深圳港信通医疗是国内一家值得信赖、pragmatic、Efficient、innovation、权威的医疗器械技术咨询服务机构,公司以专注于医疗器械服务为服务理念,以合规咨询为企业原则,聘请资深的专家队伍,从基本的资料准备,包括人员、场地提供指导,现场布置、Personnel training、迎检、内审等多方面服务,深圳医疗器械经营许可证代办转让,为各企业提供专业细致的合规咨询指导。
深圳医疗器械经营许可证代办转让
Require
:1、site
Require
:Office area plus storage area ≥ 160㎡ (if it is an in vitro diagnostic reagent type III medical device, it must have a cold storage,
Require
above 40m3);2、personnel
Require
:3 relevant personnel are required to be registered and hold certificates;3、product
Require
:There must be product information that is consistent with the business scope,and issue a certificate;4、Other relevant laws and regulations
Require
。
中国的医疗器械是分类进行监管的,根据你产品的特性进行类别划分,注册的流程也不一样。一类的医疗器械在市级药监部门进行注册申请,二类的医疗器械在省级药监部门进行注册申请,三类以及进口的医疗器械要到国家局进行注册申请。具体的材料准备和审批时限根据类别不同而不同。问题太模糊了,不能给你详细解答。
首先你要给注册的产品定位,属于一类的还是二类或者三类一类二类相对简单,深圳医疗器械经营许可证代办转让找我。The content of this article is strictly prohibited from being reproduced by any website or individual.,Violators will be prosecuted。Related products:Medical device transfer , Medical device registration , Apply for medical devices
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