Interim measures for the configuration and application of large medical equipment management

Chapter I General Provisions Article 1 In order to promote the development of medical and health care, to protect people's health, the rational allocation and effective use of large-scale medical equipment, and give full play to the comprehensive benefits of health resources, the formulation of these measures. Article 2 The large medical equipment referred to in these measures refers to the application of health care work with a high level of technology, large, precise, valuable instruments and equipment.

Large medical equipment varieties catalog by the Ministry of Health regularly announced, and adjusted as needed. Article III of the Ministry of Health on the national configuration of large medical equipment, application and personnel on the implementation of three management; and in the spirit of safety, effective and appropriate principles, the establishment of large medical equipment, technical and economic efficiency evaluation and related configuration, technology, personnel management system, standards.

Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments in conjunction with the actual situation in the administrative region to implement. Article IV of this approach applies to the Chinese people *** and the state configuration, application of large medical equipment, medical and health institutions. Chapter II Configuration Management Article 5 The Ministry of Health in accordance with the national and different areas of socio-economic development, health care needs and medical institutions set up, the development of the national large-scale medical equipment, the overall configuration of the planning and regional quota allocation plan. Article VI Provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative departments according to the Ministry of Health to develop the overall allocation of large-scale medical equipment planning, regional quota allocation plan, combined with the situation in the region to develop a regional allocation of large-scale medical equipment planning and annual allocation plan, and submitted to the Ministry of Health for approval and implementation of the organization. Article VII application for the allocation of large medical equipment procedures are:

One, by the configuration of large-scale medical equipment to meet the conditions of health care institutions to the provincial, autonomous regions, municipalities directly under the Central People's Government of the health administrative department to apply and fill out the "configuration of large-scale medical equipment application form";

Second, the provinces, autonomous regions, municipalities directly under the Central People's Government of the administrative department of health, based on the large-scale medical equipment annual allocation plan approved by the Ministry of Health. Medical equipment annual allocation plan, unified approval and according to the specified time summary reported to the Ministry of Health for the record;

Third, the Ministry of Health in accordance with the provincial, autonomous regions, municipalities directly under the Central People's Government of the health administrative department reported annual allocation plan for approval and issuance of "large-scale medical equipment allocation license";

Only with the "configuration of large-scale medical equipment license" of the medical and health institutions can purchase large-scale Medical equipment. Article VIII of the Ministry of Health regularly organize professional and technical demonstration, based on the technical performance of large-scale medical equipment price ratio, regularly announced the national guide to equipment models. The purchase work advocates the use of public bidding, centralized purchasing. Chapter III Application Management Article IX Ministry of Health to identify and develop large-scale medical equipment application of safety, health protection, application of quality management standards, reported to the national technical supervision departments for the record; where the configuration of large-scale medical equipment, medical and health institutions must comply with the implementation and development of appropriate systems and operating procedures, the establishment of job responsibility system. Article 10 The Ministry of Health set up a "national application of large medical equipment technology review committee", responsible for the application of large medical equipment safety, health protection, technical quality management review.

Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments, can set up the corresponding organization, responsible for the administrative region of the application of large-scale medical equipment technology review. Article XI of large medical equipment application technology review committee by the health care administrators, engineers and technicians, clinical application professionals. Its work bylaws developed by the Ministry of Health Organization. Article XII of large-scale medical equipment into use, should be applied by the province of large-scale medical equipment application technology review committee to review the application of technology, qualified by the review, issued by the "large-scale medical equipment application of quality certification". Review every two to three years.

"Large medical equipment application quality certificate" printed by the Ministry of Health. Article XIII of the Ministry of Health, in conjunction with the national price management department to develop the application of large medical equipment charges.

Provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative department in conjunction with the regional price management department in accordance with the above principles to develop the local application of large-scale medical equipment charges. Chapter IV personnel management Article XIV of large-scale medical equipment, the implementation of technical assessment of personnel, on-the-job qualification system. Large medical equipment operators must be qualified by the examination, obtain the appropriate certificate, and in the provinces, autonomous regions and municipalities directly under the Central People's Government health administrative departments to register before taking up their work. Article XV of the Ministry of Health in accordance with relevant state regulations and large-scale medical equipment items unified development of the use of personnel qualification assessment standards and methods, printing and production of "large-scale medical equipment, technical qualification certificate".

Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments to organize and implement the use of large-scale medical equipment in the region operator technical assessment and qualification. Chapter V Supervision and Penalties Article XVI of the Ministry of Health is responsible for the implementation of these measures at the national level to carry out comprehensive supervision and inspection. Provinces, autonomous regions and municipalities directly under the Central People's Government health administrative departments are responsible for the implementation of these measures in the administrative region for comprehensive supervision and inspection. Article XVII of the violation of these measures, one of the following circumstances of institutions and individuals, by the provinces, autonomous regions, municipalities directly under the Central Government and the people's governments of the health administrative departments to impose penalties:

A health care institutions without the approval of the provinces, autonomous regions, municipalities directly under the Central Government and the people's governments of the health administrative departments, that is, without obtaining the "configuration of large-scale medical equipment licenses," and the unauthorized purchase of large-scale medical equipment, and shall be ordered to cease use! And may impose a fine of less than 10% of the purchase price; the main person in charge of the medical and health institutions and the person in charge of administrative sanctions.

Second, did not obtain the "application of large-scale medical equipment quality certification" and unauthorized use of large medical equipment, ordered to stop using; the application of large-scale medical equipment by the review and inspection of the quality of unqualified, ordered to stop using, and revoke its "application of large-scale medical equipment quality certification". The person concerned and the person in charge of administrative sanctions. Serious cases, the revocation of its "large medical equipment configuration license".

Three, without the assessment that did not obtain "large medical equipment on board personnel technical qualification certificate" of personnel, unauthorized use and operation of large-scale medical equipment, ordered to stop the use of the operation, and the person in charge of the parties and give administrative sanctions.