Zhong Guo Zhi Liang Xin Wen Wang·2025-11-20 08:23Core Insights - The article presents the results of quality management system inspections for medical device registrations in October 2025, highlighting the compliance status of various companies and their products [2][3] Group 1: Company Compliance Results - Shenzhen Huian Biological Technology Co., Ltd. successfully passed the inspection for the Influenza Virus Antigen Detection Kit after rectification on October 8, 2025 [2] - Shenzhen Yihuilong Biotechnology Co., Ltd. passed the inspection for the EB Virus Antigen IgG Antibody Detection Kit on October 8, 2025 [2] - Shenzhen Gamma Knife Technology Co., Ltd. passed the inspection for the Head Gamma Ray Stereotactic Radiotherapy System after rectification on October 10, 2025 [2] - Shenzhen Jingfeng Medical Technology Co., Ltd. passed the inspection for the Single-Port Laparoscopic Surgery System after rectification on October 15, 2025 [2] - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. passed multiple inspections for various medical testing kits and products between October 17 and October 22, 2025 [2][3] Group 2: Product Categories - The inspected products include diagnostic kits for various viruses, surgical systems, and medical imaging devices, indicating a diverse range of medical technologies being evaluated [2][3] - The successful inspections reflect the companies' adherence to quality management standards set by the Guangdong Provincial Drug Administration [3] Group 3: Regulatory Context - The inspections are part of a regulatory framework established by the Guangdong Provincial Drug Administration, which began notifying applicants of inspection results via SMS or web queries since May 2022 [3]