In recent years, the National Medical Products Administration has fully implemented the requirements of the CPC Central Committee and the State Council on deepening the reform of the medical device review and approval system, and actively promoted the marketing of innovative medical devices, including those in the national key research, the development program and the major project of science and technology, therefore to reinforce the innovation and high-quality development of the industry and to better meet the health needs of patients.

　　On September 26, 2022, the innovative product "Proton Therapy System" by Shanghai APACTRON Particle Equipment Co., Ltd. is approved by NMPA in China. The product is a major supporting project of the key research and development program "Digital Diagnostic and Therapeutic Equipment Program" of the Ministry of Science and Technology during the "13th Five Year Plan", and also the first domestically developed proton therapy system approved for marketing in China. The marketing of this product marks another step forward in the progress of the advanced medical devices made in China, and demonstrates great significance to improve the means and level of medical diagnosis and treatment of cancers in China.

　　The product consists of the accelerator system and the treatment system. The proton accelerator system includes a linac injector, a low-energy beam transfer line, a synchrotron, a high energy beam transfer line and an auxiliary electrical system. The treatment system includes a fixed-beam treatment system, 180-degree rotational beam treatment system and treatment planning system. The product provides proton beam for radiotherapy. It can deliver high dose in tumor volume, while significantly reducing the dose in surrounding normal tissues, especially in tissues behind the target volume. It is applicable to the treatment of solid malignant tumors and some benign diseases in the whole body. The specific indications should be determined by the clinicians according to the actual situation.

　　The product shall be used in strict accordance with the approved scope of indication, and at the same time the diagnosis and treatment guidelines formulated by the health authority shall be strictly followed.

　　During the registration of the product, NMPA, in accordance with the principle of "early intervention, assignment to specific person, whole process guidance, and scientific review and approval", under the premise of no compromising in standards and procedures, actively communicates and coordinates with multiple parties, and enhances guidance to accelerate the review and approval process. NMPA works to promote the marketing process as soon as possible on the basis that the safety and effectiveness of the product is ensured, so as to meet the patients' need of using advanced medical devices.

　　Attachment: Innovative Medical Devices Approved by NMPA (to be translated)