医疗器械经营许可证代办过程披露

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，为各企业提供专业细致的合规咨询指导。

医疗器械经营许可证代办过程披露。

two、Declaration information：医疗器械经营许可证代办过程披露

1. 填写医疗器械经营企业许可证申请表一式3份（复印件无效）；
2. 1 application report；
3. 企业自查总结对照广东省医疗器械经营企业资格认可实施细则和广东省核换验收标准
4. 企业公司章程和新验资报告换证的提供企业资产负债表和损益表；
5. business、Warehouse property ownership certificate or lease agreement and 1 copy of floor plan；
6. technology、维修人员一览表及其毕 业 证、One copy of each professional title certificate (stamped with the official seal of the unit)；
7. 市药品监管局的详细书面初审验收报告1份（省属企业除外）；
8. Various management rules and regulations：Quality responsibility and veto system，Warehouse acceptance、Storage and warehouse review system，Quality analysis and feedback system，Validity period management system，Store sales quality management system，special、Imported medical device management system，售后服务（安装、Use technology training、maintainance、Maintenance, etc.) system，Implantation and special medical device quality tracking and adverse reaction reporting system，return the goods、Unqualified、Expiration date or obsolete medical device disposal reporting system，卫生管理制度；three、Approval process：医疗器械经营许可证代办过程披露
9. 省药品监管局对申报资料齐全和符合报批程序

Require

的方可受理。

经办人应在受理之日起15个工作日内组织有关人员或委托市药品监管部门对照广东省医疗器械经营企业资格认可实施细则进行现场验收。

验收内容包括：office、business、warehousing、维修场所，Detection、维修设备及安装维修记录、质量制度执行、技术人员在岗情况，经营品种及收集保存医疗器械的法规、规章及所经营品种的质量标准、医疗器械产品注册证等有关资料。2、现场验收合格者，10个工作日内填写医疗器械审批表，Provide preliminary opinions，按程序报处、局领导审批。

Our main business：Medical device product registration consulting agent、Medical device production license、Medical device business license、Product registration and production registration for Class I medical device manufacturers、Product registration for Category II business enterprises、Licensing for Category Three Business Enterprises、In vitro diagnostic reagent registration、Imported medical device registration、医疗器械经营许可证代办过程披露互联网药品（医疗器械）服务资格证书申请、Consulting and guidance on clinical trials。

Related products：Medical device transfer , Medical device registration , Apply for medical devices

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