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]

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]