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植入材料和人工器官类医疗器械
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上海市嘉定区市场监督管理局2025年9月医疗器械经营企业监督检查结果公示
Core Points - The article presents the results of regulatory inspections for medical device companies in Shanghai, highlighting compliance and areas needing improvement [4][5][6][7] Group 1: Inspection Results - Shanghai Tinghe Technology Co., Ltd. passed the inspection for sterile products and implant materials on September 1, 2025 [4] - Shanghai Xinzhu Science and Trade Co., Ltd. required rectification but passed after improvements on September 1, 2025 [4] - Shanghai Haiyuyang Medical Technology Co., Ltd. successfully passed the inspection for medical devices on September 1, 2025 [4] - Shanghai Bobo Bibi Internet Technology Co., Ltd. passed the inspection for corneal contact lenses on September 1, 2025 [4] - Shanghai Hantao Medical Technology Co., Ltd. was given a deadline for rectification on September 1, 2025 [4] Group 2: Regulatory Categories - Companies were categorized into different regulatory levels, with most being classified as Level 2 or Level 3, indicating varying degrees of oversight [4][5] - The inspections covered various categories including sterile products, implant materials, medical protective equipment, and diagnostic reagents [4][5][6] Group 3: Compliance Status - A significant number of companies, including Shanghai Yirun Link Technology Group Co., Ltd. and Shanghai Jialong Radiation Protection Technology Co., Ltd., passed inspections without issues [4][5] - Several companies, such as Shanghai Furan Health Management Co., Ltd., required rectification but ultimately passed after improvements [4][5][6] - The inspections were conducted on various dates, primarily in early September 2025, with a focus on ensuring compliance with health and safety regulations [4][5][6][7]