Large medical equipment configuration license management directory (2023) policy interpretation
I. Background
In order to implement the spirit of General Secretary Xi Jinping's important instructions and approvals on health work and the decision-making and deployment of the CPC Central Committee and the State Council, based on the new stage of the development of the cause of health, and to further implement the "release of services" reform requirements. "Reform requirements, the National Health Commission in accordance with the "People's Republic of China *** and the Basic Medical Care and Health Promotion Law" "Medical Device Supervision and Management Regulations" and other laws, regulations and systems, in a comprehensive sorting out of large-scale medical equipment configuration management work based on the current situation of R & D and application of high-end medical equipment, the 2018 version of the large-scale medical equipment management directory Evaluation, extensive consultation with local health administrative departments, public medical institutions, social medical institutions, production enterprises and other relevant aspects of the views of the development of the "large medical equipment configuration licensing management catalog (2023)", together with the relevant departments reported to the State Council for approval and consent.
Two, the development of principles
One is in accordance with the law. Strictly in accordance with the "People's Republic of China *** and the State of basic medical care and health promotion law" "People's Republic of China *** and the State of administrative licensing law" "supervision and management of medical devices regulations" and other laws, regulations and systems to carry out their work. Secondly, simplification and decentralization. Actively implement the requirements of the reform of "management and service", mature technology, stable performance, application of standardized equipment, and actively promote the change from Class A to Class B or Class B out of the catalog. Third, safety first. Adhere to the people-centered, safeguard people's life safety and health. Fourth, promoting development. Promote the expansion of high-quality medical resources and regional balanced layout, and promote the high-quality development of health care.
Three, adjustments
Compared with the 2018 version of the catalog, the management items were adjusted from 10 to 6, of which, Category A was reduced from 4 to 2, and Category B was reduced from 6 to 4.
First, positron emission magnetic **** vibration imaging system (PET/MR) is adjusted from Category A to Category B. Second, 64 rows and above X-ray computed tomography scanner, 1.5T and above magnetic **** vibration imaging system out of the management items. Thirdly, heavy ion radiation therapy system and proton radiation therapy system were merged into heavy ion proton radiation therapy system. Class A spiral tomotherapy system (referred to as Tomo) HD and HDA models, Edge and VersaHD models of linear gas pedals and Class B linear gas pedals, gamma ray stereotactic radiation therapy system into conventional radiation therapy equipment. Fourth, the magnetic *** vibration-guided radiation therapy system into the Class A high-end radiation therapy equipment. Fifth, standardize the names of some equipment items. Sixth, adjusting the standard of pocket. Category A large medical equipment touting provisions set the price limit of a single unit (set) from 30 million yuan to 50 million yuan, Category B from 10-30 million yuan to 30-50 million yuan.
Four, supporting measures
The next step will be based on the new stage of development, the implementation of the new development concept, adhering to the people-centered, closely around the construction of a healthy China, improve the large medical equipment configuration management system, improve the access standards, the preparation of a new round of configuration planning, firmly guarding the people's lives and safety bottom line, to promote the cause of health development of high-quality, to better meet the health needs of the masses of people. The health needs of the people are better met.