The latest large-scale medical equipment management measures introduced | No more than 5 units for the first time

According to the medical website of June 20, the National Food and Health Administration and the Food and Drug Administration of the United Nations issued a "Measurement for the Management of the Configuration and Use of Large Medical Devices" (hereinafter referred to as the "Measures") to regulate and strengthen the management of the deployment and use of large-scale medical equipment. At the same time, The former Ministry of Health, National Development and Reform Commission and the Ministry of Finance “Administrative Measures for the Allocation and Use of Large-scale Medical Equipment” (Weigui Financial Development [2004] No. 474), the former Ministry of Health “Regulations for the Management of New Large-scale Medical Equipment Configuration” (Guardian Financial [2013] No. 13) Repeal.

The "Measures" issued this time define the meaning and classification management of large-scale medical equipment again, which means large-scale medical equipment with complex technology, large capital investment, high operating cost, large impact on medical expenses, and inclusion of directory management. The medical equipment configuration management catalogue is divided into two categories: A and B. The National Health and Health Commission is responsible for configuration management and issuance of configuration licenses for Type A large-scale medical equipment. The Type B large-scale medical equipment is managed and issued by the provincial health administrative department. For licenses, health administrative departments at or above the provincial level should carry out assessments and assessments of large-scale medical equipment deployment plans and establish and improve third-party monitoring and evaluation mechanisms.

It is worth noting that the "measures" make it clear that the planning for the deployment of large-scale medical equipment for the first time shall not exceed 5 sets in principle. Among them, no more than 3 will be produced by a single enterprise. It is proposed for the first time that the planning of large-scale medical equipment deployment should fully consider the social office. Medical development needs, reasonable reservation planning space.

In addition, the "Measures" emphasized that medical device users must not use non-qualified certificates, expired, and expired. Large-scale medical equipment that has been phased out must not be used to upgrade equipment configuration performance or specifications in an unauthorized manner, avoid large-scale medical device configuration management, and strictly prohibit medical devices. The use unit has introduced large-scale medical equipment that has been developed overseas but has not yet been deployed outside the country.

In fact, the National Health and Safety Commission has never relaxed the supervision of the configuration and use of large-scale medical equipment. As early as April 9th ​​this year, the National Health and Nutrition Committee issued the “Large Medical Equipment Configuration License Management Catalog (2018)” (below Abbreviated as '2018 catalogue' ), major changes were made to Class A and Class B large-scale medical equipment that required permission to be configured.

The “Catalogue” reduces the number of Category A management catalogs from 12 to 5, among which, considering the narrow range of applications, the small clinical needs, and the elimination of technology updates, there will be 2 (medical electron cyclotron therapy systems, 306 magnetoencephalography ) Adjusted out the management catalog; Considering the maturity of technology development, price drop, clinical requirements and similar product development substitution and other factors, will be 6 (X-ray positron emission tomography scanner, endoscopic surgical instrument control system, gamma ray stereo Directional radiotherapy systems, popular types of helical tomotherapy systems, TrueBeam/Truebeam STX and Axesse linear accelerators) are adjusted to the category B management catalog; consider high technology, high risk and high prices, promote competition and other factors, will be 5 ( X-ray Stereotactic Radiotherapy System, Helical Tomotherapy System HD and HDA Two Models, Edge and Versa HD Two New Model Linear Accelerator) were merged into one. At the same time, the first deployment of large-scale medical equipment was included in the Category A management catalogue. The lower price limit has been adjusted from RMB 5 million to more than RMB 30 million.

Category B management directory was adjusted from 5 to 7, of which 3 were from the original category A (X-ray positron emission tomography scanner, endoscopic surgical instrument control system and gamma-ray stereotactic radiotherapy system) Adapted to Category B management catalog, the popular types of spiral tomotherapy systems and TrueBeam/Truebeam STX and Axesse linear accelerators were adjusted to linear accelerators in the Category B management catalog; consider technological developments, prices, clinical needs and development alternatives for similar products Factors such as adjusting X-ray computed tomography scanner (CT) to CT with 64 or more rows, adjusting the magnetic resonance imaging system (MR) to 1.5T or more MR; considering clinical application specifications, low configuration requirements and clinical diagnosis and treatment needs, etc. Factors, two (single photon emission computed tomography and X-ray digital subtraction angiography system) adjusted out of the management directory. At the same time will be the first configuration of 10-30 million yuan between large-scale medical equipment into Category B management directory.

On the whole, the list of licensed equipment is reduced by 30%. According to the 'Twelve Five' configuration quantity, the number of licensed equipment is reduced by 65%.

It is understood that in order to implement State Council Decree No. 680 and promote the scientific deployment and rational use of large-scale medical equipment, the National Health and Hygiene Committee has researched and proposed a '1+5' management framework for the deployment of large-scale medical equipment, ie, a regulation (State Council Order No. 680) plus five supporting system measures, namely a management directory ("Large Medical Device Configuration License Management Directory") and a configuration management method ("Management and Management of Large-Scale Medical Equipment"), 1 A configuration implementation details ("Details for the implementation of the "Large-scale Medical Equipment Configuration License Management"), a "13th Five-Year" configuration plan and a configuration approval and supervision platform, which will be constructed in accordance with China's national conditions for a period of time in the future. medicine The management of large-scale medical equipment required by the reform of the health system makes institutional regulations, focusing on key points, detailed measures, and efforts to solve problems such as 'what to manage', 'how to manage', 'total number', and 'where' and so on. The documents, other supporting management documents are currently submitted for approval.

All provinces, autonomous regions, municipalities and Xinjiang Production and Construction Corps Health and Family Planning Commission, Food drug Supervision Authority:

According to the "State Council, Amendments <medical instruments The "Decision of the Regulations and Regulations" (Decree No. 680 of the State Council) stipulates and strengthens the management of the deployment and use of large-scale medical equipment, and formulates the "Administrative Measures for the Deployment and Use of Large Medical Equipment (for Trial Implementation)" (available for download from the National Health Council's official website). ). Is now issued to you, please follow the implementation.

The first one is to further promote the decentralization of government, simplify management, decentralize management, optimize services, promote the rational allocation and effective use of large-scale medical equipment, ensure the quality and safety of medical care, control the excessive growth of medical expenses, and safeguard the health rights and interests of the people, according to the Administrative Licensing Law. 》"The State Council changes <医疗器械监督管理条例>The "Decision" and other laws and regulations stipulate that this method is formulated.

Article 2 The term "large-scale medical equipment" as used in these Measures refers to a large-scale medical device with complex use technology, large amount of capital investment, high operating cost, large impact on medical expenses, and inclusion of directory management.

Article 3 The list of large-scale medical equipment is proposed by the National Health and Sanitation Commission and the relevant State Council department and reported to the State Council for approval and implementation.

Article 4 The State implements hierarchical classification and configuration planning and configuration of license management for large-scale medical equipment according to the catalogue.

Article 5 The National Health Committee is responsible for the formulation and implementation of management systems for the deployment and use of large-scale medical equipment, and guides the evaluation and supervision of the deployment and use of large-scale medical equipment. Local health authorities at or above the county level are responsible for large-scale Medical equipment configuration and use behavior supervision and management work.

Article 6 The National Health and Sanitation Committee establishes an expert consultation committee for large-scale medical equipment management. It provides technical support for the identification, adjustment and management of catalogues, formulation and implementation of configuration plans, and configuration and use of the whole process management for assessment, consultation and demonstration.

The provincial health administrative department can set up a corresponding expert group.

Article VII of the medical device use unit configuration and use of large-scale medical equipment for medical services, apply these methods.

Article 8 The National Health and Hygiene Committee proposes a list of large-scale medical equipment configuration management based on the needs of medical services and the development of medical devices, combining capital investment, operating costs and operating costs, and technical requirements.

Article IX of the configuration of large-scale medical equipment management is divided into two categories of A, B. A large medical equipment by the National Health and Health Commission is responsible for the configuration management and issuance of the configuration license; B type large-scale medical equipment by the provincial health administrative department is responsible for configuration Manage and issue configuration licenses.

Article 10 The National Health and Hygiene Committee shall evaluate the safety, effectiveness, economy, and suitability of large-scale medical devices, and timely propose proposals for the adjustment of large-scale medical device management catalogues.

(i) Inclusion in the management directory;

(2) The equipment of Category A management directory is adjusted to the equipment of category B management directory;

(3) The equipment of Category B management directory is adjusted to be the equipment of Category A management directory;

(d) No longer included in the management directory.

Article 12: National health-related industry organizations and provincial-level health administrative departments may submit proposals to the National Health and Health Commission for the adjustment of large-scale medical equipment management catalogues. Medical equipment users may make adjustments to their provincial health administrative departments. , After assessment and evaluation, the provincial health administrative department deems it necessary, it may propose adjustments to the National Health and Sanitation Committee.

If the National Health and Hygiene Commission considers it necessary to adjust the management catalogue in the management of large-scale medical equipment, it shall promptly initiate the adjustment work.

The National Health and Sanitation Committee recommends the organization of argumentation and evaluation for the adjustment of large-scale medical equipment management catalogs. According to the argumentation and evaluation opinions, the relevant State Council department reports to the State Council for approval.

Article 13 The planning of large-scale medical equipment deployment shall be commensurate with the level of national economic and social development, advancement of medical science and technology, and the health needs of the people, in line with the planning of the medical and health service system, and promote the sharing of regional medical resources.

Article XIV of large-scale medical equipment configuration planning principle every five years, once implemented in different parts of the year. Configuration planning includes the number of plans, annual implementation plan, regional layout and configuration standards and other content.

The planning for the deployment of large-scale medical equipment for the first time shall in principle not exceed 5 units, of which, enterprise Produced, not more than 3 units.

The planning of large-scale medical equipment deployment should fully consider the development needs of social medical treatment, and reasonably reserve planning space.

Article 15 The provincial health administrative department, in conjunction with the regional health care service system plan, proposes regional large-scale medical equipment allocation plans and implementation plan proposals and submits them to the National Health and Sanitation Committee. The National Health and Health Commission is responsible for formulating large-scale medical equipment configuration plans. , To the public.

Article 16 The health administrative department at or above the provincial level shall carry out evaluations and assessments on the implementation of large-scale medical equipment deployment plans, and establish and improve third-party supervision and evaluation mechanisms.

Article 17: Where large-scale medical equipment deployment plans obviously do not meet national economic and social development, medical scientific and technological progress and people's health needs, or major changes to the planning of medical and health service systems, the National Health and Hygiene Committee should plan the deployment of large-scale medical equipment. Make adjustments.

The provincial health administrative department can propose adjustment proposals for the configuration of large-scale medical equipment in the region.

Article 18 The National Health and Sanitation Committee organizes the development and issuance of ladder types for large medical equipment grades. The medical device users should reasonably select large medical equipment according to functional positioning, clinical service requirements, medical technology level, and specialist development. Grades and models.

Article 19 Medical device users who apply for configuring large-scale medical equipment shall meet the configuration plan for large-scale medical equipment, be adapted to their functional orientation, clinical service requirements, have corresponding technical conditions, supporting facilities, and professional and technical personnel with appropriate qualifications and capabilities. .

If you apply for the configuration of a large-scale medical equipment for category A, apply to the National Health and Hygiene Committee; if you apply for the configuration of a large-scale medical equipment for category B, apply to the local provincial-level health administration department.

Article 20 The medical device users who apply for configuring large-scale medical equipment shall faithfully submit the following materials accurately:

(1) Large-scale medical equipment configuration application form;

(2) A photocopy of the medical device use unit's license for practice (or a copy of the medical device use unit's establishment approval document, or a copy of the certification of other legal person qualifications engaged in medical services that meet the requirements of relevant regulations);

(3) A copy of the unified social credit code certificate (or organization code certificate);

(IV) The technical conditions corresponding to the application for the configuration of large-scale medical equipment, the qualifications of supporting facilities and professional and technical personnel, and the capability certification materials.

Article 21 The health administrative department that accepts the application for disposition shall perform the third party expert review on the matters declared by the medical device user, and shall make a permit decision within 20 working days from the date of the application acceptance.

If it is necessary to organize the expert review in accordance with this method, the expert review time is not calculated within the license period.

Article 22 The National Health and Sanitation Committee is responsible for formulating the licenses for the configuration of large-scale medical equipment and the printing and distribution of "Large Type A Medical Device Allocation Permit". The provincial health administrative department is responsible for the administrative area. "B class large-scale medical equipment configuration permit" printing, distribution and other management work.

Article 23 The license for the deployment of large-scale medical equipment shall be issued in one machine, divided into originals and duplicates. For styles, see Appendix 1.

The original should specify: the name of the configuration unit, the legal representative or the main person in charge, the nature of the ownership, the address of the equipment configuration, the unified social credit code (or organization code), the name of the licensed device, the ladder configuration model, the license number, and the issuance Agency, issuing date and QR code.

The copy shall contain: The information contained in the original and the manufacturer of the configuration equipment, the specific model, the ladder configuration model, the product serial number, the installation date, the information submission date and the remarks information.

The date of issuance of a license for a large medical device configuration is the date of the license decision.

Article 24 The license number for large-scale medical equipment configuration consists of Chinese A and B (A and B represent A and B large-scale medical equipment) and 10 Arabic numerals. The numbering numbers are from left to right: 2 Province (autonomous region, municipality directly under the Central Government) code, 2 large-scale medical equipment category codes, 1 ladder type code, 5-digit sequential code. See Appendix 2 for the license number rules.

Article 25 After the medical device-using unit obtains a large-scale medical equipment configuration permit, it shall promptly allocate the corresponding large-scale medical equipment, and submit the relevant large-scale medical equipment-related information to the issuing authority. The time limit for configuration shall be stipulated by the issuing authority.

In the event of a change in the license information for a large-scale medical equipment configuration, the unit that uses the medical device shall submit the information to the original issuing authority within 10 working days from the date of the change of information. The issuing authority shall modify it within 10 working days from the date of receipt. Related Information.

Article 26 Units that use medical devices shall use and properly store large-scale medical equipments allocation licenses in accordance with the law, and shall not forge, alter, purchase, sell, rent or lend.

Medical device users should list information on large-scale medical device configuration licenses as information that is actively disclosed to the public. The original large-scale medical device configuration license must be suspended in a conspicuous place for use of large-scale medical equipment.

Article 27 Under any of the following circumstances, the license for the deployment of a large-scale medical device shall be invalidated automatically. The unit that uses the medical device shall return the license for the deployment of a large-scale medical device to the original issuing authority within 5 working days from the date of invalidation. The issuing authority will cancel it.

(1) The termination of the medical device use unit's license to practice (or the qualification of other legal person engaged in medical services);

(2) The related medical treatment subjects were cancelled;

(3) Failure to be allocated within the prescribed time limit without justification;

(4) Failing to configure the corresponding equipment according to the license issued for the distribution of large-scale medical equipment;

(e) the law, Regulation Other conditions specified.

If the third item of this article results in the invalidation of the configuration license, the applicant organization and the person in charge shall include the bad credit record.

If the license for a large-scale medical equipment configuration fails but the medical device-using unit still needs to use the equipment, it shall apply again according to the provisions of Article 19 and Article 20 of the present Measures.

Article 28 Large-scale medical equipments used by medical equipment use units shall obtain medical equipment registration certificates or record vouchers according to law.

Article 29 The National Health and Sanitation Committee and the provincial health administrative department shall separately disclose the permit conditions for the configuration of Class A and Class B large-scale medical equipment.

The provincial health administrative department shall submit to the National Health and Sanitation Committee in January of each year the permission of the large-scale medical equipment configuration of the previous year.

Article 30 The use of large-scale medical equipment should follow the principles of safety, efficiency, reasonableness and necessity.

Article 31 Units that use medical devices shall establish large medical equipment management files, record their purchase, installation, inspection, acceptance, use, maintenance, and quality control, and truthfully record the relevant information.

Article 32 Units that use medical devices shall carry out regular inspections, inspections, calibrations, maintenance, and maintenance in accordance with the specifications of large-scale medical equipment products, etc., to ensure that large-scale medical equipment is in good condition. Large-scale medical equipment must meet the requirements for accurate metering (dosage). , Radiation protection safety, performance indicators can be used before qualified.

Article 33 Units that use medical devices shall, in accordance with the requirements of national laws and regulations, establish and improve information security protection measures for the use of large-scale medical equipment to ensure the safety of relevant information systems and the safety of medical data.

Article 34 The health administrative department shall supervise and evaluate the use of large-scale medical equipment.

The medical device user shall bear the responsibility of using the main body. It shall establish and improve the evaluation system for the use of large-scale medical equipment, strengthen the assessment and analysis, promote the rational application, and regularly report the use condition to the health administrative department at or above the county level.

Article 35 Persons who use large-scale medical equipment should have corresponding qualifications and capabilities, and use large-scale medical equipment according to product specifications, technical operating specifications, etc.

Article 36 A medical device user shall promptly report a medical device adverse event monitoring technology institution in accordance with regulations when he discovers a large-scale medical equipment adverse event or suspicious adverse event.

If the medical device user finds that there is a potential safety hazard in the use of a large medical device, or if the external environment, user, or technology changes, and the use of safety and quality cannot be guaranteed, the user shall immediately stop using it. If the safety standard cannot be met after inspection and repair, the device may not continue to be used. use.

Article 37 Units that use medical devices must not use non-qualified certificates, expire or expire, and large-scale medical equipment that has been phased out must not be used to upgrade equipment configuration performance or specifications in the name of upgrading, and avoid large-scale medical device configuration management.

It is forbidden for medical device users to introduce large-scale medical equipment that has been developed overseas but has not yet been deployed outside the country.

Article 38 The National Health Council relies on the supervision and management information system for the configuration and use of large-scale medical equipment to promptly publish information on the supervision and management of the configuration and use of large-scale medical equipment, so as to facilitate public enquiries and social supervision. Medical device users should regularly report large-scale medical supplies. Device configuration using related information.

(i) Implementation of large-scale medical equipment deployment planning;

(ii) License and use of "Large Medical Device Configuration Licenses";

(iii) The use of large medical equipment and the use of information security;

(iv) Staffing of large-scale medical equipment;

(5) The unit that uses the medical device submits the use according to the regulations;

(6) Other circumstances stipulated by the health administrative department at or above the provincial level.

Article 40 For the supervision and inspection of medical equipment use unit allocation and use of large-scale medical equipment, random inspection objects shall be randomly selected, and law enforcement inspectors shall be randomly selected. The spot checks and investigation results shall be disclosed to the public in a timely manner. The following methods may be adopted:

(i) Regular inspections and random inspections;

(2) To inquire photocopying management documents, records, files, medical records, etc., or request relevant data and materials;

(c) On-site inspections, verification inspections and measurements;

(d) Real-time online supervision;

(5) Other supervision and inspection measures prescribed by laws and regulations.

Units and individuals using medical devices shall cooperate with related supervision and inspection, and shall not falsely report or report the relevant conditions.

Article 41 The health administrative department at or above the county level shall establish credit files for the units that configure and use large-scale medical equipment and their users. For those who have bad credit records, increase the frequency of supervision and inspection.

If the medical device user makes a false report on the application of a large-scale medical device configuration license and the use of a large-scale medical device, and the related situation is reported, the health and health administrative department shall notify the relevant department of the illegal record of the responsible person of the medical device use unit and the person directly responsible for the relevant information. Person's credit file.

Article 42 The State encourages industry associations to establish and improve self-discipline mechanisms, strengthen industry self-discipline and mutual supervision, and promote the safe and rational use of large-scale medical equipment.

Article 43 In case of violation of the provisions of these Measures, the health administrative department fails to submit the annual allocation permit information as required, or the management system of large-scale medical equipment is not perfect, and when the performance of its duties is not in place, the health administrative department at a higher level shall give a circular criticism to it. Order to correct.

Article 44 In case of violating the provisions of the present Measures, over-planning, exceeding the authority or illegally implementing the license for large-scale medical equipment configuration, it shall be dealt with in accordance with the "Administrative Licensing Law" and "Regulations on the Supervision and Administration of Medical Devices" and other relevant regulations.

Article 45: The medical device use unit does not follow the operating procedures, and the rational use of diagnosis and treatment norms. If the person who does not have the appropriate qualifications and ability uses large-scale medical equipment and cannot guarantee the quality and safety of the medical treatment, the health administrative department at or above the county level shall deal with.

Article 46 The National Health Council and the provincial health administrative department shall separately formulate the implementation rules for the administration of the license for the configuration of Class A and Class B large-scale medical equipment.

Article 47 Units that use medical devices shall report the technical conditions and use information of large-scale medical device users who have the same item in the catalog but have not implemented the configuration permit to the local health administrative department at or above the county level for record and publicize it.

Article 48 The configuration and management of large-scale medical equipment in the free trade trial zone approved by the State Council shall be carried out in accordance with relevant state regulations.

The purchase of large-scale medical equipment is performed in accordance with the relevant regulations of the country.

Article 49 These Measures shall come into force as of the date of promulgation. The Ministry of Health, the National Development and Reform Commission and the Ministry of Finance “Measures for the Administration of the Configuration and Use of Large Medical Equipment” (Weigui Financial Development [2004] No. 474), former Ministry of Health Regulations on the Administration of the Configuration of New Large-scale Medical Equipment (Waifeng Financial Development (2013) No. 13) is abolished at the same time.