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。
· 申请材料6：
i. 申请表：《医疗器械经营备案申请表》。
ii. 营业执照：企业营业执照副本复印件。
iii. 人员证明：法定代表人、企业负责人、质量管理人员的身份证明、学历或者职称证明复印件。
iv. 场地证明：经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议复印件。
v. 制度文件：经营质量管理制度、工作程序等文件目录。
vi. 设备目录：经营设施、设备目录。
vii. 授权证明：经办人授权证明。
viii. 其他材料：根据当地监管部门要求可能需要提供的其他相关材料。
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。
· 制度要求：应建立健全质量管理体系，包括质量管理机构或者质量管理人员的职责，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。
· 设备要求：应具备与经营的医疗器械相适应的设施设备，包括办公设备、仓储设备、运输设备等，确保医疗器械的储存、运输条件符合要求。
· 申请材料378：
· 申请表：《医疗器械经营许可申请表》。
· 营业执照：企业营业执照副本复印件。
· 人员证明：法定代表人、企业负责人、质量负责人、技术人员等的身份证明、学历或者职称证明复印件。
· 场地证明：经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议复印件。
· 制度文件：经营质量管理制度、工作程序等文件目录。
· 设备目录：经营设施、设备目录。
· 计算机系统说明：计算机信息管理系统基本情况介绍和功能说明。
· 授权证明：经办人授权证明。
· 其他材料：根据当地监管部门要求可能需要提供的其他相关材料。
Handling of business licenses for three types of medicaldevices
·Application condition 378:
·Personnel requirements: It should have a computer informationmanagement system that meets the quality management requirementsfor medical device operation, ensuring the traceability of theproducts being operated; Enterprise leaders should have a collegedegree or above, be familiar with the laws, regulations, rules andnorms of medical device supervision and management, and haverelevant knowledge of the medical devices they operate; The qualitymanager should have a relevant college degree or above or anintermediate technical title, and should also have at least 3 yearsof experience in medical device operation quality management;Technical personnel suitable for the business scope and scaleshould be equipped, including at least one chief inspector orpersonnel with a bachelor's degree or above in inspection relatedfields and more than 3 years of experience in inspection work.
·Venue requirements: The venue should have a business premisesand warehouse that are suitable for the business scope and scale.The area of the business premises should generally not be less than30 square meters, and the area of the warehouse should generallynot be less than 40 square meters. The venue should be relativelyindependent and suitable for the business scope and scale.
·Institutional requirements: A sound quality management systemshould be established, including the responsibilities of qualitymanagement institutions or personnel, procurement, incominginspection, warehousing, outbound review, quality tracking, adverseevent reporting, and other systems.
·Equipment requirements: It should have facilities and equipmentthat are compatible with the medical devices being operated,including office equipment, storage equipment, transportationequipment, etc., to ensure that the storage and transportationconditions of medical devices meet the requirements.
·Application Material 378:
·Application Form: "Application Form for Medical Device BusinessLicense".
·Business License: Copy of the duplicate of the enterprise'sbusiness license.
·Personnel certification: copies of identity certificates,educational background or professional title certificates of thelegal representative, enterprise leader, quality manager, technicalpersonnel, etc.
·Venue proof: geographical location map, floor plan, propertyownership certificate or copy of lease agreement of the businesspremises and warehouse address.
·Institutional documents: Catalog of business quality managementsystem, work procedures and other documents.
·Equipment catalog: Business facilities, equipment catalog.
·Computer System Description: Introduction to the BasicInformation and Function Description of Computer InformationManagement System.
·Authorization certificate: Authorization certificate from theagent.
·Other materials: Other relevant materials that may be requiredby local regulatory authorities.