The Rules for Unique Device Identification System in China is issued by the NMPA/CFDA on August 23rd, 2019 and effective from October 1st, 2019.
The UDI shall be composed of product identifier and manufacturing identifier. The product identifier shall be the only identifier for the product registration holder, the model, the configuration and the package of the medical device, which is the “keyword” of the device from the device registered database. The manufacturing identifier provides the information for the manufacturing process, including product batch number, series number, manufacturing date, expiring date, etc, which shall be used together with the product identifier to fulfill the needs for medical device traceability during product distribution and usage.
The UDI can be in the format of 1D-code, 2D-code or Radio Frequency Identification (RFID). An UDI database shall be developed by the NMPA for public access.
This regulation is still very general, more detailed guidelines are expected in the near future to direct the implementation of the UDI system.