In China, Category I and Category II disinfectants and disinfector/sterilizers using existing material/technology need to pass a number of tests run by CMA labs and the final test reports must be included in the “Report on the Hygienic and Safety Assessment of Disinfection Products”. This document should then be submitted to the corresponding health authority at a provincial level. The test scope varies significantly depending on the product type, usage, composition and mechanism applied.

Since the last time NHFPC/NHC approved new disinfectant or sterilizer/disinfecting apparatus was back in 2014, when the management of existing products was delegated to provincial departments, hygienic and safety assessment became the only feasible way to have access to the disinfectants and sterilizers market in China. To help improve compliance with China’s disinfectant/sterilizer regulations, this article will focus on the enforceability and most practical issues involved in the premarketing assessment of disinfection products.