Abstract: 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.