| Message: | Understanding China Disinfection Product RegulationChina Regulation on Disinfection Products was dramatically revised in 2014.Since 2014, disinfection products (refer to 'List of Disinfection Products') are classified into 2 catalogues: New Disinfection Products (N-DP). and non-New Disinfection Products (NN-DP).New Disinfection Products (N-DP)N-DP refer to disinfectant and disinfection apparatus (disinfector) that are produced through the use of new material, new technology and new sterilization principle.New materials refer to materials that are covered by 'Active Ingredient List of Disinfectant's Raw Materials', by materials with disinfection/antisepsis efficacy as stated by China Pharmacopoeia, or by other currently effective China hygienic standards/files.New technology refers to production and processing technology, through which the changes in production technology parameters and / or process flow result in the effectiveness, safety performance and circumstance adaptability of disinfectant / disinfectors are equal to or better than conventional ones.New sterilization principle refers to these not covered by List of Disinfection Factor and their Corresponding Disinfector, by List of Indicators.Active Ingredient List, List of Disinfection Factor and their Corresponding Disinfector, and List of Indicators were published on December 20th of 2013.N-DP shall be evaluated and approved by China central authority (China National Health and Family Planning Commission, N-HFPC). The evaluation and approval process will take normally more than 3 months, excluding the time needed for tests. The approval is valid for 4 years.After N-DP is approved and the approval is publicized, then it will be managed as NN-DP.non-New Disinfection Products (NN-DP)NN-DP refers to disinfectors and disinfecting apparatus that are not N-DP, and refer to sanitary products.NN-DP are. classified as Category I 'High Risk NN-DP', Category II 'Middle Risk NN-DP' and Category III 'Low Risk NN-DP'.Category I inc......url:http://www.randiscn.com |
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