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脐带护理液小编提示:市场红利持续释放医疗器械注册人制度试点步入新阶段

发布日期:2019-05-20 作者: 点击:

QIDAIHULIYEXIAOBIANTISHI:“MUQIAN,QUANGUOYOUDUOGESHENGFENZAISHENQINGJIARUYILIAOQIXIEZHUCERENZHIDUSHIDIAN,YONGYUECHENGDUCHAOGUOYUQI。”ZHEISHIJINRIJIZHECONGGUOJIAYAOPINJIANGUANJUHUOXIDEXIAOXI。


    

4月19日,国家药监局在上海召开了医疗器械注册人制度(以下简称“注册人制度”)试点座谈会。会上,上海、广东、天津三地药品监管部门分别就前期试点工作进行了交流。来自19个省(区、市)药监部门的参会代表表达了对进一步扩大注册人制度试点、更大限度释放政策红利的期许。此次座谈会也释放出注册人制度将进一步扩大试点的信号,我国注册人制度试点工作有望步入新阶段。


三地先行先试


注册人制度先行先试于上海、广东、天津三地自贸区。


    

2017年3月,国务院印发的《全面深化中国(上海)自由贸易试验区改革开放方案》提出,要优化创新要素的市场配置机制,允许自贸试验区内医疗器械注册申请人委托上海市医疗器械生产企业生产产品。


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2017年10月,中办、国办印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》明确,推动上市许可持有人制度全面实施。允许医疗器械研发机构和科研人员申请医疗器械上市许可。


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“一直以来,我国二、三类医疗器械生产实行产品注册和生产许可二证制度,即产品要获得产品注册证、生产要获得生产许可证,并由组织生产的同一主体(创新产品除外)申请。注册人制度实现了产品注册和生产许可的‘解绑’,更利于鼓励创新、整合社会资源、加快医疗器械产品上市。”上海市药监局医疗器械监管处处长林森勇认为。


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