Recently, the innovative product Carbon Ion Therapy System of Lanzhou Ion Therapy Co., Ltd. is approved by China NMPA.

This product is the second domestic Carbon Ion Therapy System which is on par with international standards and with independent intellectual property rights. The approval of this products marks another important step forward of homemade high-end medical devices in China, and is of great significance for improving the methods and levels of tumors diagnosis and treatment in China.

This product includes 4 treatment terminals. Compared with the formerly approved carbon ion therapy system, it adds 2 more therapy rooms, the 45° and the 90° beam therapy room, reduces the beam spot size of the modulation scanning head, improves the beam intensity, shortens the beam turn-off time, configures an image guidance system, and upgrades the patient support device, therefore improving the efficiency and safety of treatment. After being approved, this product will further improve the treatment level, reduce treatment costs, and meet the treatment needs of patients with malignant solid tumors.

The practitioners should strictly use the product in accordance with the approved scope of application, and at the same time, strictly comply with the diagnostic and treatment standards of the health department.

Taking it as an innovative high-end product, China NMPA in accordance with the principle of "early intervention, special person in charge, whole process guidance and scientific review and approval", conducted active communication, made adjustment regularly and coordinated multiple departments to enhance the guidance of registration application and accelerate the marketing process of this product, so as to on the premise of ensuring safety and effectiveness, better meet the needs of patients to use high-end medical devices.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.