my country's first proton treatment system is approved to be listed

In recent years, the State Drug Administration has fully implemented the requirements of the Party Central Committee and the State Council on the reform of the reform and approval system for deepening medical device review, and actively promoted the listing of innovative medical devices, national key R & D plans and major scientific and technological medical devices to promote high -quality development of industrial innovation. Better meet the health needs of patients.

On September 26, 2022, the State Drug Administration approved the application for the "proton treatment system" innovative product registration application produced by Shanghai Aipuqiang ion Equipment Co., Ltd. This product is a key support project of the "Digital Diagnosis and Treatment Equipment Special" during the "Thirteenth Five -Year Plan" period of the "Thirteenth Five -Year Plan" period. It is also the first domestic proton treatment system for listing in China. The approval of this product marks another step in the localization of my country's high -end medical equipment and equipment in China, which is of great significance for improving the medical tumor diagnosis and treatment methods and levels of my country's medical tumor.

This product consists of two parts: accelerator system and treatment system. The accelerator system includes an injector system, a low -energy transmission system, a main accelerator system, a high -energy beam transmission system and auxiliary electrical system. The treatment system includes a fixed beam therapy system, a 180 ° rotating beam treatment system and the treatment planning system. The product provides a proton beam for radiation therapy. While realizing the high doses of the tumor area, it can reduce the dosage of the surrounding normal tissue, especially the dose of tissue in the rear target area. The clinician is determined according to the actual situation.

Users should use the product strictly in accordance with the scope of application approved by the product, and at the same time, they should strictly abide by the diagnosis and treatment specifications of the health department.

In the process of registration and declaration of this product, the State Drug Administration in accordance with the principles of "advance intervention, special person responsibility, full guidance, scientific approval", actively communicated, coordinated by multi -party coordination, and increased by the premise of non -reduced standards and decreased procedures. Product registration and application guidance, accelerate the review and approval process, promote the product to be listed as soon as possible on the basis of ensuring safety and effectiveness, and meet the needs of patients using high -level medical devices.

Attachment: Innovative medical equipment approved by the State Drug Administration

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