KYB CHINA(2003年6月16日中华人民共和国国务院令第380号公布 根据2011年1月8日《国务院关于废止和修改部分行政法规的决定》修订)
(Promulgated by Decree No. 380 of the State Council of the People's Republic of China on June 16, 2003, and revised in accordance with the Decision of the State Council on Repealing and Amending Certain Administrative Regulations on January 8, 2011)
总则
General Provisions
为了加强医疗废物的安全管理，防止疾病传播，保护环境，保障人体健康，根据《中华人民共和国传染病防治法》和《中华人民共和国固体废物污染环境防治法》，制定本条例。
This Regulation is formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases and the Law of the People's Republic of China on the Prevention and Control of Environmental Pollution by Solid Wastes, with a view to strengthening the safe management of medical waste, preventing the spread of diseases, protecting the environment, and safeguarding human health.
本条例所称医疗废物，是指医疗卫生机构在医疗、预防、保健以及其他相关活动中产生的具有直接或者间接感染性、毒性以及其他危害性的废物。
For the purposes of this Regulation, 'medical waste' refers to waste generated by medical and health institutions in medical treatment, prevention, health care, and other related activities that has direct or indirect infectious, toxic, or other hazardous properties.
医疗废物分类目录，由国务院卫生行政主管部门和环境保护行政主管部门共同制定、公布。
The classification catalogue of medical waste shall be jointly formulated and published by the competent administrative department of health under the State Council and the competent administrative department of environmental protection under the State Council.
本条例适用于医疗废物的收集、运送、贮存、处置以及监督管理等活动。
This Regulation applies to activities such as the collection, transportation, storage, disposal, and supervision and management of medical waste.
医疗卫生机构收治的传染病病人或者疑似传染病病人产生的生活垃圾，按照医疗废物进行管理和处置。
Domestic waste generated by infectious disease patients or suspected infectious disease patients admitted to medical and health institutions shall be managed and disposed of as medical waste.
医疗卫生机构废弃的麻醉、精神、放射性、毒性等药品及其相关的废物的管理，依照有关法律、行政法规和国家有关规定、标准执行。
The management of waste narcotic, psychotropic, radioactive, toxic drugs and related wastes discarded by medical and health institutions shall be implemented in accordance with relevant laws, administrative regulations, and relevant state provisions and standards.
国家推行医疗废物集中无害化处置，鼓励有关医疗废物安全处置技术的研究与开发。
The State promotes centralized harmless disposal of medical waste and encourages research and development of safe disposal technologies for medical waste.
县级以上地方人民政府负责组织建设医疗废物集中处置设施。
Local people's governments at or above the county level shall be responsible for organizing the construction of centralized medical waste disposal facilities.
国家对边远贫困地区建设医疗废物集中处置设施给予适当的支持。
The state shall provide appropriate support for the construction of centralized medical waste disposal facilities in remote and impoverished areas.
县级以上各级人民政府卫生行政主管部门，对医疗废物收集、运送、贮存、处置活动中的疾病防治工作实施统一监督管理；环境保护行政主管部门，对医疗废物收集、运送、贮存、处置活动中的环境污染防治工作实施统一监督管理。
The health administrative departments of the people's governments at or above the county level shall implement unified supervision and management of disease prevention and control activities in the collection, transportation, storage, and disposal of medical waste; the environmental protection administrative departments shall implement unified supervision and management of environmental pollution prevention and control activities in the collection, transportation, storage, and disposal of medical waste.
县级以上各级人民政府其他有关部门在各自的职责范围内负责与医疗废物处置有关的监督管理工作。
Other relevant departments of the people's governments at or above the county level shall be responsible for supervision and management related to medical waste disposal within their respective duties.
任何单位和个人有权对医疗卫生机构、医疗废物集中处置单位和监督管理部门及其工作人员的违法行为进行举报、投诉、检举和控告。
Any unit or individual has the right to report, complain, inform, and accuse illegal acts of medical and health institutions, centralized medical waste disposal units, and supervision and management departments and their staff.
医疗废物管理的一般规定
General Provisions on Medical Waste Management
医疗卫生机构和医疗废物集中处置单位，应当建立、健全医疗废物管理责任制，其法定代表人为第一责任人，切实履行职责，防止因医疗废物导致传染病传播和环境污染事故。
Medical and health institutions and centralized medical waste disposal units shall establish and improve the responsibility system for medical waste management, with their legal representatives as the primary responsible persons, and shall earnestly perform their duties to prevent the spread of infectious diseases and environmental pollution accidents caused by medical waste.
医疗卫生机构和医疗废物集中处置单位，应当制定与医疗废物安全处置有关的规章制度和在发生意外事故时的应急方案；设置监控部门或者专(兼)职人员，负责检查、督促、落实本单位医疗废物的管理工作，防止违反本条例的行为发生。
Medical and health institutions and centralized medical waste disposal units shall formulate rules and regulations related to the safe disposal of medical waste and emergency plans in the event of accidents; set up monitoring departments or full-time (part-time) personnel responsible for inspecting, supervising, and implementing the management of medical waste in their units to prevent violations of these regulations.
医疗卫生机构和医疗废物集中处置单位，应当对本单位从事医疗废物收集、运送、贮存、处置等工作的人员和管理人员，进行相关法律和专业技术、安全防护以及紧急处理等知识的培训。
Medical and health institutions and centralized medical waste disposal units shall provide training on relevant laws, professional techniques, safety protection, and emergency handling knowledge to personnel and management staff engaged in the collection, transportation, storage, and disposal of medical waste.
医疗卫生机构和医疗废物集中处置单位，应当采取有效的职业卫生防护措施，为从事医疗废物收集、运送、贮存、处置等工作的人员和管理人员，配备必要的防护用品，定期进行健康检查；必要时，对有关人员进行免疫接种，防止其受到健康损害。
Medical and health institutions and centralized medical waste disposal units shall adopt effective occupational health protection measures, equip personnel and management staff engaged in the collection, transportation, storage, and disposal of medical waste with necessary protective supplies, and conduct regular health checks; when necessary, carry out immunization for relevant personnel to prevent health damage.
医疗卫生机构和医疗废物集中处置单位，应当依照《中华人民共和国固体废物污染环境防治法》的规定，执行危险废物转移联单管理制度。
Medical and health institutions and centralized medical waste disposal units shall implement the hazardous waste transfer manifest management system in accordance with the provisions of the Law of the People's Republic of China on the Prevention and Control of Environmental Pollution by Solid Waste.
医疗卫生机构和医疗废物集中处置单位，应当对医疗废物进行登记，登记内容应当包括医疗废物的来源、种类、重量或者数量、交接时间、处置方法、最终去向以及经办人签名等项目。登记资料至少保存3年。
Medical institutions and centralized medical waste disposal units shall register medical waste. The registration content shall include the source, type, weight or quantity, handover time, disposal method, final destination, and signature of the person in charge. Registration records shall be kept for at least 3 years.
医疗卫生机构和医疗废物集中处置单位，应当采取有效措施，防止医疗废物流失、泄漏、扩散。
Medical institutions and centralized medical waste disposal units shall take effective measures to prevent the loss, leakage, or spread of medical waste.
发生医疗废物流失、泄漏、扩散时，医疗卫生机构和医疗废物集中处置单位应当采取减少危害的紧急处理措施，对致病人员提供医疗救护和现场救援；同时向所在地的县级人民政府卫生行政主管部门、环境保护行政主管部门报告，并向可能受到危害的单位和居民通报。
When loss, leakage, or spread of medical waste occurs, medical institutions and centralized medical waste disposal units shall take emergency measures to reduce harm, provide medical rescue and on-site assistance to affected persons, and simultaneously report to the local county-level people's government health administrative department and environmental protection administrative department, and notify units and residents that may be endangered.
禁止任何单位和个人转让、买卖医疗废物。
No unit or individual is allowed to transfer or sell medical waste.
禁止在运送过程中丢弃医疗废物；禁止在非贮存地点倾倒、堆放医疗废物或者将医疗废物混入其他废物和生活垃圾。
It is prohibited to discard medical waste during transportation; it is prohibited to dump or pile medical waste in non-storage sites or mix medical waste with other waste and household garbage.
禁止邮寄医疗废物。
It is prohibited to mail medical waste.
禁止通过铁路、航空运输医疗废物。
It is prohibited to transport medical waste by railway or air.
有陆路通道的，禁止通过水路运输医疗废物；没有陆路通道必需经水路运输医疗废物的，应当经设区的市级以上人民政府环境保护行政主管部门批准，并采取严格的环境保护措施后，方可通过水路运输。
Where land routes exist, it is prohibited to transport medical waste by water; where there is no land route and water transport is necessary, it shall be approved by the environmental protection administrative department of the city with districts or above, and strict environmental protection measures shall be taken before water transport is allowed.
禁止将医疗废物与旅客在同一运输工具上载运。
It is prohibited to carry medical waste together with passengers on the same transport vehicle.
禁止在饮用水源保护区的水体上运输医疗废物。
It is prohibited to transport medical waste on water bodies within drinking water source protection areas.
医疗卫生机构对医疗废物的管理
Management of Medical Waste by Medical and Health Institutions
医疗卫生机构应当及时收集本单位产生的医疗废物，并按照类别分置于防渗漏、防锐器穿透的专用包装物或者密闭的容器内。
Medical and health institutions shall promptly collect the medical waste generated by their own unit and place it in special packaging or closed containers that are leak-proof and puncture-resistant, according to the category.
医疗废物专用包装物、容器，应当有明显的警示标识和警示说明。
Special packaging and containers for medical waste shall have obvious warning signs and warning instructions.
医疗废物专用包装物、容器的标准和警示标识的规定，由国务院卫生行政主管部门和环境保护行政主管部门共同制定。
The standards for special packaging and containers for medical waste and the provisions for warning signs shall be jointly formulated by the health administrative department of the State Council and the environmental protection administrative department.
医疗卫生机构应当建立医疗废物的暂时贮存设施、设备，不得露天存放医疗废物；医疗废物暂时贮存的时间不得超过2天。
Medical and health institutions shall establish temporary storage facilities and equipment for medical waste, and shall not store medical waste in the open air; the temporary storage period for medical waste shall not exceed 2 days.
医疗废物的暂时贮存设施、设备，应当远离医疗区、食品加工区和人员活动区以及生活垃圾存放场所，并设置明显的警示标识和防渗漏、防鼠、防蚊蝇、防蟑螂、防盗以及预防儿童接触等安全措施。
Temporary storage facilities and equipment for medical waste shall be located away from medical areas, food processing areas, personnel activity areas, and domestic waste storage sites, and shall be equipped with obvious warning signs and safety measures such as leak-proof, rodent-proof, mosquito-proof, cockroach-proof, theft-proof, and prevention of children's contact.
医疗废物的暂时贮存设施、设备应当定期消毒和清洁。
Temporary storage facilities and equipment for medical waste shall be regularly disinfected and cleaned.
医疗卫生机构应当使用防渗漏、防遗撒的专用运送工具，按照本单位确定的内部医疗废物运送时间、路线，将医疗废物收集、运送至暂时贮存地点。
Medical and health institutions shall use special transport tools that are leak-proof and spill-proof, and collect and transport medical waste to the temporary storage location according to the internal medical waste transport time and route determined by the unit.
运送工具使用后应当在医疗卫生机构内指定的地点及时消毒和清洁。
After use, transport tools shall be promptly disinfected and cleaned at a designated location within the medical and health institution.
医疗卫生机构应当根据就近集中处置的原则，及时将医疗废物交由医疗废物集中处置单位处置。
Medical and health institutions shall, in accordance with the principle of centralized disposal nearby, promptly hand over medical waste to a centralized medical waste disposal unit for disposal.
医疗废物中病原体的培养基、标本和菌种、毒种保存液等高危险废物，在交医疗废物集中处置单位处置前应当就地消毒。
High-risk waste such as culture media, specimens, and bacterial or viral stock preservation liquids containing pathogens in medical waste shall be disinfected on-site before being handed over to a centralized medical waste disposal unit.
医疗卫生机构产生的污水、传染病病人或者疑似传染病病人的排泄物，应当按照国家规定严格消毒；达到国家规定的排放标准后，方可排入污水处理系统。
Wastewater generated by medical institutions and excreta of patients with infectious diseases or suspected infectious diseases shall be strictly disinfected in accordance with national regulations; they may be discharged into the sewage treatment system only after meeting the national discharge standards.
不具备集中处置医疗废物条件的农村，医疗卫生机构应当按照县级人民政府卫生行政主管部门、环境保护行政主管部门的要求，自行就地处置其产生的医疗废物。自行处置医疗废物的，应当符合下列基本要求：
In rural areas where conditions for centralized medical waste disposal are not available, medical institutions shall dispose of their medical waste on-site in accordance with the requirements of the health administrative department and the environmental protection administrative department of the county people's government. When disposing of medical waste on-site, the following basic requirements shall be met:
(一)使用后的一次性医疗器具和容易致人损伤的医疗废物，应当消毒并作毁形处理；
(1) Used disposable medical devices and medical waste that may easily cause injury shall be disinfected and destroyed by reshaping;
(二)能够焚烧的，应当及时焚烧；
(2) Waste that can be incinerated shall be incinerated promptly;
(三)不能焚烧的，消毒后集中填埋。
(3) Waste that cannot be incinerated shall be disinfected and then centrally landfilled.
医疗废物的集中处置
Centralized Disposal of Medical Waste
从事医疗废物集中处置活动的单位，应当向县级以上人民政府环境保护行政主管部门申请领取经营许可证；未取得经营许可证的单位，不得从事有关医疗废物集中处置的活动。
Units engaged in centralized medical waste disposal activities shall apply to the environmental protection administrative department of the people's government at or above the county level for an operating license; units that have not obtained an operating license shall not engage in any centralized medical waste disposal activities.
医疗废物集中处置单位，应当符合下列条件：
Centralized medical waste disposal units shall meet the following conditions:
(一)具有符合环境保护和卫生要求的医疗废物贮存、处置设施或者设备；
(1) Having medical waste storage and disposal facilities or equipment that meet environmental protection and health requirements;
(二)具有经过培训的技术人员以及相应的技术工人；
(2) Having trained technical personnel and corresponding technical workers;
(三)具有负责医疗废物处置效果检测、评价工作的机构和人员；
(3) Having institutions and personnel responsible for testing and evaluating the effectiveness of medical waste disposal;
(四)具有保证医疗废物安全处置的规章制度。
(4) Having rules and regulations to ensure the safe disposal of medical waste.
医疗废物集中处置单位的贮存、处置设施，应当远离居(村)民居住区、水源保护区和交通干道，与工厂、企业等工作场所有适当的安全防护距离，并符合国务院环境保护行政主管部门的规定。
The storage and disposal facilities of a medical waste centralized disposal unit shall be located away from residential areas, water source protection zones, and major traffic arteries, with appropriate safety distances from factories, enterprises, and other workplaces, and shall comply with the provisions of the environmental protection administrative department of the State Council.
医疗废物集中处置单位应当至少每2天到医疗卫生机构收集、运送一次医疗废物，并负责医疗废物的贮存、处置。
A medical waste centralized disposal unit shall collect and transport medical waste from medical and health institutions at least once every two days, and shall be responsible for the storage and disposal of medical waste.
医疗废物集中处置单位运送医疗废物，应当遵守国家有关危险货物运输管理的规定，使用有明显医疗废物标识的专用车辆。医疗废物专用车辆应当达到防渗漏、防遗撒以及其他环境保护和卫生要求。
When transporting medical waste, a medical waste centralized disposal unit shall comply with the relevant state regulations on the transport of dangerous goods and use special vehicles with clear medical waste identification. The special vehicles for medical waste shall meet the requirements for anti-leakage, anti-spillage, and other environmental protection and hygiene requirements.
运送医疗废物的专用车辆使用后，应当在医疗废物集中处置场所内及时进行消毒和清洁。
After use, the special vehicles for transporting medical waste shall be disinfected and cleaned promptly at the medical waste centralized disposal site.
运送医疗废物的专用车辆不得运送其他物品。
Special vehicles for transporting medical waste shall not be used to transport other items.
医疗废物集中处置单位在运送医疗废物过程中应当确保安全，不得丢弃、遗撒医疗废物。
A medical waste centralized disposal unit shall ensure safety during the transportation of medical waste and shall not discard or spill medical waste.
医疗废物集中处置单位应当安装污染物排放在线监控装置，并确保监控装置经常处于正常运行状态。
A medical waste centralized disposal unit shall install online monitoring devices for pollutant emissions and ensure that the monitoring devices are always in normal operation.
医疗废物集中处置单位处置医疗废物，应当符合国家规定的环境保护、卫生标准、规范。
Centralized medical waste disposal units shall dispose of medical waste in compliance with the national environmental protection and health standards and specifications.
医疗废物集中处置单位应当按照环境保护行政主管部门和卫生行政主管部门的规定，定期对医疗废物处置设施的环境污染防治和卫生学效果进行检测、评价。检测、评价结果存入医疗废物集中处置单位档案，每半年向所在地环境保护行政主管部门和卫生行政主管部门报告一次。
Centralized medical waste disposal units shall, in accordance with the regulations of the environmental protection administrative department and the health administrative department, regularly conduct testing and evaluation of the environmental pollution prevention and health effects of medical waste disposal facilities. The testing and evaluation results shall be kept in the archives of the centralized medical waste disposal unit and reported to the local environmental protection administrative department and health administrative department every six months.
医疗废物集中处置单位处置医疗废物，按照国家有关规定向医疗卫生机构收取医疗废物处置费用。
Centralized medical waste disposal units shall charge medical institutions for medical waste disposal fees in accordance with relevant national regulations.
医疗卫生机构按照规定支付的医疗废物处置费用，可以纳入医疗成本。
The medical waste disposal fees paid by medical institutions in accordance with regulations may be included in medical costs.
各地区应当利用和改造现有固体废物处置设施和其他设施，对医疗废物集中处置，并达到基本的环境保护和卫生要求。
All regions shall utilize and renovate existing solid waste disposal facilities and other facilities to centrally dispose of medical waste and meet basic environmental protection and health requirements.
尚无集中处置设施或者处置能力不足的城市，自本条例施行之日起，设区的市级以上城市应当在1年内建成医疗废物集中处置设施；县级市应当在2年内建成医疗废物集中处置设施。县(旗)医疗废物集中处置设施的建设，由省、自治区、直辖市人民政府规定。
For cities without centralized disposal facilities or with insufficient disposal capacity, cities at or above the prefecture level shall complete the construction of centralized medical waste disposal facilities within one year from the implementation date of these Regulations; county-level cities shall complete such construction within two years. The construction of centralized medical waste disposal facilities in counties (banners) shall be prescribed by the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government.
在尚未建成医疗废物集中处置设施期间，有关地方人民政府应当组织制定符合环境保护和卫生要求的医疗废物过渡性处置方案，确定医疗废物收集、运送、处置方式和处置单位。
During the period before the completion of centralized medical waste disposal facilities, the relevant local people's governments shall organize the formulation of transitional medical waste disposal plans that meet environmental protection and health requirements, and determine the methods and units for medical waste collection, transportation, and disposal.
监督管理
Supervision and Management
县级以上地方人民政府卫生行政主管部门、环境保护行政主管部门，应当依照本条例的规定，按照职责分工，对医疗卫生机构和医疗废物集中处置单位进行监督检查。
The health administrative departments and environmental protection administrative departments of local people's governments at or above the county level shall, in accordance with these Regulations and their respective responsibilities, conduct supervision and inspection of medical institutions and centralized medical waste disposal units.
县级以上地方人民政府卫生行政主管部门，应当对医疗卫生机构和医疗废物集中处置单位从事医疗废物的收集、运送、贮存、处置中的疾病防治工作，以及工作人员的卫生防护等情况进行定期监督检查或者不定期的抽查。
The health administrative departments of local people's governments at or above the county level shall conduct regular supervision and inspection or unscheduled spot checks on the disease prevention and control work in the collection, transportation, storage, and disposal of medical waste by medical institutions and centralized medical waste disposal units, as well as the health protection of workers.
县级以上地方人民政府环境保护行政主管部门，应当对医疗卫生机构和医疗废物集中处置单位从事医疗废物收集、运送、贮存、处置中的环境污染防治工作进行定期监督检查或者不定期的抽查。
The environmental protection administrative department of the local people's government at or above the county level shall conduct regular supervision and inspection or unscheduled spot checks on the pollution prevention and control work of medical institutions and centralized medical waste disposal units in the collection, transportation, storage, and disposal of medical waste.
卫生行政主管部门、环境保护行政主管部门应当定期交换监督检查和抽查结果。在监督检查或者抽查中发现医疗卫生机构和医疗废物集中处置单位存在隐患时，应当责令立即消除隐患。
The health administrative department and the environmental protection administrative department shall regularly exchange the results of supervision and inspection and spot checks. If hazards are found in medical institutions or centralized medical waste disposal units during supervision and inspection or spot checks, they shall order the immediate elimination of the hazards.
卫生行政主管部门、环境保护行政主管部门接到对医疗卫生机构、医疗废物集中处置单位和监督管理部门及其工作人员违反本条例行为的举报、投诉、检举和控告后，应当及时核实，依法作出处理，并将处理结果予以公布。
After receiving reports, complaints, accusations, or charges against medical institutions, centralized medical waste disposal units, or supervisory and management departments and their staff for violations of these regulations, the health administrative department and the environmental protection administrative department shall promptly verify, handle according to law, and publish the results.
卫生行政主管部门、环境保护行政主管部门履行监督检查职责时，有权采取下列措施：
When performing supervision and inspection duties, the health administrative department and the environmental protection administrative department have the right to take the following measures:
(一)对有关单位进行实地检查，了解情况，现场监测，调查取证；
(1) Conduct on-site inspections of relevant units, understand the situation, conduct on-site monitoring, and investigate and collect evidence;
(二)查阅或者复制医疗废物管理的有关资料，采集样品；
(2) Review or copy relevant materials on medical waste management and collect samples;
(三)责令违反本条例规定的单位和个人停止违法行为；
(3) Order units or individuals that violate these regulations to cease illegal activities;
(四)查封或者暂扣涉嫌违反本条例规定的场所、设备、运输工具和物品；
(4) Seal up or temporarily seize premises, equipment, means of transport, and articles suspected of violating these regulations;
(五)对违反本条例规定的行为进行查处。
(5) Investigate and punish acts that violate these regulations.
发生因医疗废物管理不当导致传染病传播或者环境污染事故，或者有证据证明传染病传播或者环境污染的事故有可能发生时，卫生行政主管部门、环境保护行政主管部门应当采取临时控制措施，疏散人员，控制现场，并根据需要责令暂停导致或者可能导致传染病传播或者环境污染事故的作业。
When an infectious disease transmission or environmental pollution accident occurs due to improper medical waste management, or when there is evidence that such an accident is likely to occur, the health administrative department and the environmental protection administrative department shall take temporary control measures, evacuate personnel, control the scene, and, as necessary, order the suspension of operations that cause or may cause the infectious disease transmission or environmental pollution accident.
医疗卫生机构和医疗废物集中处置单位，对有关部门的检查、监测、调查取证，应当予以配合，不得拒绝和阻碍，不得提供虚假材料。
Medical and health institutions and centralized medical waste disposal units shall cooperate with inspections, monitoring, and investigations conducted by relevant departments, and shall not refuse or obstruct them, nor provide false materials.
法律责任
Legal Liability
县级以上地方人民政府未依照本条例的规定，组织建设医疗废物集中处置设施或者组织制定医疗废物过渡性处置方案的，由上级人民政府通报批评，责令限期建成医疗废物集中处置设施或者组织制定医疗废物过渡性处置方案；并可以对政府主要领导人、负有责任的主管人员，依法给予行政处分。
If a local people's government at or above the county level fails to organize the construction of centralized medical waste disposal facilities or to formulate transitional medical waste disposal plans in accordance with the provisions of these Regulations, the people's government at the next higher level shall circulate a notice of criticism, order it to complete the construction of centralized medical waste disposal facilities or formulate transitional medical waste disposal plans within a time limit; and may impose administrative sanctions on the principal leaders and responsible persons in charge according to law.
县级以上各级人民政府卫生行政主管部门、环境保护行政主管部门或者其他有关部门，未按照本条例的规定履行监督检查职责，发现医疗卫生机构和医疗废物集中处置单位的违法行为不及时处理，发生或者可能发生传染病传播或者环境污染事故时未及时采取减少危害措施，以及有其他玩忽职守、失职、渎职行为的，由本级人民政府或者上级人民政府有关部门责令改正，通报批评；造成传染病传播或者环境污染事故的，对主要负责人、负有责任的主管人员和其他直接责任人员依法给予降级、撤职、开除的行政处分；构成犯罪的，依法追究刑事责任。
If the health administrative department, environmental protection administrative department, or other relevant departments at or above the county level fail to perform their supervision and inspection duties in accordance with these Regulations, fail to timely handle illegal acts of medical and health institutions and centralized medical waste disposal units, fail to take timely measures to reduce harm when infectious disease transmission or environmental pollution accidents occur or may occur, or have other acts of dereliction of duty, negligence, or malfeasance, the people's government at the same level or the relevant department of the people's government at the next higher level shall order correction and circulate a notice of criticism; if infectious disease transmission or environmental pollution accidents are caused, administrative sanctions of demotion, removal from office, or expulsion shall be imposed on the principal leaders, responsible persons in charge, and other directly responsible persons according to law; if a crime is constituted, criminal liability shall be pursued according to law.
县级以上人民政府环境保护行政主管部门，违反本条例的规定发给医疗废物集中处置单位经营许可证的，由本级人民政府或者上级人民政府环境保护行政主管部门通报批评，责令收回违法发给的证书；并可以对主要负责人、负有责任的主管人员和其他直接责任人员依法给予行政处分。
If the environmental protection administrative department at or above the county level issues an operating license to a centralized medical waste disposal unit in violation of the provisions of these Regulations, the people's government at the same level or the environmental protection administrative department of the people's government at the next higher level shall circulate a notice of criticism, order the revocation of the illegally issued certificate; and may impose administrative sanctions on the principal leaders, responsible persons in charge, and other directly responsible persons according to law.
医疗卫生机构、医疗废物集中处置单位违反本条例规定，有下列情形之一的，由县级以上地方人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令限期改正，给予警告；逾期不改正的，处2000元以上5000元以下的罚款：
If a medical and health institution or centralized medical waste disposal unit violates the provisions of these Regulations in any of the following circumstances, the health administrative department or environmental protection administrative department of the local people's government at or above the county level shall, within their respective responsibilities, order correction within a time limit and give a warning; if correction is not made within the time limit, a fine of not less than 2,000 yuan but not more than 5,000 yuan shall be imposed:
(一)未建立、健全医疗废物管理制度，或者未设置监控部门或者专(兼)职人员的；
(1) Failure to establish or improve the medical waste management system, or failure to set up a monitoring department or full-time (part-time) personnel;
(二)未对有关人员进行相关法律和专业技术、安全防护以及紧急处理等知识的培训的；
(2) Failure to provide training to relevant personnel on relevant laws, professional techniques, safety protection, and emergency handling;
(三)未对从事医疗废物收集、运送、贮存、处置等工作的人员和管理人员采取职业卫生防护措施的；
(3) Failure to take occupational health protection measures for personnel engaged in the collection, transportation, storage, and disposal of medical waste and management personnel;
(四)未对医疗废物进行登记或者未保存登记资料的；
(4) Failure to register medical waste or to keep registration records;
(五)对使用后的医疗废物运送工具或者运送车辆未在指定地点及时进行消毒和清洁的；
(5) failing to promptly disinfect and clean used medical waste transport tools or vehicles at designated locations;
(六)未及时收集、运送医疗废物的；
(6) failing to collect and transport medical waste in a timely manner;
(七)未定期对医疗废物处置设施的环境污染防治和卫生学效果进行检测、评价，或者未将检测、评价效果存档、报告的。
(7) failing to regularly test and evaluate the environmental pollution prevention and hygiene effects of medical waste disposal facilities, or failing to archive and report the test and evaluation results.
医疗卫生机构、医疗废物集中处置单位违反本条例规定，有下列情形之一的，由县级以上地方人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令限期改正，给予警告，可以并处5000元以下的罚款；逾期不改正的，处5000元以上3万元以下的罚款：
Where a medical institution or a centralized medical waste disposal unit violates these Regulations in any of the following circumstances, the competent health administration department or environmental protection department of the local people's government at or above the county level shall, within their respective functions and duties, order correction within a time limit, give a warning, and may concurrently impose a fine of not more than 5,000 yuan; if correction is not made within the time limit, a fine of not less than 5,000 yuan but not more than 30,000 yuan shall be imposed:
(一)贮存设施或者设备不符合环境保护、卫生要求的；
(1) storage facilities or equipment do not meet environmental protection or hygiene requirements;
(二)未将医疗废物按照类别分置于专用包装物或者容器的；
(2) failing to place medical waste in dedicated packaging or containers according to category;
(三)未使用符合标准的专用车辆运送医疗废物或者使用运送医疗废物的车辆运送其他物品的；
(3) using non-compliant dedicated vehicles to transport medical waste or using vehicles for medical waste transport to carry other items;
(四)未安装污染物排放在线监控装置或者监控装置未经常处于正常运行状态的。
(4) failing to install online pollutant emission monitoring devices or the monitoring devices are not in normal operation.
医疗卫生机构、医疗废物集中处置单位有下列情形之一的，由县级以上地方人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令限期改正，给予警告，并处5000元以上1万元以下的罚款；逾期不改正的，处1万元以上3万元以下的罚款；造成传染病传播或者环境污染事故的，由原发证部门暂扣或者吊销执业许可证件或者经营许可证件；构成犯罪的，依法追究刑事责任：
Where a medical institution or a centralized medical waste disposal unit commits any of the following acts, the competent health administration department or environmental protection department of the local people's government at or above the county level shall, within their respective functions and duties, order correction within a time limit, give a warning, and concurrently impose a fine of not less than 5,000 yuan but not more than 10,000 yuan; if correction is not made within the time limit, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; if the act causes the spread of infectious diseases or an environmental pollution accident, the original issuing authority shall suspend or revoke the practice license or business license; if a crime is constituted, criminal liability shall be pursued according to law:
(一)在运送过程中丢弃医疗废物，在非贮存地点倾倒、堆放医疗废物或者将医疗废物混入其他废物和生活垃圾的；
(1) discarding medical waste during transport, dumping or piling medical waste in non-storage locations, or mixing medical waste with other waste or household garbage;
(二)未执行危险废物转移联单管理制度的；
(2) Failing to implement the hazardous waste transfer manifest management system;
(三)将医疗废物交给未取得经营许可证的单位或者个人收集、运送、贮存、处置的；
(3) Handing over medical waste to units or individuals without a business license for collection, transportation, storage, or disposal;
(四)对医疗废物的处置不符合国家规定的环境保护、卫生标准、规范的；
(4) Disposal of medical waste not in compliance with national environmental protection and hygiene standards and specifications;
(五)未按照本条例的规定对污水、传染病病人或者疑似传染病病人的排泄物，进行严格消毒，或者未达到国家规定的排放标准，排入污水处理系统的；
(5) Failing to strictly disinfect sewage, excreta of infectious disease patients or suspected patients as per this regulation, or discharging into the sewage treatment system without meeting national discharge standards;
(六)对收治的传染病病人或者疑似传染病病人产生的生活垃圾，未按照医疗废物进行管理和处置的。
(6) Failing to manage and dispose of domestic waste generated by admitted infectious disease patients or suspected patients as medical waste.
医疗卫生机构违反本条例规定，将未达到国家规定标准的污水、传染病病人或者疑似传染病病人的排泄物排入城市排水管网的，由县级以上地方人民政府建设行政主管部门责令限期改正，给予警告，并处5000元以上1万元以下的罚款；逾期不改正的，处1万元以上3万元以下的罚款；造成传染病传播或者环境污染事故的，由原发证部门暂扣或者吊销执业许可证件；构成犯罪的，依法追究刑事责任。
If a medical institution violates this regulation by discharging sewage or excreta of infectious disease patients or suspected patients that do not meet national standards into the urban drainage network, the construction administrative department of the local people's government at or above the county level shall order correction within a time limit, issue a warning, and impose a fine of not less than 5,000 yuan but not more than 10,000 yuan; if correction is not made within the time limit, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; if the act causes the spread of infectious diseases or environmental pollution accidents, the original licensing department shall temporarily seize or revoke the practice license; if a crime is constituted, criminal liability shall be pursued according to law.
医疗卫生机构、医疗废物集中处置单位发生医疗废物流失、泄漏、扩散时，未采取紧急处理措施，或者未及时向卫生行政主管部门和环境保护行政主管部门报告的，由县级以上地方人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令改正，给予警告，并处1万元以上3万元以下的罚款；造成传染病传播或者环境污染事故的，由原发证部门暂扣或者吊销执业许可证件或者经营许可证件；构成犯罪的，依法追究刑事责任。
If a medical institution or centralized medical waste disposal unit fails to take emergency measures or fails to promptly report to the health administrative department and environmental protection administrative department when medical waste is lost, leaked, or spread, the health administrative department or environmental protection administrative department of the local people's government at or above the county level shall, within their respective responsibilities, order correction, issue a warning, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the act causes the spread of infectious diseases or environmental pollution accidents, the original licensing department shall temporarily seize or revoke the practice license or business license; if a crime is constituted, criminal liability shall be pursued according to law.
医疗卫生机构、医疗废物集中处置单位，无正当理由，阻碍卫生行政主管部门或者环境保护行政主管部门执法人员执行职务，拒绝执法人员进入现场，或者不配合执法部门的检查、监测、调查取证的，由县级以上地方人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令改正，给予警告；拒不改正的，由原发证部门暂扣或者吊销执业许可证件或者经营许可证件；触犯《中华人民共和国治安管理处罚法》，构成违反治安管理行为的，由公安机关依法予以处罚；构成犯罪的，依法追究刑事责任。
If a medical institution or centralized medical waste disposal unit, without justifiable reasons, obstructs law enforcement personnel of the health administrative department or environmental protection administrative department from performing their duties, refuses to allow law enforcement personnel to enter the site, or fails to cooperate with the inspection, monitoring, investigation, and evidence collection of the law enforcement department, the health administrative department or environmental protection administrative department of the local people's government at or above the county level shall, within their respective responsibilities, order correction and issue a warning; if correction is refused, the original licensing department shall temporarily seize or revoke the practice license or business license; if the act violates the Public Security Administration Punishments Law of the People's Republic of China and constitutes a public security violation, the public security organ shall impose punishment according to law; if a crime is constituted, criminal liability shall be pursued according to law.
不具备集中处置医疗废物条件的农村，医疗卫生机构未按照本条例的要求处置医疗废物的，由县级人民政府卫生行政主管部门或者环境保护行政主管部门按照各自的职责责令限期改正，给予警告；逾期不改正的，处1000元以上5000元以下的罚款；造成传染病传播或者环境污染事故的，由原发证部门暂扣或者吊销执业许可证件；构成犯罪的，依法追究刑事责任。
If a medical institution in a rural area lacking conditions for centralized medical waste disposal fails to dispose of medical waste in accordance with the requirements of this regulation, the health administrative department or environmental protection administrative department of the county people's government shall, within their respective responsibilities, order correction within a time limit and issue a warning; if correction is not made within the time limit, a fine of not less than 1,000 yuan but not more than 5,000 yuan shall be imposed; if the act causes the spread of infectious diseases or environmental pollution accidents, the original licensing department shall temporarily seize or revoke the practice license; if a crime is constituted, criminal liability shall be pursued according to law.
未取得经营许可证从事医疗废物的收集、运送、贮存、处置等活动的，由县级以上地方人民政府环境保护行政主管部门责令立即停止违法行为，没收违法所得，可以并处违法所得1倍以下的罚款。
If a unit engages in the collection, transportation, storage, or disposal of medical waste without a business license, the environmental protection administrative department of the local people's government at or above the county level shall order an immediate cessation of the illegal act, confiscate the illegal gains, and may concurrently impose a fine of not more than one times the illegal gains.
转让、买卖医疗废物，邮寄或者通过铁路、航空运输医疗废物，或者违反本条例规定通过水路运输医疗废物的，由县级以上地方人民政府环境保护行政主管部门责令转让、买卖双方、邮寄人、托运人立即停止违法行为，给予警告，没收违法所得；违法所得5000元以上的，并处违法所得2倍以上5倍以下的罚款；没有违法所得或者违法所得不足5000元的，并处5000元以上2万元以下的罚款。
For transferring, buying or selling medical waste, mailing or transporting medical waste by railway or air, or transporting medical waste by water in violation of these regulations, the environmental protection administrative department of the local people's government at or above the county level shall order the transferor, buyer, seller, mailer, or consignor to immediately cease the illegal act, issue a warning, and confiscate illegal gains; if the illegal gains are 5,000 yuan or more, a fine of not less than 2 times but not more than 5 times the illegal gains shall also be imposed; if there are no illegal gains or the illegal gains are less than 5,000 yuan, a fine of not less than 5,000 yuan but not more than 20,000 yuan shall also be imposed.
承运人明知托运人违反本条例的规定运输医疗废物，仍予以运输的，或者承运人将医疗废物与旅客在同一工具上载运的，按照前款的规定予以处罚。
If a carrier knowingly transports medical waste in violation of these regulations, or if a carrier transports medical waste together with passengers on the same vehicle, the carrier shall be punished in accordance with the provisions of the preceding paragraph.
医疗卫生机构、医疗废物集中处置单位违反本条例规定，导致传染病传播或者发生环境污染事故，给他人造成损害的，依法承担民事赔偿责任。
If a medical and health institution or a centralized medical waste disposal unit violates these regulations, causing the spread of infectious diseases or an environmental pollution accident, and causing harm to others, it shall bear civil liability for compensation in accordance with the law.
附则
Supplementary Provisions
计划生育技术服务、医学科研、教学、尸体检查和其他相关活动中产生的具有直接或者间接感染性、毒性以及其他危害性废物的管理，依照本条例执行。
The management of waste with direct or indirect infectivity, toxicity, and other hazardous properties generated in family planning technical services, medical research, teaching, autopsy, and other related activities shall be implemented in accordance with these regulations.
军队医疗卫生机构医疗废物的管理由中国人民解放军卫生主管部门参照本条例制定管理办法。
The management of medical waste from military medical and health institutions shall be formulated by the health authority of the People's Liberation Army with reference to these regulations.
本条例自公布之日起施行。
These regulations shall come into force on the date of promulgation.