北京朝阳》医疗器械网络销售备案Zui快一周下证专业辅助办理

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

质量管理与追溯体系

· 建立质量管理体系：应建立完善的医疗器械质量管理体系，涵盖采购、验收、储存、销售、运输、售后服务等各个环节，确保所经营的医疗器械符合相关质量标准和技术要求。需制定并执行质量管理制度和操作流程，包括进货查验记录制度、销售记录制度等，对产品的来源和去向进行详细记录，以便追溯7.

· 定期开展质量自查：定期对质量管理体系的运行情况进行自查，评估各项质量管理制度的执行效果，发现问题及时整改，不断优化质量管理体系，确保其持续有效运行。

· 配合监管部门检查：积极主动地配合监管部门的日常监督检查、专项检查等，按照要求提供相关的文件、记录和资料，如实反映企业的经营情况，不得拒绝、阻挠或隐瞒4.

人员与培训要求

· 人员配备：配备与经营规模和经营范围相适应的技术人员，如质量管理人员、售后服务人员等，相关人员应具备相应的知识和技能，熟悉医疗器械相关法律法规和质量管理要求67.

· 人员培训教育：定期组织员工参加医疗器械法律法规、质量管理、知识等方面的培训，不断提高员工的业务水平和法律意识，确保员工能够正确履行岗位职责，保障医疗器械的经营质量.

产品管理与追溯

· 产品采购与验收：从具有合法资质的供应商处采购医疗器械，并严格按照规定对购进的产品进行验收，检查产品的包装、标签、说明书、合格证明等文件，确保产品的合法性和质量可靠性.

· 产品储存与养护：按照医疗器械的储存要求，设置相应的库房和储存条件，做好温湿度控制、防虫防鼠等工作，定期对储存的产品进行检查和养护，防止产品变质、损坏或过期67.

· 产品销售与追溯：在销售过程中，应向购买方提供合法有效的票据和产品相关信息，确保产品的可追溯性。建立销售记录档案，记录产品的销售日期、销售对象、产品名称、规格型号、数量等信息，以便在需要时能够快速追溯产品的流向17.

The following are the specific methods for filing Class IImedical devices:

Understand the filing requirements

Prepare filing materials

·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 arerequired

·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 of Business Premises: Provide proof of property ownershipor lease agreement for the business premises, as well as ageographical location map, floor plan, etc., to prove that it meetsthe business requirements, and that the business premises andwarehouse must not be located within residential buildings

·Quality management documents: Establish a sound qualitymanagement system document, including management systems andoperating procedures for procurement, acceptance, storage, sales,after-sales service, and other links, such as quality managementsystem, work procedure document directory, etc

·List of Facilities and Equipment: List the list of facilitiesand equipment equipped in the business premises and warehouses thatare suitable for the operation of medical devices, such as shelves,temperature and humidity monitoring equipment, insect and rodentprevention equipment, etc

·Product information: If there are specific Class II medicaldevice products that need to be registered, the technicalinformation, product registration certificate, supplier businesslicense, and permit of the product must also be provided

Waiting for approval

On site inspection (required in some areas)

Obtain the filing certificate

Quality Management and Traceability System

·Establish a quality management system: A comprehensive medicaldevice quality management system should be established, coveringvarious aspects such as procurement, acceptance, storage, sales,transportation, and after-sales service, to ensure that the medicaldevices operated comply with relevant quality standards andtechnical requirements. It is necessary to establish and implementquality management systems and operating procedures, includingpurchase inspection record system, sales record system, etc., tomake detailed records of the source and destination of products fortraceability

·Regular quality self inspection: Regularly conduct selfinspections of the operation of the quality management system,evaluate the effectiveness of various quality management systems,identify problems and rectify them in a timely manner, continuouslyoptimize the quality management system, and ensure its continuousand effective operation.

·Cooperate with regulatory authorities for inspections: Activelycooperate with regulatory authorities for daily supervision andinspections, special inspections, etc., provide relevant documents,records, and materials as required, truthfully reflect the businesssituation of the enterprise, and shall not refuse, obstruct, orconceal

Personnel and Training Requirements

·Personnel allocation: Equipped with technical personnel thatare suitable for the business scale and scope, such as qualitymanagement personnel, after-sales service personnel, etc. Relevantpersonnel should have corresponding knowledge and skills, befamiliar with relevant laws, regulations, and quality managementrequirements of medical devices

·Personnel training and education: Regularly organize employeesto participate in training on medical device laws and regulations,quality management, knowledge, etc., continuously improveemployees' business level and legal awareness, ensure thatemployees can correctly fulfill their job responsibilities, andguarantee the quality of medical device operation