It is the most important part of the medical device unique identification system, with global uniqueness, can be used for accurate identification of medical device products, easy to regulate and traceability, so it is also known as the medical device product "digital ID card".
UDI exists in the entire life cycle of medical device production, circulation and use, and is the basis for accurate identification of medical device information. Its implementation will reduce the barriers of under-recognized medical devices in the marketplace, quickly and accurately identify critical information about the safety and effectiveness of devices, and reduce the number of resulting medical errors.
UDI consists of two parts: product identification (DI) and production identification (PI):
DI is the static information of the product, including the enterprise code and product ID, of which, the enterprise code is applied by the filer and issued by the code-issuing organization that conforms to the coding rules and standards for medical devices in China, and is a code with uniqueness.
PI is the product dynamic information, including production date, expiration date, production batch, serial number, calibration bit and so on.
In order to realize the traceability of the whole supply chain of medical devices, to assist in supervision and to protect the safety of patients, the concept of UDI has been put forward in the international arena, aiming to provide a globally unified program for the effective marking of medical devices. The GS1 international standard meets the requirements of all the UDI-related regulations that have been issued so far, which is not only conducive to international trade and helps medical device products to go out and come in in a better way. Moreover, it helps to expand the articulation and application of UDI in the fields of medical treatment and health insurance, and promotes the healthy development of the pharmaceutical industry.
First, standardize and vigorously implement. First of all, we should unify the device ID card, adopt UDI, unify the language of the medical device industry, improve the efficiency of the medical supply chain through the application of GS1 international standards in all aspects of the medical supply chain, and realize the medical device a code to determine the real body, a code to go all over the world, a code to trace the whole process.
Secondly, multiple parties should be involved to form a synergy. It is also important to note that medical devices involve a variety of industries and varieties, and are related to health. We hope that the production, operation, use, application, and even supervision of medical devices can be unified in all aspects of the coding standards, the full application of standardized concepts and methods to promote the orderly development of the medical industry.
Third, strengthen the publicity, good training. Through training, let our enterprises understand the standard, learn the standard, use the standard. Let the standard become the basis for supporting and leading the management of our enterprises, but also let the standard become an effective means to enhance the competitiveness of enterprises.