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2025年5月医疗器械注册质量管理体系核查结果
Group 1 - The article discusses the results of the quality management system inspections for medical device registrations conducted in May 2025 by the Guangdong Provincial Drug Administration [2][6] - Various companies and their respective products were evaluated, with some passing the inspection while others required corrective actions [3][4] - The inspections included a range of medical devices such as disposable catheters, X-ray systems, and diagnostic kits, indicating a broad scope of the medical device industry in Guangdong [5][6] Group 2 - Companies like Shenzhen Mindray Biomedical Electronics and Siemens (Shenzhen) Magnetic Resonance Co., Ltd. were mentioned, highlighting their involvement in the medical device sector [4][6] - The inspection results show a mix of compliance and non-compliance, with several companies needing to implement corrective measures before receiving approval [3][5] - The article emphasizes the importance of quality management systems in ensuring the safety and efficacy of medical devices in the market [2][6]