China: SFDA Permits Unannounced Inspections of Medical Device Manufacturers

On June 18, 2012 the State Food and Drug Administration (SFDA) of China released the Working Procedures for Unannounced Inspection of Medical Device Manufacturers, effective immediately. It stated that the purpose of unannounced inspections is to standardize and strengthen inspection and supervision over the medical device manufacturing process in China. Manufacturing facilities of all types of medical devices are now subject to unannounced inspections. The SFDA may carry out unannounced inspections if the medical device manufacturer has a suspicious event, such as a significant product quality accident or illegal activity. Companies should keep a record internally of any inspection they have received.

An inspection team must involve at least two officers of either the SFDA or local provincial FDA. The Chinese officers will complete at least two forms that communicate to the manufacturer—(1) the reasoning behind initiation of the inspection and (2) the results of the inspection. The provincial FDA presiding over the manufacturer will receive the final report of the inspection process.

The inspection team may notify the local FDA of violations in order to sanction the manufacturers for administrative liability. Possible penalties may entail business activity suspension, business license retraction, or a fine up to five times the value of any income attained illegally. Once a manufacturer’s inspection has led to punishment by the authorities, the manufacturer will be subject to the risk of more frequent unannounced inspections. Throughout the inspection, however, the manufacturer may immediately explain, rectify, or contest any concerns found by the SFDA or local provincial FDA officials. While the concerns will still appear on the official forms, such action may discourage the inspectors from reporting the manufacturer to officials for sanction.