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.