A complete UDI system includes three parts: unique identifier, data carrier and database. The only identification is the electronic identification of medical device products; The data carrier is a data medium for storing or transmitting the unique identification of medical equipment; The database is used to store information related to product identification and unique identification of medical devices.
Under the background of information age, UDI is the key basic element to realize automatic identification, accurate recall, traceability, universal inquiry, information interconnection and intelligent management of medical device products.
Composition of UDI:
UDI consists of equipment identification (DI) and/or product identification (PI).
DI is a necessary and fixed part of UDI, which consists of enterprise identification code and product specification code. The enterprise identification code is applied by the registrant or the applicant, and the application is accepted by the coding organization that conforms to the coding rules and standards of medical devices in China, and the unique enterprise identification code in the world is allocated; Product specification code is a code compiled by registrant or record holder according to the characteristics of product model, specification and packaging. DI consists of enterprise identification code and product specification code, which is unique in the world.
PI is an unnecessary and variable part of the unique identification of medical devices, including production date, expiration date, batch number or serial number, etc. PI data does not need to be uploaded to the coding database, and all units can use general scanning equipment to analyze relevant production information locally.
UDI should conform to the principles of uniqueness, stability and expansibility. Uniqueness is the first principle of UDI, and ensuring that the unique logo of the product is not repeated is the basis of accurate identification and the core principle of the unique logo. The stability principle requires that UDI should be related to the basic characteristics of the product. If the basic characteristics of the product have not changed, the product identification should remain unchanged. The principle of scalability requires that UDI should adapt to the regulatory requirements and the continuous development of practical applications.