Circular on Issuing the Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation)
Circular on Issuing the Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation)
Circular on Issuing the Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation)
Guo Wei Gui Hua Fa [2018] No.12
May 22, 2018
Health and family planning commissions and food and drug administrations of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps,
The Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation) (hereinafter referred to as the "Measures"), which can be downloaded from the official website of the National Health Commission) have been formulated in accordance with the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices (Order of the State Council No.680), in order to standardize and strengthen the administration of the allocation and use of large medical equipment. The Measures are hereby issued to you for your compliance and implementation.
Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation)
Chapter I General Provisions
Article 1 The Measures are formulated in accordance with the Administrative Licensing Law, the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations, in order to further advance streamlining government functions and administration and delegating powers while improving regulation, and optimizing services, promote the rational allocation and effective use of large medical equipment, ensure the medical quality and safety, control the rapid growth of medical expenses, and safeguard the health rights and interests of the general public.
Article 2 For the purpose of the Measures, large medical equipment refers to large medical devices that adopt complex technology, require large capital investment, have high operation costs, have significant impact on medical expenses, and have been included in catalogue management.
Article 3 The catalogue of large medical equipment shall be proposed by the National Health Commission in consultation with the relevant department under the State Council, reported to the State Council for approval, and issued for implementation.
Article 4 The State administrates large medical equipment through the classified and hierarchical allocation plan and through the issue of licenses according to the catalogue.
Article 5 The National Health Commission is responsible for formulating and organizing the implementation of the management system for the allocation and use of large medical equipment, and guides the evaluation and supervision of the allocation and use of large medical equipment. Local health administrative departments at or above the county level are responsible for the supervision and administration of the allocation and use of large medical equipment in respective regions.
Article 6 The National Health Commission establishes an expert consultation committee for the administration of large medical equipment, to provide technical support such as review, consultation and argumentation in the determination and adjustment of the management catalogue, the formulation and implementation of allocation plans and the management of the entire allocation and use process.
Provincial health administrative departments may establish the corresponding expert panels.
Article 7 Where a medical device user allocates and uses large medical equipment for medical service purposes, the Measures shall apply.
Chapter II Management Catalogue
Article 8 The National Health Commission puts forward suggestions for the large medical equipment allocation management catalogue according to the needs of medical services and the development of medical devices, and in combination with factors such as capital investment, operation costs and use costs, and technical requirements.
Article 9 The large medical equipment allocation management catalogue is divided into Category A and Category B. The large medical equipment of Category A shall be allocated and managed by the National Health Commission and issued with allocation licenses by it; the large medical equipment of Category B shall be allocated and managed by provincial health administrative departments and issued with allocation licenses by them.
Article 10 The National Health Commission shall evaluate the safety, effectiveness, economical efficiency and suitability of the use of large medical devices, and propose timely recommendations for the adjustment to the large medical equipment management catalogue.
Article 11 The adjustment to the large medical equipment management catalogue includes:
1.
......
Guo Wei Gui Hua Fa [2018] No.12
May 22, 2018
Health and family planning commissions and food and drug administrations of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps,
The Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation) (hereinafter referred to as the "Measures"), which can be downloaded from the official website of the National Health Commission) have been formulated in accordance with the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices (Order of the State Council No.680), in order to standardize and strengthen the administration of the allocation and use of large medical equipment. The Measures are hereby issued to you for your compliance and implementation.
Administrative Measures for Allocation and Use of Large Medical Equipment (for Trial Implementation)
Chapter I General Provisions
Article 1 The Measures are formulated in accordance with the Administrative Licensing Law, the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations, in order to further advance streamlining government functions and administration and delegating powers while improving regulation, and optimizing services, promote the rational allocation and effective use of large medical equipment, ensure the medical quality and safety, control the rapid growth of medical expenses, and safeguard the health rights and interests of the general public.
Article 2 For the purpose of the Measures, large medical equipment refers to large medical devices that adopt complex technology, require large capital investment, have high operation costs, have significant impact on medical expenses, and have been included in catalogue management.
Article 3 The catalogue of large medical equipment shall be proposed by the National Health Commission in consultation with the relevant department under the State Council, reported to the State Council for approval, and issued for implementation.
Article 4 The State administrates large medical equipment through the classified and hierarchical allocation plan and through the issue of licenses according to the catalogue.
Article 5 The National Health Commission is responsible for formulating and organizing the implementation of the management system for the allocation and use of large medical equipment, and guides the evaluation and supervision of the allocation and use of large medical equipment. Local health administrative departments at or above the county level are responsible for the supervision and administration of the allocation and use of large medical equipment in respective regions.
Article 6 The National Health Commission establishes an expert consultation committee for the administration of large medical equipment, to provide technical support such as review, consultation and argumentation in the determination and adjustment of the management catalogue, the formulation and implementation of allocation plans and the management of the entire allocation and use process.
Provincial health administrative departments may establish the corresponding expert panels.
Article 7 Where a medical device user allocates and uses large medical equipment for medical service purposes, the Measures shall apply.
Chapter II Management Catalogue
Article 8 The National Health Commission puts forward suggestions for the large medical equipment allocation management catalogue according to the needs of medical services and the development of medical devices, and in combination with factors such as capital investment, operation costs and use costs, and technical requirements.
Article 9 The large medical equipment allocation management catalogue is divided into Category A and Category B. The large medical equipment of Category A shall be allocated and managed by the National Health Commission and issued with allocation licenses by it; the large medical equipment of Category B shall be allocated and managed by provincial health administrative departments and issued with allocation licenses by them.
Article 10 The National Health Commission shall evaluate the safety, effectiveness, economical efficiency and suitability of the use of large medical devices, and propose timely recommendations for the adjustment to the large medical equipment management catalogue.
Article 11 The adjustment to the large medical equipment management catalogue includes:
1.
......