
Medical Device and Pharmaceutical R&D Manufacturer
Medical Device UDI Implementation Accelerates: This Medical Device Company Has Completed UDI Coding for All Products
Recently, WEGO Medical Products Company completed all technical validation work for the WEGO medical device Unique Device Identification (hereinafter referred to as “UDI”). The UDI coding for all products has been finalized, and the WEGO UDI database has been established. This database is integrated with the ERP and MES systems, enabling data sharing and interaction. To date,UDI Implementation Advanced Ahead of Schedule: WEGO Medical Products Company Took the Lead in Implementing UDI Management Among Domestic Peers
On December 25, 2018, the National Medical Products Administration issued the medical device industry standard “Basic Requirements for Unique Device Identification,” which came into effect on January 1, 2020. The related regulation “Rules for the Unique Device Identification System” and the standards “Terminology and Definitions for the Unique Device Identification System” and “Basic Data Set for the Unique Device Identification Database” are also imminent, signaling that the comprehensive implementation of Unique Device Identification (UDI) in China’s medical device industry is inevitable.
It is reported that the UDI consists of three components: the UDI code, the UDI data carrier, and the UDI database. The UDI code adopts a Data Matrix barcode format compliant with GS1 standards.Each product specification has a globally unique identification code, which serves as the product's exclusive "electronic ID."It enables automatic identification and precise traceability throughout the entire product lifecycle, including manufacturing, warehousing and logistics, hospital consumables management, national adverse event surveillance, and product recalls. This lays the foundation for informatized management of the product supply chain and will have a profound impact on optimizing supply chain efficiency. The UDI database consists of product identifiers together with the enterprise’s business license, production license, product registration certificate, and other product information.Users can query all information related to the product through the UDI database.
WEGO Medical Products Company Adopts a Phased, Step-by-Step Approach to UDI Implementation.
In the first phase, by the end of January, WEGO Medical Products Co., Ltd. completed the application of UDI labels on product outer packaging, developed an automatic UDI code assignment system for packaging, a networked label printing system, and a UDI scanning management system for inbound and outbound operations at the sales end. This enabled scan-based inventory management, ensuring consistency between goods and documentation while eliminating errors caused by manual data entry. The company also completed internal system debugging and on-site pilot testing in trial markets, with plans to promote and implement the system in the market from March to May 2019.
In the second phase, WEGO Medical Products Company planned to implement UDI coding for all product primary and secondary packaging from August to December 2019, thereby fully implementing UDI management. Ultimately, based on management needs, applications of UDI in automated warehouse management and logistics anti-channel conflict will be developed, and the experience gained from UDI implementation will be gradually extended to the Medical Products Group and the entire company.