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Medical Waste Management Regulations 

Original Language Title: 医疗废物管理条例 

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People's Republic of China promulgated by Decree No. 380, the medical waste management regulations adopted by the State Council on June 4, 2003 the tenth executive session, are hereby promulgated and, as of the date of promulgation.
Premier Wen Jiabao on June 16, 2003, medical waste management regulations chapter I General provisions article in order to strengthen safety management of medical waste, preventing the spread of diseases, protect the environment, safeguard human health, according to the People's Republic of China Law on prevention of infectious diseases and the People's Republic of China Law on prevention and control of environmental pollution by solid waste, this Ordinance is enacted.
Medical waste referred to in article II of this Ordinance refers to medical and health institutions in health, prevention, health care and other related activities have directly or indirectly to the infectious, toxic and other hazardous waste.
Medical waste category, shall be formulated by the health Administrative Department and jointly designed and published by the Administrative Department of environmental protection.
Article of the Ordinance applies to medical waste collection, transportation, storage, disposal, and regulatory activities.
Health institutions treated infectious disease patients or suspected patients of infectious diseases from the garbage, according to medical waste management and disposal.
Abandoned narcotic, mental health institutions, radioactive, toxic and other drugs and related waste management, in accordance with relevant laws, administrative regulations and the relevant national regulations, standards.
Fourth State promotes centralized harmless treatment of medical waste, encourage research and development on technology of safe disposal of medical waste.
Local people's Governments at or above the county level responsible for organizing the construction of centralized disposal of medical waste facilities.
States for construction of medical waste disposal facility in remote and poor areas given the right support.
The fifth administrative departments of people's Governments at or above the county level health and medical waste collection, transport, storage, disposal activities in exercise unified supervision and management of prevention and control of diseases; Administrative Department of environmental protection, and medical waste collection, transport, storage, disposal activities in exercise unified supervision and management of prevention and control of environmental pollution.
Relevant departments under the people's Governments at or above the county level within their respective areas of responsibility is responsible for the supervision and management work of medical waste disposal.  
Sixth article of any unit and individual have the right to medical and health institutions, medical waste disposal unit and monitoring violations of management and staff reports, complaints, exposures or charges.
Chapter II general provisions article seventh medical waste management medical institutions and medical waste disposal units, shall set up and perfect the responsibility system of medical waste management, its first responsible person of the legal representative, earnestly perform their duties, preventing the spread of infectious diseases due to medical waste and environmental pollution accidents.
Article eighth medical institutions and medical waste disposal units, should be established with regard to the safe disposal of medical waste rules and contingency plans in case of accidents; set the monitoring Department or (and) staff, responsible for the inspection, supervision, and the implementation of the management of medical waste, and prevent the occurrence of acts in violation of this Ordinance.
Nineth medical institutions and medical waste disposal units, should be on the unit for medical waste collection, transportation, storage, disposal and management personnel, the related legal and technical expertise, security and training of emergency treatment and other knowledge.
The tenth medical institutions and medical waste disposal units, occupational health protection measures to be effective, engaged in medical waste collection, transportation, storage, disposal and management personnel, equipped with the necessary protective equipment, regular health checks, if necessary, to immunize against the officer, prevention of health damage to it.
11th medical institutions and medical waste disposal units, should be in accordance with the People's Republic of China provisions of the law on prevention and control of environmental pollution by solid waste, implementation of the transfer of hazardous waste management system. 12th medical institutions and medical waste disposal units, medical wastes should be registered, registration should be types of sources, including medical waste, weight or quantity, transition time, final destination and handling, disposal method signatures and other projects.
Registration data for at least 3 years.
13th medical institutions and medical waste disposal units, effective measures should be taken to prevent loss, leakage, diffusion of medical waste.
When there is a loss, leakage, diffusion of medical waste, medical institutions and medical waste disposal unit should take emergency measures to reduce harm, causing staff to provide medical care and rescue; and to the local people's Governments at the county level health administrative departments, Administrative Department of environmental protection reported, and to inform the units and residents may be compromised.
14th prohibits any transfer of units and individuals, the sale of medical waste.
Ban on discarding medical waste in transit; prohibit dumping in non-storage sites, piling up medical waste or medical waste mixed with other wastes and garbage.
The 15th prohibited for mailing medical waste.
Banned the use of railways, air transport of clinical waste.
Land crossings, prohibition of medical waste by water transport; no overland access required by water transport of medical wastes, must pass through the District of the city-level people's Government for approval by the Administrative Department of environmental protection, and strict environmental protection measures, available through waterways.
Prohibition of medical waste and passengers in the carriage on the same transport vehicle.  
Ban on drinking water source protected zone of water transport of clinical waste.
Chapter III administration of health care institutions for medical waste 16th medical and health institutions shall collect these wastes from medical units, and according to the category under seepage, sharps prevention through special packaging or an airtight container.
Special packaging and containers for medical waste, there should be an obvious warning marks and warning specifications.
Medical waste in special containers, container standards and labels provided by the health Administrative Department under the State Council and the Administrative Department of environmental protection to develop.
Article 17th of medical wastes in medical and health institutions shall set up interim storage facilities and equipment shall not open storage of medical waste medical waste for temporary storage of no more than 2 days.
Medical waste in temporary storage facilities, equipment should be away from the medical, food processing areas and activities as well as solid waste storage areas, and set a clear warning labels and seepage, mice, anti-mosquitoes, cockroaches, anti-theft and security measures such as preventing children's access.
Medical waste in temporary storage facilities, equipment should be disinfected on a regular basis and clean.
18th medical institutions should use leakage-proof private conveyance, anti-littering, determined in accordance with the unit's internal medical waste transport times, routes, medical waste collection, transport and temporary storage location.
Transport tools used within medical and health institutions shall specify the place and time of disinfection and cleaning.
19th article should be based on principles of centralized disposal of medical and health institutions, timely clinical wastes to disposal of medical waste disposal.
Of pathogens in medical waste media, specimens and virus strains and species preservation solutions such as hazardous waste, medical waste disposal unit should be disinfected before disposal.
20th medical and health institutions of sewage generated from the excreta of patients or suspected patients of infectious diseases, and infectious diseases, should be strictly disinfected according to state regulations to meet national emission standards, to be discharged into the sewage system. 21st do not have centralized disposal of medical waste in rural conditions, medical and health institutions shall, in accordance with the County Health Department, Administrative Department of environmental protection requirements, in-place disposal of medical waste produced on their own.  
To deal with medical waste, shall comply with the following requirements: (a) after use, disposable medical devices, and easy to damage caused by medical waste, should be disinfected and disfigurement; (b) to burn, should be burned in a timely manner, (iii) cannot be burned, concentrated landfill after disinfection.
The centralized disposal of medical waste in the fourth chapter the 22nd units engaged in centralized disposal of medical waste, shall apply to the environmental protection Administrative Department of the people's Governments above the county level for the operating license; units without business permit, shall not be engaged in activities related to centralized disposal of medical waste.
23rd article medical waste concentrated disposal units, should meet following conditions: (a) has meet environmental protection and health requirements of medical waste storage, and disposal facilities or equipment; (ii) has after training of technicians and corresponding of technology workers; (three) has is responsible for medical waste disposal effect detection, and evaluation work of institutions and personnel; (four) has guarantee medical waste security disposal of regulations.
24th medical waste disposal unit of storage and treatment facilities should be away from home (village) of residential areas, water source protection areas and major roads, and factories, businesses and other workplace has appropriate security protection zone and meet the requirements of environmental protection Administrative Department under the State Council.
25th medical waste disposal unit shall, at least once every 2 days to health institutions collecting, transporting medical waste, and is responsible for the storage and disposal of medical waste. 26th medical waste disposal unit transporting medical waste, shall comply with the national provisions relating to the transport of dangerous goods management, the use of vehicles used exclusively on clear identification of medical waste.
Medical waste-specific vehicles shall meet the leakage-proof, anti-littering and other environmental and health requirements.
Special vehicles carrying medical waste after use, shall in the centralized disposal of medical waste sites in time for disinfection and cleaning.
Private vehicles transporting other goods transport the waste.
27th medical waste disposal unit in the course of transport the waste should make sure that safety shall not be discarded, leaving medical waste.
28th medical waste disposal unit should install pollutant discharge online monitoring devices, and ensuring that monitoring devices often run in the normal state.
29th medical waste disposal of medical waste disposal units, shall conform to the regulations of the State environmental protection, hygiene standards and specifications. 30th medical waste centralized treatment units shall be in accordance with the environmental protection Administrative Department and the provisions of the Administrative Department of public health, regular medical waste disposal facility pollution prevention and hygiene test and assessment of results.
Test and assessment of results in medical waste centralized treatment units file, every six months to the local environmental protection Administrative Department and the Administrative Department of public health reports.
31st medical waste disposal of medical waste disposal units, in accordance with the relevant provisions of the State medical waste disposal fees charged to health institutions.
Medical and health institutions of medical waste treatment fees paid in accordance with the provisions can be incorporated into the health care costs.
Article 32nd all districts should use and transformation of the existing solid waste disposal facilities and other facilities, medical waste disposal, and meet the basic environmental and health requirements. 33rd article, there is no centralized disposal facilities or lack of disposal capacity of the city, from the date of enforcement of this Act, city-level cities divided into districts shall, within 1 year of medical waste disposal facility built; counties should be completed in 2 years medical waste disposal facility.
County (banner), the construction of centralized disposal of medical waste facilities, by people's Governments of provinces, autonomous regions and municipalities.  
In the absence of medical waste disposal facilities built during, the relevant local people's Governments shall develop in accordance with environmental and health requirements of the transitional medical waste disposal programs, medical waste collection, transportation, treatment and disposal units.
Fifth chapter, supervision and management of the 34th local people's Governments above the county level health administrative departments, environmental protection Administrative Department shall, in accordance with the provisions of this regulation, in accordance with the duties of medical institutions and medical waste disposal unit carried out supervision and inspection.
35th health administrative departments under local people's Governments at or above the county level shall, should health care institutions and centralized disposal of medical waste medical waste collection, transportation, storage, disposal of disease prevention and treatment, and health protection of staff, undertake periodic supervision and inspection or irregular spot checks.
36th local environmental protection Administrative Department of the people's Government at or above the county level shall, for medical and health institutions and medical unit that centralized disposal of medical waste collection, transportation, storage and disposal of environmental pollution prevention and control work in regular supervision and inspection or irregular spot checks. The 37th health administrative departments and the Administrative Department of environmental protection should be a regular exchange of surveillance and inspection results.
Supervision or checks found in medical and health institutions and medical waste disposal unit when there is a risk, shall be ordered to immediately eliminate hidden dangers.
Article 38th of health Administrative Department, Administrative Department of environmental protection received for medical and health institutions, medical waste disposal unit and supervision and management departments and the staff of a violation of this Ordinance reports, complaints, exposures or charges should be verified in a timely manner and dealt with according to law, and the results made public.
39th article health administrative competent sector, and environmental protection administrative competent sector perform supervision check duties Shi, right to take following measures: (a) on units for field check, understand situation, site monitoring, survey Forensics; (ii) check out or copy medical waste management of about information, collection samples; (three) ordered violation this Ordinance provides of units and personal stop violations; (four) seized or temporarily buckle suspected violation this Ordinance provides of places, and equipment, and transport tool and items;
(E) to investigate the acts in violation of the provisions of this Ordinance.
40th due to improper waste management leads to the spread of infectious diseases or environmental pollution accident, or there is evidence that the spread of infectious diseases or environmental pollution accidents are likely to occur, Department of health administration, the environmental protection administration departments should take temporary control measures, evacuation, control, and if necessary, to suspend lead or may lead to the spread of infectious diseases or environmental pollution accidents jobs.
41st health bodies and medical waste disposal units, inspection, monitoring, investigation and evidence of the relevant departments, shall cooperate, refuse and impede shall not provide false information.
Sixth chapter legal liability 42nd local people's Governments at or above the county level shall not, in accordance with the provisions of this Ordinance, organizations medical waste disposal facility or organization to develop transitional medical waste disposal programmes, by the higher people's Government criticized, ordered into medical waste disposal facility or organization to develop transitional medical waste disposal programmes; and can be responsible for government leaders, managers, administrative sanctions according to law. Article 43rd people's Government at or above the county level health administrative departments, environmental protection administrative department or other relevant departments, has not been checked in accordance with the provisions of this Ordinance, in discharging its oversight responsibilities, finding medical and health institutions and medical waste disposal unit does not handle violations, or possible spread of infectious diseases or environmental pollution accidents, failing immediately to take harm reduction measures, as well as other acts of negligence, dereliction of duty, malfeasance,
The people's Government of the people's Governments at the corresponding level or by the relevant Department in charge shall command a correction and criticism causing the spread of infectious diseases or environmental pollution accidents, responsible for directors, supervisors and other personnel directly responsible shall be given administrative sanctions of demotion, dismissal, discharge constitutes a crime, criminal responsibility shall be investigated according to law.
44th environmental protection Administrative Department of the people's Governments above the county level shall, in violation of the provisions of this Ordinance issued business licenses of medical waste disposal units, by the people's Government of the people's Governments at the corresponding level or by the competent administrative Department of environmental protection criticized ordered recovery of illegal certificates issued; and can be responsible for directors, managers and other persons directly responsible shall be given administrative sanctions.
45th article medical health institutions, and medical waste concentrated disposal units violation this Ordinance provides, has following case one of of, by County above place Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered deadline corrected, give warning; late not corrected of, at 2000 Yuan above 5000 Yuan following of fine: (a) not established, and sound medical waste management system, or not set monitoring sector or designed (and) vocational personnel of;
(Ii) not on about personnel for related legal and professional technology, and security protection and emergency processing, knowledge of training of; (three) not on engaged in medical waste collection, and transport, and storage, and disposal, work of personnel and management personnel take career health protection measures of; (four) not on medical waste for registration or not save registration information of; (five) on using Hou of medical waste transport tool or transport vehicles not in specified locations timely for disinfection and clean of; (six) not timely collection, and transport medical waste of;
(VII) not for medical waste disposal facility on a regular basis by the environmental pollution control and health effects testing, evaluation, or fail to test and evaluate the effect of the archive, reported.
46th article medical health institutions, and medical waste concentrated disposal units violation this Ordinance provides, has following case one of of, by County above place Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered deadline corrected, give warning, can and at 5000 Yuan following of fine; late not corrected of, at 5000 Yuan above 30,000 yuan following of fine: (a) storage facilities or equipment not meet environmental protection, and health requirements of;
(B) medical waste is not in accordance with the categories in special packaging or containers, (iii) not using a standards-compliant special vehicles transport the waste or transporting medical waste transporting other goods; (iv) pollution online monitor is not installed devices or monitoring device is not often run in the normal state. 47th article medical health institutions, and medical waste concentrated disposal units has following case one of of, by County above place Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered deadline corrected, give warning, and at 5000 Yuan above 10,000 yuan following of fine; late not corrected of, at 10,000 yuan above 30,000 yuan following of fine; caused infectious diseases spread or pollution accident of, by original sent card sector temporarily buckle or revoked practice industry license pieces or business license pieces
; Constitute crime of, law held criminal: (a) in transport process in the discarded medical waste, in non-storage locations dumping, and stacked medical waste or will medical waste mix other waste and life garbage of; (ii) not implementation dangerous waste transfer joint single management system of; (three) will medical waste handed not made business license of units or personal collection, and transport, and storage, and disposal of; (four) on medical waste of disposal not meet national provides of environmental protection, and health standard, and specification of;
(V) not in accordance with the provisions of this Ordinance to sewage, wastes of infectious disease patients or suspected patients of infectious diseases, rigorous disinfection, or has failed to meet the national emission standards, discharged into the sewage system, and (vi) of infectious disease patients or suspected patients of infectious diseases treated from garbage, not according to the management and disposal of medical wastes. 48th article medical health institutions violation this Ordinance provides, will not reached national provides standard of sewage, and infectious diseases patients or suspected infectious diseases patients of waste row into city drain network of, by County above place Government construction administrative competent sector ordered deadline corrected, give warning, and at 5000 Yuan above 10,000 yuan following of fine; late not corrected of, at 10,000 yuan above 30,000 yuan following of fine; caused infectious diseases spread or pollution accident of,
By the original Licensing Department temporary suspension or revocation of license to practice constitutes a crime, criminal responsibility shall be investigated according to law. 49th article medical health institutions, and medical waste concentrated disposal units occurred medical waste loss, and leak, and diffusion Shi, not take emergency processing measures, or not timely to health administrative competent sector and environmental protection administrative competent sector report of, by County above place Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered corrected, give warning, and at 10,000 yuan above 30,000 yuan following of fine; caused infectious diseases spread or pollution accident of,
By the original Licensing Department suspended or revoked license to practice or business license constitutes a crime, criminal responsibility shall be investigated according to law. 50th article medical health institutions, and medical waste concentrated disposal units, no due reason, hinder health administrative competent sector or environmental protection administrative competent sector law enforcement personnel implementation positions, refused to law enforcement personnel into site, or not tie law enforcement sector of check, and monitoring, and survey forensics of, by County above place Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered corrected, give warning; refused to corrected of,
By the original Licensing Department suspended or revoked license to practice or business license; breach of the People's Republic of China on public security administration punishments Ordinance, the activities contravening public security management, the public security organs shall be punished; constitutes a crime, criminal responsibility shall be investigated according to law. 51st article not has concentrated disposal medical waste conditions of rural, medical health institutions not according to this Ordinance of requirements disposal medical waste of, by County Government health administrative competent sector or environmental protection administrative competent sector according to their of duties ordered deadline corrected, give warning; late not corrected of, at 1000 Yuan above 5000 Yuan following of fine; caused infectious diseases spread or pollution accident of, by original sent card sector temporarily buckle or revoked practice industry license pieces; constitute crime of,
Criminal responsibility shall be investigated according to law.
52nd without business licenses of medical waste collection, transportation, storage, disposal activities, local environmental protection Administrative Department of the people's Government at or above the county level shall be ordered to immediately stop the illegal practice, confiscate the illegal income, and may be fined not more than the illegal income 1 time. 53rd article transfer, and sale medical waste, mailing or through railway, and air transport medical waste, or violation this Ordinance provides through waterway transport medical waste of, by County above place government environmental protection administrative competent sector ordered transfer, and buyers and sellers, and mailing people, and checked people immediately stop violations, give warning, confiscated illegal proceeds; illegal proceeds 5000 Yuan above of, and at illegal proceeds twice times above 5 times times following of fine; no illegal proceeds or illegal proceeds insufficient 5000 Yuan of,
And to a fine of up to 5000 Yuan and 20,000 yuan.
Known shipper violates the provisions of this Ordinance the carrier transporting medical waste, will be transported, or if he will be carrying medical waste and passengers in the same tool, in accordance with the provisions of the preceding paragraph shall be punished.  
The 54th medical and health institutions, medical waste disposal unit violates the provisions of this Ordinance, resulting in the spread of infectious diseases or environmental pollution accidents occurred, causing damage to others shall bear civil liability.
The seventh chapter VIII supplementary provisions 55th article of family planning technical services, medical research and teaching, autopsy and other related activities have directly or indirectly to the infectious, toxic and other hazardous waste management, in accordance with this Ordinance.
56th army medical and health institutions of medical waste management by Chinese health authorities in the light of administrative measures for the enactment of this Ordinance. 57th these regulations come into force on the date of promulgation.