办理条件
· 人员要求：
· 企业应具有与经营产品相关的在岗人员，具备相应知识和技能。
· 具有与经营产品相关的中专以上学历的技术人员。
· 质量管理人员应具有国家认可的、与经营产品相关的大专以上学历或相关中级以上技术职称。经营一次性使用无菌医疗器械的，还应有一名以上持有医疗器械质量管理体系内审员证书的内审员。
· 经营场所与仓库要求3：
· 经营场所的面积应满足低要求，通常经营场所的使用面积不得小于40 平方米；经营助听器的，经营场所使用面积应当不小于 25 平方米；经营隐形眼镜及护理用液的，经营场所使用面积应当不小于 10平方米。
· 企业应具备与经营规模相适应的仓库，仓库的面积、设施、环境等应满足医疗器械的储存要求。对于经营一次性使用无菌医疗器械的企业，仓库应在同一建筑物内，且使用面积不得小于200 平方米。
· 质量管理体系要求37：
· 企业应建立与经营的医疗器械相适应的质量管理制度，包括采购、验收、储存、销售、售后服务等各个环节的管理要求。
· 建立医疗器械质量管理档案或表格，对医疗器械的质量进行全程跟踪和记录。
· 定期对医疗器械进行质量检查和维护保养，确保医疗器械的质量和安全。
· 产品要求：必须要有合乎业务范围的产品信息，并出具证书3.
· 其他要求3：
· 企业应当为独立法人资格，经营范围带有“第三类医疗器械经营”。
· 应当具有与从事医疗器械经营活动相适应的计算机信息管理系统和库房信息管理系统。
· 具有与从事医疗器械经营活动相适应的售后服务能力。
办理流程
1. 准备材料347：
· 《医疗器械经营企业许可证申请表》。
· 营业执照副本及复印件。
· 法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明等资质材料。
· 房产证明、房屋租赁证明等，证明企业经营场所和仓库的产权或使用权。
· 企业负责人、质量管理人的简历。
· 医疗器械质量管理档案或表格。
· 申请材料真实性的自我保证声明。
· 其他相关材料，如供应商营业执照、许可证及授权书；质量管理文件；符合医疗器械经营要求的办公场地及仓库证明；公司章程、股东会决议；财务人员身份证和上岗证等。
2. 提交申请：将准备好的申请材料提交给所在地设区的市级食品药品监督管理部门37.
3. 受理审查37：
· 相关部门受理申请后，会在规定时间内对申请材料进行审查。
· 审查内容包括材料的完整性、真实性，以及企业是否符合二、三类医疗器械经营许可证的办理条件，如人员资质、经营场所和仓库条件、质量管理体系等方面是否达标。
4. 现场勘察：相关部门会安排工作人员到企业的经营场所和仓库进行实地勘察，核实场所的实际情况与申请材料中描述的是否一致，包括面积、布局、设施设备等是否符合要求37.
Processing conditions
·Personnel requirements:
·Enterprises should have on-the-job personnel related to theoperation of products, with corresponding knowledge and skills.
·Technical personnel with a vocational school diploma or aboverelated to the operation of products.
·Quality management personnel should have a nationallyrecognized college degree or above or a relevant intermediatetechnical title related to the operation of products. For theoperation of disposable sterile medical devices, there should alsobe one or more internal auditors holding a certificate of medicaldevice quality management system internal auditor.
·Business premises and warehouse requirements 3:
·The area of the business premises should meet low requirements,and usually the usable area of the business premises should not beless than 40 square meters; For those who operate hearing aids, theoperating area should not be less than 25 square meters; For thosewho operate contact lenses and care fluids, the operating areashould not be less than 10 square meters.
·Enterprises should have warehouses that are suitable for theirbusiness scale, and the warehouse area, facilities, environment,etc. should meet the storage requirements for medical devices. Forenterprises operating disposable sterile medical devices, thewarehouse should be located in the same building and the usablearea should not be less than 200 square meters.
·Quality Management System Requirement 37:
·Enterprises should establish a quality management system thatis suitable for the operation of medical devices, includingmanagement requirements for procurement, acceptance, storage,sales, after-sales service, and other aspects.
·Establish medical device quality management files or forms totrack and record the quality of medical devices throughout theprocess.
·Regularly conduct quality inspections and maintenance ofmedical devices to ensure their quality and safety.
·Product requirements: There must be product information thatmeets the business scope and a certificate must be issued
·Other Requirement 3:
·The enterprise should have independent legal personality andits business scope should include the operation of "Class IIImedical devices".
·It should have a computer information management system andwarehouse information management system that are suitable forengaging in medical device business activities.
·Having after-sales service capabilities that are suitable forengaging in medical device business activities.
Handling process
1. Prepare Material 347:
·Application Form for Medical Device Business License.
·Copy and photocopy of business license.
·Proof of identity, educational background or professionaltitle, and other qualification materials for the legalrepresentative, enterprise leader, and quality manager.
·Property certificates, rental certificates, etc., prove theownership or use rights of the enterprise's business premises andwarehouses.
·Resume of enterprise leader and quality managementpersonnel.
·Medical device quality management records or forms.
·Self assurance statement on the authenticity of applicationmaterials.
·Other relevant materials, such as supplier's business license,permit, and authorization letter; Quality management documents;Proof of office space and warehouse that meet the requirements formedical device operation; Articles of Association and Shareholders'Meeting Resolutions; Financial personnel ID card and work permit,etc.
2. Submit application: Submit the prepared application materialsto the food and drug supervision and management department at thecity level where the district is located