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Regulatory Status of Disinfectant Wet Wipes in China

In China, disinfection products are defined as disinfectant, sterilizing agent, antimicrobial agent, medical/common disinfector/sterilizer, packed-sterilized articles with sterilization marking, biological and chemical indicators of sterilization effect and various hygiene products including wet wipe and hygiene/disinfection wipes. The definition, classification, national registration/ provincial record filling of novel/existing disinfectant and sterilizer are complete while the legal framework of other disinfection products types is comparatively absent. As disinfectant-carrying wipes are rapidly developing in China, the term “vehicle disinfectant” has been proposed by the NHFPC/NHC and would affect regulation of certain consumer products. 

With the rise of emerging infectious diseases such as SARS and human avian Influenza and so on, a sort of wet wipes called "hygiene wet wipe" or "disinfection wet wipe" have appeared on the market and are developing rapidly in China. As wet wipes are traditionally categorized as hygienic products and exempted from premarketing evaluation on its antimicrobial/disinfection claims, safety concerns have long been discussed by regulators. In this article, we will explore the statutory definition, classification, technical criteria, and regulatory forecast of wet wipes.

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