1. Why is UDI so important?
When the FDA released its proposed UDI rule, it identified several goals:
1.reduce medical errors;
2.Simplify the integration of device usage information into data systems;
3.Faster identification of medical devices with adverse events;
4.develop solutions to reported issues more quickly;
5.Provide a faster and more effective solution to device recalls;
6.Achieve more focused and effective FDA safety communications;
7.Easy access to original** unambiguous device identification information.
Under the UDI Final Rule, UDI will significantly reduce the barriers to adequate identification of medical devices in the U.S. market. Because UDI can quickly and unambiguously identify key attributes of device safety and efficacy, the presence of UDI will greatly reduce such medical errors. This is because these errors can be caused by improper labeling of the device or confusion about its proper use.
The advantages of the UDI system will gradually be reflected in the medical distribution system. The major medical device systems are included in the introduction to the promotion of UDISecurity, traceability, efficiency
The UDI system improves user safety, aftermarket supervision of new medical devices, and facilitates the innovation of medical devices. Considering the safety of users, when the UDI system is complete, medical devices with quality risks will be easier to track and monitor, the feedback on adverse events can be more effective, the review and analysis will be more accurate, which will help users solve potential safety hazards in the fastest time, and also facilitate the liquidation of medical insurance. Once counterfeit and shoddy products enter the market, query the sales network of the GUDID database, so that users can judge the authenticity of the products.
On the other hand, the introduction of the UDI system has also promoted the transformation of production enterprises, and urged enterprises to improve the quality management system to ensure the effectiveness and safety of products for the loss of profits caused by product recalls and potential safety hazards.
What are the Product Identification (DI) and Production Identification (PI) in 1-UDI?
Answer: "The product identification is the only one that identifies the registrant, the filing person, the model specification and packaging of the medical device; The production mark is composed of information related to the production process of medical devices, and can include the serial number of the medical device, the production batch number, the production date, the expiration date, etc., according to the regulatory and practical application needs. (Article 7 of the Rules for the Unique Identification System of Medical Devices).
2- Responsibility for creating, maintaining, and giving UDIWho is the subject?
Answer: "The registrant filing person is responsible for creating and maintaining the unique identification of medical devices in accordance with these rules, giving the unique identification data carrier of medical devices on the product or packaging, uploading relevant data, and using the unique identification of medical devices to strengthen the management of the whole process of the product. (Article 6 of the Rules for the Unique Identification System of Medical Devices).
Registrant The filing person shall create and maintain the unique identification of medical devices in accordance with the compilation standards for the unique identification of medical devices. The standards for the compilation of unique identification of medical devices shall comply with the relevant standards formulated by the State Drug Administration and the code issuing institutions that meet the requirements of these rules. (Article 9 of the Rules for the Unique Identification System of Medical Devices).
3- The current UDI issuance codeWhat are the institutions?
Answer: At present, there are 3 coding agencies that have uploaded the coding rules in the unique identification database of medical devices of the State Drug Administration, namely China Article Coding Center, Zhongguancun Gongxin Technology Research Institute and Ali Health Technology (China)** For information about coding institutions and their rules, please check the official website of the unique identification database of medical devices (
4-What forms can UDI data carriers take?
A: "The data carriers commonly used in the market today include 1D codes, ** and radio frequency tags (RFIDs). Registrant The filing person can select the appropriate unique identification data carrier for medical devices according to the characteristics, value, main application scenarios and other factors of the product. (Interpretation of the Rules for the Unique Identification System of Medical Devices).
5- What is the Unique Medical Device Identification Database (UDI Database)? Answer: The unique identification database of medical devices refers to the database that stores the product identification and associated information of the unique identification of medical devices. (Article 3 of the Rules for the Unique Identification System of Medical Devices).
The State Drug Administration formulates standards and specifications related to the unique identification data of medical devices, and organizes the establishment of a unique identification database of medical devices for public inquiry. (Article 13 of the Rules for the Unique Identification System of Medical Devices). In December 2019, the UDI database system was put into operation (in March 2020, the database provided shared services through three ways: query and interface docking. Who is responsible for uploading, maintaining, and updating the relevant data in the 6-UDI database? Answer: "The registrant filing person shall upload, maintain and update the relevant data in the unique identification database in accordance with the requirements of relevant standards or specifications, and shall be responsible for the authenticity, accuracy and completeness of the data. Article 14 of the Rules for the Unique Identification System for Medical Devices).7-Registrant Need to upload the Production Identifier (PI) information to the UDI database? A: No, you don't. Registrant The filing person needs to fill in the database whether the production identification (PI) contains the batch number, serial number, production date, and expiration date, please refer to the data filling instructions in the data declaration description column on the home page of the UDI database9. Which packaging levels are required to be given to UDI?
Answer: "The registrant filing person shall select the data carrier standard that is compatible with the unique identification of the medical device it creates, assign the unique identification data carrier to the minimum sales unit and higher-level packaging or medical device products of the medical device listed in its name, and ensure that the unique identification data carrier is firm, clear and readable during the operation and use of the medical device." (Article 12 of the Rules for the Unique Identification System of Medical Devices).