Disinfection product supervision process "Regulations on Hygiene and Safety Evaluation of Disinfection Products" (Health Supervisory Commission [2009] No. 105), in order to strengthen the subsequent supervision and management of canceled disinfection products, establish a health and safety evaluation system. The "Regulations on Hygiene and Safety Evaluation of Disinfection Products" (National Health Supervision and Administration Bureau [2014] No. 36) and the "Working Standards for Sanitary Supervision of Disinfection Products" (National Health Supervision and Administration Bureau [2014] No. 40) implement risk supervision based on the purpose and use objects of disinfection products. Disinfection products are divided into three categories for supervision. Product responsibility units shall conduct health and safety evaluations by themselves or entrust a third party to form a "Hygiene and Safety Evaluation Report for Disinfection Products" before the first-class and second-class disinfection products are put on the market for the first time. Only disinfection products that pass the health and safety evaluation can be put on the market for sale. "Technical Requirements for Hygiene and Safety Evaluation of Disinfection Products" (WS 628-2018) is the first mandatory health standard formulated as technical requirements for the hygienic and safety evaluation of disinfection products. ) used together. Disinfection product classification: Disinfection products are divided into three categories according to their purpose and the risk level of the objects they are used for: 1. Disinfection products that have higher risks and require strict management to ensure safety and effectiveness, including high-level disinfection of medical devices Agents and disinfection equipment, sterilants and sterilization equipment, skin and mucous membrane disinfectants, biological indicators, chemical indicators of sterilization effect. 2. It is a disinfection product with a moderate risk that needs to be strengthened to ensure safety and effectiveness, including disinfectants, disinfection equipment, chemical indicators other than Category 1 products, and packaging of sterilization items with sterilization labels. , antibacterial preparations. 3. It is a sanitary product with low risk, and routine management can ensure safety and effectiveness except for antibacterial (antibacterial) preparations. (Note: Filing is not required) When the same disinfection product involves different categories, it should be managed in a higher risk category. Scope of Application of Hygiene and Safety Assessment of Disinfection Products Hygiene and Safety Assessment of Disinfection Products applies to Class I and Class II disinfection products that are produced and operated within the territory of the People's Republic of China and do not require administrative approval. Specific inspection items and requirements are based on the requirements of the "Technical Requirements for Hygienic Safety Evaluation of Disinfection Products" (WS 628-2018). The specific inspection items are as follows: Table 1 Disinfectant inspection items Table 2 Ethanol, glutaraldehyde, sodium hypochlorites, bleaching powder and bleaching powder essence Disinfectant testing items Table 3 Disinfection equipment testing items Table 4 Antibacterial (anti)bacterial preparation testing items health and safety evaluation report template For details, please refer to "Technical Requirements for Health and Safety Evaluation of Disinfection Products" (WS 628-2018) Appendix A (Normative Appendix) Disinfection Product health and safety evaluation report format. Filing Types and Requirements First Filing The product responsible unit shall conduct a health and safety evaluation by itself or entrust a third party to form a "Disinfection Product Health and Safety Evaluation Report" before the first and second class disinfection products are put on the market for the first time, and shall be responsible for the evaluation results. The health and safety evaluation report has complete information and meets the requirements. Registration materials include basic information and evaluation information: Basic information, including cover, basic information table, evaluation information directory and registration form; Commercial labels (nameplates), commercial instructions; Inspection reports (including conclusions); Domestic product registration enterprise standards Or the quality standards of imported products; the health license of domestic product manufacturing enterprises or the certification documents and customs declaration forms that allow production and sales in the country (region) where imported products are produced; product formulas of disinfectants and antibacterial (bacterial) preparations; disinfection equipment structure diagram (main elements) devices and parameters); others (product photos, entrusted processing contracts, trademark documents, etc.).

If the following circumstances change for a disinfectant product that has been updated and registered and put on the market, the product responsibility unit shall re-test the relevant inspection items and update the evaluation data: a) The actual production address is moved, a new branch factory or workshop is established, or the production and processing is transferred to another entrustment; b) Disinfection Agents, antibacterial (antibacterial) preparations, biological indicators, chemical indicators, packaging of sterilized items with sterilization labels and PCD to extend the validity period of products; c) Increase in disinfectants, disinfection equipment and antibacterial (antibacterial) preparations The scope of use or changes make the update of the disinfection product hygiene and safety evaluation report true, and the changed content information is complete and meets the requirements. Filing materials include: basic information, including updated filing instructions, cover, basic information table, evaluation data catalog and filing registration form; commercial labels (nameplates), commercial instructions; inspection reports (including conclusions); domestic product registration enterprise standards Or the quality standards of imported products; the health license of domestic product manufacturing enterprises or the certification documents and customs declaration forms that allow production and sales in the country (region) where imported products are produced; product formulas of disinfectants and antibacterial (bacterial) preparations; disinfection equipment structure diagram (main elements) devices and parameters); others (product photos, entrusted processing contracts, trademark documents, etc.). Re-filing: The re-filing of the sanitary and safety evaluation report of disinfection products requires that the product belongs to the first category of disinfection products, and the key items of the product must be re-inspected. Inspection items that pass the national supervision and spot inspection within two years may no longer be carried out. Filing materials include: basic information, including re-filing description, cover, basic information table, evaluation data catalog and registration form; commercial labels (nameplates), commercial instructions; inspection reports (including conclusions); domestic product registration enterprise standards Or the quality standards of imported products; the health license of domestic product manufacturing enterprises or the certification documents and customs declaration forms that allow production and sales in the country (region) where imported products are produced; product formulas of disinfectants and antibacterial (bacterial) preparations; disinfection equipment structure diagram (main elements) devices and parameters); others (product photos, entrusted processing contracts, trademark documents, etc.). Registration Service Platform The responsible unit for disinfection products needs to conduct a health and safety evaluation before the first and second types of disinfection products are put on the market for the first time. The relevant health and safety evaluation report can be entered into the national information service platform for filing. The national information service platform was launched on October 8, 2018. It mainly provides online registration services for disinfection product hygiene and safety evaluation for national disinfection product responsible units, and provides social supervision and information inquiry, social credit system construction, and supervision agencies for ongoing and post-event activities. Supervise law enforcement and provide standardized and unified information services. Application method Online application: Responsible units upload electronic files of filing materials through the national integrated government service platform or the national disinfection product online filing information service platform. The basic registration process is as follows: Review form The provincial (municipal) health administrative department will conduct a formal review of the disinfection product health and safety evaluation report filing materials. The hygiene and safety evaluation reports of disinfection products that pass the formal review will be filed; for those that fail the formal review, opinions on the need to supplement or modify the materials will be provided remotely on the platform. Product-related materials that do not require health and safety evaluation uploaded by the product responsible unit will be returned directly. The review content of the sanitary and safety evaluation report form of disinfection products includes the completeness, standardization and legality of the data. (1) Integrity review includes the following contents: 1. The materials are complete and should comply with the "Regulations on Hygiene and Safety Evaluation of Disinfection Products", "Technical Requirements for Hygiene and Safety Evaluation of Disinfection Products" (WS 628-2018) and the provisions of these Measures; 2. Fill in The content should be complete, with no missing or missing items; 3. The inspection items should be complete and should comply with the provisions of the "Regulations on Hygiene and Safety Evaluation of Disinfection Products" and "Technical Requirements for Hygiene and Safety Evaluation of Disinfection Products" (WS 628-2018). (2) Normative review includes the following content: 1. The content of the material should be consistent, such as product name, dosage form/model, responsible unit and actual production company name, actual production address, etc.; 2. The material should be clear and without alteration; 3. The materials must be stamped with the official seal of the responsible unit page by page, and the copy of the sanitary license of the disinfectant product manufacturer must also be stamped with the official seal of the actual manufacturer.

(3) Legality review includes the following: 1. The product name, label (nameplate), and instructions should comply with the relevant provisions of the "General Requirements for Labels and Instructions for Disinfection Products" (GB 38598-2020), and approved drug names must not be used; 2 .Product labels and instructions must not appear or imply disease treatment effects; 3. The corporate standards of domestic products are filed in accordance with the law and are within the validity period; 4. The sanitary license of the disinfection product manufacturing enterprise for domestic products is within the validity period, and the registered products are approved by the license within the production category. Release of filing information: Provincial (municipal) health administration departments will make public the information on disinfection products that have been approved for filing on the national disinfection product online filing information service platform, and information involving commercial secrets will not be made public. Information release content includes product name, product risk classification (first or second category), dosage form, model, specification, scope of use, product responsible unit name and unified social credit code, actual production company name, disinfection product production company hygiene License number, health and safety evaluation conclusion, evaluation date, commercially available product labels, nameplates, instructions, inspection reports, filing dates, etc. Supervision during and after the event The provincial health administrative department is responsible for the supervision of disinfection products in the province, making full use of the Internet platform to strengthen inspections on the filing of health and safety evaluation reports of first- and second-class disinfection products, and establishing an inter-provincial, municipal, and county collaborative inspection mechanism. Local health administrative departments and health supervision and law enforcement agencies at all levels shall carry out supervision and law enforcement of disinfection product manufacturers and disinfection products in their respective jurisdictions, and include the disinfection products registered in the current year as key annual spot checks. At the same time, the filing of disinfection product health and safety evaluation reports and the results of interim and post-event supervision will be applied to the construction of corporate credit systems, and comprehensive supervision mechanisms such as collaborative supervision, information sharing, and joint punishment among government departments will be established.