Guowei Supervision [2014] No. 36

Regulations on Hygiene and Safety Evaluation of Disinfection Products

Article 1 In order to further deepen the reform of the health administrative examination and approval system, standardize the production and operation of disinfection products, and ensure the effectiveness and safety of disinfection products used for the prevention and control of infectious diseases, these Provisions are formulated in accordance with the Law of the Peoples Republic of China on the Prevention and Control of Infectious Diseases, the Measures for Disinfection Management and relevant regulations.

Article 2 Classified management shall be implemented according to the purpose of disinfection products and the risk degree of users.

The first category is disinfection products that have higher risks and require strict management to ensure safety and effectiveness, including high-level disinfectants and disinfection devices for medical devices, sterilizers and disinfection devices, skin and mucous membrane disinfectants, biological indicators, chemical indicators of sterilization effect.

The second category is disinfection products with moderate risks and need to be strengthened to ensure safety and effectiveness, including disinfectants, disinfection equipment, chemical indicators except the first category products, as well as packaging of sterilized articles with sterilization labels and anti-bacteriostatic preparations.

The third category is hygienic products with low-risk degree, and routine management can ensure safety and effectiveness except anti-bacteriostatic preparations.

When the same disinfection product involves different categories, it should be managed as a higher risk category.

Article 3 These Provisions apply to Class I and Class II disinfection products produced and operated within the territory of the Peoples Republic of China that do not require administrative examination and approval.

Article 4 The product responsibility unit shall conduct health and safety evaluation by itself or entrust a third party before the first listing of Class I and Class II disinfection products, and be responsible for the evaluation results. Only disinfection products that have passed the hygiene and safety evaluation can be put on the market and sold. Product responsibility unit refers to the unit or individual that is legally liable for compensation for personal injury or property loss caused by product defects. The responsible unit for domestic products is a production enterprise. When entrusting production and processing, it specifically refers to the entrusting party; The responsible unit for imported products is the responsible unit in China.

Article 5 The content of health and safety evaluation includes product labels (nameplates), instructions, inspection reports (including conclusions), enterprise standards or quality standards, health license qualifications of domestic product manufacturers, and approval documents allowed for production and sales in the producing countries (regions) of imported products. Among them, disinfectants, biological indicators, chemical indicators, packaging of sterilized articles with sterilization marks, and anti-bacteriostatic preparations also include product formulas, and disinfection equipment should also include the main components and structural diagrams 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 for disinfection products and the requirements for raw materials such as the main components of disinfection equipment shall meet the requirements of the corresponding hygienic standards, technical specifications and enterprise standards for disinfection products.

Article 8 The structural diagram of disinfection instruments shall be consistent with the structure of actual products, and the names, technical parameters and quantities of main components shall be indicated.

Article 9 The labels (nameplates) and instructions of disinfection products shall comply with the requirements of the Management Standards for Labels and Instructions of Disinfection Products and relevant hygiene standards.

Article 10 When evaluating the hygiene and safety of disinfection products, the product responsible unit shall inspect the disinfection products and be responsible for the authenticity of the samples. All inspection items shall be completed with the same batch of products (see Annex 2 for inspection items and requirements).

Article 11 The inspection of disinfection products shall be carried out in a disinfection product inspection institution with corresponding conditions. Disinfection product inspection institutions shall comply with the relevant regulations on disinfection management, pass laboratory qualification accreditation, and engage in disinfection product inspection activities within the scope of approved inspection capabilities.

Disinfection product inspection institutions shall comply with relevant laws, regulations and these Provisions, carry out inspections according to disinfection product hygienic standards, technical specifications and inspection specifications, 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 hygienic standards and technical specifications, inspection can be carried out according to enterprise standards.

Disinfection product inspection institutions that issue false inspection reports or neglect management and are difficult to guarantee inspection quality shall be dealt with severely.

Article 12 Under any of the following circumstances, the product shall be re-inspected:

(1) the actual production address is relocated, another branch factory or workshop is set up, and production and processing are subentrusted. Among them, disinfectants and anti-bacteriostatic preparations should be determined for the content of active ingredients, the stability test of stock solution and the pH value; disinfection equipment shall be measured for the intensity of main bactericidal factors, and simulated field tests shall be carried out if the conditions for measuring bactericidal factors are not met; biological indicators should be measured for bacterial content, chemical indicators should be measured for color change, and sterilization packages with sterilization marks should be measured for sterilization factor penetration performance.

(2) if disinfectants and anti-bacteriostatic preparations prolong the validity period of products, the content of active ingredients, pH value, a microbial killing (or inhibition) test and stability test with the strongest resistance shall be carried out; if the original sample is used, only the stability test is required.

(3) if the scope of use of disinfectants, disinfection equipment and anti-bacteriostatic preparations is increased or the method of use is changed, corresponding physical and chemical, microbial killing (or inhibition) and toxicological tests shall be carried out.

Article 13 The enterprise standards of domestic products and the quality standards of imported products shall meet the following requirements:

(1) The product standards of disinfectants and anti-bacteriostatic preparations shall include the hygienic quality requirements of raw materials (including grade and purity), technical requirements (including sensory indicators, physical and chemical indicators, microbiological indicators, microbial killing indicators) and their inspection methods, type inspection items, factory inspection items, etc. Disinfection equipment standards shall include name and model, raw materials, technical parameters of main components, technical requirements (including bactericidal factor intensity and microbial killing indicators) and their inspection methods, type inspection items, factory inspection items, etc.

(2) The technical requirements of products shall comply with 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 comply with the requirements of national health laws, regulations, standards, norms and regulations.

(4) The enterprise standards of 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 responsible unit shall form a complete “Disinfection Product Hygiene and Safety Evaluation Report”, which includes two parts: basic information and evaluation data (see Annex 3 for the format). Health safety evaluation reports are valid nationwide. The hygiene and safety evaluation report of Class I disinfection products is valid for four years, and the hygiene and safety evaluation report of Class II disinfection products 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 the health and safety evaluation report with the local provincial health and family planning administrative department for the record (see Annex 4 for the registration form). The provincial health and family planning administrative department shall conduct a formal review of the health and safety evaluation report. If the information is complete, it shall issue a filing certificate to the product responsibility unit within 5 working days (see Annex 5 for the filing certificate), and affix the filed health and safety evaluation report with a riding seal.

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 have the circumstances specified in Article 12 of these Provisions, the product responsibility unit shall promptly update the relevant contents of the Health and Safety Evaluation Report of Disinfection Products, 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 validity period of the hygiene and safety evaluation report of Class I disinfection products, the production enterprise shall re-conduct the hygiene and safety evaluation and filing. When inspecting disinfection products, only key items are used. Among them, the inspection items of disinfection (sterilization) agent are the content of active ingredients, pH value and a microbial killing test with the strongest resistance, the inspection items of disinfection (sterilization) equipment are the strength of main bactericidal factors and a microbial killing test with the strongest resistance, the inspection items of biological indicators are the determination of bacteria content, and the inspection items of sterilization chemical indicators are the determination of color change. The inspection items that have passed the national supervision and sampling inspection within two years may no longer be done.

Article 15 Product operators and users shall obtain copies of health and safety evaluation reports and filing certificates before operating and using Class I and Class II disinfection products. 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 and customs declaration forms that allow production and sales in the producing countries (regions) of imported products.

Article 16 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 the health and safety evaluation of disinfection products carried out by enterprises. The provincial health and family planning administrative department shall regularly announce the information related to the health license of production enterprises and the health and safety evaluation of products.

Article 17 If any of the following circumstances occurs, it does not meet the requirements of national health standards, health norms or the health quality is unqualified, and it shall be dealt with in accordance with Article 73 of the Law of the Peoples Republic of China on the Prevention and Control of Infectious Diseases or Article 47 of the Measures for Disinfection Management:

(1) the first and second category disinfection products have not been evaluated for health and safety before they are first put on the market;

(2) the health and safety evaluation report of Class I disinfection products have not been re-evaluated after the expiration of the expiration of the health and safety evaluation report;

(3) issuing false health and safety evaluation reports;

(4) The evaluation items in the health and safety evaluation report are incomplete or the results of the evaluation report show that the product does not meet the requirements for marketing and use;

(5) The validity period of disinfection products has expired;

(6) Under any of the circumstances specified in Article 12 of these Provisions, the inspection is not re-conducted;

(7) after the product is marketed, if there is any change (formula or structure, production process) or any of the circumstances specified in Article 12 of these regulations, the contents of the health and safety evaluation report are not updated.

Article 18 These Provisions shall come into force as of the date of issuance.