经过全院员工的共同努力，近期我院医学检验科、妇科、产科、麻醉科、泌尿外科、心血管内科等6个新增专业在医疗器械临床试验机构备案管理信息平台上成功备案，广东省将组织专家到我院再次现场评审。此前我院内分泌科、神经内科和神经外科己通过广东省药品监督管理局组织的首次现场监督检查。至此，我院目前共有9个专业具备开展相关医疗器械临床试验研究的资质，表明我院在医疗器械临床试验方面的能力明显提升，也标志着我院临床研究工作迈上新台阶！

Through the joint efforts of all staff of the hospital, recently,t he 6 newly added specialties, namely Diagnostic Laboratory, Gynecology Division, Obstetrics Division, Anesthesiology Department, Urology Department and Cardiovascular Medicine Department, got registered successfully on the registration management information platform for clinical trial institutions of medical devices. Guangdong Province will organize experts to come to our hospital for another on-site review. Previously, the Endocrinology Department, Neurology Department and Neurosurgery Department of our hospital have passed the first on-site supervision and inspection organized by Guangdong Medical Products Administration. So far, a total of 9 specialties in our hospital have obtained the license to conduct relevant clinical trials of medical devices, which indicates that our hospital's ability in clinical trials of medical devices has been significantly improved and marks that the clinical research work of our hospital has entered a new stage!

2022年我院还计划争取完成内分泌科、心血管内科、妇产科、麻醉科等科室的药物GCP临床试验备案工作。未来，我院还将推动更多科室完成医疗器械临床试验机构备案工作，同时严格按照GCP相关要求，秉持着对临床试验价值和风险的正确认识及敬畏之心，加强对试验项目的质量管控，促进临床试验质量不断提高。

In 2022, our hospital also plans to strive to complete the registration of GCP clinical trials of drugs for Endocrinology Department, Cardiovascular Medicine Department, Obstetrics and Gynecology Department, Anesthesiology Department and other departments. In the future, our hospital will also motivate more departments to complete the registration of clinical trial institution of medical devices. Meanwhile, we will, in accordance with relevant requirements for GCP and upholding a correct understanding and respect for the values and risks of clinical trials, strengthen the quality control of trial projects and promote the continuous improvement of clinical trial quality.

特此报喜！

This good news is hereby issued!

深圳市萨米医疗中心

Shenzhen Sami Medical Center

2023年3月23日

March. 23/2022