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State Food and drug administration official website recently disclosed two flight inspection rectification notice, Boka virus nucleic acid detection kit Hubei Landes medical technology limited production (PCR- fluorescent probe) mitochondrial DNA A1555 mutation detection kit and three March Shandong gene technology limited production (PCR- enzyme), with the discovery of quality management the system of different degree in the flight inspection and instructed the enterprises rectification. Together with the previous "in vitro diagnostic reagent registration amendment" (General Order No. thirtieth) officially released, the implementation of enterprise product quality and safety responsibility, and vigorously promote the in vitro diagnostic reagents (IVD) products in the clinical, registration, the whole production chain dynamic quality management standards implementation, has become the important direction of the new period to optimize product structure regulation to enhance the industrial structure.