• Home
  • > UDI
  • > Chinese UDI requirements
  • Chinese UDI requirements

    Standard basis

    YY/T 1630-2018 Fundamental requirements for unique device identifier

    Basic principles and requirements

    Basic principles for UDI

    · Character requirements - GB/T 1988

    · Identification levels and requirements - regular models, lots and individual products

    · Checking mechanism - check code, to effectively avoid errors

    · Length of UDI - as short as possible

    · Each component of UDI can be identified - including data separator

    Product identification requirements

    · Structure composition - manufacturer identification code and product code

    · Related to package - all levels of package remain unique

    Production identification requirements

    Structure composition - including production lot number, serial number, production date and expiration date depending on the identification requirements

     Process for the registrant/recorder to implement the unique identification

    Step 1: the registrant/recorder selects the code issuing agency in accordance with the Rules and related standards, as well as the actual situation of the enterprise.

    Step 2: the registrant/recorder creates the product identification in accordance with the standards of the code issuing agency and determines the composition of the product identification.

    Step 3: from the implementation date of the Rules, for medical device registration, registration change, or recording, the registrant/recorder shall submit the product identification in the registration/recording management system.

    Step 4: the registrant/recorder selects the appropriate data carrier according to the standards of the code issuing agency, and assigns the unique device identification data carrier to the SKU and the higher-level package or medical device product.

    Step 5: the registrant/recorder uploads the product identification and related information to the unique device identification database before the product goes on sale.

    Step 6: when product identification and data-related information changes, the registrant/recorder updates the unique device identification database in a timely manner.