one Definition of disinfection products 

Disinfection products include disinfectant Disinfection equipment Containing biological indicators Chemical indicators and Packaging of sterilized articles Sanitary supplies and disposable medical supplies.

according to Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases Disinfection management measures Management specification for labels and instructions of disinfection products Regulations on health and safety evaluation of disinfection products Technical specification for disinfection Measures for the administration of health administrative license Regulations on the administration of health administrative license for new disinfection products and new aquatic products Requirements,

Using new materials Production of disinfectants and disinfection instruments with new process technology and new sterilization principle Hereinafter referred to as new disinfection products ,Only after obtaining the health license and approval issued by the National Health Commission shall it be imported.

Disinfectants other than imported new disinfection products Anti in disinfection instruments and sanitary articles Suppress Bacterial preparation,No permission or filing is required before entry Some customs will need to provide information such as risk assessment ,Import enterprises shall conduct health and safety evaluation in accordance with relevant provisions,Meet the requirements of health standards and health specifications.When the product is on the market, the health and safety evaluation report shall be filed with the provincial health commission,Materials shall be provided for filing in accordance with the specified requirements.

two Classification of disinfection products

According to the purpose of disinfection products The risk degree of the object of use shall be classified,The details are as follows

The first category is high risk,Strict management is required to ensure safety Effective disinfection products,It includes high-level disinfectants and disinfection devices for medical devices Sterilizing agent and sterilizing apparatus Skin mucosal disinfectant,Biological indicator and chemical indicator of sterilization effect.

(notes High level disinfectant It means that it can kill all bacterial propagules Mycobacterium virus Fungi and their spores, etc,It also has a certain killing effect on pathogenic bacterial spores,Disinfectants that meet high-level disinfection requirements.

The second category is moderate risk,Management needs to be strengthened to ensure safety Effective disinfection products,Including disinfectants other than class I products Disinfection equipment,And resistance Suppress Bacterial preparation.

notes resist Suppress Bacterial preparation It refers to direct contact with skin and mucous membrane Have certain killing ability Bacteriostatic preparation suppository Except soap .Antimicrobial agents at dosage,Kill rate of test bacteria specified for inspection items≥90% killing log value ≥1.0 Bacteriostatic agents at the dosage,Bacteriostatic rate of test bacteria specified in test items≥50%.

The third category is low risk,Routine management can ensure safety Effective anti resistance Suppress Sanitary articles other than bacterial preparations. 
exceptional case When the same disinfection product involves different categories,It should be managed in a higher risk category.

three Provisions on approval and filing of disinfection products

1 Administrative approval required That is, it is often said that the font size approval document Imported disinfection products

      New disinfection products need to obtain the approval document of disinfection product license.New disinfection products include Using new materials Production of disinfectants and disinfectants by new process technology and new sterilization principle           Poison instrument.

2 It is necessary to complete the filing of safety assessment report That is, it is often referred to as erasure filing Imported disinfection products

      The safety evaluation report shall be made for class I and class II disinfection products first,And complete the filing on the national disinfection product safety evaluation report filing platform,Obtain filing review            Pass and publicize.

3 De lettering products that do not require filing and licensing

      Class III disinfection products,No filing is required,If the enterprise can ensure that the product quality meets the corresponding technical requirements, it can produce and sell on the market.

four Filing requirements and instructions

Filing requirements

first kind Type IIDisinfection productsOn initial market,The unit responsible for the product shall evaluate the hygiene and safety of the product,The evaluation must have a complete scientific basis,formation Health and safety evaluation report of disinfection products ,And submit the evaluation report and other complete sets of materials required for filing,Submit to the national online filing information service platform for disinfection products, The health commission of the place where the domestic responsible unit is registered shall conduct formal examination on the submitted materials,Those that pass the examination shall be publicized,For public enquiry.

Evaluation content

The content of health and safety evaluation includes product label Nameplate instructions Inspection report Including conclusion quality standard Producing country region Supporting documents allowing production and sales.among,disinfectant Biological indicator Chemical indicator Package of sterilized articles with sterilization mark resist Suppress The bacterial preparation also includes the product formula,Disinfection instruments shall also include the main components of the product Structure diagram.

Inspection requirements

Regulations on samples submitted for inspection Inspection method The inspection conclusion puts forward clear requirements.

In the health and safety evaluation of disinfection products,Disinfection products shall be inspected,And be responsible for the authenticity of the sample.All inspection items shall be completed with the same batch of products The inspection items shall meet the requirements of laws and regulations

For the first time,It shall be tested according to different categories of products, The inspection shall be conducted in an inspection institution with metrological certification.

It is necessary to continue the filing of class I disinfection products at the expiration of their validity,When inspecting disinfection products,Only for key projects.among,The test item of disinfectant is the content of active ingredient pHAnd a microbial killing test with the strongest resistance,The inspection items of disinfection instruments are the strength of main bactericidal factors and a microbial killing test with the strongest resistance,The test item of biological indicator is the determination of bacterial content,The inspection item of sterilization chemical indicator is the measurement of color change.The inspection items that pass the national supervision and sampling inspection within two years may not be carried out.

term of validity

The health and safety evaluation report of class I disinfection products is valid for four years,Before the expiration of the term of validity, the production enterprise shall conduct a new health and safety evaluation and record.

The health and safety evaluation report of class II disinfection products is long-term effective.

The health and safety assessment report is effective nationwide.

five List of materials provided by customers for filing

1.product labeling Nameplate instructions

2.Inspection report Including conclusion

3.Product quality standard

4.Producing country region Supporting documents and customs declaration allowing production and sales

5.Product formula

6.Structure diagram of disinfection equipment Main components and parameters

7.Trademark registration certificate/Notification of acceptance If registered/Application for registration

8.Business license of responsible unit in China

9.Letter of authorization of responsible unit in China Imported products .

six Flow chart of disinfection product filing

seven Professional services provided by Zongpu

       With the support of Zongpu's senior regulatory team and qualified laboratories,And the strategic cooperation of high-efficiency University R & D laboratory,We provide

       1.  Registration of erasure products Detect the whole process agent service

       2.  Entrusted service for product testing

       3.  Enterprise standard preparation and publicity services

       4.  New raw materials, new processes, disinfection product definition and license application agency services

       5.  Consulting and training services for disinfection product regulations.