New Disinfection Apparatus Licensing

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. Research Report;

a.Reports on research progress at home and abroad.

b.Novelty Assessment Report on technology.

c.Technical support for product development and R&D process.

d.Product structure diagram,brand, specification and main bactericidal factor intensity (concentration) of main components.

e.Product disinfection and sterilization procedures and control requirements for disinfection and sterilization parameters.

f.The working principle and laboratory data of product research,the specific function of each step in disinfection and sterilization procedures,the basis for parameter selection, the experimental data for parameter selection and the reasons for parameter determination, etc.;for apparatus with multiple disinfection factors, a study report on the killing effect of each disinfection factor and the killing effect of the compound factor shall be provided.

g.The R&D data of factors affecting the disinfection and sterilization effect of product , such as temperature, relative humidity,pressure, cleaning quality, humidity of the items to be sterilized, loading method and full quantity, etc. on disinfection and sterilization effect, and detailed description in the use instructions of products.

h.R&D data of the damage degree of the material to be disinfected and sterilized.

i.Data on the value that article can be used directly without cleaning after sterilization or the determination data of the residue after sterilization,R&D data on the biological safety of apparatus after disinfection and sterilization. (GB/T16886.1-2001 "Biological Evaluation of Medical Devices Part I: Evaluation and Tests").

j.For disinfection and sterilization apparatus that need to be equipped with chemical disinfectants, R&D data on the concentration of disinfectants, the stability of disinfectants used in apparatus and the R&D data on ensuring the concentration of disinfectants used in daily use shall be provided.

k.R&D data of disinfectant factors or disinfectant leakage in the environment .

l.Study report on the corresponding bactericidal effect of disinfection apparatus.

m.The monitoring equipment for disinfection and sterilization effect,the research and verification data of disinfection and sterilization method.

4. Quality standard

5. Test method

6. Power of attorney for application(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.

 

三、Application Process

Collect product research data -- provincial examination for 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

 

四、Required Period

5-12 months (It is a reference period only,the actual period depends on the product)

 

五、Legal Accordance

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.