Symposium on the Implementation of the Unique Device Identification System for Medical Devices Held in Beijing

China Food and Drug Network News – On the afternoon of July 18, the Symposium on the Implementation of the Unique Device Identification for Medical Devices, a key event of the 2022 National Medical Device Safety Publicity Week, was held in Beijing. The symposium was hosted by the Department of Medical Device Registration Administration of the National Medical Products Administration (NMPA), and co-organized by the Medical Device Standard Management Center and the Information Center. A responsible official from the Department of Medical Device Registration Administration of the NMPA delivered opening remarks. Representatives from medical device manufacturing and distribution enterprises, medical institutions shared their experience in implementing the Unique Device Identification (UDI) for medical devices. Representatives from provincial drug regulatory authorities introduced the progress of UDI implementation in their provinces (municipalities). The Information Center and the Medical Device Standard Management Center of the NMPA respectively introduced the progress of the UDI database construction, as well as relevant standards and technical follow-up research.

The Unique Device Identification (UDI) for medical devices is the “ID card” of a medical device. Assigning an ID to each medical device to realize transparency and visibility across all stages of production, distribution, and use, and to enhance product traceability, is an important lever for innovating regulatory approaches and improving regulatory efficiency. It plays a positive role in ensuring the safety bottom line of medical devices and promoting the high-quality development of the medical device industry.

In 2019, the NMPA issued the Rules for the Unique Device Identification System for Medical Devices, officially launched pilot work in July of the same year, and promoted the development of related information systems. In September 2020, the NMPA, the National Health Commission, and the National Healthcare Security Administration jointly issued the Announcement on Deepening the Pilot and Ensuring the Implementation of the First Batch of Medical Devices under the Unique Device Identification System, which clearly stipulated that, starting from January 1, 2021, the first batch of 69 product types in 9 categories of medical devices would officially implement UDI. In July 2021, the NMPA, the National Health Commission, and the National Healthcare Security Administration jointly issued the Announcement on the Implementation of the Second Batch of Medical Devices under the Unique Device Identification System, clarifying that, on the basis of the first batch, all remaining Class III medical devices (including in vitro diagnostic reagents) would be included in the second batch, to be officially implemented from June 1, 2022. Over the past three years, with strong support and joint efforts from all parties, the work has been steadily advanced and achieved good results.

During the discussion session, enterprise and medical institution representatives conducted in-depth exchanges with experts from regulatory authorities, discussing the challenges and difficulties encountered in the implementation of UDI for medical devices. They also put forward suggestions on the product scope and transition period for the third batch of UDI implementation, and offered insights for improving relevant UDI policies and standards. (Guoxun)