北京朝阳》医疗器械网络销售备案五个工作日内办结zui短时间拿证

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.

等待审批

现场检查（部分地区需要）

领取备案凭证

医疗器械二类备案的办理时间因多种因素存在差异，一般情况如下：

· 资料齐全且符合要求：

· 若企业前期准备充分，资料准确完备并满足规定，部分地区快当天可拿到备案凭证。

· 通常不少地区能在3-5 个工作日内完成备案，如太平洋投资（深圳）有限公司称一般资料齐全 5 个工作日可拿到证件16.

· 国甲商务服务(上海) 有限公司提到，若已有主体单位直接办理经营备案，一般 3 个工作日可完成3.

· 需要补充或修改材料：若提交的备案材料有问题或不完整，需按要求补充修改，会延长办理时间，申请人应在收到补正通知1 年内，按要求一次性提供补充资料6.

· 特殊情况或政策调整：

· 在政策调整、监管部门工作量大等特殊时期，办理时间可能延长6.

部分地区会优化审批流程，缩短办理时间，如湖北省重新修订相关程序后，整个流程时限压缩50% 以上

The following are the specific methods for filing Class II medicaldevices: Understand the filing requirements Prepare filingmaterials ·Basic information: Usually, a copy and photocopy of thebusiness license, a photocopy of the organization code certificate,and a photocopy of the legal representative's ID card are required·Personnel Qualification Certificate: Identity certificates,educational or professional title certificates of enterpriseleaders and quality management personnel. Quality managementpersonnel generally need to have a college degree or above andrelevant background, as well as some work experience ·Proof ofBusiness Premises: Provide proof of property ownership or leaseagreement for the business premises, as well as a geographicallocation map, floor plan, etc., to prove that it meets the businessrequirements, and that the business premises and warehouse must notbe located within residential buildings ·Quality managementdocuments: Establish a sound quality management system document,including management systems and operating procedures forprocurement, acceptance, storage, sales, after-sales service, andother links, such as quality management system, work proceduredocument directory, etc ·List of Facilities and Equipment: List thelist of facilities and equipment equipped in the business premisesand warehouses that are suitable for the operation of medicaldevices, such as shelves, temperature and humidity monitoringequipment, insect and rodent prevention equipment, etc ·Productinformation: If there are specific Class II medical device productsthat need to be registered, the technical information, productregistration certificate, supplier business license, and permit ofthe product must also be provided Waiting for approval On siteinspection (required in some areas) Obtain the filing certificateThe processing time for Class II filing of medical devices variesdue to various factors, and the general situation is as follows:·The information is complete and meets the requirements: ·If theenterprise is well prepared in the early stage, the information isaccurate and complete, and meets the regulations, some areas canobtain the filing certificate on the same day. ·Usually, manyregions can complete the filing within 3-5 working days. Forexample, Pacific Investment (Shenzhen) Co., Ltd. claims that thedocuments can be obtained within 5 working days with completegeneral information ·Guojia Business Services (Shanghai) Co., Ltd.mentioned that if an existing entity directly handles businessregistration, it can generally be completed within 3 working days·Materials need to be supplemented or modified: If the submittedfiling materials have problems or are incomplete, they need to besupplemented and modified as required, which will extend theprocessing time. The applicant should provide the supplementarymaterials as required within one year after receiving thecorrection notice ·Special circumstances or policy adjustments:·During special periods such as policy adjustments and heavyworkload of regulatory departments, the processing time may beextended by 6 However, some regions will optimize the approvalprocess and shorten the processing time. For example, afterrevising the relevant procedures in Hubei Province, the entireprocess time limit will be reduced by more than50%