In 2024, the first round of Class A large-scale medical equipment configuration license application has begun! This round only accepts applications from social medical institutions for the configuration of heavy ion proton radiotherapy systems.
Source: According to the official website of the National Health Commission, it is edited
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On April 24, the National Health Commission issued the first round of Class A large-scale medical equipment configuration license declaration in 2024, and the current round of declaration time is from April 25 to June 24, 2024 (8:30-17:00 on working days).
According to the "14th Five-Year Plan" large-scale medical equipment configuration approval service guide, this round of planning and approval of 5 heavy ion proton radiation therapy systems is specially used in social medical institutions.
The guidelines provide guidance on the paper application materials required by applicants who have obtained the "Medical Institution Practice License" and those that are preparing or under construction.
However, it is clarified in the instructions for the declaration of Class A large-scale medical equipment configuration license that the declaration shall be made according to the type of medical institution declaration in accordance with three situations: (1) new medical institutions (obtaining the practice license of medical institutions for less than 3 years, excluding 3 years), ;( 2) existing social medical institutions (obtaining the practice license of medical institutions for more than 3 years, including 3 years), ;(3) The declaration content of medical institutions under construction shall be subject to a commitment system, and the access standards for the configuration of Class A large-scale medical equipment shall be compared (please refer to the "About the Release of the 14th Five-Year Plan") Notice of large-scale medical equipment configuration planning) is committed item by item.
In fact, in February this year, the National Health Commission issued a notice on adjusting the "14th Five-Year Plan" large-scale medical equipment configuration plan, proposing to meet the people's diversified diagnosis and treatment service needs and support the healthy and orderly development of social medical services, the "14th Five-Year Plan" large-scale medical equipment configuration plan was adjusted.
That is to say, during the "14th Five-Year Plan" period, 8 sets (sets) of heavy ion proton radiotherapy systems will be set aside for social medical services, and 5 units can be approved in this round of planning.
Attachment 1: Notice of the General Office of the National Health Commission on doing a good job in the first round of application for the configuration license of Class A large-scale medical equipment in 2024
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Notice of the General Office of the National Health Commission on Doing a Good Job in the First Round of Application for Class A Large Medical Equipment Configuration Licenses in 2024
Financial Letter [2024] No. 128 of the National Health Office
Health commissions of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps:
In accordance with the "Administrative Licensing Law of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for the Configuration and Use of Large-scale Medical Equipment (Trial)", "Implementation Rules for the Management of Class A Large-scale Medical Equipment Configuration Licenses", "Catalogue of Large-scale Medical Equipment Configuration Licenses (2023)", "Notice on Issuing the "14th Five-Year Plan" Large-scale Medical Equipment Configuration Plan" and "Notice on Adjusting the "14th Five-Year Plan" Large-scale Medical Equipment Configuration Plan and other laws, regulations and document requirements, the first round of Class A large-scale medical equipment configuration license application in 2024 is hereby notified as follows:
1. Declaration time
April 25 - June 24, 2024 (8:30 - 17:00 on weekdays)
Second, the way to declare
Apply online (see Appendix 1 for details).
3. Relevant requirements
(1) In this round, only applications for the configuration of heavy ion proton radiotherapy systems by social medical institutions will be accepted.
(2) Please notify the medical institutions in the jurisdiction that have the need to log in to the website of our committee to disclose information, and submit an online application within the specified time in accordance with the "Guidelines for the Approval Service for the Configuration of Class A Large Medical Equipment", "Instructions for the Application of Class A Large Medical Equipment Configuration License" and "Evaluation Standards for the Configuration License of Class A Large Medical Equipment" (see Annexes 1, 2 and 3).
(3) When submitting the application, the applicant shall promise in writing that the application materials are true, valid and legal. Our committee will organize experts or entrust local health administrative departments to conduct verification. If the reporting unit conceals the relevant information, provides false materials, or applies for a configuration license by improper means such as deception, it will not be licensed and held accountable in accordance with the "Administrative Licensing Law", "Regulations on the Supervision and Administration of Medical Devices" and other relevant laws and regulations.
Application consultation telephone:
Government Affairs Hall of the National Health Commission (Application Acceptance Consultation)
Contact number: 010-68791409
Finance Department of the National Health Commission (Declaration Policy Consultation)
Contact number: 010-68791650
Technical support and consultation of the declaration system
Contact number: 13601265932
Attachment: 1. Class A large-scale medical equipment configuration approval service guide
2. Instructions for the declaration of Class A large-scale medical equipment configuration license
3. Catalogue of Class A large-scale medical equipment configuration license review standards
General Office of the National Health Commission
April 22, 2024
(Form of information disclosure: voluntary disclosure)
Appendix 2: Catalogue of Class A large-scale medical equipment configuration license review standards
