Article 1 These Provisions are formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases, the Measures for the Administration of Disinfection and other relevant provisions in order to further deepen the reform of the health administrative examination and approval system, standardize the production and business operations in disinfection products, and ensure the effectiveness and safety of disinfection products for the prevention and control of infectious diseases.
Article 2 Classified management shall be implemented according to the use of disinfection products and the degree of danger of users.
The first category is disinfection products, which is risky and needs strict management to ensure safety and effectiveness. Including advanced disinfectants and disinfection equipment, medical equipment disinfectants and disinfection equipment, skin and mucous membrane disinfectants, biological indicators and chemical indicators of sterilization effect. The second category is disinfection products with moderate risk, which needs to be strengthened to ensure safety and effectiveness, including disinfectants, disinfection instruments and chemical indicators, as well as packaging of sterilized articles with sterilization marks and antibacterial (bacteriostatic) preparations except the first category products. The third category is low-risk sanitary products, and the implementation of routine management can ensure the safety and effectiveness of sanitary products except antibacterial (bacteriostatic) preparations.
When the same disinfection products involves different categories, it should be managed in the higher risk category.
Article 3 These Provisions shall apply to Class I and Class II disinfection products that are produced and operated within the territory of People's Republic of China (PRC) without administrative examination and approval.
Article 4 Before the first listing of Category I and Category II disinfection products, the product responsible unit shall conduct health and safety evaluation by itself or entrust a third party, and be responsible for the evaluation results. Only disinfection products qualified in health and safety evaluation can be listed for sale.
The product responsibility unit refers to the unit or individual who is legally responsible for personal injury or property loss caused by product defects. The responsible unit of domestic products is the production enterprise, and when entrusting production and processing, it refers to the entrusting party; The responsible unit of imported products is the responsible unit in China.
Article 5 The contents of health and safety evaluation include product labels (nameplates), instructions, inspection reports (including conclusions), enterprise standards or quality standards, sanitary license qualifications of domestic product manufacturers, and production and sales approval documents of imported products producing countries (regions). Among them, disinfectants, biological indicators, chemical indicators, packaging of sterilized articles with sterilization marks, and antibacterial (bacteriostatic) preparations should also include product formulas, and disinfection instruments should also include the main components and structural drawings of products.
Article 6 The formula of disinfection products shall be consistent with the actual production. See annex 1 for the writing format and requirements of the formula.
Article 7 The grade and purity of raw materials in disinfection products and the requirements of raw materials such as main parts of disinfection equipment shall meet the requirements of the corresponding sanitary standards, technical specifications and enterprise standards in disinfection products.
Article 8 The structural drawing of disinfection equipment shall be consistent with the actual product structure, and the names, technical parameters and quantity of main components shall be indicated.
Article 9 The labels (nameplates) and instructions of disinfection products shall conform to the requirements of "disinfection products Label Instructions Management Standard" and relevant health standards.
Tenth product responsibility units in the health and safety evaluation of disinfection products, disinfection products should be inspected, and be responsible for the authenticity of the samples. All inspection items shall be completed by the same batch of products (see Annex 2 for inspection items and requirements).
Eleventh disinfection products inspection shall be carried out in disinfection products inspection institutions with corresponding conditions. Disinfection products inspection institutions shall abide by the relevant provisions of disinfection management, pass the laboratory qualification certification, and engage in disinfection products inspection activities within the approved inspection capacity.
Disinfection products inspection institutions shall abide by the relevant laws and regulations and these Provisions, carry out inspection in accordance with the hygiene standards, technical specifications and inspection specifications of disinfection products, issue inspection reports (including conclusions), and be responsible for the authenticity and accuracy of inspection data and results. If there is no clear inspection method in health standards and technical specifications, it can be inspected according to enterprise standards.
Disinfection products inspection institutions that issue false inspection reports or neglect management to ensure inspection quality will be severely punished.
Article 12 In any of the following circumstances, the product shall be reinspected:
(a) the actual production address is moved, and another factory or workshop is set up to entrust production and processing. Among them, disinfectants and antibacterial (bacteriostatic) preparations should be tested for effective component content, stock solution stability and pH value; Disinfection instruments should detect the intensity of main sterilization factors, and simulated field tests should be carried out if they do not have the conditions to detect sterilization factors; Biological indicators should detect bacterial content, chemical indicators should detect color changes, and packaging of sterilized articles with sterilization marks should detect sterilization factor penetration;
(2) Disinfectants and antibacterial (bacteriostatic) preparations that extend the validity period of products should be tested for the content of effective components, pH value, killing (or inhibiting) a microorganism with the strongest resistance and stability; Only the stability test is needed to use the original sample;
(three) disinfectants, disinfection equipment and antibacterial (bacteriostatic) preparations to increase the scope of use or change the method of use, should be the corresponding physical and chemical, microbial killing (or inhibition) and toxicology tests.
Article 13 The enterprise standards for domestic products and the quality standards for imported products shall meet the following requirements:
(1) The product standards of disinfectants and antibacterial (bacteriostatic) preparations shall include the hygienic quality requirements (including grade and purity) and technical requirements (including sensory indicators, physical and chemical indicators, microbial indicators and sterilization indicators) of raw materials, as well as their inspection methods, type inspection items and ex-factory inspection items; The standard of disinfection equipment should include the name and model, raw materials, technical parameters of main components, technical requirements (including sterilization factor strength and microbial killing index), inspection methods, type inspection items and ex-factory inspection items, etc.
(2) The technical requirements of products shall meet the requirements of national health laws, regulations, norms and regulations, and shall not be lower than the corresponding product hygiene standards;
(3) The inspection method shall meet the requirements of national health laws, regulations, standards, norms and regulations;
(four) the enterprise standards for domestic products shall be filed in accordance with the law and within the validity period.
Article 14 The health and safety evaluation of the product responsibility unit shall form a complete health and safety evaluation report of disinfection products, including basic information and evaluation data (see Annex 3 for the format). The health and safety assessment report is valid nationwide. The first type of disinfection products health and safety evaluation report is valid for four years, and the second type of disinfection products health and safety evaluation report is valid for a long time.
When Class I and Class II disinfection products are listed for the first time, the product responsibility unit shall file a health and safety evaluation report with the local provincial health and family planning administrative department (see Annex 4 for the registration form). The provincial health and family planning administrative department shall formally review the health and safety evaluation report, and if the information is complete, it shall issue a record certificate to the product responsibility unit within 5 working days (see Annex 5 for the record certificate), and affix the seal of riding seam on the health and safety evaluation report for the record.
After the products that have completed the health and safety evaluation are put on the market, if the products change (formula or structure, production process) or the circumstances specified in Article 12 of these Provisions occur, the product responsible unit shall update the relevant contents of the health and safety evaluation report of disinfection products in time to ensure that the evaluated products are consistent with the products produced and sold, and at the same time file with the original filing authority.
Before the expiration of the first type of disinfection products health and safety evaluation report, the production enterprise shall re-evaluate the health and safety and put it on record. In the inspection of disinfection products, only the key items are done. Among them, the inspection items of disinfectant (disinfectant) are active ingredient content, pH value and a sterilization test with the strongest resistance, the inspection items of disinfectant (disinfectant) are the strength of main sterilization factors and a sterilization test with the strongest resistance, the inspection items of biological indicators are the determination of bacterial content, and the inspection items of sterilization chemical indicators are the determination of color change. Inspection items that have passed the national supervision and sampling inspection within two years can no longer be done.
Fifteenth product management and use of units in the operation and use of the first and second categories of disinfection products, it should obtain a copy of the health and safety evaluation report and filing documents. Among them, the evaluation materials in the health and safety evaluation report only include labels (nameplates), instructions, conclusions of inspection reports, health licenses of domestic product manufacturers, certification documents of imported products that are allowed to be produced and sold, and customs declarations.
Sixteenth local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies shall strengthen the health supervision and inspection of enterprises that carry out health and safety evaluation in disinfection products. The provincial health and family planning administrative department shall regularly publish the relevant information about the hygiene license of production enterprises and the hygiene and safety evaluation of products.
Seventeenth any of the following circumstances, does not meet the requirements of national health standards, health norms or health quality is unqualified, according to the "People's Republic of China (PRC) infectious disease prevention law" article seventy-third or "disinfection management measures" article forty-seventh:
(a) the first and second categories of disinfection products have not been evaluated for health and safety before their initial listing;
(2) The health and safety evaluation report of disinfection products of Category I has not been re-evaluated;
(three) issued a false health and safety evaluation report;
(four) the evaluation items in the health and safety evaluation report are incomplete or the results of the evaluation report show that the products do not meet the requirements for listing and use;
(5) The validity period of disinfection products has expired;
(6) Failing to conduct re-inspection under any of the circumstances specified in Article 12 of these Provisions;
(seven) the product has changed (formula or structure, production process) after listing or has one of the circumstances stipulated in Article 12 of these Provisions, and the contents of the health and safety evaluation report have not been updated.
Eighteenth the provisions shall come into force as of the date of issuance.
Attachment 1 formula writing format and requirements
Appendix 2 Inspection Items and Requirements
Annex 3 Health and Safety Assessment Report of disinfection products
Attachment 4 Registration Form of Health and Safety Assessment Report of disinfection products City
Attachment 5 disinfection products City Health and Safety Evaluation Report Filing Voucher