Shanghai Chainpharm Bio-medical Technology CO.,Ltd
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Shanghai pilot liberalized large-scale medical equipment allocation in private medical institutions, and favorable development of private medical institutions
On August 15, 2018, the State Council promulgated the "Approval of the State Council on the Pilot Program for Further Promoting the Reform of the"Separation of Licenses"in Shanghai (State Letter No. 12 ). The State Council decided to temporarily adjust and implement the following administrative regulations and regulations in Shanghai Pudong New Area from now on until December 31, 2018:
We will temporarily adjust and implement the provisions of the second paragraph of Article 34 of the Regulations on the Supervision and Administration of Medical Devices on the issue of licenses for the allocation of large-scale medical equipment. We will not implement license management for the allocation of large-scale medical equipment of type B by social medical institutions in the pilot areas, and strengthen the supervision after the event.
According to the regulations of the former Ministry of Health, medical institutions need to obtain a large-scale medical equipment allocation certificate first, and then apply to the local health administration for a "radiation permit". At present, large-scale medical equipment is allocated and managed according to the plan in our country. Medical institutions can not purchase large-scale medical equipment until they have obtained the "Allocation License for Large-scale Medical Equipment". Large-scale medical equipment is divided into Class A and Class B. Purchase of Class A large-scale medical equipment (PET-MR, etc.) requires approval of the Ministry of Health to issue a configuration license. Class B large-scale medical equipment (64-row and above CT, 1.5T and above NMR, etc.) requires approval of the provincial health administrative department to issue a configuration license, 64-row and below CT, 1.5T NMR, DSA. No configuration certificate is needed.
According to the Regulations on the Configuration and Use of Large-scale Medical Equipment issued in 2014, medical institutions should obtain a permit for the allocation of large-scale medical equipment. In January 2017, the State Health Planning Commission issued a reply to Shanxi, which referred to the suspension of large-scale medical equipment configuration licensing. In May 2018, the State Health Planning Commission and CFDA issued a document to clarify the large-scale medical equipment configuration licensing policy. In January 2017, the "Approval on Issues Relating to the Issuance of Radiation Diagnosis and Treatment Licenses" issued by the National Health Planning Commission to Shanxi Province mentioned that, as the National Health Planning Commission was carrying out the new licensing procedures, it was suspended to apply for large-scale medical equipment configuration permits; during the suspension of large-scale medical equipment configuration permits, medical institutions applied for radiation diagnosis and treatment permits. It is not necessary to submit the permit documents for large medical devices. In May 2017, the newly revised Regulations on the Supervision and Administration of Medical Devices promulgated by the State Council require medical device users to configure large-scale medical equipment and obtain a permit for the allocation of large-scale medical equipment. In May 2018, the National Health Planning Commission and CFDA promulgated the Measures for the Configuration and Use of Large-scale Medical Equipment (Trial Implementation) (hereinafter referred to as "Measures") and the Detailed Rules for the Configuration and Permit Administration of Class A Large-scale Medical Equipment, which clearly stipulated that the state should implement the system for the allocation planning and management of large-scale medical equipment and the system for the allocation license. The State Health Commission and the provincial health administrative departments are responsible for the management and issuance of the allocation license, and have formulated the application procedures for the allocation license of large-scale medical equipment of Class A. The provinces have formulated the implementation procedures for the allocation license of large-scale medical equipment of Class B in accordance with the actual situation of the locality.