyaopinjianduguanlidebumen、weishengzhuguanbumenkaizhandebuliangshijiandiaochabuyupeihe;

  (liu)yiliaoqixiezhuceren、beianrenweianzhaoguidingzhidingshangshihouyanjiuhefengxianguankongjihuabingbaozhengyouxiaoshishi;

  (qi)yiliaoqixiezhuceren、beianrenweianzhaoguidingjianlibingzhixingchanpinzhuisuzhidu;

  (ba)yiliaoqixiezhuceren、beianren、jingyingqiyecongshiyiliaoqixiewangluoxiaoshouweianzhaoguidinggaozhifuzeyaopinjianduguanlidebumen;

  (jiu)duixuyaodingqijiancha、jianyan、xiaozhun、baoyang、weihudeyiliaoqixie,yiliaoqixieshiyongdanweiweianzhaochanpinshuomingshuyaoqiujinxingjiancha、jianyan、xiaozhun、baoyang、weihubingyuyijilu,jishijinxingfenxi、pinggu,quebaoyiliaoqixiechuyulianghaozhuangtai;

  (shi)yiliaoqixieshiyongdanweiweituoshanbaocungourudisanleiyiliaoqixiedeyuanshiziliao。

  dijiushitiao youxialieqingxingzhiyide,youxianjiyishangrenminzhengfuweishengzhuguanbumenzelinggaizheng,geiyujinggao;jubugaizhengde,chu5wanyuanyishang10wanyuanyixiafakuan;qingjieyanzhongde,chu10wanyuanyishang30wanyuanyixiafakuan,zelingzantingxiangguanyiliaoqixieshiyonghuodong,zhizhiyouyuanfazhengbumendiaoxiaozhiyexukezheng,yifazelingxiangguanzerenrenyuanzanting6geyueyishang1nianyixiazhiyehuodong,zhizhiyouyuanfazhengbumendiaoxiaoxiangguanrenyuanzhiyezhengshu,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen:

  (yi)duizhongfushiyongdeyiliaoqixie,yiliaoqixieshiyongdanweiweianzhaoxiaoduheguanlideguidingjinxingchuli;

  (er)yiliaoqixieshiyongdanweizhongfushiyongyicixingshiyongdeyiliaoqixie,huozheweianzhaoguidingxiaohuishiyongguodeyicixingshiyongdeyiliaoqixie;

  (san)yiliaoqixieshiyongdanweiweianzhaoguidingjiangdaxingyiliaoqixieyijizhiruhejieruleiyiliaoqixiedexinxijizaidaobinglidengxiangguanjiluzhong;

  (si)yiliaoqixieshiyongdanweifaxianshiyongdeyiliaoqixiecunzaianquanyinhuanweilijitingzhishiyong、tongzhijianxiu,huozhejixushiyongjingjianxiurengbunengdadaoshiyonganquanbiaozhundeyiliaoqixie;

  (wu)yiliaoqixieshiyongdanweiweiguishiyongdaxingyiyongshebei,bunengbaozhangyiliaozhilianganquan。

  dijiushiyitiao weifanjinchukoushangpinjianyanxiangguanfalv、xingzhengfaguijinkouyiliaoqixiede,youchurujingjianyanjianyijigouyifachuli。

  dijiushiertiao weiyiliaoqixiewangluojiaoyitigongfuwudedianzishangwupingtaijingyingzheweifanbentiaoliguiding,weilvxingduiruwangyiliaoqixiejingyingzhejinxingshimingdengji,shenchaxuke、zhuce、beianqingkuang,zhizhibingbaogaoweifaxingwei,tingzhitigongwangluojiaoyipingtaifuwudengguanliyiwude,youfuzeyaopinjianduguanlidebumenyizhao《zhonghuarenmingongheguodianzishangwufa》deguidinggeiyuchufa。

  dijiushisantiao weijinxingyiliaoqixielinchuangshiyanjigoubeiankaizhanlinchuangshiyande,youfuzeyaopinjianduguanlidebumenzelingtingzhilinchuangshiyanbinggaizheng;jubugaizhengde,gailinchuangshiyanshujubudeyongyuchanpinzhuce、beian,chu5wanyuanyishang10wanyuanyixiafakuan,bingxiangshehuigonggao;zaochengyanzhonghouguode,5nianneijinzhiqikaizhanxiangguanzhuanyeyiliaoqixielinchuangshiyan,bingchu10wanyuanyishang30wanyuanyixiafakuan,youweishengzhuguanbumenduiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen。

  linchuangshiyanshenbanzhekaizhanlinchuangshiyanweijingbeiande,youfuzeyaopinjianduguanlidebumenzelingtingzhilinchuangshiyan,duilinchuangshiyanshenbanzhechu5wanyuanyishang10wanyuanyixiafakuan,bingxiangshehuigonggao;zaochengyanzhonghouguode,chu10wanyuanyishang30wanyuanyixiafakuan。gailinchuangshiyanshujubudeyongyuchanpinzhuce、beian,5nianneibushoulixiangguanzerenrenyijidanweitichudeyiliaoqixiezhuceshenqing。

  linchuangshiyanshenbanzheweijingpizhunkaizhanduirentijuyoujiaogaofengxiandedisanleiyiliaoqixielinchuangshiyande,youfuzeyaopinjianduguanlidebumenzelinglijitingzhilinchuangshiyan,duilinchuangshiyanshenbanzhechu10wanyuanyishang30wanyuanyixiafakuan,bingxiangshehuigonggao;zaochengyanzhonghouguode,chu30wanyuanyishang100wanyuanyixiafakuan。gailinchuangshiyanshujubudeyongyuchanpinzhuce,10nianneibushoulixiangguanzerenrenyijidanweitichudeyiliaoqixielinchuangshiyanhezhuceshenqing,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan。

  dijiushisitiao yiliaoqixielinchuangshiyanjigoukaizhanyiliaoqixielinchuangshiyanweizunshoulinchuangshiyanzhiliangguanliguifande,youfuzeyaopinjianduguanlidebumenzelinggaizhenghuozhelijitingzhilinchuangshiyan,chu5wanyuanyishang10wanyuanyixiafakuan;zaochengyanzhonghouguode,5nianneijinzhiqikaizhanxiangguanzhuanyeyiliaoqixielinchuangshiyan,youweishengzhuguanbumenduiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen。

  dijiushiwutiao yiliaoqixielinchuangshiyanjigouchujuxujiabaogaode,youfuzeyaopinjianduguanlidebumenchu10wanyuanyishang30wanyuanyixiafakuan;youweifasuodede,meishouweifasuode;10nianneijinzhiqikaizhanxiangguanzhuanyeyiliaoqixielinchuangshiyan;youweishengzhuguanbumenduiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen。

  dijiushiliutiao yiliaoqixiejianyanjigouchujuxujiajianyanbaogaode,youshouyuqizizhidezhuguanbumenchexiaojianyanzizhi,10nianneibushoulixiangguanzerenrenyijidanweitichudezizhirendingshenqing,bingchu10wanyuanyishang30wanyuanyixiafakuan;youweifasuodede,meishouweifasuode;duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,meishouweifaxingweifashengqijianzibendanweisuohuoshouru,bingchusuohuoshouru30%yishang3beiyixiafakuan,yifageiyuchufen;shoudaokaichuchufende,10nianneijinzhiqicongshiyiliaoqixiejianyangongzuo。

  dijiushiqitiao weifanbentiaoliyouguanyiliaoqixieguanggaoguanliguidingde,yizhao《zhonghuarenmingongheguoguanggaofa》deguidinggeiyuchufa。

  dijiushibatiao jingwaiyiliaoqixiezhuceren、beianrenzhidingdewoguojingneiqiyefarenweiyizhaobentiaoliguidinglvxingxiangguanyiwude,yousheng、zizhiqu、zhixiashirenminzhengfuyaopinjianduguanlibumenzelinggaizheng,geiyujinggao,bingchu5wanyuanyishang10wanyuanyixiafakuan;qingjieyanzhongde,chu10wanyuanyishang50wanyuanyixiafakuan,5nianneijinzhiqifadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuancongshiyiliaoqixieshengchanjingyinghuodong。

  jingwaiyiliaoqixiezhuceren、beianrenjubulvxingyijubentiaolizuochudexingzhengchufajuedingde,10nianneijinzhiqiyiliaoqixiejinkou。

  dijiushijiutiao yiliaoqixieyanzhi、shengchan、jingyingdanweihejianyanjigouweifanbentiaoliguidingshiyongjinzhicongshiyiliaoqixieshengchanjingyinghuodong、jianyangongzuoderenyuande,youfuzeyaopinjianduguanlidebumenzelinggaizheng,geiyujinggao;jubugaizhengde,zelingtingchantingyezhizhidiaoxiaoxukezhengjian。

  diyibaitiao yiliaoqixiejishushenpingjigou、yiliaoqixiebuliangshijianjiancejishujigouweiyizhaobentiaoliguidinglvxingzhize,zhishishenping、jiancegongzuochuxianzhongdashiwude,youfuzeyaopinjianduguanlidebumenzelinggaizheng,tongbaopiping,geiyujinggao;zaochengyanzhonghouguode,duiweifadanweidefadingdaibiaoren、zhuyaofuzeren、zhijiefuzedezhuguanrenyuanheqitazerenrenyuan,yifageiyuchufen。

  diyibailingyitiao fuzeyaopinjianduguanlidebumenhuozheqitayouguanbumengongzuorenyuanweifanbentiaoliguiding,lanyongzhiquan、wanhuzhishou、xunsiwubide,yifageiyuchufen。

  diyibailingertiao weifanbentiaoliguiding,gouchengfanzuide,yifazhuijiuxingshizeren;zaochengrenshen、caichanhuozheqitasunhaide,yifachengdanpeichangzeren。

  第八章 附則

  diyibailingsantiao bentiaolixialieyongyudehanyi:

  yiliaoqixie,shizhizhijiehuozhejianjieyongyurentideyiqi、shebei、qiju、tiwaizhenduanshijijixiaozhunwu、cailiaoyijiqitaleisihuozhexiangguandewupin,baokuosuoxuyaodejisuanjiruanjian;qixiaoyongzhuyaotongguowulidengfangshihuode,bushitongguoyaolixue、mianyixuehuozhedaixiedefangshihuode,huozhesuiranyouzhexiefangshicanyudanshizhiqifuzhuzuoyong;qimudeshi:

  (yi)jibingdezhenduan、yufang、jianhu、zhiliaohuozhehuanjie;

  (er)sunshangdezhenduan、jianhu、zhiliao、huanjiehuozhegongnengbuchang;

  (san)shenglijiegouhuozheshengliguochengdejianyan、tidai、diaojiehuozhezhichi;

  (si)shengmingdezhichihuozheweichi;

  (wu)renshenkongzhi;

  (liu)tongguoduilaizirentideyangbenjinxingjiancha,weiyiliaohuozhezhenduanmudetigongxinxi。

  yiliaoqixiezhuceren、beianren,shizhiqudeyiliaoqixiezhucezhenghuozhebanliyiliaoqixiebeiandeqiyehuozheyanzhijigou。

  yiliaoqixieshiyongdanwei,shizhishiyongyiliaoqixieweitarentigongyiliaodengjishufuwudejigou,baokuoyiliaojigou、jihuashengyujishufuwujigou、xuezhan、dancaixuejiangzhan、kangfufuzhuqijushipeijigoudeng。

  daxingyiyongshebei,shizhishiyongjishufuza、zijintouruliangda、yunxingchengbengao、duiyiliaofeiyongyingxiangdaqienarumuluguanlidedaxingyiliaoqixie。

  diyibailingsitiao yiliaoqixiechanpinzhucekeyishouqufeiyong。jutishoufeixiangmu、biaozhunfenbieyouguowuyuancaizheng、jiagezhuguanbumenanzhaoguojiayouguanguidingzhiding。

  diyibailingwutiao yiliaoweishengjigouweiyingduitufagonggongweishengshijianeryanzhideyiliaoqixiedeguanlibanfa,youguowuyuanyaopinjianduguanlibumenhuitongguowuyuanweishengzhuguanbumenzhiding。

  congshifeiyinglidebiyunyiliaoqixiedecunchu、diaobohegongying,yingdangzunshouguowuyuanweishengzhuguanbumenhuitongguowuyuanyaopinjianduguanlibumenzhidingdeguanlibanfa。

  zhongyiyiliaoqixiedejishuzhidaoyuanze,youguowuyuanyaopinjianduguanlibumenhuitongguowuyuanzhongyiyaoguanlibumenzhiding。

  diyibailingliutiao junduiyiliaoqixieshiyongdejianduguanli,yizhaobentiaolihejunduiyouguanguidingzhixing。

  diyibailingqitiao bentiaolizi2021nian6yue1riqishixing。


huanyingnintongguoruxiazaixianbiaogeyuwomenlianxi。

womenjiangtongguogezhongfangshijiedanindezixun,gongtongweinindedeyanfaxuqiutigongdingzhihuadezhuanyezixunhejiejuefangan。

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