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国家药监局UDID数据同步实施指南(NMPA UDID GDSN Implementation Guide)

一、背景介绍 [Background]

  中国国家药品监督管理局分别于2018年12月20日和2019年7月24日发布了“YY/T 1630-2018 《医疗器械唯一标识基本要求》”和“YY/T 1681-2019 《医疗器械唯一标识系统基础术语》,并将分别于2020年1月1日和2020年8月1日实施。该两项医药行业标准对医疗器械唯一标识的基本原则、产品标识和生产标识做出了一系列要求,凡在中国境内销售、使用的医疗器械须遵守这些要求。随后,国家药品监督管理局信息中心组织编制了《医疗器械唯一标识数据库基本数据集》和《医疗器械唯一标识数据库填报指南》两项标准,并于2019年7月发布了征求意见稿[China National Medical Products Administration (NMPA) issued "Fundamental Requirements for Unique Device Identifier (YY/T 1630-2018)" on December 20, 2018 and "Basic Terms of Unique Device Identification System (YY/T 1681-2019)" on July 24, 2019, which will be implemented on January 1, 2020 and August 1,2020, respectively. The two pharmaceutical industry standards set out requirements for the basic principles of unique identification of medical devices, including product identification and production identification. All medical devices sold and/or used in China must meet these requirements. Subsequently, NMPA Information Center organized the drafting of "Basic Data Sets of the Unique Device Identification Database" and "Unique Device Identification Database Guidelines", and their drafts for comments were released in July 2019.]

        

  2019年8月23日,为贯彻落实《国务院办公厅关于印发治理高值医用耗材改革方案的通知》,规范医疗器械唯一标识系统建设,加强医疗器械全生命周期管理,依据《医疗器械监督管理条例》,国家药监局制定并发布了《医疗器械唯一标识系统规则》,自2019年10月1日起施行。随后,国家药品监督管理局根据前述标准和规则,建设了医疗器械唯一标识数据库(NMPA UDID,以供医疗器械企业填报UDI数据。20191210日,该数据库正式上线,进入试点阶段:201912月至20206月仅对试点企业开放数据申报功能。[On August 23, 2019, NMPA formulated and issued the “Rules of the Unique Device Identification System”, effective as of October 1,2019, according to the “Regulations for the Supervision and Administration of Medical Devices”, aimed at implementing the “Notice of the General Office of the State Council on Issuing the Reform Plan for the Control of High-value Medical Consumables”, standardizing the construction of the unique device identification system, and strengthening the whole-life-cycle management of medical devices. On December 10, 2019, NMPA launched its UDI Database (NMPA UDID) for selected pilot medical device enterprises to report their UDI data. The pilot is planned to last from December 2019 to June 2020.]

   中国物品编码中心GS1 China是中国医疗器械唯一标识的主要发码机构,其中国商品信息服务平台GS1 GDSN认证数据池。为方便系统成员统一填报和管理数据,特提供全球商品数据共享平台(http://b2b.gds.org.cn/,帮助国内外医疗器械行业的GS1系统成员通过GDSN向国家药监局UDID发布和管理UDI数据,以实现以下重要优势:[GS1 China is a major unique identification and coding institution for medical devices in China, and its China Product Information Service Platform is a GS1 GDSN certified data pool. In order to facilitate GS1 system members to report and manage data in a unified manner, we hereby provide a global product data sharing platform (http://b2b.gds.org.cn/)to release and manage UDI data in NMPA UDID through GDSN data pool(s) at home and abroad, so as to achieve the following important advantages:]

1.   单一数据源:为所有客户提供单一数据源的产品信息。通过使用全球公认的GS1标准和适用于所有供应商的GDSN流程,共享统一的产品主数据属性;[Single data source: provide all customers with product information from a single data source. A unified set of master data attributes is shared through the adoption of globally recognized GS1 standards and GDSN process that apply to all suppliers;]

2.  促进统一性:通过全球商品数据共享平台与中国商品信息服务平台的互连互通,实现基本数据的统一性;[Consistency: realize the consistency of basic data through the connection of the global product data sharing platform with China Product Information Service Platform;]

3.  增强合规性:通过从源头直接提供准确及时的产品信息,提高数据可视性,促进符合中国医疗器械可追溯性政策和法规。[Compliance: improve data visibility by providing accurate product information directly from the data source in a timely manner to promote compliance with China's medical device traceability policies and regulations.]

二、实施流程 [Implementation Process]


  具体步骤如下:[Actions to take]

  中国物品编码中心系统成员:请登录中国商品信息服务平台,在“我的应用”中,点击进入“UDI数据管理”,进行UDI数据填报和管理。[GS1 China members: please log in China Product Information Service Platform and click to enter “UDI Data Management”to report and manage your UDI data.]


   


  境外GS1系统成员联系当地GS1成员组织和/或GDSN数据池,通过数据池发布UDI数据至中国国家药监局UDID的GLN:6907777443952,或发布至目标市场:中国。请访问GS1全球总部官网查询当地GDSN数据池信息[Overseas GS1 members: please contact your local GS1 member organization and/or a GDSN data pool to publish your UDI data to NMPA UDID's GLN:6907777443952,or to Target Market: China. You may find a data pool on GS1 global website.


  注意:请按照NMPA UDID主数据属性要求填报数据。所有描述型UDI数据,都须以中文填报,明确允许使用英文的除外。[Note: please provide your UDI data according to the NMPA UDID Attribute Requirements (see below). All UDI data values of description fields must be provided in Chinese, except where English is expressly allowed or logical.]


三、国家药监局UDID主数据属性要求 [NMPA UDID Attribute Requirements]

  国家药监局UDID主数据属性分为必填属性和选填属性,例如,最小销售单元产品标识、分类编码、本体产品标识、注册证编号或者备案凭证编号、医疗器械注册人/备案人名称、目标市场、品牌名称、功能名称、产品描述、原产国、医疗器械灭菌方式、医疗器械尺寸,等等。关于属性要求的更多详情参见附件一。[China NMPA UDID's master data attributes include Mandatory, Required, Conditionally Required and Optional ones e.g., minimumSalesUnitDeviceIdentifier, productCode, directMarkDI, registrationOrFilingNumber, licenseHolder, brandName, productName/ProductGeneralName, deviceDescription, and so on. See Annex I for more details on attribute requirements.]


相关链接:[Useful Links]


  1. 中国医疗器械分类目录(2018年8月1日起施行)[Chinese National “Medical Device Classification Catalogue” (Effect as of August 1, 2018)]

  2. 6840 体外诊断试剂分类子目录(2013版)[Chinese“6840 In Vitro Diagnostic Reagents Classification Subcatalogue”(2013 Edition)]


  3. 免责声明: [Disclaimer]

    附件一”为国家药监局UDID数据属性与GDSN数据属性的映射表(“属性表”),由中国物品编码中心免费提供给行业及相关解决方案提供商参考使用。UDI数据的真实性、准确性和完整性由提供该等数据的医疗器械注册人/备案人负责。中国物品编码中心一直在努力使属性表保持完整、最新并提高其准确性,但不能保证属性表始终是准确、完整和最新的。因此,中国物品编码中心不对属性表中可能出现的任何错误承担任何责任,不为任何企业/组织机构或个人使用属性表所导致的结果负责。中国物品编码中心保留随时更改属性表而不另行通知的权利。[“Annex I”contains a mapping of NMPA UDID attributes to the GDSN data attributes (the “Mapping”). It is provided by GS1 China free of charge, as acourtesy, to industry and the solution providers supporting industry. The accuracy, completeness and correctness of the data provided to NMPA UDID are the responsibility of the data provider such as the manufacturer and/or license holder. While GS1 China is permanently undertaking efforts to keep the Mapping complete, up to date and to improve its accuracy, GS1 China cannot warrant that the Mapping is accurate, complete and up to date. GS1 China therefore disclaims any liability for any errors which may appear in the Mapping or for any use of the Mapping by any company, organization or individual.GS1 China retains the right to make changes to the Mapping at any time, without notice.]


  附件一:国家药监局UDID主数据属性表[Annex I: NMPA UDID to GDSN Attribute Mapping 20200211 v1.3]


附件列表


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