In order to help the majority of Class II medical device enterprises understand and implement the relevant policies and standards of UDI, and improve the compliance level and efficiency of UDI, on February 29, Ruizhan Data and Feitian Education successfully held a special training on "Unique Identification of Medical Device (UDI) Compliance Implementation Operation and Registration Declaration System Verification" through online live broadcast.
Lin Lei, product director of Ruizhan Data, served as the lecturer of the training. Based on the work experience and achievements of guiding enterprises to implement UDI in recent years, Mr. Lin shared dry goods and led everyone to start an in-depth UDI cloud classroom journey. The training content mainly focuses on the key points of UDI policy, UDI implementation process and division of labor, GS1-UDI registration application, UDI coding, UDI coding, label detection, and analysis of UDI difficulties.
At the end of the course, Mr. Lin answered many UDI-related questions raised by the participants. Considering that other non-participating companies may also encounter similar problems, this article summarizes some of the questions asked at the meeting:
QDo different packaging levels of medical device products have to be assigned different codes?
A:The DI will be different at each packaging level, except in special cases, for example, the minimum sales unit of the product and the use unit are in a 1:1 ratio, and the DI can be the same.
QDo different language versions of the packaging have to be given different UDI codes?
A:According to the GS1 General Specification, if the language of the packaging of medical device products is changed or deleted, a new DI needs to be assigned and the language is added, and the DI does not need to be changed.
QWhat should I do if some active equipment products cannot be marked on the body, and there is not enough space?
A:There are no hard and fast regulations on ontology identification in China. If exporting to the EU, UDI carriers can be placed on higher-level packaging if there are significant space constraints on the device itself.
QFor products that have already obtained the registration certificate, is it enough to directly handle the code assignment, and do they need to make other declaration changes?
A:For products that have been approved for registration, the registrant shall submit the product identification of its smallest sales unit in the registration management system when the product is renewed or the registration is changed.
QFor large electronic active products, one unit corresponds to a serial number, can UDI-PI not add a batch number?
A:OK. The composition of PI is determined according to the production management mode of the enterprise, for example: the product produced and managed by batch number can have no serial number; Products that are managed by serial number can be produced without a lot number if they do not have a lot number.
QCan downstream operators assign serial numbers to products?
A:No, the coding subject of the unique identification of medical devices should be the medical device registrant and filing person.
QThe UDI of the product is coded from the smallest sales unit, and the packaging indicator starts from 0 or 1?
A:There is no specific requirement for this, but it is generally recommended to start with 0.
QDo the DIs on the Level 0 and Level 1 labels need to be reported to the database, or do I only need to upload the DI on the Level 0 label?
A:The DI of each packaging level of the product must be reported to the NMPA database.
QWhat equipment can be used to detect the UDI code after printing to ensure the correctness of the UDI?
A:You can use professional PDA, grade testing instruments, etc. to detect the UDI code. The one-stop service platform of Ruizhan Data provides manual detection solutions (Ruisao Tong PDA) and automatic detection solutions (intelligent UDI tag detectors) to help enterprises build a solid line of defense for compliance.