Requirements of the health and Family Planning Commission: all medical institutions shall stop purch

According to the website of Suqian health and Family Planning Commission of Jiangsu Province on June 30, due to the adjustment of large-scale medical equipment configuration approval from non administrative approval to administrative approval, according to the unified requirements of the provincial health and Family Planning Commission, from June 22, 2017, all kinds of medical institutions in Suqian City will stop purchasing large-scale medical equipment, and any unauthorized purchase will be deemed as illegal purchase. In literal sense, first of all, the "stop" measure is the unified requirement of Jiangsu Province, not only Suqian. Secondly, all kinds of medical institutions have been "stopped", including private hospitals. This is not a small movement. In addition, the website of Suqian health and Family Planning Commission did not make clear when the relevant "stop" measures would be terminated. Perhaps, it will continue until the end of the transition period of configuration management mode of large medical equipment. The state health and Family Planning Commission has also called for a halt to the licensing of large-scale equipment. In fact, due to the reform of administrative approval matters of the State Council, it is not only Jiangsu province that purchases large-scale medical equipment. In January this year, when the national health and Family Planning Commission approved the request for instructions on issues related to the issuance of radiation diagnosis and treatment licenses issued by the Shanxi provincial health and Family Planning Commission, it said that the large-scale medical equipment configuration license was changed from non administrative license to administrative license. The national health and Family Planning Commission is implementing the new licensing process, and in accordance with the relevant requirements of the State Council's review and Reform Office, during this period, the large-scale medical equipment configuration license was suspended Yes. The spirit of the above reply document issued by the state health and Family Planning Commission is applicable to all provinces. However, when the national health and Family Planning Commission called for "stop", the regulations on the supervision and administration of medical devices had not yet been revised. On May 4 this year, the State Council issued Order No. 680, announcing the decision of the State Council on Amending the regulations on the supervision and administration of & lt; medical devices, which shall go into effect as of the date of promulgation. The revised "Regulations on the supervision and administration of medical devices" added several new contents, including: the allocation of large-scale medical equipment in medical institutions must be approved by the health and family planning departments at or above the provincial level, and the allocation license must be obtained; the detailed rules for the punishment of medical institutions using large-scale equipment without permission were clarified. &Nbsp; according to the new version of the regulations on the supervision and administration of medical devices, from June 22, in Suqian City or even in Jiangsu Province, medical institutions that violate the "stop" measure will be warned, confiscated of illegal income, fined 10000-50000 yuan, and fined 5-10 times of the illegal income for those who are serious; no large-scale medical equipment will be allocated within 5 years for those who are serious. Two new regulations on the allocation of large-scale medical equipment are in the process of formulating the regulations on the supervision and administration of medical devices revised from May this year, which also adds an important content. It is clearly proposed that the administrative measures for the allocation of large-scale medical equipment shall be formulated by the health and family planning department of the State Council in conjunction with the relevant departments of the State Council; the catalogue of large-scale medical equipment shall be proposed by the health and Family Planning Commission in consultation with the relevant departments of the State Council and implemented after being approved by the State Council. The regulations on the supervision and administration of medical devices is the "parent law" of the current medical device industry;. With its modification, some experts in the industry said that the national competent department may make corresponding modifications to the specific large-scale equipment management measures in the next step, and the items of class A and class B equipment may also be adjusted to the website of Suqian health and Family Planning Commission. It is confirmed that the national health and Family Planning Commission is working with relevant departments to develop the "management measures for large-scale medical equipment configuration" and the large-scale medical equipment management catalogue. Whether it is the change of the purpose of class A and class B equipment products or the modification of relevant configuration regulations, it will not only affect the medical institutions, but also directly affect the economic interests of the relevant medical equipment manufacturers. Cypress blue equipment will continue to pay attention to the two new regulations.