Recently, the State Food and Drug Administration organized an inspection team to conduct unannounced inspections on three companies including Tianjin Soma Technology Co., Ltd., and found defects in the quality management system of the companies. Details are as follows: 1. Tianjin Soma Technology Co., Ltd. (1) Institutions and personnel Insufficient ability of inspectors to perform …
On June 20, the NMPA approved the registration application for the innovative product “Head and Neck X-ray Stereotactic Radiosurgery Therapy System” produced by Ruipu Surgical Systems Co., Ltd. Product Information The product consists of 3MV medical linear accelerator, inclined axis and vertical axis frame, X-ray high voltage generator, X-ray tube assembly, X-ray detector, treatment bed, …
Head and Neck X-ray Stereotactic Radiosurgery System Approved for Marketing Read More »
In May 2023, the NMPA approved a total of 175 registered medical device products. Among them, there are 128 domestic Class III medical device products, 27 imported Class III medical device products, and 20 imported Class II medical device products.
