China NMPA Inspection - Zhejiang Judian Medical Equipment Co., Ltd. - July 19, 2016

An important report from the Zhejiang Provincial Food and Drug Administration, published on July 19, 2016, detailed the findings of an unannounced inspection of Zhejiang Guangci Medical Device Co., Ltd. The inspection revealed that the company's operations were not in compliance with the relevant requirements of the Good Manufacturing Practice for Medical Devices. Specifically, significant deficiencies were identified within the company's quality management system. As a result of these findings, the regulatory authority has issued a directive to Zhejiang Guangci Medical Device Co., Ltd., ordering them to rectify all identified deficiencies within a specified timeframe to ensure adherence to established medical device manufacturing standards.