China Clarifies Seven UDI Exemption Categories and Special Labeling Cases
NMPA clarifies UDI exemptions, direct marking for reusable devices and electronic identification for standalone software. Regulix
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Medical Device UDI Implementation and Labeling Policy Insights
Regulix tracks implementation of China’s unique device identification system, including rollout schedules, exemptions, and special labeling cases. Coverage helps companies understand UDI requirements and assess the connections between regulatory submissions, device labeling, and identification data management.
China Sets 2027 and 2029 Milestones for Broader Medical Device UDI Coverage
China sets phased UDI requirements for remaining device categories, including registration-system submissions and database updates. Regulix
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