上海市嘉定区市场监督管理局2025年6月份医疗器械经营企业监督检查结果公示

Summary of Medical Device Supervision Inspection Results in Shanghai Core Viewpoint The inspection results of medical device operating enterprises in Shanghai for June 2025 indicate a generally positive compliance status, with many companies passing inspections or being allowed to continue operations after necessary corrections. Group 1: Inspection Results - Shanghai Guoda Guangyuan Pharmacy Co., Ltd. passed the inspection on June 2, 2025 [4] - Shanghai Senhui Family Health Technology Development Co., Ltd. passed after rectification on June 3, 2025 [4] - Shanghai Shangjiu Medical Device Co., Ltd. was notified for limited rectification [4] - Shanghai Jiuying Trading Co., Ltd. passed the inspection on June 4, 2025 [4] - Shanghai Ligu Medical Technology Co., Ltd. passed after rectification on June 4, 2025 [4] Group 2: Categories of Medical Devices - Companies inspected include those dealing with medical protective equipment, sterile products, implant materials, and other categories [4][5] - The inspection results cover various levels of regulatory compliance, including Class I, II, and III devices [4][6] Group 3: Compliance and Rectification - Several companies were allowed to continue operations after making necessary corrections, indicating a proactive approach to compliance [5][6] - Companies such as Shanghai Yifeng He Xuan Pharmacy Co., Ltd. and Shanghai Aiyang Biotechnology Co., Ltd. passed inspections on June 5, 2025 [6][7] - The inspection process emphasizes the importance of maintaining standards in the medical device industry to ensure safety and efficacy [6][8]