The health ministry office on strengthening the positron emission tomography magnetic resonance imaging system configuration management of the notice

Health ministry of China www.moh.gov.cn the 2011-12-19 09:44:21

Who do rules wealth hair [2011] no. 155

        All provinces, autonomous regions, municipalities directly under the central government health TingJu:

        Positron emission tomography magnetic resonance imaging system (hereinafter referred to as PET-MRI) is the collection molecular imaging technology (PET) and magnetic resonance imaging (MRI) as one of the new large equipment, is in its early stages of development, some key technical problems to be further perfected. At present the equipment in our country have not obtained the registration of medical devices, in foreign market price is very expensive, about 500-7 million dollars, far more than the prevalence of large medical equipment management category of RMB 5 million to determine the limit.

        According to the national development and reform commission, and the ministry of finance "large medical equipment configuration and use to manage the way" (WeiGui wealth hair [2004] 474 date) regulation, PET-MRI should belong to the prevalence of large medical equipment. At present our ministry is studying the PET-MRI configuration management. In order to guide the reasonable and orderly configuration, the smooth implement next plan the work, now the matters related to notice the following:

        A, without the configuration for examination and approval, medical institutions must not with any forms introduce equipment PET-MRI used for clinical work, including MRI or PET name purchase PET-MRI, to have the equipment 3.0 T MRI technology upgrading for PET-MRI etc form, avoid large medical equipment configuration planning management. Medical institutions and producers to scientific research cooperation, introduction of PET name in clinical test-MRI activities, not as the next step of the configuration of examination and approval basis and the reference. Without the configuration of examination and approval of the medical institutions without authorization, equipment, according to the relevant provisions will be dealt with harshly.

        Second, PET-MRI get medical equipment registration certificate, according to the health ministry large medical equipment configuration of the prevalence of the work of examination and approval system (interim), (who do rules wealth sends [2008] no. 8) regulation, our ministry to the organization carries out the PET-MRI configuration planning and declare work.

        Please convey to the spirit of this circular, within the jurisdiction of the medical institution. The various localities should strengthen supervision, strict according to deepen the reform of the medical care system requirements, adhere to the public health agency purchase large medical equipment as the government investment, giving priority to the equipment and with the suitable equipment and technology, resolutely put an end to illegal equipment large medical equipment, the correct guidance of medical institutions development direction, safeguarding the public medical institutions public benefits.

December 12, 2011