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进口医疗器械注册常见违规事项

FABUSHIJIAN:2022-03-04  LIULAN:CI

引言:无论国产医疗器械注册还是进口医疗器械注册企业,取证都是万里长征第一步,企业如何合规、如何持续合规是企业高级管理层持之以恒的任务和挑战。

医疗器械注册.jpg

一、进口医疗器械注册企业检查案例2项:

WENTI1:JINKOUYILIAOQIXIEZHUCEZHENGYOUXIAOQIWAISHENGCHAN

MOUGONGSIJINKOULE1PIDUODAOSHUIMIANJILUYIPEIJIAN,BINGTIGONGLEXIANGYINGDEJINKOUYILIAOQIXIEZHUCEZHENG。NG,ZHUCEZHENGSHI2019NIAN11YUE18RIPIZHUNBANFADE,SUOYOUDEPEIJIANDOUSHI2019NIANHE2020NIANSHENGCHANDE,KANQILAIMEIWENTI。HUOYANJINJINGDEXIANCHANGGUANYUANTONGGUOZHUTAIQINGDIAN,FAXIANQIZHONG2JIANSHENGCHANRIQIFENBIEWEI2020-07-26HE2020-11-07,JUNZAIZHUCEZHENGPIZHUNRIQIZHIQIANSHENGCHANDE。YEJIUSHISHUO,ZHEI2JIANYILIAOQIXIEPEIJIANSHIWEIHUOZHENGCHANPIN!

WENTI2:CHANPINYIJIUCHONGXIN

MOUGONGSISHENBAOJINKOU1TAIYANGUGUANYALICESHIYI,XIANCHANGGUANYUANZAICHAJIANGUOCHENGZHONGFAXIAN:GAISHEBEIZHONGWENBIAOQIANWEIBIAOZHUSHENGCHANRIQI;DIANYUANCHATOUFEIZHONGGUOZHISHI;WAIGUANCUNZAIMINGXIANHUAHENHEMOSUNHENJI。JINGJINYIBUHESHI,SHANGSHUSHEBEIWEI2015NIANSHENGCHAN,QIEYOUSHIYONGJINGLI。


二、进口医疗器械注册企业特别注意事项:

1.JINKOUYILIAOQIXIEBIXUQUDEGUOWUYUANSHIPINYAOPINJIANDUGUANLIBUMENDEBEIANHUOYILIAOQIXIEZHUCEZHENG(KEYAN、SHENQINGZHUCEDENGTESHUQINGKUANGCHUWAI),JINKOUSHENBAOSHIYINGZHUDONGTIANXIEBEIANHUOZHUCEZHENGBIANHAO。MUQIANHAIGUANYISHIXIANLIANWANGHECHA,KEYIZIDONGBIDUI。

CIWAI,JINKOUDEYILIAOQIXIEYINGDANGYOUZHONGWENSHUOMINGSHU、ZHONGWENBIAOQIAN,QIEFUHEXIANGGUANGUIDINGHEQIANGZHIXINGBIAOZHUNDEYAOQIU。BUFUHEGUIDINGDE,YILVBUDEJINKOU。

2.SHUYUJIDIANCHANPINDEJINKOUYILIAOQIXIEDEANQUANJINGGAOBIAOSHI、DIANQIJIJIXIEANQUANXIANGMUYEBIXUFUHEWOGUOXIANGGUANJISHUFAGUIYAOQIU,LIRUJINGGAOBIAOZHI、DIANYUANCHATOU、JIEDIBAOHUDENG。

3.DUOSHUJIUYILIAOQIXIESHUYU《JINZHIJINKOUDEJIUJIDIANCHANPINMULU》FANWEINEI,YANJINJINKOU。





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北京飞速度医疗科技有限公司专注于医疗器械、诊断试剂产品政策与法规规事务服务,提供产品注册申报代理、临床合同(CRO)研究、产品研发、GMP质量辅导等方面的技术外包服务。

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