The 3rd batch of UDI will be fully implemented, upgrading the regulation of Class II and III medical devices

UDI, Unique Device Identifier, is a code consisting of numbers, letters or symbols attached to medical device products or packaging, which is used to uniquely identify medical devices and can effectively enhance the management efficiency of medical devices.

As the basis for the unique and accurate identification of medical devices, UDI is used throughout the production, distribution, and use of medical devices, helping to manage the whole life cycle of medical devices.

On 1 January 2021, the first batch of 69 medical devices in 9 categories was uniquely labelled; And on 1 June 2022, the second batch of Class III medical devices were labelled.

In early 2023, National Healthcare Security Administration issued a notice on "Rules and Methods for Coding In Vitro Diagnostic Reagents".

According to NHSA, China will follow the general requirements of "unified classification, unified coding, unified maintenance, unified publication and unified management" to unify the medical insurance coding standard as the common language for medical insurance information exchange in the new era.

Recently, the Tianjin Medical Products Administration issued the "Notice on the Demonstration and Promotion of the Unique Identification of Medical Devices" (hereinafter referred to as the "Notice").

The Notice points out that from 1 June 2024, the third batch of the UDI for medical devices will be fully implemented nationwide.

The Notice points out that all departments should further expand the implementation and application of UDI, take the initiative to connect with the whole stream, and strengthen the linkage of the whole UDI chain; further summarize their experience, form a long-term mechanism, continuously improve their work level, and effectively play a leading role; and actively undertake UDI dissemination training and observation and learning to further enhance the effect.

In the future, a unified and dynamic maintenance platform will be built to implement "full integration and coverage", forming a top-down coding system with uniform standards and norms for medical insurance, improving the quality of medical insurance business operations and decision-making management, and playing a supporting and leading role in the management of medical insurance through information standardization.