The large medical equipment catalog changes greatly! The Weijian Committee burns out the medical industry | 'The first fire'
Medical Network April 10 News The newly established National Health and Sanitation Committee burned the 'head fire' to the medical device industry until the deployment of large-scale medical equipment.
On April 9th, the National Health and Nutrition Commission issued a notice regarding the issuance of the "Large-scale Medical Equipment Configuration License Management Catalogue (2018)". The new edition of Category A and B-type large-scale medical equipment management items was formally released.
Our country implements strict configuration license management for large-scale medical equipment, in which category A large-scale medical equipment is managed by the State Council’s administrative department of health; category B large-scale medical equipment is managed by provincial-level health administrative departments, and medical institutions must not configure themselves without approval.
The country's classification of management items for large category A and B equipment has also undergone changes.
Before the 2018 version of the directory, the 2005 version of the directory was used.
From March 1, 2005, the “Measures for the Management of the Configuration and Use of Large-scale Medical Equipment” issued jointly by the former Ministry of Health, the National Development and Reform Commission, and the Ministry of Finance were formally implemented, and the “configuration and application of large-scale medical equipment” issued by Order No. 43 of the Ministry of Health in 1995. Interim Measures for Administration shall be repealed at the same time.
The 2005 edition of the catalog defines large medical equipment as medical equipment that is included in the administrative department of the State Council for managing pharmaceutical products, and medical equipment that has not yet been included in the management category, and has been set up for the first time in the provincial region with a unit price of RMB 5 million or more.
Since 2005, before the release of the 2018 catalogue, the former Ministry of Health/Health and Welfare Commission has divided the three categories of designated categories of large-scale equipment for category A and B. There are 12 categories of category A equipment in total. , Class B equipment a total of 5.
In May 2017, the State Council announced the "about amendments <medical instruments "Decision of the Regulations and Regulations" (Decree No. 680 of the State Council) to reclassify large-scale medical equipment as "large-scale medical care with complex use of technology, large amount of capital investment, high operating cost, large impact on medical expenses, and inclusion of directory management Equipment. '
Reclassify category A large-scale equipment as: 'Technical requirements are particularly strict, clinical risks are particularly high, capital investment is huge, and operating costs are high. At this stage, there are no large-scale promotion and use conditions or technology development is in its infancy, and safety is used effectively. Sex needs to track and evaluate large equipment'.
The introduction of the 2018 version of the Catalogue was made by the National Health and Nutrition Committee for the implementation of the State Council's Order No. 680.
Compared with the 2005 version of the directory, the 2018 version of the directory changes significantly.
Not only will the threshold for large-scale medical equipment be raised, but low-end CT, MR, etc. will no longer be managed as Class B large-scale equipment. That is, it will no longer implement configuration licenses. Medical institutions do not need to be approved by the provincial health and health committee. You can decide on your own configuration or not;
Some items originally listed in category A were also moved to category B items, ie, such as PET-CT, gamma knife, surgical robots, etc. will no longer be held by the National Health Committee, but by the provincial Weijian Committee. Planning Commission) to perform configuration approval.
Under the 2018 catalogue, the coverage of large-scale equipment of Class A has been greatly reduced, leaving only PET-MR, high-end and ultra-high-end radiotherapy equipment, and the entry threshold has been raised from the unit price of 5 million yuan to 30 million yuan. The scope of coverage has increased, but mainly due to the transfer of Class A equipment, the entry threshold for Class B equipment has also been substantially increased to 10 million yuan.
Changes in the directory are significant, and enterprise The impact will also be significant.
Part of the device configuration approval authority is decentralized, some devices can be configured without approval, and the addition of large-scale devices to medical institutions will provide positive incentives. Such as PET-CT, surgical robots will accelerate into the domestic large hospital , Such as CT, MR and other equipment will also be accelerated to the township hospitals and other basic medical institutions.
Since last year, the state's configuration and management of large-scale medical equipment can be described as continuous action.
In May 2017, the "Regulations on the Supervision and Management of Medical Devices" was amended to include many new regulations on the configuration and use of large-scale medical equipment. The approval of large-scale medical equipment was changed from non-administrative permit examination and approval to administrative licensing.
In August 2017, the National Health and Family Planning Commission issued the "Notice on Deepening the Reform of 'Regulations for Discharge of Hospitals' to Invigorate the Investing Vitality in the Medical Field." It proposed to explore the deployment of large-scale Class B medical equipment to socially-run medical institutions in the Free Trade Zone approved by the State Council. Implementation of the notification commitment system. If the Shanghai Pudong Free Trade Zone has been piloted first, private medical institutions will be greatly encouraged in the deployment of large-scale equipment for category B.
In addition, the National Medical and Health Commission focused on large-scale medical equipment purchase The management platform, it is reported that it is under intense preparation, large-scale equipment centralized procurement reform soon.
The introduction of the 2018 version of the catalog is another major action. The introduction of the catalog means that the “13th Five-Year Plan for the Deployment of Large Medical Equipment” should come soon. According to the news, Class A and Class B equipment, Both public and private medical institutions will be included in the 'Thirteen Five' configuration plan and will guide the deployment of domestic large-scale medical equipment.
The management of the deployment and use of large-scale medical equipment is ushering in a new era. There is tightness and looseness in the pines.
The following is a comparison of the specific items of category A and category B large-scale equipment under the 2018 edition, and the comparison between the edition of the 2018 edition and the 2005 edition of the catalogue:
