China NMPA UDI Requirements | Medical Device Compliance Resources

China NMPA UDI

China has implemented a national Unique Device Identification (UDI) framework administered by the  National Medical Products Administration (NMPA) to strengthen regulatory oversight and device traceability. The system supports standardized product identification and regulatory data submission requirements for medical devices marketed in China.

Implementation has progressed through phased compliance batches based on device classification. As additional milestones apply to remaining Class II and Class I devices, manufacturers placing products on the Chinese market must submit and maintain accurate UDI data in accordance with NMPA requirements, including defined issuing standards and product data elements.

As part of the Understanding UDI Series, this page provides access to slides, PDFs, video tutorials, and related resources to support organizations managing China NMPA UDI compliance.

LexisNexis Life Sciences simplifies that complexity. We support manufacturers across the entire product lifecycle — from initial market entry and UDI data preparation to ongoing updates, change management, and post-market compliance. Our global regulatory expertise and technology-driven solutions help ensure your device data stays accurate, synchronized, and inspection-ready, so you can focus on innovation while we help safeguard compliance.