In order to further strengthen the configuration and use of large-scale medical equipment management, developed the "large-scale medical equipment configuration and use of management measures" (see annex), is issued around, please follow.
Ministry of Health, National Development and Reform Commission, Ministry of Finance
December 31, 2004
Chapter I General
Article 1
In order to rationally configure and effectively use large medical equipment, to control the rapid growth of health costs, to safeguard the rights and interests of patients, and to promote the healthy development of the health sector, in accordance with the "Central Committee of the ****, State Council on health reform and development of the decision", the State Council forwarded by the State Council Reform Office and other eight departments "on the reform of the medical and health system in towns and cities of the guiding opinions" and "the General Office of the State Council on the retention of some of the non-administrative licensing approval program notice" to develop the measures.
Second
The large-scale medical equipment referred to in these measures refers to the State Council administrative department of health management items of medical equipment, as well as has not been included in the management of the items, the provincial area for the first time the configuration of the whole set of unit price of more than 5 million yuan of medical equipment.
Article 3
Large medical equipment management items by the State Council administrative department of health and relevant departments to determine, adjust and publish.
Article 4
Large medical equipment management items are divided into A and B categories. The amount of capital investment, high operating costs, the use of complex technology, the impact on the growth of health costs for large-scale medical equipment category A (hereinafter referred to as Category A), managed by the State Council administrative department of health. Management of other large-scale medical equipment in the catalog for large-scale medical equipment in Category B (hereinafter referred to as Category B), managed by the provincial health administrative departments. The relevant classification is shown in the Annex.
Article 5
Configuration of large medical equipment must be suitable for China's national conditions, in line with the principles of regional health planning, taking full account of the advanced technology, appropriateness and accessibility, the realization of the regional health resources **** enjoyment, and constantly improve the utilization rate of equipment.
Article VI
Large medical equipment management implementation of configuration planning and configuration certificate system. Class A large medical equipment configuration license issued by the State Council administrative department of health; Class B large medical equipment configuration license issued by the provincial health administrative department.
Article 7
Medical institutions to strengthen the use of large medical equipment management, strict operational standards to ensure that the use of equipment is safe and effective.
Article VIII
These measures are applicable to the Chinese people*** and the State territory of all levels and types of nature of medical institutions.
Chapter II Configuration Planning Editor
Article IX
The State Council administrative department of health, in conjunction with the National Development and Reform Commission, based on the development of China's national economy, medical science and technology advances, as well as social demand for multi-level medical services, the preparation of large-scale medical equipment, Class A configuration planning and large-scale medical equipment, Class B, the proposed configuration of the planning of planning guidance.
Article 10
Provincial health administrative departments, in conjunction with the relevant provincial departments under the State Council health administrative departments issued by the Class B large-scale medical equipment configuration planning guidance, combined with the allocation of health resources in the region to develop the Class B large-scale medical equipment configuration planning, reported to the State Council health administrative departments for approval and implementation.
Article 11
The State Council administrative department of health commissioned by the intermediary organization of large-scale medical equipment, advanced, economic and appropriate professional and technical demonstration, the regular release of ladder configuration of the selected models, to guide the configuration work.
Article 12
The State Council administrative department of health according to the clinical use of large medical equipment, combined with technological development and China's national conditions in due course to announce the elimination of models.
Chapter III configuration
Article XIII
Large medical equipment configuration approval must follow the scientific, reasonable, fair and transparent principle, strictly based on the configuration plan, after expert verification, according to the management authority for approval.
Article XIV
Configuration of large medical equipment procedures are:
A, the configuration of large medical equipment, by the medical institutions in accordance with the principle of localization of the location of the health administrative department of the application, level by level, the provincial health administrative department of the State Council for approval after examination and approval of the administrative department of health;
Second, the configuration of large medical equipment, the configuration of large medical equipment, by the medical institutions in accordance with the principle of localization of the health administrative department of the State Council. Medical institutions in accordance with the principle of localization to the local health administrative department to apply, reported to the provincial health administrative department for approval;
Third, the medical institutions to obtain "large medical equipment configuration license" before the purchase of large medical equipment.
Article XV
Health administrative departments in accordance with the management authority, from the date of acceptance of applications for large-scale medical equipment configuration within 60 working days, to make the approval of whether to agree.
Article 16
Article application materials and the main content
A new large medical equipment
1, application report. The main content includes: the basic situation of the applicant organization; to apply for the name of the equipment, specifications and main accessories; related auxiliary equipment name, number and use of personnel to obtain job training certificate;
2, feasibility study report, demand analysis. The main content includes: the main reasons for the application configuration; the application of the equipment technology development prospects; the role of clinical and scientific research; expected utilization; personnel to obtain post qualifications; acquisition of financial resources and economic analysis.
Two, update large medical equipment
1, the reason for updating the equipment, the purchase time;
2, apply for updating the equipment, "large medical equipment configuration license" copy;
3, the use of the situation: including the annual number of checkups and treatments, the number of days of power on, the number of days of failure and downtime;
4, the treatment of the update of equipment and The grade of equipment to be equipped.
Article XVII
The large-scale medical equipment purchased must have a state-issued production or import registration certificate; it must be purchased in accordance with the procurement methods stipulated by the state, and the procurement of equipment financed by government appropriations must be carried out in accordance with the provisions of the government procurement.
Article 18
The development, reform and finance departments shall not arrange funding for large-scale medical equipment that is not approved for configuration.
Article 19
The State Council administrative department of health, the provincial health administrative departments to the community to publish the annual approval of the configuration of large-scale medical equipment.
Article 20
Provincial health administrative departments shall report to the State Council administrative department of health annual approval of large medical equipment.
Chapter IV Management of the use of
Article 21
Large-scale medical equipment personnel (including doctors, operators, engineers and technicians, etc.) to receive job training, to obtain the appropriate qualifications.
Article 22
Large-scale medical equipment must be metered (dosage) accurate, safety and protection, performance indicators qualified before use.
Article 23
A, B large-scale medical equipment inspection and treatment charges by the State Council, the competent department in charge of prices in conjunction with the health administrative department to develop, and included in the "National Medical Services Price Project Specification". The State Council price department in conjunction with the State Council administrative department of health to develop large medical equipment inspection and treatment charges for pricing methods, to guide the local pricing behavior. Specific pricing methods by the State Council department in charge of prices, in conjunction with the State Council administrative department of health to formulate. For-profit medical institutions to implement market regulation of fees.
Article 24
It is strictly prohibited for medical institutions to purchase imported second-hand large medical equipment. Acquisition of other medical institutions to update the replacement of large-scale medical equipment, must be in accordance with the procedures set forth in these measures for the configuration of the approval.
Article 25
Strictly prohibit the use of the state has announced the elimination of models.
Chapter V Supervision and Management
Article 26
In accordance with the principle of hierarchical management, the configuration and use of large-scale medical equipment by the State Council administrative department of health and the supervision of the relevant departments at the same level; large-scale medical equipment by the provincial administrative department of health and the supervision of the relevant departments at the same level.
Article 27
Health administrative departments in accordance with the management authority, the configuration and use of large-scale medical equipment to supervise and inspect; the use of large-scale medical equipment and operational standards and the application of the quality of safety, effectiveness, protection of supervision and evaluation; large-scale medical equipment to obtain the qualifications of the staff to supervise and inspect.
Article 28
Price authorities at all levels above the county are responsible for the supervision and inspection of large-scale medical equipment inspection and treatment when the price charged.
Article 29
Development and reform, financial departments are responsible for government grants to subsidize the acquisition of large-scale medical equipment funds, investment supervision and inspection.
Article 30
Medical institutions shall promptly report to the relevant state management departments and the approval of large-scale medical equipment to report the adverse application of large-scale medical equipment occurring during the use of events.
Article 31
On violation of the provisions of these measures, over-planning, ultra-authoritative approval of the allocation of large-scale medical equipment of the health administrative department, the State Council administrative department of health shall be the main person in charge of the person in charge, the operator of the notification of criticism, and has the right to revoke its approval decision.
Article 32
On the violation of the provisions of these measures, unauthorized acquisition of large-scale medical equipment for medical institutions, the health administrative department shall order them to stop using and seal the equipment. The handling of the situation shall be announced through the media. The competent price department of the location shall have the right to confiscate the corresponding examination and treatment revenues it has acquired and impose a fine of up to five times the corresponding revenues.
Article 33
On the violation of the provisions of this Measures, the use of obsolete models and unqualified large-scale medical equipment for medical institutions, the health administrative department shall promptly seal the equipment, revoke its "large-scale medical equipment configuration license". The circumstances are serious, causing adverse impact, can be ordered to suspend its rectification; the local price authorities have the right to confiscate the corresponding examination and treatment income obtained, and impose a fine of up to five times.
Article 34
On violation of the provisions of this Measures, the employment of unqualified personnel to operate, use of large-scale medical equipment in medical institutions, the health administrative department shall promptly seal its large-scale medical equipment, and revoke the "large-scale medical equipment configuration license".
Chapter VI Supplementary Provisions
Article 35
After the promulgation of these measures, the medical institutions need to re-apply for the "large-scale medical equipment configuration license". Health administrative departments in accordance with the provisions of these Measures, in accordance with the management authority to handle the configuration license. In this way before the effective date of the acquisition of large medical equipment, but due to the total configuration of the region is still unable to obtain "large medical equipment configuration license" of the medical institutions, issued by the "temporary configuration of large medical equipment license. With "large medical equipment temporary configuration license" of the medical institutions, the corresponding equipment, diagnosis and treatment of income according to the for-profit institutions pay taxes, the equipment shall not be renewed at the expiration of the scrap.
Article 36
The Chinese People's Liberation Army medical institutions of large medical equipment configuration and use, by the Chinese People's Liberation Army health administrative departments with reference to the implementation of this approach to the management of its configuration planning and annual approval of the State Council's health administrative departments for the record.
Article 37
Large medical equipment configuration license printed by the State Council administrative department of health.
Article 38
The State Council administrative department of health is responsible for the interpretation of these measures.
Article 39
Provincial health administrative departments in conjunction with the relevant departments in accordance with these measures to formulate the corresponding implementation details.
Article 40
These Measures shall come into force on March 1, 2005, and the Interim Measures for the Management of the Configuration and Application of Large-Scale Medical Equipment issued by the Ministry of Health Order No. 43 of 1995 shall be repealed at the same time.
December 31, 2004
Attachment 2
Large medical equipment management items (the first batch)
Class A (State Council administrative department of health management)
1, X-ray - positron emission computed tomography (PET - CT, including positron emission tomography PET)
2, gamma-ray stereoscopic scanners (PET), gamma-ray stereoscopic scanners, gamma-ray stereoscopic scanners, gamma-ray stereoscopic scanners, gamma-ray stereoscopic scanners, and gamma-ray stereoscopic scanners. p>2, gamma ray stereotactic treatment system (γ knife)
3, medical electron cyclotron acceleration system (MM50)
4, proton therapy system
5, other items not included in the management of the region for the first time configured more than 5 million yuan unit price of medical equipment
Category B (managed by the provincial health administrative departments)
1, X-ray computed tomography (CT)
2, medical magnetic **** vibration imaging equipment (MRI)
3, 800 mA or more digital subtraction angiography X-ray machine (DSA)
4, single-photon emission computed tomography (SPECT)
5, medical electronic linear gas pedal ( LA)[1]
Ministry of Health on the announcement of the second batch of Class A large medical equipment management items notice
Wei Ji Cai Fa [2009] No. 43
Provinces, autonomous regions, municipalities directly under the Central Health Department:
According to the "large-scale medical equipment configuration and use of the management approach" (Wei Ji Cai Fa [2004] No. 474) is now announced. The second batch of Class A large medical equipment management items.
Please strictly in accordance with the relevant provisions of the management of large-scale medical equipment, conscientiously implement the system, and further improve the configuration of large-scale medical equipment, the use of centralized procurement management.
May 6, 2009
Attachments:
Category A large medical equipment management items (the second batch)
I. X-ray stereotactic radiotherapy system (in English called CyberKnife)
II. Tomotherapy system (in English called Tomo Therapy)
III, 306-channel magnetoencephalography
Four, endoscopic surgical instrument control system (in English called da Vnici S)
Ministry of Health on the announcement of the third batch of Class A large-scale medical equipment management items notification
Weijiwei regulations Caifa 〔2013〕 No. 4
Provinces, autonomous regions, municipalities directly under the central government Department of Health Bureau：
According to the "Large-scale Medical Equipment According to the "configuration and use of large medical equipment management approach" (health regulation financial hair [2004] No. 474), is now published in the third batch of Class A large medical equipment management items. Please strictly in accordance with the relevant provisions of the management of large-scale medical equipment, conscientiously implement the system, and further improve the configuration of large-scale medical equipment, the use of centralized procurement management.
January 17, 2013
Attachments:
Category A large medical equipment management items (the third batch)
A, positron emission magnetic **** vibration imaging system (PET-MR, including integrated and split two types)
TrueBeam, TrueBeam STX-type Medical linear accelerator
Three, Axesse-type medical linear accelerator