Comparison of Classifcation and Regulation of in Vitro Diagnostic Products for Clinical Pathology in China and Foreign Country

The classification and the regulatory requirement among U.S., E.U., Japan and China were summarized and compared for the immunohistochemistry and in situ hybridization products. The results indicate that:the regulatory classifications of the related products are higher in Japan and China, than U.S.and E.U.; the classification and regulatory requirement are adjusted more flexibly in the centralized system. The difference was discussed and accordingly some suggestions and implications were given for the China's regulation.