北京朝阳》医疗器械二类备案五个工作日内办结省心省事拿证

以下是医疗器械二类备案的具体做法：

了解备案要求

准备备案材料

· 基础资料：通常需提供营业执照副本及复印件、组织机构代码证复印件、法定代表人身份证复印件等.

· 人员资质证明：企业负责人、质量管理人员的身份证明、学历或职称证明等，质量管理人员一般需具有大专以上学历及相关背景，并有一定的工作经验7.

· 经营场所证明：提供经营场所的房产证明或房屋租赁协议，以及场所的地理位置图、平面图等，证明其符合经营要求，且经营场所和仓库不得设置在居民住宅内7.

· 质量管理文件：建立健全的质量管理体系文件，包括采购、验收、储存、销售、售后服务等环节的管理制度和操作流程，如质量管理制度、工作程序文件目录等.

· 设施设备清单：列出经营场所和仓库内配备的与医疗器械经营相适应的设施设备目录，如货架、温湿度监测设备、防虫防鼠设备等.

· 产品信息：如果有特定的二类医疗器械产品需要备案，还需提供该产品的技术资料、产品注册证书、供应商营业执照及许可证等4.

医疗器械经营企业备案信息的维护需要从以下几个方面着手：

定期自查与信息核对

· 定期全面自查：企业应定期对备案信息进行全面自查，包括企业名称、法定代表人、地址、经营范围、库房地址等关键信息，确保这些信息与实际经营情况相符，自查频率建议至少每半年一次.

· 关键信息即时核对：对于涉及经营许可范围、经营方式等核心要素的信息，要做到随时关注、即时核对，一旦发现实际情况与备案信息有出入，应立即着手准备变更申请。

及时变更与申请更新

· 变更情形及时申报：当企业发生如法定代表人变更、企业名称变更、经营场所和库房地址变更、经营范围和经营方式变更等情况时，需在规定时间内，通常是变更后的30 个工作日内，向原备案部门提交变更申请125.

申请材料准确完备：提交变更申请时，要按照要求准备准确、完备的申请材料，如变更后的营业执照副本复印件、相关人员的身份证明及资质证明文件、新地址的产权证明或租赁协议等

The maintenance of registration information for medical deviceoperating enterprises needs to be approached from the followingaspects:

Regular self inspection and information verification

·Regular comprehensive self-examination: Enterprises shouldconduct comprehensive self-examination of filing information on aregular basis, including key information such as enterprise name,legal representative, address, business scope, warehouse address,etc., to ensure that this information is consistent with the actualbusiness situation. The frequency of self-examination isrecommended to be at least once every six months

·Real time verification of key information: For informationrelated to core elements such as business license scope andoperating methods, it is necessary to pay attention to and verifyit at any time. Once discrepancies are found between the actualsituation and the recorded information, immediate preparation forchange applications should be carried out.

Timely changes and application updates

·Timely declaration of changes: When an enterprise undergoeschanges such as changes in legal representative, company name,business premises and warehouse address, business scope and mode,etc., it must submit a change application to the original filingdepartment within the prescribed time, usually within 30 workingdays after the change

Accurate and complete application materials: When submitting achange application, accurate and complete application materialsshould be prepared according to the requirements, such as a copy ofthe changed business license, identification and qualificationdocuments of relevant personnel, proof of property rights or leaseagreement for the new address, etc