Disinfection products refer to disinfectants, disinfection equipment (including biological indicators, chemical indicators and sterilized packaging ), sanitary products and disposable medical products.
As required by Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases, Measures for the Administration of Disinfection ,Regulation Standard of labels and Instructions of Disinfection Products,Hygiene and Safety evaluation of disinfection products, Technical Standard of Disinfection,Measures for Regulation of Hygienic Administrative License,Management Regulation on Hygienic Administrative License of New Disinfection Products and Drinking Water- Related Products,
Disinfection products produced and sold within the territory of China shall be subject to classified and management according to different risks.
The classification is carried out according to the use of disinfection products and the risk of the object, as follows:
The first category refers to disinfection products with high risks, which need strict management to ensure safety and effectiveness, including high-level disinfectants and disinfection apparatus used for medical devices, sterilizers and sterilizing devices, disinfectants for skin and mucous membranes, biological indicators and chemical indicators for sterilization effect.
(Note: High-level disinfectants refer to disinfectants that can kill all bacterial propagators, mycobacteria, viruses, fungi and their spores, etc., and have certain killing effect on pathogenic bacterial spores, so as to meet the requirements of high-level disinfection.)
The second category is those that are moderately risky and requires strengthening of management to ensure safe and effective disinfection products, including disinfectants, disinfection apparatus, and antibacterial (bacteriostatic) preparations other than the first category.
(Note: Antibacterial (bacteriostatic)) preparations: refer to preparations that directly contact the skin and mucous membranes and have certain killing and antibacterial effects (except suppositories and soaping agent). The killing rate of the antibacterial agent to the test bacteria specified in the test item is more than 90% (killing logarithm is more than 1.0) under the dosage, under the dosage, the bacteriostatic rate of the test bacteria shall be more than 50%.)
The third category is hygiene products with a low risk level, which can be safely and effectively managed by routine management in addition to anti-bacterial preparations.
Special circumstances: when the same disinfection product is involved in different categories, it should be managed in a higher risk category.
三、Regulations on Approval
1. Disinfection products that require administrative license.
New Disinfection Products need to obtain administrative license of disinfection products. And it refers to produce disinfectants and disinfection apparatus with New Raw Material, New Technology and New Sterilization Principles.
2. Disinfection Products that require online filing
The first and second category of disinfection products should be evaluated for hygiene and safety before they are first launched, and shall be filed on the national filing system for disinfection products which shall be reviewed and approved by the local Health Commission and publicized.
3. Disinfection products with no need for licensing.
The third category of disinfection products do not need to be filed. Enterprises can produce and sell the products if they can ensure that the product quality meets the corresponding technical requirements.
四、Requirements and instructions for filing
When the first and second category of disinfection products are listed for the first time, product liability entity shall make a hygiene and safety evaluation of the products. the evaluation should be a complete scientific basis with "Hygiene and Safety Evaluation Report of Disinfection Products", submit the evaluation report and other required documents to the filing system for disinfection products ,The local Health Commission where the responsible entity is registered shall make a formal examination of the submitted materials, and publicize the approved materials for public inquiry.
The content of the Hygiene and Safety Evaluation covers: product label (nameplate), instructions, test report (including conclusions), enterprise standards, and hygiene license of enterprise producing disinfection products.Among them, disinfectants, biological indicators, chemical indicators,sterilized packaging with sterilization marks,and antibacterial ( bacteriostasis) preparations also include product formulas, and disinfection equipment should also include product main components and structural drawings.
The hygiene safety evaluation from the responsible entity should be a complete evaluation report consisting of two parts: basic information and evaluation data.
The regulations set clear requirements on the samples to be tested, test methods, test conclusions, etc.
When evaluating the hygiene and safety of the disinfection product, the disinfection product shall be tested and the authenticity of the sample shall be held responsible.All test items shall be conducted with the same batch of products (test items shall meet the regulatory requirements).
If the products are filed for the first time, they shall be tested in accordance with the provisions according to different categories of products, and the test shall be conducted in an inspection institution with metrology certification.
Where the validity period of the first category of disinfection products for filing needs to be extended,only the key items shall be included in the test of the disinfection products.Among them, the disinfectant test items are the effective ingredient content, pH value and a most resistant microbial killing test.The test items for disinfection apparatus are the strength of the main bactericidal factors and a most resistant microbial killing test,item for biological indicator is the determination of the bacterial content and item for chemical indicator is the determination of the color change. The inspection items that pass the sampling inspection under state supervision within two years may no longer be carried out.
The hygiene and safety evaluation report is valid nationwide. The hygiene and safety evaluation report of the disinfection products in first category is valid for four years, and for the second category is valid for a long time.
Before the expiry of the validity period of the hygiene and safety evaluation report of the disinfection products in first category, the production enterprise shall conduct a new evaluation on the hygiene and safety and filing again.
五、Required documents for record-filing
1. Product label (nameplate),manual.
2. Test report(including conclusion).
3. Product quality standard.
4. Hygiene license of the manufacturing enterprise.
5. Product formula .
6. Diagram of disinfection apparatus.
7. Trademark Registration Certificate/Receipt Notice(If registered/applied for registration).
8. Business license of the responsible entity.
六、Flow Diagram of Filing Process
七、Professional Services from ZOOP
With the support of the ZOOP's senior regulatory team and qualified laboratory, as well as the strategic cooperation of university R&D laboratory, services are available as follows：
1. Fully acting for filing and testing for disinfection products.
2. Acting for product test.
3. Compilation of Enterprises Standard and publicity.
4. License application and definition for disinfection products with new raw materials and new process.
5. Consultation and training service on regulations of disinfection products;
6. Apply for hygiene license of disinfection products of the factory, and apply for extension of projects and other related services.