UDI (Unique Device Identification) is the abbreviation of the unique identification of medical devices, which is composed of product identification and production identification, which can give each medical device product a unique "digital ID", realize the transparency and visualization of production, operation and use, and improve the traceability of products.
The UDI system consists of a UDI identifier, a ULID database, and an AIDC data carrier
The UDI identifier consists of two parts: the production identification PI and the product identification DI.
1.Production Identifier (PI):The production mark is dynamic information, which is used to identify the production information of medical device products, including serial number, batch number, production date and expiration date, etc., and can be used in conjunction with DI to point to a specific medical device product.
2.Product Identification (DI):The product identification is static information, which is the identification of the device product, including the unique identification of the registrant, the filing person, the model specification and packaging of the medical device.
.Medical Device Unique Identification Management Information System (UDID):The unique identification database of medical devices "UDID" is organized and established by the State Drug Administration, and relevant standards and specifications for unique identification data of medical devices are formulated for public inquiry. The medical device unique identification management information system is mainly used for the declaration and management of medical device product identification (UDI-DI) and related information, and has the functions of UDI-DI maintenance, change and management.
4.AIDC Data Carrier:The UDI data carrier is the data medium through which the unique identification of a medical device is stored and/or transmitted. The UDI carrier of the device shall meet the requirements of machine identification (AIDC) and human eye readability (HRI), and can be in the form of one-dimensional barcode, two-dimensional barcode or RFID electronic tag.
According to the requirements of the "Rules for the Unique Identification System of Medical Devices" (hereinafter referred to as the "Rules") formulated by the State Food and Drug Administration:
Registrant The filing person shall submit its product identification in the registration and filing management system when applying for medical device registration, registration change or filing.
Registrant The filing person shall upload the product identification and related data to the unique identification database of medical devices before the product is put on sale.
The UDI traceability system integrates medical device usage information into the operation of the data system, identifies medical devices with adverse events, develops solutions to reported issues more quickly, enables focused and effective safety communication, and provides secure access to the original** with clear device marking information.