Circular on Issuing the Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities
Circular on Issuing the Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities
Circular on Issuing the Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities
Guo Wei Gui Hua Fa [2018] No.14
May 30, 2018
The health and family planning commissions of all provinces, autonomous regions and municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
In order to implement 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), regulate administrative licensing for the allocation of class-A large medical facilities, we have formulated, after research and in accordance with the Circular on Issuing the Administrative Measures for Allocation and Use of Large Medical Facilities (for Trial Implementation) (Guo Wei Gui Hua Fa [2018] No.12) issued by the National Health Commission and the State Drug Administration, the Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities, which are hereby issued to you for your compliance and implementation.
Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities
Chapter I General Provisions
Article 1 The Rules are formulated in accordance with the Administrative Licensing Law of the People's Republic of China, the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for Allocation and Use of Large Medical Facilities (for Trial Implementation) and other relevant provisions, with a view to deeply advancing the reform of streamlining administration, delegating powers, improving regulation and optimizing services, further regulating the licensing for the allocation of Class-A large medical facilities.
Article 2 The Rules apply to the application for, the acceptance, review and examination, and management of, and the decision-making on the licensing for the allocation of Class-A large medical facilities.
Article 3 The licensing for the allocation of Class-A large medical facilities shall follow the principles of being lawful and compliant, open and transparent, disinterested and efficient.
Article 4 The National Health Committee shall organize the implementation of the licensing for the allocation of Class-A large medical facilities according to the plan on allocation of Class-A large medical facilities.
Article 5 The National Health Committee shall establish the information system for supervision and management of the allocation and use of large medical devices, apply whole-process information-based management of the application for, and the acceptance and handling of allocation licensing and other activities, facilitate application entities to inquire about the progress and results, and timely disclose licensing results to the public.
Chapter II Application for and Acceptance of Allocation Licensing
Article 6 To apply for licensing for the allocation of Class-A large medical facilities, the following conditions shall be met:
1.
......
Guo Wei Gui Hua Fa [2018] No.14
May 30, 2018
The health and family planning commissions of all provinces, autonomous regions and municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
In order to implement 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), regulate administrative licensing for the allocation of class-A large medical facilities, we have formulated, after research and in accordance with the Circular on Issuing the Administrative Measures for Allocation and Use of Large Medical Facilities (for Trial Implementation) (Guo Wei Gui Hua Fa [2018] No.12) issued by the National Health Commission and the State Drug Administration, the Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities, which are hereby issued to you for your compliance and implementation.
Implementing Rules for the Administrative Licensing for the Allocation of Class-A Large Medical Facilities
Chapter I General Provisions
Article 1 The Rules are formulated in accordance with the Administrative Licensing Law of the People's Republic of China, the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for Allocation and Use of Large Medical Facilities (for Trial Implementation) and other relevant provisions, with a view to deeply advancing the reform of streamlining administration, delegating powers, improving regulation and optimizing services, further regulating the licensing for the allocation of Class-A large medical facilities.
Article 2 The Rules apply to the application for, the acceptance, review and examination, and management of, and the decision-making on the licensing for the allocation of Class-A large medical facilities.
Article 3 The licensing for the allocation of Class-A large medical facilities shall follow the principles of being lawful and compliant, open and transparent, disinterested and efficient.
Article 4 The National Health Committee shall organize the implementation of the licensing for the allocation of Class-A large medical facilities according to the plan on allocation of Class-A large medical facilities.
Article 5 The National Health Committee shall establish the information system for supervision and management of the allocation and use of large medical devices, apply whole-process information-based management of the application for, and the acceptance and handling of allocation licensing and other activities, facilitate application entities to inquire about the progress and results, and timely disclose licensing results to the public.
Chapter II Application for and Acceptance of Allocation Licensing
Article 6 To apply for licensing for the allocation of Class-A large medical facilities, the following conditions shall be met:
1.
......