The UDI (Unique Device Identification) medical device unique identifier is a series of numbers, letters or characters created through globally recognized standards for device identification and coding. It clearly identifies medical devices on the market.
The UDI consists of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier), which can include information about lot or serial numbers and can be used anywhere in the world.
The domestic UDI application can be divided into the following steps:
Step 1: Form an implementation team
Enterprises first need to self-examine and form a UDI implementation team. If the conditions for the formation of the team is not enough, or the implementation of a higher demand for efficiency, you can choose to fit the professional UDI service organizations, in the professional team guidance and technical support to carry out the full cycle of work.
The second step: choose the right code issuing organization
Enterprises need to follow the Rules and related standards, combined with their own situation to choose the right code issuing organization. At present, there are three organizations certified by GS1, according to AHM in the market. If you only consider the Chinese market, you can choose any one of the three code-issuing organizations. If you want to take into account the overseas market, you have to choose GS1 organizations that can meet the requirements of the regulatory authorities in China, the EU and the United States at the same time. (For more details, please refer to the previous article "When implementing UDI, how should an enterprise choose the right code issuing organization?)
The third step: UDI declaration
After selecting the code issuing organization, it is necessary to declare UDI:
First of all, it is the registration application of DI, and the more common declaration process is as follows: complete the registration and payment on the code issuing platform, and get the DI code → Enterprises code and verify according to the coding rules, and then log in to the platform of the Food and Drug Administration (FDA) to fill in the product information, and report DI code to the platform of the Food and Drug Administration (FDA). code to the FDA platform → the FDA database audits all the reported DI data and publishes the declaration status.
The fourth step: UDI code
After the audit, we must start the label design, through the software to generate the appropriate data carrier will be assigned to the product, if the use of RFID, it must be accompanied by a one-dimensional code or two-dimensional code labels, labels, in addition to the code charts but also Chinese labeling instructions, the label printing quality needs to be in line with ISO15415 standards, level C or above, and UDI data must be reported to the Drug Administration database and announced the declaration. Standard C or above, at the same time UDI code and code map content to maintain consistency, a code and a map, UDI also need to comply with the AIDC and HRI principles. Different coding devices require different software and different operating modes