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FDAnews Device Daily Bulletin
July 13, 2012 | Vol. 9 No. 137
Chinese Devicemakers to Face Tougher, More Frequent Inspections, SFDA Says
China’s State Food and Drug Administration (SFDA) has launched a trial program to increase unannounced inspections of medical device manufacturers and ensure companies are following good manufacturing practices. The program involves monitoring companies suspected of producing and marketing illegal or substandard products and ensuring the quality of company management. SFDA inspectors will also check for weaknesses in corporate supervision and in-house quality audits, according to a June 18 agency notice.
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