北京朝阳》医疗器械网络销售备案Zui快一周下证省心省事拿证

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

不良事件监测与报告

· 建立监测体系：建立医疗器械不良事件监测体系，指定专人负责收集、分析、报告医疗器械不良事件信息，及时发现和控制医疗器械可能存在的安全隐患4.

· 及时报告事件：当发现所经营的医疗器械出现不良事件时，应按照规定的程序和时限，及时向监管部门报告，并配合相关部门进行调查和处理，不得隐瞒、缓报或谎报4.

广告宣传与合规推广

· 在进行广告宣传和市场推广时，必须遵守国家有关广告法律法规的规定，确保宣传内容真实、准确、合法，不得含有虚假、夸大、误导性的内容，不得对产品的功效和适用范围进行虚假宣传，误导消费者

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

Adverse event monitoring and reporting

·Establish a monitoring system: Establish a monitoring systemfor adverse events of medical devices, designate a dedicated personto collect, analyze, and report information on adverse events ofmedical devices, and promptly discover and control potential safetyhazards of medical devices

·Timely reporting of incidents: When adverse events are found inthe medical devices operated, they should be reported to theregulatory authorities in a timely manner according to theprescribed procedures and time limits, and cooperate with relevantdepartments for investigation and handling. Concealment, delayedreporting, or false reporting are not allowed

Advertising and Compliance Promotion

·When conducting advertising and market promotion, it isnecessary to comply with the relevant advertising laws andregulations of the country, ensure that the promotional content istrue, accurate, and legal, and must not contain false, exaggerated,or misleading content. It is not allowed to make false propagandaabout the efficacy and scope of application of the product, whichmay mislead consumers