China Biocide Registration

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 includes High Level Disinfectants (Glutaraldehyde, ortho-phthalaldehyde, peracetic acid, hydrogen peroxide, chlorine dioxide, chlorine disinfectants, etc.) and disinfectors (glutaraldehyde disinfection cabinet, electrolyzed-oxidizing water generator, endoscopic cleaning disinfectants, ventilator tubing disinfector, anesthesia machine pipeline disinfector, dialyzer disinfector, etc.). sterilant (glutaraldehyde, peracetic acid, hydrogen peroxide, chlorine dioxide, chlorine disinfectants, etc.) and sterilizer (Low-temperature hydrogen peroxide gas plasma sterilizer, low temperature formaldehyde steam sterilizer, ethylene oxide sterilizer, dry heat sterilizer, microwave dental drill disinfector, sterilization of endoscopic equipment, etc.). skin disinfectants (skin disinfectants with as main components of alcohols such as ethanol, isopropanol; guanidine such as chlorhexidine; iodine e.d. iodine tincture, iodophor; phenols such as chloroxylenol, triclosan, etc.) and mucous membrane disinfectants (with main components of chlorhexidinedigluconate, iodophor, triclosan, etc.). biological indicators (e.g. pressured steam sterilization, ethylene oxide biological sterilization indicators, low-temperature hydrogen peroxide gas plasma, ionizing radiation, sterilization process challenge device FCD, etc.). chemical indicators (class 4/5/6 pressured steam sterilization chemical indicator card, the package instructions card; sterilization effect indicators for pressured steam, ethylene oxide, low temperature steam formaldehyde, hydrogen peroxide gas plasma, ionizing radiation, etc.).Category II includes disinfectants not belonging to Category I and other disinfectors e.g. medical appliance cleaning and disinfecting machines, tableware disinfection machine, tableware disinfection cabinet, etc..Category III includes sanitary products (excluding bacteriostasis agents, antibacterial agents) e.g. sanitary wipes, contact lens care solutions, sanltary towel, etc..For Category I and II NN-DP, some tests shall be conducted, then 'Hygiene and Safety Assessment' shall be made before these products are put on the market. A notification with the test reports, the assessment reports and other materials shall be reported to local China authority (L-HFPC). L-HFPC will make formality evaluation of the notification dossier, and issue a voucher if formality evaluation finds no defects.The 'Hygiene and Safety Assessment' and the notification voucher are valid for 4 years for Category I NN-DP. Key test items, Hygiene and Safety Assessment and the notification of Category I NN-DP shall be re-performed before the expiration. The 'Hygiene and Safety Assessment' and the notification voucher are valid without time limitation for Category II NN-DP.For Category 1 and II NN-DP, some key test items shall be re-performed if some changes occur to the product, for example production site is changed, etc..For Category III NN-DP, 'Hygiene and Safety Assessment' and notification are not needed, while they shall meet related hygienic and quality standards.Registrant: Disinfection Products manufacturers outside China shall appoint Representative in China to make the registration jointly. The Chinese Representative takes the legal responsibility.Summary:Chart 1 below illustrates catalogues and categories of China Disinfection Products.Chart 1Chart 2 below illustrates the management of NN-DP in China.Chart 2Appendix: China List of Disinfection Products1 Disinfectant  1.1for disinfection and sterilization of medical supplies  1.2for skin and mucous membrane disinfection  1.3for tableware disinfection  1.4for fruits, vegetables disinfection  1.5for water disinfection  1.6for the disinfection of the environment  1.7for surface disinfection  1.8for air disinfection  1.9for disinfection of feculence e.g. excreta, secretions  1.10for hand disinfection2 Disinfection apparatus (disinfector)  2.1disinfection apparatus  1) for disinfection and sterilization of medical supplies and medical appliance  2) for tableware disinfection  3) for air disinfection  4) for water disinfection  5) for surface disinfection  2.2biological indicators  1). for pressured steam sterilization effect  2). for ethylene oxide sterilization effect  3). for UV disinfection effect  4). for formaldehyde sterilization effect  5). for ionizing radiation sterilization effect  2.3chemical indicators  1). for pressured steam sterilization effect  2). for ethylene oxide sterilization effect  3). for UV disinfection effect  4). for dry heat sterilization effect  5). for ionizing radiation sterilization effect  6). for measuring the concentration of chemical disinfectants  2.4Sterilization package  1). for pressured steam sterilization  2). for ethylene oxide sterilization  3). formaldehyde sterilization  2.5Others  1). indicator and package for low temperature hydrogen peroxide gas plasma sterilizer3 Sanitary Products  3.1women's menstrual hygiene products  1). sanitary napkins (paper, tape)  2). sanitary pads  3). tampon (built sliver)  3.2excrement hygiene products  1). panty-shape diapers  2). diapers (pads, paper)  3). changing mat  3.3skin and mucous membrane health supplies  1). wipes (paper)  2). sanitary wipes (paper)  3). bacteriostasis/antibacterial lotion (excluding suppositories, soaps)  3.4contact lens care products  1). the contact lens care solution  2). contact lens storage solution  3). contact lens cleaner  3.5other disposable hygiene products  1). tissue paper (paper)  2). the sanitary napkin (rods, check, ball)  3). cotton pads (paper towel)  4). glove, fingertip  5). paper tableware