Chapter I General Provisions
Article 1 In order to protect public health and standardize the hygienic supervision of disinfection products, this specification is formulated in accordance with the Law of the Peoples Republic of China on the Prevention and Control of Infectious Diseases (hereinafter referred to as the Law on the Prevention and Control of Infectious Diseases), the Measures for the Administration of Disinfection and other relevant laws and regulations.
Article 2 The hygienic supervision of disinfection products as mentioned in this Code refers to the activities of local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies in accordance with the Law on the Prevention and Control of Infectious Diseases, the Measures for the Administration of Disinfection and other relevant laws and regulations to carry out hygienic supervision and inspection of disinfection product manufacturers, responsible units of imported disinfection products in China, and units operating and using disinfection products.
Article 3 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 and chemical indicators of sterilization effect.
The second category is disinfection products that have moderate risks and need to be strengthened to ensure safety and effectiveness, including disinfectants, disinfection equipment, and anti-bacteriostatic preparations other than the first category products.
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 4 Local health and family planning administrative departments at or above the county level are responsible for building the capacity of sanitary supervision of disinfection products, ensuring staffing, rationally allocating working equipment, and incorporating supervision and sampling inspection and other work funds into budget management.
Article 5 Local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies shall apply this specification when carrying out hygienic supervision of disinfection products.
Chapter II Supervision Responsibilities and Requirements
Article 6 Responsibilities of provincial health and family planning administrative departments and their comprehensive supervision and law enforcement agencies:
(1) Formulate the provinces (autonomous region, municipality) disinfection product hygiene supervision work system, plan and annual work plan. According to the classification and supervision of disinfection products, determine the key work contents of annual hygiene supervision of disinfection products;
(2) Organize and implement provincial (autonomous region, municipality) disinfection product hygiene supervision work and related training, and provide guidance and supervision on lower-level disinfection product hygiene supervision work;
(3) Responsible for the hygiene license of disinfection product manufacturers within the scope of responsibilities;
(4) Carry out spot checks on disinfection product manufacturers and responsible units in China;
(5) Organize hygienic supervision and random inspection of disinfection products within the jurisdiction;
(6) Organize, coordinate, supervise, investigate and handle major illegal cases of disinfection products within the jurisdiction;
(7) Responsible for the audit of the production capacity of new disinfection products and the collection and sealing of samples in accordance with the provisions of the “Standards for the Audit of Sanitary Conditions of Health-related Product Manufacturing Enterprises”;
(8) Responsible for the province (autonomous region, municipality) disinfection product hygiene supervision information management and data summary, verification, analysis and reporting;
(9) Undertake the hygiene supervision tasks of disinfection products designated or assigned by superiors.
Article 7 Responsibilities of municipal and county health and family planning administrative departments divided into districts and their comprehensive supervision and law enforcement agencies:
(1) According to the province (autonomous region, municipality) disinfection product hygiene supervision work system, plan and annual work plan, combined with the actual situation, formulate a disinfection product hygiene supervision work plan within the jurisdiction, clarify the key supervision work content and organize its implementation; Organize and carry out hygienic supervision and training of disinfection products within the jurisdiction;
(2) Responsible for the supervision and inspection of disinfection products within the scope of duties;
(3) Responsible for hygienic supervision and sampling inspection of disinfection products within the jurisdiction;
(4) Responsible for investigating and handling illegal cases of disinfection products within the jurisdiction;
(5) Responsible for the summary, analysis and reporting of hygiene supervision information of disinfection products within the jurisdiction;
(6) The city divided into districts shall guide and supervise the hygienic supervision of disinfection products at the county level;
(7) Undertake the hygiene supervision tasks of disinfection products designated or assigned by superiors.
Article 8 Comprehensive supervision and law enforcement agencies at or above the municipal level divided into districts shall set up infectious disease prevention and control supervision departments (departments) or disinfection product supervision departments (departments) to undertake the hygienic supervision of disinfection products; County-level supervisory agencies shall designate departments to undertake hygienic supervision of disinfection products.
Article 9 Before implementing on-site hygiene supervision of disinfection products, supervisors shall clarify the tasks, methods and requirements of hygiene supervision, equip them with safety protection equipment, and do a good job in safety protection. When illegal acts are discovered, evidence shall be collected according to law. When the evidence may be lost or difficult to obtain in the future, evidence preservation measures should be taken first according to law.
Article 10 According to the risk degree of disinfection products, classified supervision shall be implemented.
County-level comprehensive supervision and law enforcement agencies are responsible for the health supervision of all disinfection product manufacturers and responsible units in China within their jurisdiction, at least once a year. Municipal comprehensive supervision and law enforcement agencies shall carry out health supervision on the production enterprises of Class I and Class II disinfection products and the responsible units of imported disinfection products in China within their jurisdiction, at least once a year. Provincial comprehensive supervision and law enforcement agencies are responsible for spot checks of all disinfection product manufacturers and responsible units in China within their jurisdiction.
Article 11 The comprehensive supervision and law enforcement agencies at the provincial, municipal and county levels shall, according to their duties, establish files of sanitary supervision of disinfection products, and master the basic situation of disinfection product production enterprises and disinfection products within their jurisdiction, as well as the sanitary supervision of disinfection products.
Chapter III Contents and Methods of Supervision
Section I Hygienic Supervision of Disinfection Product Manufacturing Enterprises
Article 12 Supervision contents of disinfection product manufacturing enterprises:
(1) Hygiene license qualifications of disinfection products and production enterprises;
(2) Production conditions and production process;
(3) Hygienic quality of raw materials used;
(4) Storage conditions of disinfection products and materials;
(5) Staffing and management of disinfection product practitioners;
(6) Hygienic quality of disinfection products.
Article 13 Supervision and inspection methods of sanitary license qualifications of disinfection products and production enterprises:
(1) Check the health license of the production enterprise, and verify whether the actual production address, production method, production project, production category, legal representative or person in charge, and registered address of the production enterprise are consistent with those indicated in the health license of the production enterprise; Check whether the health license is within the validity period, and check whether the health license has been altered, transferred, forged, rented, lent, etc.;
(2) Check whether the new disinfection product has a valid product hygiene license approval document, and verify whether the address of the manufacturer marked on the product hygiene license approval document is consistent with that indicated on the manufacturers hygiene license; For entrusted production and processing, verify whether the actual address of the production enterprise marked in the approval document of the product hygiene license is consistent with that indicated on the hygiene license of the production enterprise.
Article 14 Supervision and inspection methods of production conditions and production processes of disinfection product manufacturing enterprises:
(1) Check whether the factory layout, production area, production equipment, inspection equipment and other production conditions of the production enterprise meet the requirements of the “Hygienic Standards for Disinfection Product Manufacturing Enterprises”; Check whether the approved production process, production workshop layout, etc. are changed without authorization. When necessary, conduct on-site sampling and testing of the sanitary quality of the production environment and production water;
(2) Check whether standard operating procedures and management systems are implemented during the production process, and whether substances prohibited by national regulations are added. Whether all records in the production process are complete, traceable, and properly kept until 3 months after the expiry date of the product.
Article 15 Supervision and inspection methods for the hygienic quality of raw materials used in disinfection products:
(1) Verify whether the raw material names of the main active ingredients of the disinfectant in the new disinfection product are consistent with the product hygiene license approval document;
(2) Verify whether the names of raw materials used in disinfectants and anti-bacteriostatic preparations that require health and safety evaluation, the CAS code of a single chemical substance, product name, content, grade and dosage are consistent with the products “Health and Safety Evaluation Report” same;
(3) Check whether sanitary products other than anti-(antibacterial) preparations have non-toxic, harmless, and pollution-free inspection reports or certification materials provided by corresponding raw material suppliers, and verify whether the raw materials are consistent with the formula ingredients, specifications, and specifications of the produced products. Grade requirements are consistent;
(4) Check whether there are substances prohibited by national regulations in the raw materials (materials) warehouse of disinfection products;
(5) Check whether the purchase records and warehousing registrations of raw materials (materials) of disinfection products are complete.
Article 16 Supervision and inspection methods of storage conditions of disinfection products and materials:
Check whether the storage conditions of disinfection products and materials meet the requirements of Hygienic Standards for Disinfection Product Manufacturing Enterprises.
Article 17 Supervision and inspection methods for the management of employees of disinfection products:
(1) Check whether the enterprise is equipped with full-time or part-time health management personnel and quality management personnel;
(2) Check the preventive health examination certificates of operators directly engaged in the production of disinfection products, check the pre-job training materials of production operators and quality inspectors, and the academic certificates of inspectors;
(3) Check whether the hygienic conditions of personnel during the production process meet the requirements of the “Hygienic Standards for Disinfection Product Manufacturing Enterprises”.
Article 18 Supervision and inspection methods for the hygienic quality of disinfection products:
(1) Check whether the disinfectants, disinfection equipment and anti-bacterial preparations that require health and safety evaluation have health and safety evaluation reports and filing certificates that comply with the “Regulations on Hygiene and Safety Evaluation of Disinfection Products”;
(2) Review the sanitary quality factory inspection report before the disinfection product is put on the market, and verify whether the inspection items, inspection frequency, and inspection results meet the requirements of the “Hygienic Standards for Disinfection Product Manufacturing Enterprises”; For enterprises entrusted with inspection, the legal qualification of inspection institutions and the entrusted inspection agreement should also be checked;
(3) Check whether the enterprise standards are filed in accordance with the law and whether they are within the validity period;
(4) Check whether the labels and instructions of new disinfection products are consistent with the product hygiene license approval documents; Verify whether the contents marked on the labels (nameplates) and instructions of disinfection products that require health and safety evaluation comply with the requirements of the “Management Specifications for Disinfection Product Labels and Instructions” and relevant standards and specifications, and are consistent with those submitted for filing; Check whether other disinfection products comply with the requirements of the “Management Standards for Labeling Instructions of Disinfection Products” and relevant standards and specifications.
(5) Conduct supervision and random inspection of disinfection products when necessary.
Article 19 Sanitary supervision and sampling inspection methods of disinfection products:
(1) The sample collection of disinfection products should be representative, within the validity period or shelf life, and the packaging should be intact. The number of samples in the same batch should meet the needs of hygienic quality inspection, label (nameplate) and instruction determination, and sample retention;
(2) Samples should be sent to an inspection agency that has obtained laboratory qualification accreditation for inspection in a timely manner, samples should be handed over in accordance with prescribed procedures, and sample packaging should be kept intact;
(3) Samples of disinfection products for random inspection must be subject to product confirmation, notification of inspection results and attachment of inspection reports; Samples that have objections to the sampling results shall be re-inspected according to the procedures; Local health and family planning administrative departments at or above the county level are responsible for announcing the sampling results to the public;
(4) Comprehensive supervision and law enforcement agencies shall set up sample storage places, facilities and equipment, and store them in accordance with the storage conditions marked by the samples. The unqualified samples shall be kept until 3 months after the announcement of the spot check results.
Section II Health Supervision of Responsible Units in China
Article 20 Supervision contents of the responsible units for imported disinfection products in China:
(1) Industrial and commercial business license;
(2) Hygiene license approval documents for new disinfection products;
(3) Health and safety evaluation report;
(4) Hygienic quality of imported disinfection products.
Article 21 Supervision and inspection methods of responsible units for imported disinfection products in China:
(1) Verify whether the business scope of the industrial and commercial business license, the certification documents and customs declaration forms allowing production and sales in the country (region) where the imported products are produced are consistent with the disinfection products being distributed;
(2) Verify whether the hygiene license approval documents for imported new disinfection products are consistent with the disinfection products distributed;
(3) Check whether imported disinfectants, disinfection equipment and anti-bacterial preparations that require health and safety evaluation have health and safety evaluation reports and filing certificates that comply with the “Regulations on Hygiene and Safety Evaluation of Disinfection Products”;
(4) Check whether the imported disinfection products sold are within the validity period;
(5) Please refer to Article 18 for the hygienic quality inspection methods of imported disinfection products, in which the product quality standards shall meet the requirements of relevant standards and specifications for disinfection products, and be consistent with those submitted for the record;
(6) Conduct supervision and random inspection of imported disinfection products when necessary. Please refer to Article 19 for sampling inspection methods.
Section III Supervision of Units Operating and Using Disinfection Products
Article 22 Supervision contents of units operating and using disinfection products:
(1) Establishment of a disinfection product purchase inspection and acceptance system;
(2) Obtaining hygiene licenses, disinfection product hygiene license approvals or health safety evaluation reports and filing certificates for domestic disinfection product manufacturers; Check the name of the disinfection product, the name of the manufacturer or responsible unit in China, and the label (nameplate) and instructions of the disinfection product;
(3) Check the use of disinfection products;
(4) Hygienic supervision and sampling inspection of disinfection products.
Article 23 Supervision and inspection methods of disinfection product management and use units:
(1) Check whether the domestic disinfection products operated and used are consistent with the product hygiene license approval document or health safety evaluation report and filing certificate, the name of the manufacturer and product category marked on the production enterprises hygiene license, and whether the imported disinfection product hygiene license approval document or health safety evaluation report is consistent with the name and product category of the responsible unit in China marked on the filing certificate;
(2) Verify whether the hygiene license of the manufacturer selling domestic disinfection products or the business license, product hygiene license approval document or product hygiene safety evaluation report of the responsible unit for importing disinfection products in China are legal and valid;
(3) Check the purchase records and validity periods of disinfection products; The hand disinfectant in use should also be checked whether it is used within the validity period after unsealing;
(4) Check the labels (nameplates) and instructions of disinfection products operated and used, please refer to Article 18;
(5) When necessary, conduct supervision and random inspection of disinfection products. Please refer to Article 19 for random inspection methods.
Chapter IV Information Management
Article 24 Health and family planning administrative departments at all levels and comprehensive supervision and law enforcement agencies shall strengthen the construction of disinfection product hygiene supervision information system, carry out the analysis of disinfection product hygiene supervision information within their respective jurisdictions, and provide a basis for formulating disinfection product hygiene-related policies.
Article 25 Health and family planning administrative departments at all levels shall establish a list system of bad records of disinfection product manufacturers, and publish information on unqualified disinfection products in accordance with the law.
The provincial health and family planning administrative department shall promptly update the health license information of disinfection product manufacturers, and promptly release the information of sanitary supervision and sampling inspection of disinfection products.
Article 26 Comprehensive supervision and law enforcement agencies at all levels shall arrange full-time (part-time) personnel to be responsible for the submission of hygiene supervision information of disinfection products in their respective jurisdictions. Make full use of the national health supervision information reporting system, report it in time, and comprehensive supervision and law enforcement agencies at all levels should regularly summarize and analyze the health supervision information of disinfection products, and report it to the health and family planning administrative department at the same level and the comprehensive supervision and law enforcement agencies at higher levels.
Chapter V Handling of Supervision
Article 27 The local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies shall promptly feed back the results of hygiene supervision and inspection of disinfection products to the inspected units, issue health supervision opinions for those with problems, investigate and deal with illegal acts according to law, and promptly transfer suspected crimes to local public security organs.
The local health and family planning administrative departments at or above the county level shall promptly report the relevant information of major illegal cases of disinfection products within their jurisdiction to the higher-level health and family planning administrative departments step by step.
Article 28 If the local health and family planning administrative department or comprehensive supervision and law enforcement agency at or above the county level finds that the product responsibility unit of unqualified disinfection products is not within its jurisdiction, it shall promptly report the situation to the health and family planning administrative department or comprehensive supervision and law enforcement agency where the product responsibility unit of disinfection products is located.
Chapter VI Supplementary Provisions
Article 29 The meanings of the following terms in this specification:
(1) New disinfection products: refer to disinfectants and disinfection equipment produced using new materials, new process technologies and new sterilization principles.
(2) High-level disinfectant: refers to a disinfectant that can kill all bacterial propagules (including mycobacteria), viruses, fungi and their spores, etc., and can kill most bacterial spores to meet high-level disinfection requirements.
(3) Disinfection product manufacturer: refers to an enterprise that has obtained a hygiene license for a disinfection product manufacturer in accordance with the law.
(4) CAS code: It is the registration number established by the American Chemical Abstracts Service for chemical substances.
(5) Responsible unit in China: refers to the responsible unit with independent legal personality registered in China in accordance with the law for imported disinfection products that need to undergo health and safety evaluation.
Article 30 The provincial health and family planning administrative department may, in light of the actual situation, formulate and implement the specific provisions of this specification, which are applicable to the hygienic supervision and management of disinfection products within its administrative area.
Article 31 These specifications shall come into force as of the date of promulgation. July 3, 2014