Large medical facilities

What is large medical equipment?

The notice on printing and distributing management measures for the allocation and use of large medical equipment (Trial) (gwgf [2018] No. 12) issued by the National Health Commission and the State Drug Administration on May 22, 2018 clearly stipulates that:

Large medical equipment refers to large-scale medical devices with complex technology, large amount of capital investment, high operating cost, great impact on medical expenses and included in the catalog management.

What are the categories of large medical equipment?

According to the decision of the State Council on Amending the regulations on the supervision and administration of medical devices (Order No. 680 of the State Council), the Configuration Management Catalogue of large medical equipment is divided into two categories: A and B.

On march29,2018, the National Health Commission issued the Management Catalogue of large medical equipment configuration license (2018), which defined the Management Catalogue of class A and class B.

Class a large medical equipment

Class a large-scale medical equipment class a large-scale medical equipment shall be configured and managed by the National Health Commission, and the configuration license shall be issued.

Class a large-scale equipment refers to large-scale medical devices with huge capital investment, high operating costs and particularly strict technical requirements. They are generally configured at the provincial level or across regions.

Price above 30million yuan

The purchase price is more than 30million yuan (or equivalent US dollars. Considering the exchange rate change and actual management, it is currently 4million US dollars); The charge price for a single examination or treatment is more than 10000 yuan, and the application is relatively wide and the utilization rate is high; The risk of clinical use is very high, and the requirements for the qualification and ability of users and corresponding supporting facilities and equipment are particularly high. Improper use will have a significant impact on the quality and safety of medical treatment, or the time for clinical application is not long, the technology development is not mature, and the exploration experience needs to be used carefully. If more than two of these three conditions are met, they will be included in class a management in principle.

Considering the needs of new equipment configuration management, the large-scale medical devices with newly obtained medical device registration certificate and first configured unit price of 30million yuan or more than 4million US dollars will be listed as class a equipment temporarily, and the specific management type will be determined according to the use evaluation results.

Category A includes

1. heavy ion radiotherapy system;

2. proton radiotherapy system;

3. positron emission magnetic resonance imaging system (pet/mr for short);

4. high end radiotherapy equipment. It refers to radiotherapy equipment that integrates multi-modal imaging, artificial intelligence, complex dynamic intensity modulation, high-precision high dose rate and other precise radiotherapy technologies. At present, it includes X-ray stereotactic radiotherapy system (CyberKnife), spiral tomotherapy system (tomo) HD and HDA, edge and versa HD and other linear accelerators.

5. large medical devices with a price of 30million yuan (or 4million US dollars) or more for the first time.

Class B large medical equipment

Class B large-scale medical equipment shall be allocated and managed by the provincial health administration department and the allocation license shall be issued.

Class B large-scale medical equipment refers to large-scale medical devices with large capital investment, high operating costs and use expenses, and strict technical requirements. Generally, the provincial and below regions are the planning and allocation units.

RMB 5million to RMB 30million

The purchase price is between 5million yuan and 30million yuan (or equivalent USD); The charge for a single examination or treatment is more than hundreds to thousands of yuan, with a wide range of applications and a high utilization rate; The technology application is mature, and the qualification and ability of users and corresponding supporting facilities and equipment must meet specific requirements to ensure medical quality and safety. If more than two of these three conditions are met, they will be included in class B management in principle. The large-scale medical devices with newly obtained medical device registration certificate and first configured unit price of 10-30million yuan (or equivalent USD) are temporarily classified as class B equipment, and the specific management type will be determined according to the use evaluation results.

Category B includes

1. X-ray positron emission tomography (pet/ct, including PET);

2. endoscopic surgical instrument control system (surgical robot);

3.64 row and above X-ray computed tomography (64 row and above CT);

4.1.5t and above magnetic resonance imaging system (1.5T and above MR);

5. linear accelerator (including X-knife, excluding radiotherapy equipment listed in class a Management Catalogue);

6. gamma ray stereotactic radiotherapy system (including for head, body and whole body);

7. large medical devices with a price of RMB 10-30million for the first time.

Can I buy and use it freely?

Can large medical equipment be purchased and used at will? The answer is no!

If the user of medical devices configures and uses large-scale medical equipment without permission, should it bear legal responsibility? The answer is yes!

In may2017, the decision of the State Council on Amending the regulations on the supervision and administration of medical devices (Order No. 680 of the State Council) was promulgated and implemented, setting the configuration license for large-scale medical equipment and making provisions on the configuration, use and supervision of large-scale medical equipment.

If the user of medical devices applies for the allocation of class a large medical equipment, it shall submit an application to the National Health Commission; Those who apply for the allocation of class B large-scale medical equipment shall apply to the local provincial health administration department. After obtaining the configuration license for large-scale medical equipment, the user of medical devices shall configure corresponding large-scale medical equipment in time. That is to say, medical institutions must obtain permission to purchase large-scale medical equipment, otherwise it is illegal.

The regulations on the supervision and administration of medical devices specify the legal responsibilities for the unauthorized allocation and use of large-scale medical equipment: the competent health department of the people's government at or above the county level shall order it to stop using, give a warning, confiscate the illegal income, and impose a fine of a certain multiple of the illegal income.