Health Authorities in Asia
Resources for understanding Unique Device Identification (UDI) regulatory requirements in Asia including China and South Korea
Introduction to China UDI
The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices.
China NMPA has responsibilities including drafting laws and regulations for drugs, medical devices and cosmetics, as well as establishing medical device standards and classification systems. NMPA has implemented an electronic medical device registration management system and has identified UDI requirements. Although the regulatory process can be challenging due to rapid change, bringing medical devices to market in China is a high-potential future growth area for many US manufacturers.
See an update on medical device requirements in China. This presentation was part of RAPS 2021 Convergence.
CURRENT UPDATE: Batch 2 Medical Devices are due to NMPA for UDI submission on June 1, 2022.
September 30, 2020, China NMPA officially announced a delay to the UDI submission milestone for Batch 1 Medical Devices, from October 1, 2020 to January 1, 2021. The official/public announcement (in Chinese) is hosted here.
Additional Resources
Webinar Recording: What You Need to Know for Med Device UDI Submission to China
Blog: Fact vs Fiction UDI in China and Global Data Pools
Reference document: South Korea – UDI Guide
Reed Tech Insights: Global Data Governance Groups (Storage & Handling)
Reference document: Global UDI Timelines
Published Guidance: NMPA Medical Device UDI System Rules
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