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广东省药品监督管理局发布2025年6月医疗器械注册质量管理体系核查结果
Zhong Guo Zhi Liang Xin Wen Wang· 2025-07-17 06:59
Group 1 - Multiple medical devices and diagnostic kits have passed the quality management system inspection and are set to be approved for market use by June 2025 [3][4][5][6][7][8] - Companies involved include Shenzhen Sogang Technology Co., Ltd., Shenzhen Puhui Medical Technology Co., Ltd., and Guangzhou Wanfu Biotechnology Co., Ltd., among others [3][4][5][6][7][8] - The products range from laser treatment devices to diagnostic kits for various medical conditions, indicating a diverse portfolio in the medical technology sector [3][4][5][6][7][8] Group 2 - The inspections are part of a regulatory framework established by the Guangdong Provincial Drug Administration to ensure the quality and safety of medical devices [8] - The approval process includes a thorough review of manufacturing practices and compliance with established standards [8] - The timeline for passing inspections and receiving approvals is critical for companies aiming to launch their products in the competitive medical device market [8]