On April 16, NMPA held a seminar on the unique device identification system for medical devices to discuss the “Pilot Work Plan for Unique Identification System for Medical Devices”.
Unique Device Identification (UDI) is an identification of the medical device throughout its life cycle and is the only identification of the medical device in the product supply chain. The UDI consists of a device identification (DI) and a production identification (PI). The device identification belongs to static information, which is the identification of the medical device in the supply chain and can be used as a "keyword" to query the basic information of the product. The production identification belongs to dynamic information, which includes the serial number, batch number, production date and expiration date of the medical device. It is an additional information of the medical device, and it is used in conjunction with the device identification to direct to a specific medical device.
CIRS believes that the current process of informationization of medical devices data in China is relatively backward, and there is a problem of lag in information transmission. Therefore, the promotion of UDI will speed up the integration of China's medical device industry with the international market. From the government level, the establishment of UDI system can unify the identification of medical devices from the source, which is conducive to strengthening the supervision and management of medical devices in the development, production, operation and use. Also, the establishment of UDI system can improve the overall effectiveness of medical device supervision.
China Medical Device Regulation Related Resources provided by CIRS:
China NMPA Medical Device Filing and Registration Consulting
Clinical Trial Consulting
Medical Device GMP System Assessment
China Medical Device Regulation Training
Guideline: Medical Device Registration in China
Annual Report: Medical Device Market in China