UDI编码管理控制程序

1、UDI编码管理控制程序Control Procedure for UDI Coding Management文件编号 File No： XXXXXXX版本号/Version： 拟制/Compile： 审核/Review： 批准/Approval： 2020年12月30日发布2021年1月1日实施目的/Purpose为了控制UDI标识的唯一性和可追溯性，特制订本程序。This procedure is for controlled the unique and traceability of UDI适用范围/ Scope of application适用于本公司产品的UDI标识管理控制。This

2、 procedure is applied for controlling and management UDI on the medical device.职责/ Responsibility科技开发部负责申请和管理UDI；The technical development department is responsible for controlling the UDI coding质控部负责UDI标识的检验；The QC is responsible for inspection of the UDI marking.生产部负责UDI编码的实施。The production depart

3、ment is responsible for conducting of the UDI coding定义/ DefinitionUDI是通过全球接受的器械标识和编码标准来创立的一系列数字或字母数字字符，在市场上，允许 明确标识特定器械。UDI由UDI - DI和UDI - PI组成。欧盟的UDI那么由Basic-UDI-DI、UDI-DI和UDI-PI 组成。UDI - DI是专用于器械模型的唯一数字或字母数字码。UDI - PI是一种数字或字母数字码，用于识别器械生产单位。不同类型的UDI - PI包括序列号、批 号、软件标识和/或制造和/或到期日或上述两种日期。Basic UDI-DI

4、是器械型号的主要标识符，Basic UDI - DI是在器械使用单位的层面上分配的DIoBasic UDI - DI是在UDI数据库中记录的主键，也应在相关的证书和符合性声明中引用。The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on

5、 the market. The UDI is comprised of the UDI-DI and the UDI-PLThe UDI-DI is a unique numeric or alphanumeric code specific to a model of device.The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number

6、, software identification and manufacturing or expiry date or both types of date.要求和实施过程 Requirement and Work process一要求 General requirement标记UDI是额外要求不可替换产品标签或其他标记要求。制造商应指定并维护其器械的唯一 UDI。只有制造商可在其器械或包装上设置UDIo按欧盟法规要求，只能使用由委员会所指定颁发实体提供的编码标准。The affixing of the UDI is an additional requirement, it does n

7、ot replace any other marking or labelling requirements.The manufacturer shall assign and maintain unique UDIs for its devices.Only the manufacturer may place the UDI on the device or its packaging.Only coding standards provided by issuing entities designated by the Commission pursuant may be used.UD

8、I （唯一器械标识）要求 UDI （Unique device identification） requirementUDI应位于器械本身或其包装上，更高级别的包装应有其自己的UDLThe UDI-DI shall be unique at each level of device packaging.物流设备上无需有UDLThe UDI shall not be required on a logistics unit.UDI应包含两局部：UDI - DI和 UDI-PLThe UDI shall contain two parts: a UDI-DI and a UDI-PLUDI-DI在

9、各级别的器械包装上均是唯一的。The UDI-DI shall be unique at each level of device packaging.525假设标签上出现批号、序列号、软件标识或过期日期，那么其将是UDI - PI 一局部。假设标签上同时还标 有生产日期，那么UDI - PI中无需包含生产日期。假设在标签上只有生产日期，那么应将其用作UDI-PLIf a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the

10、UDI-PL If there is also a manufacturing date on the label, it does not need to be included in the UDI-PL If there is only a manufacturing date on the label, this shall be used as the UDI-PL526被视为器械且可在市场上购买的各组件应有其单独UDI,除非此类组件是以单独UDI销售的可配置 器械的一局部。Each component that is considered to be a device and is

11、 commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDL527在有可能导致器械的错误识别和/或其追溯性不明确时，尤其是以下任何UDI数据库元素发生的 变化需要新的UDI - DI时，将需要提供新的UDI-DLa）名称或商标名称b）器械类型或型号c）标记为一次性使用d）无菌包装e）使用前需消毒0包装中所提供器械的数量g）重要警告或禁忌症A new

12、 UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:name or trade name,device version or model,labelled as

13、 single use,packaged sterile,need for sterilization before use,quantity of devices provided in a package,critical warnings or contra-indications:UDI数据库原那么UDI数据库应支持所有UDI数据库核心数据元素的使用。制造商应负责首次提交和更新UDI数据库中的识别信息和其他器械数据元素。应运用正确的方法和程序对提供的数据进行验证。534.制造商应定期对与其投放到市场上的器械相关的所有数据进行核实，除非这些器械从市场上撤出。5.3.5 UDI数据库中存在

14、器械UDI - DI不得假设该器械符合欧盟法规的规定。5.36数据库应允许器械不同包装级别的链接。新的UDI - DI的数据应在器械投放市场时可用。产品Basic UDI-DI信息应在注册资料递交时递交。538.当对不需要新UDI - DI的元素进行更改时，制造商应在30天内更新相关的UDI数据库记录。539在可能的情况下，UDI数据库应使用国际公认的数据提交和更新标准。UDI数据库的使用者界面应适用于欧盟的所有官方语言。但为减少翻译，应尽可能减少自由文本 字段的使用。与市场上不再使用的器械相关的数据应保存在UDI数据库中。General principles of the UDI datab

15、aseThe UDI database shall support the use of all core UDI database data elementsManufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.Appropriate methods/procedures for validation of the data provid

16、ed shall be implemented.Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.The presence of the device UDI-DI in the UDI database shall not be assumed to mean that

17、 the device is in conformity with this Regulation.The database shall allow for the linking of all the packaging levels of the device.The data for new UDI-DIs shall be available at the time the device is placed on the market.Manufacturers shall update the relevant UDI database record within 30 days o

18、f a change being made to an element, which does not require a new UDI-DI.Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.The user interface of the UDI database shall be available in all official languages of the Union. The use

19、of free-text fields shall, however, be minimized in order to reduce translations.Data relating to devices that are no longer available on the market shall be retained in the UDI database.UDI的申请确定UDI编码颁发实体发码机构应满足如下要求。1）实体是具有法人资格的组织；2）其UDI分配系统足以根据本法规要求，在从分销到使用的整个过程中标识器械；3）其UDI分配系统符合相关国际标准；4）该实体可根据一组预定的和透明的条款和条件，将UDI分配系统的访问权限提供给所有相关使 用者：5）该实体做出以下几点承诺：在得到委任后，应能够运作其UDI分配系统至少10年；提供给委员会和各成员国使用，并应要求，提供UDI分配系统的相关信息；保持遵守指定标准和指定条款。在无特殊要求情况下，本公司选用中国物品编码中心(GS1)作为发码机构。申请厂商识别码科技开发部根据中国物品编码中心(GS1)的要求注册申请、续展及变更企业代码。并根据要求填 报产品信息。