(Order No.27 of the Ministry of Health promulgated on March 28, 2002 and came into effect on July 1, 2002. According to the Decision of the National Health and Family Planning Commission on Amending the Interim Administrative Measures for Foreign Physicians Short-term Medical Practice in China on January 19, 2016 (Order No.8 of the National Health and Family Planning Commission), the first revision was made according to the Decision of the National Health and Family Planning Commission on Amending the Administrative Measures for the Safety Examination of New Food Raw Materials on December 26, 2017)
Chapter I General Provisions
Article 1 In order to strengthen disinfection management, prevent and control the spread of infectious diseases, and protect human health, these Measures are formulated in accordance with the relevant provisions of the Law of the Peoples Republic of China on the Prevention and Control of Infectious Diseases and its implementation measures.
Article 2 These Measures are applicable to medical and health institutions, disinfection service institutions, and units and individuals engaged in the production and business activities of disinfection products.
The management of other places and articles that need to be disinfected is also applicable to these Measures.
Article 3 The National Health and Family Planning Commission is in charge of the national disinfection supervision and management.
The competent authorities of railway and traffic health shall be responsible for the supervision and management of disinfection in this system in accordance with these Measures.
Chapter II Hygienic Requirements for Disinfection
Article 4 Medical and health institutions shall establish disinfection management organizations, formulate disinfection management systems, implement relevant national norms, standards and regulations, and regularly carry out disinfection and sterilization effect testing.
Article 5 The staff of medical and health institutions shall receive disinfection technical training, master disinfection knowledge, and strictly implement the disinfection and isolation system according to regulations.
Article 6 Medical supplies used by medical and health institutions that enter human tissues or sterile organs must meet the sterilization requirements. All kinds of injection, puncture and blood collection instruments should be sterilized by one person. All instruments and supplies that come into contact with skin and mucous membranes must meet the disinfection requirements.
Disposable medical supplies used by medical and health institutions shall be disposed of harmlessly in a timely manner after use.
Article 7 Medical and health institutions must establish and implement the incoming inspection and acceptance system when purchasing disinfection products.
Article 8 The environment and articles of medical and health institutions shall comply with relevant national norms, standards and regulations. Discarded sewage and sewage shall be treated harmlessly in accordance with relevant national regulations. Vehicles and tools transporting infectious disease patients and their contaminated articles must be disinfected at any time.
Article 9 When an outbreak or epidemic of infectious diseases occurs in medical and health institutions, they shall promptly report to the local health and family planning administrative department and take effective disinfection measures.
Article 10 The processing, sale or transportation of fur contaminated by infectious disease pathogens or from epidemic areas that may be contaminated by infectious disease pathogens shall be disinfected.
Article 11 Kindergarten institutions should improve and implement the disinfection management system, and regularly disinfect indoor air, dining (drinking) utensils, towels, toys and other places where children’s activities and items they come into contact with.
Article 12 Units and individuals that rent clothes and wash clothes shall disinfect relevant articles and places.
Article 13 Units engaged in pathogenic microorganism experiments shall implement relevant management systems and operating procedures, and disinfect experimental equipment and contaminated articles according to regulations to prevent laboratory infection and the spread of pathogenic microorganisms.
Article 14 The articles in contact with the remains and the vehicles transporting the remains in funeral homes and crematoriums shall be disinfected in time.
Article 15 Employing units that recruit more than 200 floating workers shall regularly disinfect the places where floating workers live in concentrated daily life and the articles used.
Article 16 The disinfection of epidemic foci shall comply with relevant national norms, standards and regulations.
Article 17 The disinfection management of public places, food, drinking water and blood products shall be implemented in accordance with the provisions of relevant laws and regulations.
Chapter III Production and Operation of Disinfection Products
Article 18 Disinfection products shall comply with relevant national norms, standards and regulations.
Article 19 The production of disinfection products shall comply with relevant national norms, standards and regulations, and the produced disinfection products shall be inspected, and those who fail to pass the standard shall not leave the factory.
Article 20 After obtaining the business license issued by the administrative department for industry and commerce, the production enterprise of disinfectants, disinfection equipment and sanitary products shall also obtain the health license issued by the local provincial health and family planning administrative department before engaging in the production of disinfection products.
Article 21 Provincial health and family planning administrative departments shall make a decision on whether to approve or not within 20 days from the date of accepting the application of disinfection product manufacturers. Those who meet the requirements of the Hygienic Standards for Disinfection Products Manufacturing Enterprises shall be issued a hygienic license; If it does not conform, it will not be approved, and the reasons will be explained.
Article 22 The format of the sanitary license number of disinfection product manufacturers is: (referred to as provinces, autonomous regions and municipalities directly under the Central Government) Wei Xiao Zheng Zi (year of issuance) No. XXXX.
The production items of sanitary license of disinfection product manufacturers are divided into disinfectants, disinfection equipment and sanitary products.
Article 23 The hygiene license of disinfection product manufacturing enterprises is valid for four years.
Thirty days before the expiration of the validity period of the hygiene license of a disinfection product manufacturer, the manufacturer shall apply to the original license issuing authority for extension. If it meets the requirements after examination, it will be renewed and a new certificate will be issued. The new certificate extends the original health license number.
Article 24 If a disinfection product production enterprise relocates its factory site or sets up another branch factory (workshop), it shall apply to the provincial health and family planning administrative department where the production site is located for a hygiene license of disinfection product production enterprise in accordance with the provisions of these Measures.
The factory address and hygiene license number marked on the product packaging shall be the actual production address and its hygiene license number.
Article 25 If a disinfection product manufacturer that has obtained a hygiene license changes its name, legal representative or production category, it shall apply to the original license issuing authority, and after examination and approval, a new license shall be issued. The new certificate extends the original health license number.
Article 26 The production and import of disinfectants and disinfection equipment (hereinafter referred to as new disinfection products) by using new materials, new technology and new sterilization principles shall obtain the health license approval issued by the National Health and Family Planning Commission in accordance with the provisions of these Measures.
When producing and importing disinfectants other than new disinfection products, disinfection equipment and anti-bacteriostatic preparations in sanitary products, the production and import enterprises shall conduct hygiene safety evaluation in accordance with relevant regulations and meet the requirements of hygiene standards and hygiene norms. When the product is put on the market, the health and safety evaluation report shall be filed with the provincial health and family planning administrative department, and the materials shall be provided for the filing in accordance with the regulations.
Article 27 If a production enterprise applies for the approval document of hygiene license for new disinfection products or a responsible unit in China applies for the approval document of hygiene license for imported new disinfection products, it shall apply to the National Health and Family Planning Commission in accordance with the requirements of the regulations of the National Health and Family Planning Commission on the Administrative License of Hygiene for New Disinfection Products. Submit an application to the National Health and Family Planning Commission. The National Health and Family Planning Commission shall make a decision on whether to approve or not in accordance with relevant laws, regulations and relevant provisions.
The National Health and Family Planning Commission issues a health license approval document to the approved new disinfection products, and the format of the approval document number is: Weixiao Xinzhunzi (year) No. XXXX. If approval is not granted, the reasons shall be explained.
Article 28 New disinfection product hygiene license approval is valid for four years.
Article 29 The National Health and Family Planning Commission regularly announces the approval contents of new disinfection products that have obtained health administrative licenses. From the date of the announcement, similar products listed in the announcement will no longer be subject to sanitary administrative license as new disinfection products.
Article 30 When purchasing disinfection products, business operators shall obtain the following valid certificates:
(1) A copy of the hygiene license of the production enterprise;
(2) A copy of the product hygiene and safety evaluation report or the approval document of the new disinfection product hygiene license.
A copy of a valid certificate shall be stamped with the seal of the holder of the original.
Article 31 The naming and labeling (including instructions) of disinfection products shall comply with the relevant regulations of the National Health and Family Planning Commission.
The labels (including instructions) and promotional contents of disinfection products must be true, and must not appear or imply the therapeutic effect on diseases.
Article 32 It is prohibited to produce and operate the following disinfection products:
(1) no production enterprise hygiene license or new disinfection product hygiene license approval document;
(2) the product hygiene and safety evaluation is unqualified or the product hygiene quality does not meet the requirements.
Chapter IV Disinfection Service Organizations
Article 33 Disinfection service institutions shall meet the following requirements:
(1) Having disinfection and sterilization equipment that conforms to relevant national norms, standards and regulations;
(2) its disinfection and sterilization process and working environment must meet hygienic requirements;
(3) have the personnel and conditions that can test the effect of disinfection and sterilization, and establish a self-inspection system;
(4) If ethylene oxide and ionizing radiation are used for disinfection and sterilization, the requirements for safety and environmental protection shall be implemented in accordance with relevant national regulations.
Article 34 Disinfection service institutions shall not purchase or use disinfection products that do not conform to the provisions of these Measures.
Thirty-fifth disinfection service institutions shall accept the supervision of the local health and family planning administrative department.
Chapter V Supervision
Article 36 The administrative departments of health and family planning at or above the county level shall exercise the following supervisory and administrative functions and powers for disinfection work:
(1) to supervise and inspect the disinfection of relevant institutions, places and articles;
(2) to supervise and inspect the implementation of the “Hygienic Standards for Disinfection Product Manufacturing Enterprises” by disinfection product manufacturers;
(3) to supervise and inspect the hygienic quality of disinfection products;
(4) to supervise and inspect the disinfection service quality of disinfection service institutions;
(5) to take administrative control measures against violations of these measures;
(6) Administrative penalties shall be imposed on violations of these Measures.
Article 37 Under any of the following circumstances, the National Health and Family Planning Commission may re-examine the new disinfection products that have obtained the approval of the health license:
(1) The raw materials, sterilization principle and production process of the product are questioned;
(2) product safety and disinfection effect are questioned.
Article 38 The holder of the hygiene license approval document for new disinfection products shall, within 30 days from the date of receiving the re-examination notice from the National Health and Family Planning Commission, submit materials in accordance with the relevant requirements of the notice. If the relevant materials are not submitted within the time limit, it will be deemed as giving up the re-examination, and the National Health and Family Planning Commission may cancel the product hygiene license approval document.
Article 39 The National Health and Family Planning Commission shall make a re-examination decision within 30 days from the date of receiving all the materials required for re-examination. Under any of the following circumstances, the approval document of product hygiene license shall be cancelled:
(1) The raw materials, sterilization principles and production processes of products do not conform to the judgment basis of using new materials, new process technologies and new sterilization principles to produce disinfectants and disinfection equipment;
(2) the product safety and disinfection effect fail to meet the requirements.
Article 40 Disinfection product production enterprises shall test the physical and chemical indicators, microbial indicators, microbial killing indicators, toxicological indicators, etc. of disinfection products in accordance with the requirements of national health standards and sanitary norms. Those who do not have the ability to inspect may entrust inspection.
The inspection activities of disinfection products shall comply with the relevant provisions of the state. The inspection report shall be objective and true, and conform to relevant laws, regulations, standards, norms and regulations. The inspection report is valid nationwide.
Chapter VI Penalties
Article 41 If a medical and health institution violates the provisions of Articles 4, 5, 6, 7, 8 and 9 of these Measures, the local health and family planning administrative department at or above the county level shall order it to make corrections within a time limit, and may impose a fine of less than 5,000 yuan; Anyone who causes an outbreak of infectious diseases may be fined not less than 5,000 yuan but not more than 20,000 yuan.
Article 42 Anyone who processes, sells or transports fur contaminated by infectious disease pathogens or from epidemic areas that may be contaminated by infectious disease pathogens and fails to disinfect it in accordance with relevant state regulations shall be punished in accordance with the relevant provisions of Article 68 of the Measures for the Implementation of the Law on the Prevention and Control of Infectious Diseases.
Article 43 If a disinfection product production and business unit violates the provisions of Articles 31 and 32 of these Measures, the local health and family planning administrative department at or above the county level shall order it to make corrections within a time limit, and may impose a fine of less than 5,000 yuan; Anyone who causes an outbreak of infectious diseases may be fined not less than 5,000 yuan but not more than 20,000 yuan.
Article 44 If a disinfection service institution violates the provisions of these Measures and falls under any of the following circumstances, the health and family planning administrative department at or above the county level shall order it to make corrections within a time limit, and may impose a fine of less than 5,000 yuan; Those who cause infectious diseases may be fined not less than 5,000 yuan but not more than 20,000 yuan:
The disinfected items do not meet the hygienic standards and requirements.
Chapter VII Supplementary Provisions
Article 45 The meanings of the following terms in these Measures:
Infectious diseases: diseases caused by microorganisms.
Disinfection products: including disinfectants, disinfection equipment (including biological indicators, chemical indicators and packaging of sterilized articles), sanitary products and disposable medical products.
Disinfection service organization: refers to the unit that provides the society with disinfection and sterilization services for items and places that may be contaminated, sanitary products and disposable medical supplies.
Medical and health institutions: refers to medical and health care, disease control, blood collection and supply institutions and units with the same business activities as the above institutions.
Article 46 The National Health and Family Planning Commission shall be responsible for the interpretation of these Measures.
Article 47 These Measures shall come into force as of July 1, 2002. The Measures for the Administration of Disinfection issued by the Ministry of Health on August 31, 1992 shall be abolished at the same time.