China's first domestic proton therapy system was approved for listing

In recent years, the State Drug Administration has fully implemented the requirements of the Party Central Committee and the State Council on deepening the reform of the medical device review and approval system, actively promoted the listing of innovative medical devices, national key research and development plans and major scientific and technological special medical devices, promoted the high-quality development of industrial innovation, and better met the health needs of
patients.

On September 26, 2022, the State Drug Administration approved the application for
registration of innovative products of "Proton Therapy System" produced by Shanghai Aipuqiang Particle Equipment Co.

The product consists of two parts:
an accelerator system and a treatment system.

The user shall use the product in strict accordance with the scope of application approved by the product, and shall strictly comply with the diagnosis and treatment specifications
of the health department.

In the process of registration and declaration of the product, the State Food and Drug Administration in accordance with the principle of "early intervention, special person responsible, full guidance, scientific approval", under the premise of no reduction in standards and no reduction in procedures, actively communicate, multi-party coordination, increase product registration and declaration guidance, accelerate the review and approval process, and promote the listing of products as soon as possible on the basis of ensuring safety and effectiveness, so as to meet the needs
of patients using high-level medical devices.

Annex: Innovative medical devices approved by the State Food and Drug Administration

Annex .