On June 30, the general office of the National Health Commission issued the notice on printing and distributing the reform implementation plan of "separation of certificates and licenses" for the allocation of large medical equipment in social medical institutions. It is understood that, This is also an important measure to further implement the requirements of the notice of the State Council on deepening the reform of "separation of certificates and licenses" and further stimulating the development vitality of market players (GF [2021] No. 7).

The circular points out that nationwide, the notification commitment system is implemented for the allocation license of class B large medical equipment in social medical institutions, which is implemented by the provincial health administration department.

In addition, if the social medical institution is equipped with class B large medical equipment, the examination and approval department can prepare and publish the format text of the notification commitment, and inform the applicant of the license conditions and required materials for configuring class B large medical equipment at one time. If the applicant voluntarily promises to meet the licensing conditions and submit materials as required, a licensing decision shall be made on the spot.

For class a large-scale medical equipment, the notice requires that the approval service for the configuration license of class a large-scale medical equipment in social medical institutions be further optimized and implemented by the National Health Commission. Medical institutions applying for the allocation of class a large-scale medical equipment can realize the whole process of application, approval and public processing through the supervision and management information system for the allocation and use of large-scale medical equipment.

It is worth noting that the allocation of class B medical equipment within the free trade zone is more open. The notice makes it clear that the allocation of class B large medical equipment of social medical institutions in the free trade pilot zone is changed from approval to filing management, which is implemented by the provincial health administration department. The institution applies to the local provincial health administrative department for filing, which is not limited by the allocation planning of large-scale medical equipment.

In fact, the reform of large-scale medical equipment across the country has long begun. As early as January 2018, the state began to relax the approval of class B large medical equipment configuration license of social medical institutions, and began a pilot in Shanghai. Previously, although many policies have been working towards the direction of "releasing management services" in social medical management, the purchase of large equipment and the setting of beds in medical institutions must still be "in line with the plan" and need to be approved.

Xu Yucai, columnist of "medical circles" and deputy director of Shanyang County Health Bureau of Shaanxi Province, also said that all along, social medical institutions have configured large-scale equipment, which can not be bought or installed if they want to. Now, the State Council has decided to implement the "separation of certificates and licenses" for the allocation of large-scale medical equipment in social medical institutions, which is obviously a more solid step on the road of policy liberalization over the years. It is a concrete embodiment of "supporting" social medical institutions, and also makes private hospitals more free and relaxed in the allocation of large-scale equipment, so as to more effectively drive the great development of private hospitals.

Attached is the implementation plan for the reform of "license separation" of large medical equipment configuration in social medical institutions:

1、 Allocation reform of class B large medical equipment in social medical institutions (Nationwide)

（1） Reform mode and implementation scope. The notification and commitment system shall be implemented for the allocation license of class B large medical equipment in social medical institutions, which shall be implemented by the provincial health administration department.

（2） Reform initiatives.

1. The approval department shall prepare and publish the format of letter of commitment for the allocation of class B large medical equipment by social medical institutions, and inform the applicant of the license conditions and required materials for the allocation of class B large medical equipment at one time. If the applicant voluntarily promises to meet the licensing conditions and submit materials as required, a licensing decision shall be made on the spot.

The letter of commitment shall list quantifiable and operable business license conditions without bottom-up terms according to law, clarify regulatory rules and consequences of breach of commitment, and inform the enterprise at one time. Enterprises are no longer required to provide approval materials that can be reduced due to enterprise commitments; For the examination and approval materials that can be supplemented after the enterprise obtains the certificate, the vacancy tolerance shall be handled and supplemented within a time limit.

2. The provincial health administrative department shall formulate implementation rules and publish them to the public in accordance with the requirements of laws and regulations such as the administrative license law, the regulations on the supervision and administration of medical devices, the administrative measures for the allocation and use of large medical equipment (for Trial Implementation) and relevant documents.

（3） Strengthen supervision measures during and after the event.

1. The provincial health administrative department shall focus on the inspection of the implementation of the commitment of the reporting unit, and deal with those who provide false materials, fail to meet the commitment requirements or obtain the license by other deceptive means according to law.

2. The health administrative department at or above the county level shall strengthen the supervision of the practice activities of medical institutions. If it finds that it violates the commitment, it shall order it to make rectification within a time limit. If it fails to make rectification within the time limit or fails to fulfill the commitment after rectification, the license shall be revoked according to law. If it finds any illegal behavior, it shall be investigated and punished according to law and the results shall be made public.

3. The health administrative departments at or above the county level shall strengthen credit supervision, announce the credit status of medical institutions equipped with class B large medical equipment in the region to the public, and integrate the relevant punishment information into the national credit information sharing platform. For medical institutions registered and established with the market supervision department, the punishment information shall be uniformly collected into the national enterprise credit publicity system, and the punishment for dishonesty shall be implemented in accordance with the law and regulations.

4. Health administrative departments at all levels shall handle complaints and reports according to law, accept them in time and investigate and deal with them according to law.

5. Strengthen industry self-discipline. Relevant industry associations shall assist the competent departments in relevant work, improve industry standards, and carry out the evaluation of medical quality and service ability.

2、 Allocation reform of class B large medical equipment in social medical institutions (in the free trade pilot zone)

（1） Reform mode and implementation scope. The allocation of class B large medical equipment in social medical institutions in the pilot Free Trade Zone shall be changed from approval to filing management, which shall be implemented by the provincial health administration department.

（2） Reform initiatives.

1. The social medical institutions in the pilot free trade zone are equipped with class B large-scale medical equipment and apply to the local provincial health administrative department for filing, which is not limited by the planning of large-scale medical equipment configuration.

Where an enterprise submits filing materials as required, the examination and approval department shall go through the filing procedures on the spot and shall not make a decision not to file.

2. The provincial health administrative department shall formulate implementation rules and publish them to the public in accordance with the requirements of laws and regulations such as the administrative license law, the regulations on the supervision and administration of medical devices, the administrative measures for the allocation and use of large medical equipment (for Trial Implementation) and relevant documents.

（3） Strengthen supervision measures during and after the event.

1. The administrative department of health and health at or above the county level shall strengthen the supervision of the practice activities of medical institutions, improve the frequency of supervision and inspection of medical institutions that have failed to fulfill the filing procedures and other violations and bad credit records, investigate and deal with violations according to law and disclose the results.

2. The health administrative departments above the county level shall strengthen credit supervision, announce the credit status of medical institutions equipped with class B large medical equipment in the region to the public, and integrate the relevant punishment information into the national credit information sharing platform. For medical institutions registered and established with the market supervision department, the punishment information is uniformly collected into the national enterprise credit publicity system, the punishment for dishonesty is implemented according to law, and the industry prohibition measures are implemented for subjects with serious dishonesty according to law.

3. Health administrative departments at all levels shall handle complaints and reports according to law, accept them in time and investigate and deal with them according to law.

4. Strengthen industry self-discipline. Relevant industry associations shall assist the competent departments in relevant work, improve industry standards, and carry out the evaluation of medical quality and service ability.

3、 Reform of class a large medical equipment allocation in social medical institutions (Nationwide)

（1） Reform mode and implementation scope. Further optimize the approval service for the configuration license of class a large medical equipment in social medical institutions, which shall be implemented by the National Health Commission.

（2） Reform initiatives.

1. Medical institutions apply for the configuration of class a large medical equipment, and realize the online processing of the whole process of application, approval and public processing progress through the supervision and management information system for the configuration and use of large medical equipment.

2. The approval procedures, acceptance conditions and evaluation standards for the configuration license of class a large medical equipment are publicly published online.

3. In the process of reducing the elements, the applicant may no longer provide a copy of the practice license of the medical institution when submitting the application materials.

（3） Strengthen supervision measures during and after the event.

1. The health administrative departments at or above the county level shall strengthen the supervision of the practice activities of medical institutions, improve the frequency of supervision and inspection of medical institutions with bad credit records, investigate and deal with violations according to law and disclose the results.

2. The health administrative departments above the county level shall strengthen credit supervision and announce the credit status of medical institutions equipped with class a large medical equipment to the public. For medical institutions registered and established with the market supervision department, the punishment information shall be uniformly collected into the national enterprise credit publicity system, and the punishment for dishonesty shall be implemented in accordance with the law and regulations.

3. Health administrative departments at all levels shall handle complaints and reports according to law, accept them in time and investigate and deal with them according to law.

4. Strengthen industry self-discipline. Relevant industry associations shall assist the competent departments in relevant work, improve industry standards, and carry out the evaluation of medical quality and service ability.

Source: medical profession