China's first "carbon ion therapy system" of Lanzhou Ion Therapy Co., LTD. was approved for marketing on September 29, 2019. In order to further meet the needs of clinical patients, the No. 1 treatment room of the system has made technical improvements, expanded the therapeutic energy range, reduced the therapeutic beam spot size, and thus applied for registration change. The NMPA joint guidance working group, in accordance with the principle of "early intervention, special person in charge and scientific review and approval" and on the premise of not lowering standards or reducing procedures to safeguard people’s health, gives sufficient guidance and organizes institutions related to testing, inspection, evaluation etc. to review the documents of product technical requirements, registration test, clinical trial protocols and reports and to assess the quality system etc. On the basis of ensuring product safety and effectiveness, the registration change of the product is approved on December 7, 2022. After upgrading, the product will further meet the needs of malignant solid tumors treatment and improve the treatment level for clinical patients.

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