CFDA in vitro diagnostic reagents against the storm!

Source: on April 7, 2015, the general office of the food and Drug Administration issued the notice on printing and distributing the work plan for quality assessment and comprehensive treatment of in vitro diagnostic reagents (sfjbx [2015] No 55) This is an obvious message, that is, the management of CFDA to IVD has been upgraded This is another powerful action after CFDA takes special treatment on condom, which means that special treatment on medical devices or a new mode of supervision! According to the notice, risk investigation, quality investigation, special investigation and special remediation are adopted to organically combine quality assessment and comprehensive governance Through quality assessment, the purpose of finding out the bottom line, identifying problems and proposing regulatory measures is achieved Through comprehensive governance, the goal of step-by-step remediation, comprehensive implementation and gradual establishment of long-term regulatory mechanism is achieved, and the consolidation is continued“ A new mode of special management of medical device supervision, which includes multi participation, combination of fighting and prevention, combination of fighting and construction, public benefit and industry development The notice clearly points out that the production, operation and use of in vitro diagnostic reagents should be focused on special remediation Different from other medical devices, in vitro diagnostic reagents are easily affected by the environment, transportation and storage conditions, so that the safety and effectiveness of in vitro diagnosis changes Therefore, in the notice, the production, operation and use of in vitro diagnostic reagents were specifically regulated, and the key points were grasped The direct attack on the problem was conducive to the effectiveness of the regulation! In the IVD production process, some production enterprises chose raw materials that were not compliant and water preparation was not compliant Some enterprises change the production process without authorization, which seriously affects the quality and safety of IVD and causes the instability of product quality As for these problems, it will be one of the key points of this rectification Relevant enterprises must not take them for granted! In the IVD operation, we should strictly follow the new regulations, the measures for the supervision and management of medical device operation (order 8), and the GSP of medical device We will focus on the management of unlicensed products, non-compliance of cold chain storage and transportation, and non-compliance of labeling Strictly check the problems that the operating enterprises and the third-party distribution enterprises do not transport and store according to the product specifications and labels In the use of IVD, the notice requires the hospital to focus on the treatment of the use of unlicensed products, the use of expired products, non-compliance of storage conditions, non-compliance of labeling, etc Therefore, the use of overdue and invalid IVD reagents by the users of IVD reagents can be punished in strict accordance with the provisions of item 3, paragraph 1, Article 66 of the new regulations In addition, the notice also requires a series of measures, such as risk investigation, quality investigation, special investigation, activity of "quality of IVD reagent in a million miles", special training, organization of investigation and handling of cases, establishment of long-term mechanism, etc., to carry out comprehensive remediation of IVD reagent, which means that CFDA will set off a storm of safety remediation of IVD reagent in China! Not only the thunder is required, but also the rain must come! With the popularization of the application of IVD reagent, its safety and effectiveness are increasingly concerned by people! Under the background of the national efforts to strengthen the safety supervision of medical devices, the IVD reagent industry can never become a corner full of problems Relevant enterprises must not take it lightly They should tighten the string of product safety and efficiency, so as to achieve compliance management, so as to be calm in the storm of rectification, and ultimately remain invincible in the fierce market competition (the author is an associate professor of Shanghai medical equipment college and a CFDA system expert)