UDI Implementation and Status in Chinese Taipei

The Taiwan FDA had published an Administrative Guidance of UDI on Oct. 30th, 2015; which is mostly harmonized with the UDI requirements of the IMDRF and US FDA. To help high-risk medical device manufacturers/companies meeting the UDI regulation and building a well-prepared healthcare environment, the Taiwan FDA has offered on-site UDI consulting for medical device companies, established the Taiwan UDI database and assisted hospitals from Chinese Taipei to implement the UDI system - the results are quite excellent in recent years.

In addition to the manufacturers/companies meeting domestic and foreign UDI requirement, there are five hospitals in Chinese Taipei that have adopted the UDI system and AIDC solution phase by phase in the Cardiac Catheterization Room, Operating Room and Central Warehouse through the UDI project of Taiwan FDA. The significant benefits of UDI implementation are: utilizing barcode readers or PDAs to capture the information from UDI label which can quickly and correctly identify medical products without manual or additional human intervention by either hospitals or manufacturers/ companies; this will decrease the workload and medical errors in the hospital, enhance the inventory management of medical items and improve the healthcare quality. And also, Taiwan FDA can use UDI to quickly obtain the information of adverse reactions or events for follow-up measures.

Given UDI is already an international trend, the UDI Compliance Date of Chinese Taipei is under discussion with the Taiwanese Draft Medical Device Regulation; once the new Medical Device Regulation has passed and is published, UDI will be the essential tool for medical device management and even for traceability in Chinese Taipei.

More information about Chinese Taipei UDI development, please contact: Christy Chen
Tel: +886-2-2393-9145 # 114 / christy.chen@gs1tw.org
 

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