Medical Device UDI Compliance Implementation Solution
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The implementation of medical device UDI compliance is primarily driven by three key factors:
First, according to the mandatory regulations of the National Medical Products Administration (NMPA), all medical devices must implement unique identification in phases and upload the data to the national database.
Second, driven by the industry’s own pain points—traditional methods can no longer meet the demands for precise traceability and recall—there is a need to leverage UDI to enhance supply chain efficiency and risk management capabilities.
Third, the technological conditions are now mature. The development of technologies such as QR codes, automatic identification, and cloud computing provides a reliable foundation for the efficient implementation of UDI. This solution is designed to help companies address compliance challenges.
Simultaneously achieve digital upgrading of production.
Core objective: Quickly and efficiently meet the National Medical Products Administration (NMPA) regulatory requirements for unique device identification, enabling end-to-end product traceability.
Hardware:
Thermal foaming technology, automatic printing and labeling technology for laser marking machines, TTO thermal transfer technology, and others.
Collection and Verification Equipment: Industrial-grade scanners, fixed-mount code readers, and vision inspection systems.
Printing equipment: Label printer (for packaging at all levels).
On the software side: Through the UDI management platform, we achieve deep integration with enterprise ERP, MES, and WMS systems, enabling automatic validation and one-click data submission to the National Medical Products Administration’s UDI database, thereby ensuring seamless compliance.
Implement full lifecycle management from production, warehousing, and outbound logistics to clinical use.
Relevant Cases
4/F, Building A1,No.10 Xicheng Zhong Street, Huangpu District, Guangzhou ,China.(510700)
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