China Hopes To Implement Unique Device Identifier System By Year End

Article preview from "The Gray Sheet"- March 21, 2014

China has been talking about implementing a UDI system to track distribution of medical devices for years. Former CFDA and U.S. FDA experts now suggest that China plans to implement such as system by year end.

China Hopes To Implement Unique Device Identifier System By Year End

Article preview from "The Gray Sheet"- March 21, 2014

A new regulation on Unique Device Identification is likely to come out in 2014, which could impact the local medical device industry as well as foreign companies that want to export their products to China, according to experts.

U.S. FDA released its much-anticipated UDI final rule in September 2013, which requires device companies to ensure all Class III devices have a UDI entered into FDA’s global UDI database by September 2014. For Class II/I implantable and life-sustaining/life-supporting devices, the deadline is 2015 and 2016 for remaining Class II devices, and 2018 for remaining Class I and nonclassified devices. (See "Questions Remain On Incorporating UDIs Into Health Care System" — "The Gray Sheet," Nov. 27, 2013.)

China is expected to follow its peers to release a similar system in the country. “CFDA is still studying and evaluating the program of how to implement UDI in China,” Yan Liang, chairman of Shanghai Pudong’s Medical Device Trade Association [MDTA], told PharmAsia News, sister publication to “The Gray Sheet,” in an interview. “All multinational companies, such as Johnson & Johnson, Medtronic, and Smith & Nephew PLC are actively involved in discussions.” He said many hospitals are aware of UDIs and use them, and most domestic companies are taking a “wait and see” approach.

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