北京丰台销售》医疗器械资质》办理周期2-3个月省心省事拿证

医疗器械销售资质的办理主要分为以下几种情况：

一类医疗器械销售资质

一类医疗器械销售相对简单，无需办理许可证，仅需办理营业执照，在经营范围中增加 “一类医疗器械销售” 即可356.

二类医疗器械销售资质

1. 准备申请材料123 ：

1. 营业执照副本复印件。

2. 法定代表人、企业负责人身份证明复印件。

3. 质量管理人员的学历或职称证明复印件，质量管理人员需具有国家认可的相关大专以上学历或者中级以上技术职称，并具有3 年以上医疗器械经营质量管理工作经历。

4. 经营场所、库房地址的地理位置图、平面图，以及房屋产权证明文件或租赁协议复印件。产品质量管理制度文件，包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等。

5. 与经营范围和经营规模相适应的设施、设备目录及发票或购买凭证复印件。

2. 网上申报与受理：将准备好的申请材料通过当地药品监督管理部门指定的医疗器械经营备案信息系统进行网上申报，并确保填报信息准确无误1.

3. 现场核查：药品监督管理部门会根据申请情况，安排工作人员对企业的经营场所、库房等进行现场核查，核实申请材料的真实性和企业的实际经营条件是否符合要求12.

4. 领取备案凭证：经审核通过且现场核查合格后，企业即可领取《第二类医疗器械经营备案凭证》，获得二类医疗器械销售资质12.

三类医疗器械销售资质

1. 申请营业执照：先向工商行政管理部门申请营业执照，经营范围需包含第三类医疗器械经营6.

2. 准备申请材料246 ：

1. 《医疗器械经营许可申请表》。

2. 营业执照副本复印件。

3. 法定代表人、企业负责人、质量负责人的身份证明、学历或职称证书复印件。其中，法定代表人兼任企业负责人的需有大专以上学历；质量负责人需具有相关大专以上学历且有3 年以上工作经验 。

4. 企业基本情况说明，包括组织机构与部门设置、经营范围、经营方式等。

5. 经营场所及库房的地理位置图、平面图，以及房屋产权证明文件或租赁协议复印件。办公面积一般不少于30平方米，仓库面积一般不少于40 平方米，且经营场所和仓库均不得设置在居民住宅内

6. 企业设施设备情况，如货架、地台板、温湿度计、空调、灭火器、计算机、打印机等设施设备的目录及发票或购买凭证复印件。

7. 企业质量管理制度、工作程序等文件目录及具体内容，需建立完善的质量管理体系，至少包括采购、进货验收、仓储保管、出库复核、质量跟踪、不良事件报告等制度和工作程序。

8. 计算机信息管理系统基本情况介绍和功能说明，证明其能满足医疗器械经营质量管理规范的要求，实现产品的可追溯管理。

Sales qualification for Class II medical devices

1. Prepare application materials 123:

1. Copy of Business License.

2. Copies of identification documents of the legalrepresentative and the person in charge of the enterprise.

3. Copy of the educational background or professional titlecertificate of the quality management personnel. The qualitymanagement personnel must have a nationally recognized relevantprofessional college degree or above, or an intermediate or aboveprofessional technical title, and have more than 3 years ofexperience in medical device operation quality management.

4. Geographical location map and floor plan of the businesspremises and warehouse address, as well as copies of propertyownership certificates or lease agreements. Product qualitymanagement system documents, including procurement, incominginspection, warehousing and storage, outbound review, qualitytracking system, and reporting system for adverse events.

5. A list of facilities and equipment that are suitable for thebusiness scope and scale, as well as copies of invoices or purchasevouchers.

2. Online application and acceptance: Submit the preparedapplication materials online through the medical device businessregistration information system designated by the local drugregulatory department, and ensure that the information filled in isaccurate and error free

3. On site inspection: The drug supervision and managementdepartment will arrange staff to conduct on-site inspections of theenterprise's business premises, warehouses, etc. based on theapplication situation, to verify the authenticity of theapplication materials and whether the actual operating conditionsof the enterprise meet the requirements

4. Obtain filing certificate: After passing the review andon-site verification, the enterprise can obtain the "Second ClassMedical Device Operation Filing Certificate" and obtain thequalification for selling second-class medical devices

Three types of medical device sales qualifications

1. Apply for a business license: First, apply for a businesslicense from the Administration for Industry and Commerce, and thebusiness scope should include the operation of Class III medicaldevices

2. Prepare application materials 246:

1. Application Form for Medical Device Business License.

2. Copy of Business License.

3. Copies of identity certificates, educational background orprofessional title certificates of the legal representative,enterprise leader, and quality manager. Among them, the legalrepresentative who also serves as the person in charge of theenterprise must have a college degree or above; The quality managermust have a college degree or above in a relevant field and atleast 3 years of work experience.