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Understanding UDI Series
Gain answers to your questions about Unique Device Identification (UDI). Book time with a UDI expert for in-depth Q&A plus access to a library of tutorials and reference materials
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.
Slides and PDF
Video Tutorials
Related Resources
Ask the Experts: Comply with the China Class II Medical Device UDI
Staying current with China’s evolving UDI requirements can be challenging. Learn how NMPA deadlines may affect your ability to import and distribute medical devices.
Understanding UDI
Unique Device Identification (UDI) requirements vary by country and regulatory authority. Select a health authority below to access jurisdiction-specific guidance and resources.
USA
EUROPEAN UNION
CHINA
SOUTH KOREA
AUSTRALIA
SWITZERLAND
Need Guidance on UDI Compliance?
Understanding UDI obligations across global health authorities can be complex. Whether you are preparing for initial submission, managing product data updates, or aligning compliance across multiple markets, our regulatory experts provide practical guidance tailored to your organization’s needs.
