广东11选5

广东11选5

ZAIXIANKEFU

医疗器械注册人制度的发展趋势

  中国医疗器械注册管理法规变迁:

 

  1996NIAN GUOHUAYIYAOGUANLIJUTIGONGYILIAOQIXIEZHUCE

 

广东11选5  1997NIAN SUOYOUYILIAOQIXIESHANGSHIXIAOSHOUBIXUZHUCE

 

  2000NIAN GUOWUYUAN《YILIAOQIXIEJIANDUGUANLITIAOLI》(276HAO)BANBUSHISHI1.0

 

  2004NIAN GUOJIAYAOPINJIANDUGUANLIJUXIUDINGSHISHI《ZHUCEGUANLIBANFA》(4HAOLING)

 

  2014NIAN GUOWUYUANXIUDINGSHISHI《YILIAOQIXIEJIANDUGUANLITIAOLI》(650HAO)2.0

 

广东11选5  GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUXIUDINGSHISHIZHUCEGUANLIBANFA(4HAOLING)

 

广东11选5  2017NIAN GUOWUYUANXIUDING《YILIAOQIXIEJIANDUGUANLITIAOLI》(680HAO)

 

 

广东11选5  ZAIZHIDUBUDUANWANSHANDEGUOCHENGZHONG,BAOLUCHULAIDEWENTISHICHANPINZHUCEHESHENGCHANXUKEBIXUSHITONGYIZHUTI,ZHEIYANGBUSHIHESHENGCHANGUANLIGUIFANHESHENGCHANGUANFAZHAN,ZHEIYESHIJINNIANLAIBEIGOUBINGDEYIGEWENTI,QICHUZHEIMEZUOSHIYINWEIWOGUOJIBENSHIYANXUGUOWAIDECHANPIN,ZIZHUYANFADECHANPINHENSHAO,DANGSHIYANFASHENGCHANLIUTONGSHIYONGSHIYIGEZHUTI,SHINEIYITESHULISHISHISHIQIYILIAOQIXIEFAZHANQINGKUANGJUEDINGDE,DAO2007NIANZHIHOU,ZHENGCEGENJUSHICHANGHUAIJINGZUOCHUDIAOZHENG,GENJUGUOJITONGXINGDEGUANLI,YOUKUNBANGGAIWEIJIEBANG,SHANGSHIXUKEDESHENQINGREN、CHIYOUREN,KEYIHESHENGCHANQIYESHIXINGFENLI,ZHEIZHONGFENGONGHEZUOJIKEYIRANGYANFARENYUANZHUANGONGCHANPINYANFA,TONGSHIYECUJINSHENGCHANZHEZHUANGONGTIXIGUANLI,JIENENGZENGXIAOHEZHILIANGWENKONG,ZHEIYANGDEFENGONGHEZUOJISHIHUBUYESHISHUANGYING。

 

  ZHUCERENZHIDUXIANXINGYUSHANGHAI、GUANGDONG、TIANJINSANDIZIMAOQU,SUIHOUTIANJIN、BEIJINGDENGDIYE“RUJU”。

 

  2017NIAN3YUE,GUOWUYUANYINFADE《QUANMIANSHENHUAZHONGGUO(SHANGHAI)ZIYOUMAOYISHIYANQUGAIGEKAIFANGFANGAN》TICHU,YAOYOUHUACHUANGXINYAOSUDESHICHANGPEIZHIJIZHI,YUNXUZIMAOSHIYANQUNEIYILIAOQIXIEZHUCESHENQINGRENWEITUOSHANGHAISHIYILIAOQIXIESHENGCHANQIYESHENGCHANCHANPIN。

 

  2017NIAN10YUE,ZHONGBAN、GUOBANYINFADE《GUANYUSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN》MINGQUE,TUIDONGSHANGSHIXUKECHIYOURENZHIDUQUANMIANSHISHI。YUNXUYILIAOQIXIEYANFAJIGOUHEKEYANRENYUANSHENQINGYILIAOQIXIESHANGSHIXUKE。

 

  2017NIAN12YUE,YUANSHANGHAISHISHIPINYAOPINJIANGUANJUFABULEGUANYUSHISHI《ZHONGGUO(SHANGHAI)ZIYOUMAOYISHIYANQUNEIYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUOSHISHIFANGAN》DETONGZHI。2018NIAN7YUE,SHANGHAISHIYAOJIANBUMENJIANGSHIDIANKUODADAOSHANGHAIQUANSHI。

 

  2018NIAN5YUE,GUOWUYUANYINFADE《JINYIBUSHENHUAZHONGGUO(GUANGDONG)、(TIANJIN)、(FUJIAN)ZIYOUMAOYISHIYANQUGAIGEKAIFANGFANGAN》MINGQUE,YUNXUGUANGDONGZIMAOSHIYANQUNEIYILIAOQIXIEZHUCESHENQINGRENWEITUOGUANGDONGSHENGYILIAOQIXIESHENGCHANQIYESHENGCHANCHANPIN;YUNXUTIANJINZIMAOSHIYANQUNEIYILIAOQIXIEZHUCESHENQINGRENWEITUOTIANJINSHIYILIAOQIXIESHENGCHANQIYESHENGCHANCHANPIN。

 

  2018NIAN8YUE,GUOJIAYAOJIANJUFABU《GUANYUTONGYIKAIZHANYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUODEPIFU》,TONGYIZAIZHONGGUO(GUANGDONG)ZIYOUMAOYISHIYANQUYIJIGUANGZHOU、SHENZHEN、ZHUHAI,ZHONGGUO(TIANJIN)ZIYOUMAOYISHIYANQUNEIKAIZHANZHUCERENZHIDUSHIDIANGONGZUO。

 

广东11选5  2018NIAN8YUE,TIANJINSHISHICHANGHEZHILIANGJIANDUGUANLIWEIYUANHUIFABUGUANYUYINFA《ZHONGGUO(TIANJIN)ZIYOUMAOYISHIYANQUNEIYILIAOQIXIEZHUCERENZHIDUSHIDIANGONGZUOSHISHIFANGAN》DETONGZHI,JIANGYILIAOQIXIEZHUCERENZHIDUJINYIBUKUOZHANZHITIANJIN。

 

  2019NIAN2YUE,GUOWUYUANXIAFALE《GUANYUQUANMIANTUIJINBEIJINGSHIFUWUYEKUODAKAIZHANZONGHESHIDIANGONGZUOFANGAN》DEPIFU,MINGQUEXIEDAO:KAIZHANYILIAOQIXIEZHUCERENZHIDUSHIDIAN,YUNXUBEIJINGSHIYILIAOQIXIEZHUCERENWEITUOJINGJINJIDIQUYILIAOQIXIESHENGCHANQIYESHENGCHANYILIAOQIXIE。

 

  医疗器械注册人制度的发展趋势

 

  1. 从监管趋势看:

 

  (1)GESHENGCHANPINZHUCEHESHENGCHANXUKE(HUADIWEILAO)DEJUMIANJIANGBEIDAPO,SHENGJIJIANGUANLILIANGJIANGZHONGDIANJUJIAOQIYESHENGCHANXINGWEI;

 

  (2)ZHUCESHENBAOXUQIUXIAJIANG,WEIQUANGUOTONGYIZHUCEGUANLI、JIZHONGSHENPI、SHENPIDAILAIDEBIANLI;

 

广东11选5  (3)GEDIXUNQIUSHIZHONGSHIHOUJIANGUANCHUANGXINCUOSHI,RUJIAQIANG“KUAQUJIANGUANXINXIGONGXIANGHEJIANCHAJIEGUOHUREN”DENG,YICILAIWEIKONGZHIZHUCERENZHIDUDEJIANGUANFENGXIAN“TUODI”;

 

  (4)JIANGUANBUMENYINGSHUNSHIZHUANBIANYIWANGDEFENDUANGUANLI、JIENENGGUANLI、PINCIGUANLIYIJICHUANTONGDE“BAOMUSHI”HUO“MAOSHUSHI”JIANGUANFANGSHI,QIESHIZHUANBIANJIANGUANLINIAN。

 

  2. 从发展趋势来看:

 

  (1)QIYEZAIXINGYEJIAOSEHECHANYELIANZHONGDEDINGWEIHEGONGNENGJINYIBUXIFEN;

 

  (2)QIYEJIANTONGYEJINGZHENGWEIZHU,JIANBIANWEIJINGZHENGZHONGXUNQIUHEZUO,BINGGOUHEZHONGZUGENGLINGHUO,HEZUOMOSHIGENGDUOYANG,SHENGCHANKEYIWEITUOZHUANYEHUA“DAIGONG”LIANGCHANZHIZAO,XIAOSHOUKEYIZHENGXILIE、ZHENGQUYUWEITUO“FENXIAOBAOXIAO”,TONGZHIHUADEYAOXIAOPINPAIJIANG“DANCHUJIANGHU”,CHENJIULUOHOUQIYEJIANGBEI“WUJIERZHONG”,XIAOSHOUJIAMAOWEILIEDE、ZHISHICHANQUANBAOHUDANBODE,QIYUEJINGSHENQUESHIDESHIXINQIYEJIANGCUNBUNANXING。

 

  3. 从创新发展趋势来看:

 

广东11选5  (1)KEYANXINGQIYE,BUBI“MAIQINGMIAO”,KEYIXUNZHAOCROHUOZHECDMO,RANGQI“ZHUYUN”SHENZHI“DAIYUN”;

 

  (2)XIAOWEICHUANGXINQIYE,BUBIZAIZHUCEHOUDELIANGCHANZHIZAOSHANGZENGJIATOURU,KEYIZIYOUXUANZEHEZUOHUOBAN,XUNZHAOZHUANYE“DAIGONG”,CONGERQINGZICHANYUNZUO、ZHUANZHUYAFA“QINGZHUANGSHANGZHEN”;

 

广东11选5  (3)KUODACHANNENG、KUODASHENGCHANCHANGDIDE,BUBIXINJIANCHANGFANGHUOYIDISHOUGOUGONGCHANG,KEYIJIEHEKUOQUYUTUDIJIAGE、HUANBAOYAOQIU、LAODONGCHENGBEN、JIAOTONGYUNSHUCHENGBENDENGYINSU,TONGGUOHUAQUYUWEITUOSHENGCHANERJIANGPINPAIYANXUZHIMUDEDI,HAIKEYIWEITUODANGDIHEZUOFANGJINXINGXIAOSHOUHESHANGSHIHOUDEWEIHUBAOYANG、SHOUJIKEHUFANKUIDEXINXIDENGDENG。

 

  结语

 

  医疗器械注册广东11选5人制度,是我国医疗器械评审的一个重大改革,相信在未来国家政策的指引下,我国的医疗器械行业正在健康快速的发展。但有业内人士强调,在试点过程中,医疗器械注册人应当具备哪些能力或者条件,应当承担哪些义务;药监部门需要出台哪些制度保证注册人义务的有效落实;医疗器械注册人制度实施会给监管带来哪些挑战,这些挑战如何破解等问题,还需进一步讨论。而找到上述问题解决路径有待试点工作的进一步探索。