The State Council made it clear that Class A large-scale equipment was collected by the Commission for Health and Planning!

Recent signals show that large-scale medical equipment is becoming another key standardized management object in the field of medical devices in addition to high-value consumables and IVD. In addition to configuring licensing and usage supervision, there is also centralized procurement.The State Council made it clear: Class A large-scale equipment, the State Health and Planning Commission collection
days ago, the State Council issued the "13th Five-Year Plan" to deepen the reform of the medical and health system, formally proposed to carry out large-scale centralized procurement of medical equipment.
is unique. Recently, the General Office of the State Council issued the Central Budget Unit 2017-2018 government centralized procurement catalogue and standards.
According to the document, projects to be centrally procured by the National Health and Planning Commission over the next two years include:
1, contraceptives, including copper-containing ICDs, IODs, condoms, contraceptive tablets, contraceptive injections, contraceptive suppositions, contraceptive gels, contraceptive film and under-skin implants;
2, large-scale medical equipment, including electron emission fault scanner (PET/CT), electron emission magnetic resonance imaging system (PET/MR), endoscope surgical device control system (surgical robot), gamma-ray head stereotactic emission surgical treatment system (head gamma knife), X-ray stereotactic emission therapy system, helical fault radiation therapy system, high-end linear accelerator, medical electron swing acceleration treatment system, proton therapy system, 306 electron magnetic.
compared with the central budget unit's 2015-2016 government centralized procurement catalogue and standards for the previous two years, the State Council has made major adjustments to the centralized procurement projects of the State Health and Planning Commission.
, in 2017-2018, the National Health and Planning Commission's centralized procurement projects have added Class A large-scale medical equipment.
In addition, the Directory also raised the standard for public tenders for government-purchased goods and services from 1.2 million yuan to 2 million yuan, and raised the standard for decentralized procurement limits for goods and services from 500,000 yuan to 1 million yuan.
fact, the National Health and Planning Commission as early as a few years ago began to be responsible for the centralized procurement of Class A large-scale equipment, and this is clearly written into the "national character" document.
The National Health and Planning Commission's Center for International Exchange and Cooperation, as a specific undertaker of the Commission's Class A large-scale equipment collection, collected 192 Class A large-scale medical equipment for 148 medical institutions in 29 provinces (regions and cities) in the five years to November 2014, with a total turnover of nearly 2.6 billion yuan. According to the statistics of the department, the effect of centralized procurement price reduction is obvious, saving medical institutions 28% of the procurement budget funds.
In the future, with the 13th Five-Year Plan for Medical Reform and the strong holding of national documents, the centralized procurement of Class A large-scale medical equipment will continue, while class B large-scale equipment, or more provinces, such as Anhui, will implement centralized provincial procurement. Expensive large-scale medical equipment, price reduction and low adoption has also become a major trend.Large-scale medical equipment configuration license, towards legalization
is also the latest news, according to the National Health planning commission website January 10 announcement, the State Health planning commission recently approved shanxi Provincial Health planning committee "on the issue of radiological diagnosis and treatment license related issues", said that large-scale medical equipment configuration license has been adjusted from non-administrative licensing to administrative licensing, the Health and Planning Commission is fulfilling the new licensing procedures, during which the suspension of large-scale medical equipment configuration permits.For more than
years, the State Health Planning Commission has been responsible for the configuration license of Class A large-scale medical equipment in the name of "non-administrative license", while the Provincial Health and Planning Commission is responsible for the configuration license of Class B large-scale medical equipment.
, however, non-administrative permits have always been considered unclear and highly controversial in the legal profession, considered a grey area.
the new government came to power, Premier Li Keqiang pushed for approval of reforms and the cancellation of all non-administrative licensing matters. This has aroused industry concern, large-scale medical equipment configuration management will go where? Fully liberalized or further regulated?
approval of the State Health and Planning Commission shows that "large-scale medical equipment configuration license issued" from "non-administrative license" to "administrative license." That is, the unreasonable "extra-legal land" which was retained by the Commission for Health and Planning has been transformed into a reasonable and lawful measure.
get rid of the awkward position, the Health planning committee on the configuration management of large-scale medical equipment, it will be easier to start.hospitals to configure large-scale equipment without authorization, or will be fined
in fact, in the future, the Health and Planning Commission on the configuration of large-scale medical equipment management will not only continue to regulate, but also is likely to be more stringent.
May 2016, the Legal Affairs Office of the State Council publicly solicited opinions on the amendments to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review).
according to the draft, the medical supervision regulations will be overhauled, and the main content of the amendment is to increase the number of medical institutions to configure the use of large-scale medical equipment provisions.
large-scale medical equipment configuration license for the draft. The medical institutions shall have the technical conditions, professionals and supporting facilities and equipment to ensure the quality and safety of medical care, and shall comply with the configuration plan and obtain the configuration license issued by the administrative department of health and family planning at or above the provincial level.
For unauthorized allocation of large-scale medical equipment, improper means to obtain large-scale medical equipment configuration permits, can not guarantee the quality and safety of medical care without stopping the use of large-scale medical equipment, etc. , the draft also clarified that medical institutions should bear legal responsibility for the illegal situation and the corresponding administrative penalties.
e.g., add the provisions: "If large-scale medical equipment is configured without permission, the competent department of health and family planning of the people's government at or above the county level shall give a warning, order it to stop using it and confiscate the illegal income;
The main purpose of such modification is to legalize the allocation license management of large-scale medical equipment, and to stop medical institutions from blindly pursuing high-end equipment and competing equipment, and to prevent hospitals from moving from "drug-based medicine" to "complementary medicine". (Cypress Blue Equipment)