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.