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國家藥監局綜合司關于印發2021年國家醫療器械抽檢產品檢驗方案的通知
2021-04-12

gesheng、zizhiqu、zhixiashiyaopinjianduguanliju,xinjiangshengchanjianshebingtuanyaopinjianduguanliju,zhongguoshipinyaopinjiandingyanjiuyuan、xiangguanjianyanjigou:

  genju《guojiayaojianjuzonghesiguanyukaizhan2021nianguojiayiliaoqixiezhiliangchouchajianyangongzuodetongzhi》(yaojianzongxieguan〔2021〕18hao),xianjiang2021nianguojiayiliaoqixiechoujianchanpinjianyanfanganyinfageinimen,bingjiangyouguanyaoqiutongzhiruxia:

  一、檢驗工作

    gesheng、zizhiqu、zhixiashiyaopinjianduguanlijujixinjiangshengchanjianshebingtuanyaopinjianduguanliju(xiajianchengshengju)、zhongguoshipinyaopinjiandingyanjiuyuanyinganzhao《2021nianguojiayiliaoqixiechoujianpinzhongjianyanfangan》(fujian1)zuzhixiangguanjianyanjigouanyiliaoqixieqiangzhixingbiaozhunyijijingzhucehuozhebeiandechanpinjishuyaoqiu(zhucechanpinbiaozhun)kaizhanjianyangongzuo。

  二、復檢工作

  genju《yiliaoqixiezhiliangchouchajianyanguanlibanfa》disanshiertiaoguiding,beichouyangdanweihuozhebiaoshiyiliaoqixiezhuceren、beianrenhuozhejinkouchanpindailirenduijianyanjielunyouyiyide,keyizishoudaojianyanbaogaozhiriqi7gegongzuorineiyouxianxiangbenfangantuijiandefujianjigou(fujian2)tichufujianshenqing。fujianjigouyingdangjishishoulifujianshenqingbingkaizhanjianyangongzuo。yuqitichufujianshenqingde,jianyanjigoubuzaishouli。

  三、異議申訴工作

  beichouyangdanweihuozhebiaoshiyiliaoqixiezhuceren、beianrenyijijinkouchanpindailirenduijianyanfangfa、pandingyijudengcunzaiyiyi,qiewufatongguofujianjinxingyanzhengde,yingdangzishoudaojianyanbaogaozhiriqi10gegongzuorinei,xiangsuozaidishengjutichuyiyishensushumianshenqing,bingtijiaoxiangguanzhengmingcailiao。

  suozaidishengjuyingdangzaishoudaoshenqinghou2gegongzuorinei,jiangyiyishensuqingkuangtianbaozhiguojiayiliaoqixiechoujianxinxixitong,bingzai15gegongzuorineijinxingdiaochaheshi、querenheshijieguo,tichuchulijianyibaozhongguoshipinyaopinjiandingyanjiuyuanjishujianduzhongxin。xiangguanshengjuweijinxingdiaochashenhe、weitichuheshijieguohechulijianyide,youguancailiaobuyubanli。

  四、其他要求

  yiliaoqixiezhuceren、beianrenshoudaofengxianjiancechanpindejiancejieguo,yingdanggenjufengxianjiancetishi,zhudongpingguhexiaochufengxian,suozaidishengjuyingdangjianduzhidaoqiyeguankongfengxian。fengxianjiancechanpindejiancejieguobuzuoweixingzhengchufahegonggaoyiju。

  

  fujian: 1. 2021nianguojiayiliaoqixiechoujianpinzhongjianyanfangan

     2. 2021nianguojiayiliaoqixiechoujianfujianjigoutuijianmingdan

  

  

  

                               guojiayaojianjuzonghesi

                2021nian4yue9ri




huanyingnintongguoruxiazaixianbiaogeyuwomenlianxi。

womenjiangtongguogezhongfangshijiedanindezixun,gongtongweinindedeyanfaxuqiutigongdingzhihuadezhuanyezixunhejiejuefangan。

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