一、Overview of Regulations on New Disinfection Products
According to relevant regulations,the production of disinfectants and disinfection apparatus (hereinafter referred to as new disinfection products) by using new materials, new techniques and new disinfection principles and pass the evaluation on product safety and efficacy,to obtain a hygiene license before they can be produced and imported,otherwise, illegal production and import without license will be subject to recall, confiscation of illegal gains and fines.
New materials: those that are not included in the list of active ingredients of disinfectant raw materials (Table 1), and are not included in the category of disinfection and anticorrosion in the Pharmacopoeia of the People's Republic of China,those that are not included in the current national health standards and norms.New technology:refers to changes in production technical parameters and/or process flow, resulting in the effectiveness, safety, and environmental adaptability of disinfectants and disinfection apparatus equal to or better than conventional products. New disinfection principle: refers to the disinfection principle and its indicator which are not included in the list of disinfection factors and corresponding disinfection apparatus and indicators (Table 2 and Table 3) and are produced by physical, chemical and biological disinfection factors or by mutual synergistic action.
The regulations also stress that the effectiveness, safety and environmental adaptability of new disinfection products should be the same or better than conventional products, or they may not be approved.
二、Required Documents for Application
1. Application form for hygienic administrative license.
2. Review opinions on production capacity issued by provincial health supervision authorities.
3. Development Report；
a. Reports on research progress at home and abroad.
b. Technical support for product development and R&D process.
c. Product formulation and CAS Numbers for each raw material (Registration numbers established by Chemical Abstracts Service for chemical substances).
d. Sterilization mechanism of active ingredients.
e. Technical process.
f. Research report on the concentration of main bactericidal active ingredients in the product and the selection process.
g. For disinfectants containing multiple active ingredients, reports on the bactericidal effects of each active ingredient and the synergistic bactericidal effects of multiple active ingredients shall be provided.
h. Research report on the microbial killing effect related to the use scope of the product.
i. The R&D data of factors affecting the effect of product disinfection and sterilization, such as temperature, relative humidity, organic matter, and the impact on the effect of disinfection and sterilization, and detailed descriptions in the product instructions.
j. R&D data on the corrosiveness of products to metal materials.
k. R&D data on the toxicological safety related to the scope of product use.
l. R&D data of product degradation in environment.
m. R&D data of product stability and continuous use validity.
4. Quality standard.
5. Test method.
6. Power of attorney for application(required if it is commissioned).
7. Credentials that the country (region) of the product is permitted to produce and sell at local(Application for imported new disinfection products)
8. Letter of Authorization from the responsible entity in China (Application for imported new disinfection products.
9. Other material that may contribute to the review.
One sample submitted for review.If the length (or width or height) is no less than 150cm and the weight is no less than100kg, color photos (showing the appearance and internal structure) shall be provided.
Collect product research data -- provincial examination of production capacity -- make application materials -- online declaration -- pass pre-examination -- on-site submission and acceptance of materials -- experts' technical review -- administrative license -- issue approval documents and make public
5-12 months (It is a reference period only,the actual period depends on the product)
Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases,Measures for the Administration of Disinfection ,Technical Standard of Disinfection,Nomenclature Specifications for Health-related Products,Regulation Standard of labels and Instructions of Disinfection Products,Code of Hygienic Supervision for Disinfection Products,Regulation on Hygienic Administrative License of New Disinfection Products and Drinking Water- Related Products.
六、Professional Services from ZOOP
Relying on the professional team of ZOOP, with more than 10 years of experience in product declaration, filing and test certification. Services are available as follows:
1. Identification of disinfection product categories.
2. Full consultation for the application of new disinfection products.
3. Fully acting for the application of new disinfection products.
4. R&D consulting services for new disinfection products.
5. Develop a test plan for new disinfection products and testing.
6.One-stop service for the declaration of new disinfection products and the record-filing of Class I and II disinfection products.