Study on the Classification and Regulation of Medical Devices in Europe and America in IVD and the Enlightenment to Our Country

In vitro diagnostic products(IVD) involved in disease prevention, diagnosis, treatment options, efficacy evaluation, etc., the quality level directly affects the accuracy of diagnosis. Based on the correct identification of the risk of IVD, a reasonable classificationis of great significance to achieve scientific regulation, conservation of regulatory resources, promote the healthy development of the in vitro diagnostics industry. In this paper,opinions and suggestions on the reform and perfecting the regulatory classification of IVD in China is put forward through the analysis of the classification management system of IVD in Europe and the United States, combined with the status quo of China's regulatory classification and existing problems.