UDI Mandatory Implementation — Class III (Completed) and Class II (In Progress)
China's NMPA is implementing a phased mandatory Unique Device Identification (UDI) programme. Class III devices have completed mandatory UDI implementation; Class II devices are in the phased rollout.
Manufacturers must:
- Assign a UDI-DI and UDI-PI to each device and packaging level.
- Label devices with the UDI in human-readable and machine-readable (GS1 DataMatrix or QR code) format.
- Register UDI data in the NMPA national UDI database (UDID) through the NMPA's electronic submission system.
🔖 Status: Class III — completed; Class II — phased implementation in progress
Manufacturers with Class II devices entering the Chinese market should confirm the applicable UDI compliance deadline for their specific product category. Class I devices are currently excluded from mandatory UDI. Engage your Overseas Agent early to coordinate UDID registration, as the process requires a NMPA account and Chinese-language submissions.
View official source (NMPA) ↗