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Randis ChemWise (Shanghai) Co., Ltd

მისამართი:
Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai


Shanghai



საკონტაქტო ინფორმაცია
Materials needed for registration of ndp  -  07.06.2017
წარმოშობის ადგილი: Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai
განთავსების თარიღი: 07.06.2017
აღწერა: Materials Needed for Registration of New Disinfection Products


Key materials:1. Production capacity audit result by China provincial Health Inspection Bureau (applicable for China domestic disinfection products)2. Research and manufacture reportFor new disinfectant:


· Report on research development in China and international.· The R&D process and the technical supports for the R&D.· Formula of the product with CAS numbers.· Sterilization mechanism of active ingredients.· Manufacture technical process· Concentration of main active ingredients, and research progress report for the concentration selection.· Research report on bactericidal effect and synergistic bactericidal effect if multiple active ingredients exist in the product.· Research report on microbial killing effects.· Research data on impact factors of sterilization, disinfection effect, e.g. temperature, relative humidity, impact by organic substances, and these shall be described in User Brochure.· Research data on corrosivity to metals.· Research data on relevant toxicological safety.· Research data on degradation of product in the environment.· Research data on the product's stability and term of validity for continuous use.For new disinfector: (omit).3. Quality standard4. Test method5. Certificate (proof) issued by the country (area) of the manufacture for allowing production and sales in the country (area) (applicable for imported disinfection products).6. China local representative nomination letter (applicable for imported disinfection products).7. Other materials helpful for the evaluation.


Example of test items (similar requirement exists for disinfectors):Test Items for Disinfectants (for both New and non-New disinfectants)









Test Items




Disinfection Objects






skin




mucous membrane




hand




tabl


eware




Fruit/


vegetable




Drinking water




Swimming pool water




Hospital sewage




air




medical appliance




General surfaces and fabrics




Others






Sterilization and high level disinfection




Middle level




Low level






Appearance












































































Active ingredient concentration












































































pH①





























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