¡¡¡¡The Ministry of Public Health’s office issued Notice on Strengthening the Configuration Management of Positron Emission Tomography and Magnetic Resonance Imaging (PEI-MRT) System on December 19 (hereinafter called the “Notice”). The notice stated that the medical institutions shouldn’t introduce the PET-MRI equipment for clinical use without approval for configuration, in any form or by any means, including purchase of PET-MRI in the name of MRI or PET and technical upgrading of equipped 3.0 T MRI to PET-MRI, and should avoid the configuration planning for large-scale medical devices.

¡¡¡¡According to introduction, PET-MRI is new large-scale equipment integrating Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). It is still in the initial development stage with a number of key technical issues that remain to be further improved. At present, the price of this equipment without Chinese medical device registration certificate in the foreign market is $ 5 to 7 million, which is far more than the price limitation of RMB 5 million of Category A large-scale medical device item. According to the regulations of Administrative Measures for Large-scale Medical Devices Configuration and Use issued by the Ministry of Public Health, the National Development & Reform Commission and the Ministry of Finance, PET-MRI belongs to the Category A large-scale medical device. Now, the Ministry of Public Health is doing research on PET - MRI configuration management.

¡¡¡¡The Notice stipulates that the medical institutions and manufacturers should introduce PET-MRI in the name of scientific research cooperation to carry out clinical trials, the results of which could not be used as basis and reference for examination and approval of configuration in the next step. The medical institutions without approval for configuration should be sternly dealt with in accordance with the relevant provisions. The Ministry of Public Health will carry out PET-MRI configuration planning and declaration again in accordance with the provisions of Category A Large-scale Medical Equipment Configuration Approval Working System of Ministry of Public Health (Provisional) after approval for medical device registration certificate MRI-PET.