Recently, the Food and Drug Administration of Guangxi Zhuang Autonomous Region issued the Notice on the Flight Inspection of Clinical Trial of Glycosylated Hemoglobin Assay Kit (Latex Enhanced Immunoturbidimetry) Produced by Guangxi Runmeng Medical Technology Co., Ltd. (hereinafter referred to as the Notice) . According to the "Notice", the bureau organized a clinical trial of the glycated hemoglobin determination kit for medical device products (latex enhanced immunoturbidimetry) (acceptance number: Gxzf-Proj-2017-13148) in Guangxi Runmeng Medical Technology Co., Ltd. in May. The flight was inspected and the results showed that the product registered for the application was found to have the following problems in clinical trials: 1. In the clinical trial conducted by Gezhouba Group Central Hospital, the clinical trials of clinical trials use whole blood samples, which are inconsistent with the serum samples used in clinical trials and clinical trial reports; clinical trial samples cannot be traced back in the hospital LIS system; The clinical trial sample has been destroyed, and there is no original record of sample retention and destruction. It is impossible to verify whether the clinical trial sample is serum or whole blood; the original test data is not retained on the test instrument, and it has been deleted and not backed up. Traceability. 2. In the clinical trials carried out by the 161st Hospital of the People's Liberation Army, the clinical trial programs and clinical trial reports provided by the hospital were consistent with the enterprise registration reports, and serum samples and latex-enhanced immunoturbidimetry were used. However, according to the test routine, glycated hemoglobin in human body is mainly present in red blood cells, and the content in plasma and serum is very low or even absent. There is no clinical significance for its detection; the clinical trial samples have been destroyed, the destruction record has not been signed, and the sample cannot be traced; clinical The test data in the test instrument has been deleted, and there is no backup, and traceability cannot be performed. Finally, the Notice clearly states that according to Article 49 of the “Regulations on the Administration of Registration of In Vitro Diagnostic Reagentsâ€, the Guangxi Food and Drug Administration decided not to register the registration application and agreed that Guangxi Runmeng Medical Technology Co., Ltd. withdrew the above. Application for registration of 11 items including the total protein assay kit (biuret method) for clinical trials at the same time in the two medical institutions. In this incident, it is worth noting that the Guangxi Food and Drug Administration is a random inspection of the clinical trials of enterprises. It is rare, but at present, according to the unified requirements of the State Food and Drug Administration, drug administrations across the country are also strengthening. Supervision and management of clinical trials of medical devices. Next, like the Guangxi Food and Drug Administration, the clinical trials of medical device registration products will be initiated, and more or more will be launched. Shaanxi Hongbaiyi Biotech Co., Ltd. , https://www.sxhongbaiyi.com