以下是医疗器械二三类办理的相关内容：
二类医疗器械备案办理
· 申请条件28：
i. 人员要求：具有与经营规模和经营范围相适应的质量管理机构或者至少两名大专学历以上的质量管理人员，质量管理人员应当具有国家认可的相关学历或者职称。
ii. 场所要求：具有与经营规模和经营范围相适应的相对独立的经营场所，一般经营场所面积不低于50 平方米；具有与经营规模和经营范围相适应的贮存条件，库房面积一般不低于 15平方米，全部委托其他医疗器械经营企业贮存的可以不设立库房 。
iii. 制度要求：应当建立健全产品质量管理制度，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。
iv. 能力要求：应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力，或者约定由第三方提供技术支持。
三类医疗器械经营许可办理
· 申请条件378：
· 人员要求：应当具有符合医疗器械经营质量管理要求的计算机信息管理系统，保证经营的产品可追溯；企业负责人应具有大专以上学历，熟悉医疗器械监督管理的法律法规、规章规范和所经营医疗器械的相关知识；质量负责人应具有相关大专以上学历或中级以上技术职称，应具有3 年以上医疗器械经营质量管理工作经历；应当配备与经营范围和经营规模相适应的技术人员，其中至少有 1名为主管检验师，或具有检验学相关本科以上学历并从事检验工作 3 年以上的人员。
· 场所要求：具有与经营范围和经营规模相适应的经营场所和库房，经营场所面积一般不低于30 平方米，库房面积一般不低于40 平方米，场所应相对独立，并与经营范围和经营规模相适应。
以下是办理三类医疗器械经营许可证的常见申请材料清单：
1. 《医疗器械经营许可申请表》：需填写企业的基本信息、申请许可的经营范围、经营方式等内容128.
2. 营业执照：提供企业营业执照副本的复印件，以证明企业的合法经营资格，复印件需加盖企业公章126.
3. 人员证明：
1. 法定代表人、企业负责人身份证明：提供法定代表人及企业负责人的身份证复印件124.
2. 学历或职称证明：法定代表人、企业负责人、质量负责人等人员的学历证书或职称证明复印件。质量负责人通常需具有相关大专以上学历或中级以上技术职称，并具有3年以上医疗器械经营质量管理工作经历；经营植入介入类医疗器械的，还需配备医学相关大专以上学历，并经过生产企业或供应商培训合格的人员；经营体外诊断试剂的，应当有1 人为主管检验师或检验学相关本科以上学历且从事检验工作 3 年以上的人员178.
3. 人员简历：相关人员的工作简历，包括工作经历、职责范围、参与的项目等，以便监管部门了解其背景和工作经验8.
4. 组织机构与部门设置说明：提供企业的组织机构示意图，重点标注质量管理部门，并详细说明各部门的设置职能和人员组成情况14.
5. 经营范围、经营方式说明：明确企业拟经营的第三类医疗器械的具体品种目录，包括产品名称、生产厂家、规格型号、产品分类、注册证号，以及相应产品存储条件、要求的说明等内容。需说明企业的经营方式，如批发、零售、批零兼营等1.
6. 经营场所及库房证明：
1. 地理位置图：企业经营场所及库房地址的地理位置图，需清晰标注其所在位置及周边标志性建筑124.
2. 平面图：经营场所及库房的内部平面布局图，注明各区域的使用面积、功能划分，如办公区、仓储区、验收区、发货区等124.
3. 房屋产权证明文件或租赁协议：提供经营场所及库房的房屋产权证明文件复印件，若为租赁的场地，则需提供租赁协议复印件及出租方的房屋产权证明文件，租赁期限一般要求一年以上。如为转租，还需提供产权人的相关同意转租文件；如租赁协议即将到期，需提供产权人同意续租证明等124.
The following is a list of common application materials forobtaining three types of medical device business licenses:
1. "Application Form for Medical Device Business License": Basicinformation of the enterprise, the scope of business to belicensed, the mode of operation, etc. must be filled in
2. Business License: Provide a copy of the enterprise's businesslicense to prove its legal business qualification, and the copymust be stamped with the enterprise seal
3. Personnel certification:
Personnel certification:
1. Proof of identity of the legal representative and the personin charge of the enterprise: Provide copies of the ID cards of thelegal representative and the person in charge of the enterprise
2. Proof of Education or Professional Title: Copies of theeducation or professional title certificates of the legalrepresentative, enterprise leader, quality manager, and otherpersonnel. The quality manager usually needs to have a relevantcollege degree or above or an intermediate technical title, andhave more than 3 years of experience in medical device operationquality management; For the operation of implantable medicaldevices, it is also necessary to equip personnel with a medicalrelated college degree or above, who have been trained andqualified by the manufacturing enterprise or supplier; For thosewho operate in vitro diagnostic reagents, there should be oneperson as the main management inspector or a person with abachelor's degree or above in laboratory science and more than 3years of experience in laboratory work
3. Personnel Resume: Work resumes of relevant personnel,including work experience, scope of responsibilities, projectsparticipated in, etc., in order for regulatory authorities tounderstand their background and work experience
4. Explanation of Organizational Structure and DepartmentSetting: Provide a schematic diagram of the enterprise'sorganizational structure, with a focus on the quality managementdepartment, and provide a detailed explanation of the functions andpersonnel composition of each department
5. Business scope and mode of operation description: Clarify thespecific variety catalog of the third type of medical devices thatthe enterprise intends to operate, including product name,manufacturer, specifications and models, product classification,registration certificate number, as well as corresponding productstorage conditions and requirements. At the same time, it isnecessary to explain the business model of the enterprise, such aswholesale, retail, wholesale and retail operations, etc
6. Proof of business premises and warehouse:
1. Geographical location map: A geographical location map of theenterprise's business premises and warehouse address, clearlyindicating its location and surrounding landmark buildings
2. Floor plan: An internal layout plan of the business premisesand warehouse, indicating the usage area and functional division ofeach area, such as office area, storage area, acceptance area,shipping area, etc
3. Property ownership certificate or lease agreement: Providecopies of the property ownership certificate for the businesspremises and warehouse. If it is a leased premises, provide copiesof the lease agreement and the lessor's property ownershipcertificate. The lease term generally requires more than one year.If subleasing is required, relevant consent documents from theproperty owner must also be provided; If the lease agreement isabout to expire, proof of consent from the property owner to renewthe lease must be provided