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China unveils GMP requirements

This article was originally published in The Silver Sheet

Executive Summary

Device manufacturers in China will be required to establish quality control systems under new good manufacturing practice (GMP) requirements issued by the country's State Food and Drug Administration (SFDA). The GMP interim requirements were posted on SFDA's Web site Dec. 30, along with a separate document on GMP inspections, which requires companies to file applications before facility inspections are conducted. According to an unofficial translation, provincial SFDA offices will examine GMP documents submitted by higher-risk Class II and Class III device manufacturing facilities and, in the case of Class III devices, forward an opinion to the central SFDA, which will then complete a review of the materials within 10 days. Onsite factory inspections will be performed either by the provincial SFDA offices or the central SFDA. Firms will be notified of an upcoming inspection five days ahead of time, with inspections generally expected to last two or three working days, according to the unofficial translation provided by the law firm Foley & Lardner. The rules will become effective Jan. 1, 2011
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