On Nov. 24, 2022, the Guangdong Provincial Medical Products Administration dispatched a panel of experts to conduct a post-filing supervision inspection of medical device clinical trial operations at Shenzhen Maternity and Child Healthcare Hospital.

　　During the opening presentation, Vice President Wang Hao briefed the inspection team on the standardized establishment and operation of the hospital's Medical Device Clinical Trial Institution. Party Secretary Lin Yihao presented on the management and operations of the hospital's Ethics Committee. Dr. Yang Chuanzhong, principal investigator (PI) for the Neonatology specialty group, and Dr. Wu Weiqing, PI for the Clinical Cytomolecular Genetics specialty group, subsequently reported on the Good Clinical Practice (GCP) development within their respective departments.

　　The expert team conducted a comprehensive and rigorous on-site inspection. They examined key facilities, including the GCP Institution Office, Archives Room, Ethics Committee Office, Specialty Group Resource Rooms, and Subject Interview Rooms. They reviewed institutional policies, ethics guidelines, standard operating procedures (SOPs), and archive management records. Additionally, the experts inspected ongoing clinical trial projects and interviewed personnel to evaluate operational compliance.

　　Following the daylong review, the inspection team commended the hospital’s performance and recognized its clinical trial standards. The experts also identified areas for improvement and provided valuable recommendations to enhance the future development of the hospital's GCP operations.

　　During the closing session, Secretary Lin Yihao, who serves as Chair of the Ethics Committee, expressed gratitude to the provincial administration for its continued support and to the expert panel for its guidance. He stated that Shenzhen Maternity and Child Healthcare Hospital will fully implement corrective actions based on the panel's feedback.

　　This inspection plays a pivotal role in guiding and promoting the development of the hospital's clinical trial institution. Moving forward, the institution will strengthen training, address identified gaps, and adhere to rigorous standards in conducting drug and medical device clinical trials—continuously improving management operations and elevating overall clinical research capabilities.