The Pilot UDI System Enters a Substantial Stage

The training course of the pilot unique device identification (hereinafter referred to as “UDI”) system sponsored by Department of Medical Device Registration, National Medical Products Administration and organized by National Medical Products Administration Institute of Executive Development was held in Beijing on August 27. Xu Jinghe, Deputy Director of the National Medical Products Administration (NMPA), attended the opening ceremony of the course and delivered a speech. Zhang Zongjiu, Director of Medical Administration Bureau, National Health Commission of the People’s Republic of China (hereinafter referred to as “NHC”), attended the opening ceremony of the course and delivered a speech.

In July this year, the Comprehensive Division of National Medical Products Administration and General Office of National Health Commission jointly issued Plan of Pilot UDI System, determined the pilot types of products and selected the pilot institutions. In August, National Medical Products Administration and National Health Commission jointly established the collaboration working group of the pilot UDI system department as the institution for discussion and coordination of pilot work to further strengthen the organization, leading, planning and coordination of pilot UDI system.

According to Xu Jinghe, this meeting was held not just for training, but also for mobilization and deployment, marking that the pilot UDI system had entered a substantial stage, a solid basis for the medical device supervision system in China to be scientific, law-based, international and modernized. Establishing the UDI system, reinforcing the source coding, and establishing a general inquiry and recognition of the medical devices covering the whole chain from production and clinical practice are not just helpful to realize a transparent, visual and smart medical device supply chain by lifting the enterprise informatization management, but also useful to build the big data about medical devices supervision, and ensure that the source of medical devices is traceable, the use is trackable and accountability is clear, so as to promote the smart supervision and optimize supervision effect and social governance.

Xu emphasized that in order to well accomplish the pilot UDI system, the importance to build UDI system must be fully emphasized and understood. UDI is an electronic ID card of medical products, the “international language”, “common language” and “professional language” of medical devices, and the basis to uniquely, uniformly and precisely identify the medical devices. The second is to make joint efforts to implement the pilot UDI system. The cooperation teams shall fully bear their responsibility, the using units participating in the pilot work shall bravely accumulate experience, the medical enterprises shall play well the main role and the association shall actively cooperate with them.

Zhang Zongjiu pointed out that the rapid change in medical device industry had advanced the diagnosis and treatment method, lifted clinical level and benefited numerous patients. Implementing UDI is a key to perfect precise clinical management and strengthen the risk control of medical devices in clinical application. National Health Commission will spare no efforts to cooperate with the China Drug Administration in related work, and demand the using units to actively participate in the pilot work and apply UDI, so as to play well its clinical role.

At the opening ceremony, Department of Medical Device Registration and Department of Medical Device Supervision introduced the medical devices registration management and post-market supervision respectively.
A total of 350 representatives from drug regulatory authorities and health departments from over 10 provinces (city and district), 108 using units (first batch participating in the pilot UDI system) and 116 medical device enterprises joined the training.