中国医疗行业法律法规中英数据库
第三十六条 国家实行中药品种保护制度。具体办法由国务院制定。 Article 36 The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines.第三十六条未取得国家颁发的有关合格证书，施行终止妊娠手术或者采取其他方法终止妊娠，致人死亡、残疾、丧失或者基本丧失劳动能力的，依照刑法第一百三十四条、第一百三十五条的规定追究刑事责任。 Article 36 Where anyone who has not obtained relevant qualification certificate issued by the State performs operations for termination of gestation or terminates gestation by other means, thus causing death, disability, loss or basic loss of working ability, shall be investigated for criminal responsibility according to the provisions of Article 134 and Article 135 of the Criminal Law.第三十六条 当事人对罚款决定不服的，可以自收到处罚决定通知书之日起十五日内向上一级卫生行政部门申请复议；对复议决定仍然不服的，可以自收到复议决定通知书之日起十五日内向法院提起诉讼。 Article 36. Any party who refuses to accept a decision on fine may, within 15 days of receiving the notice on the punishment decision, apply to the health administration department at the next higher level for reconsideration; any party who refuses to accept the reconsideration decision may, within 15 days of receiving the notice on the reconsideration decision, bring a lawsuit before a court of law.第三十七条（施行特殊诊疗的前置条件） Article 37 (Preconditions for Performing Special Diagnosis and Treatment)第三十七条医师在执业活动中，违反本法规定，有下列行为之一的，由县级以上人民政府卫生行政部门给予警告或者责令暂停六个月以上一年以下执业活动； Article 37 If any doctor commits any of the following acts in practice of medicine in violation of the provisions of this Law, the administrative department of health under the people’s government at or above the county level shall give him a warning or order him to suspend his practice of medicine for not less than six months and not more than one year.第三十七条检验检疫机构每年对一、二类进口单位进行至少一次监督审核，发现下列情况之一的，可以根据情节轻重对其作降类处理： Article 37 The IQ organs shall implement the supervisory examination on a Category A or B importer at least one time per year, and may degrade the importer in light of the seriousness of any of the following circumstances:第三十七条 国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院制定。 Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals.第三十七条从事母婴保健工作的人员违反本法规定，出具有关虚假医学证明或者进行胎儿性别鉴定的，由医疗保健机构或者卫生行政部门根据情节给予行政处分；情节严重的，依法取消执业资格。 Article 37 Where personnel engaged in the work of maternal and infant health care, in violation of the stipulations of this Law, issue fake medical certificates, or undertake sex identification of the fetus, medical and health institutions or administrative departments of public health shall in light of the circumstances give them administrative sanctions; if the circumstances are serious, they shall be disqualified for practice of their profession according to law.第三十七条 有本法第三十五条所列行为之一，引起甲类传染病传播或者有传播严重危险的，比照刑法第一百七十八条的规定追究刑事责任。 Article 37. If a person commits one of the acts specified in Article 35 of this Law and as a result causes the spread or a great risk of the spread of an A Class infectious disease, his criminal responsibility shall be investigated by applying mutatis mutandis the provisions of Article 178 of the Criminal Law of the People's Republic of China.第三十八条（医源性感染的控制） Article 38 (Control of Iatrogenic Infection)第三十八条医师在医疗、预防、保健工作中造成事故的，依照法律或者国家有关规定处理。 Article 38 Doctors causing accidents in medical treatment, prevention or health care shall be handled according to law or relevant state provisions.第三十八条 禁止进口疗效不确、不良反应大或者其他原因危害人体健康的药品。 Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.第三十八条本法下列用语的含义： Article 38 The definitions of the following terms as used in this Law are:第三十八条进口医疗器械出现下列情况之一的，检验检疫机构经本机构负责人批准，可以对进口医疗器械实施查封或者扣押，但海关监管货物除外： Article 38 The IQ organ, upon the approval of its principal, may seize or detain any imported medical instruments under the following circumstances, except for those subject to the customs supervision:第三十八条 从事实验、保藏、携带、运输传染病菌种、毒种的人员，违反国务院卫生行政部门的有关规定，造成传染病菌种、毒种扩散，后果严重的，依照刑法第一百一十五条的规定追究刑事责任；情节轻微的，给予行政处分。 Article 38. Any person engaged in the experimentation, storage, carrying or transportation of bacterial strains and virus strains of infectious diseases who, in violation of the relevant provisions of the health administration department under the State Council, causes a spread of the bacterial strains or virus strains of an infectious disease, with severe consequences, shall be prosecuted in accordance with Article 115 of the Criminal Law; he shall be given an administrative sanction if the circumstances are not so serious.第三十九条（病历管理） Article 39 (Control of Medical Record Cards)第三十九条未经批准擅自开办医疗机构行医或者非医师行医的，由县级以上人民政府卫生行政部门予以取缔，没收其违法所得及其药品、器械，并处十万元以下的罚款；对医师吊销其执业证书； Article 39 Establishing a medical institution for practice of medicine without approval or opening practice of medicine by an unqualified doctor shall be banned by the administrative department of health under the people’s government at or above the county level; the illegal gains and medicines and instruments involved in the case shall be confiscated, a fine of not more than RMB 100,000 yuan imposed and, if there is any doctor involved, the practicing certificate of doctors revoked;第三十九条国家质检总局负责对检验检疫机构实施进口医疗器械检验监督管理人员资格的培训和考核工作。 Article 39 The GAQSIQ shall take the responsibility of training and examining a qualification of IQ organs staff for the administration of inspection and supervision on imported medical instruments.第三十九条 药品进口，须经国务院药品监督管理部门组织审查，经审查确认符合质量标准、安全有效的，方可批准进口，并发给进口药品注册证书。 Article 39 The import of medicines must go through examinations organized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import.第三十九条本法自１９９５年６月１日起施行。 Article 39 This Law shall become effective as of June 1, 1995.第三十九条 从事传染病的医疗保健、卫生防疫、监督管理的人员和政府有关主管人员玩忽职守，造成传染病传播或者流行的，给予行政处分；情节严重、构成犯罪的，依照刑法第一百八十七条的规定追究刑事责任。 Article 39. Any person engaged in the medical care and health work, epidemic prevention, surveillance and control related to infectious diseases or any relevant responsible person of the government who causes the spread or epidemic of an infectious disease due to his dereliction of duty shall be given an administrative sanction; if the circumstances are serious enough to constitute a crime, he shall be prosecuted in accordance with Article 187 of the Criminal Law.第四条（管理部门）市卫生行政部门负责本市医疗机构的监督管理工作。区、县卫生行政部门负责本辖区内医疗机构的监督管理工作。 Article 4 (Administrative Authorities) The Municipal Public Health Administrative Department shall be responsible for the supervision and administration of municipal medical institutions while District (Country) Public Health Administrative Department shall be responsible for the supervision and administration of medical institutions within its jurisdiction.第四条县级以上各级人民政府卫生行政部门监督管理献血工作。 Article 4 Departments of public health under local people’s governments at or above the county level shall supervise over and administer the blood donation work.第四条国务院卫生行政部门负责全国中药品种保护的监督管理工作。国家中药生产经营主管部门协同管理全国中药品种的保护工作。? Article 4 Health administrative departments under the State Council are responsible for the supervision and administration of activities relating to the protection of traditional Chinese medicines. The responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines are to assist in the management of activities for the protection of all varieties of traditional Chinese medicines.第四条 精神药品由国家指定的生产单位按计划生产，其他任何单位和个人不得从事精神药品的生产活动。 Article 4 Psychotropic drugs shall be produced according to the plan by the production units appointed by the State. No other unit or individual shall be allowed to engage in the production of psychotropic drugs.
