- 中国医疗行业法律法规中英数据库 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
中国医疗行业法律法规中英数据库
- （八）收集并保存有关医疗器械的国家标准、行业标准及医疗器械的法规规章及专项规定，建立和保存比较完善的进口医疗器械资料档案，保存期不少于10年； (8) It shall have collected and preserved the national and industrial standards for relevant medical instruments and the regulations and rules as well as the exclusive provisions concerning medial instruments, and have established and preserved fairly complete data archives regarding the imported medical instruments, with a preservation period of no less than 10 years;
- （九）具备与其进口的医疗器械产品相适应的技术培训和售后服务能力，或者约定由第三方提供技术支持； (9) It shall have the capabilities of technical training and after sales service that is appropriate for the imported medical instruments, or have an agreement of acquiring technical support by a third party; and
- （九）具备与其进口的医疗器械产品相适应的技术培训和售后服务能力，或者约定由第三方提供技术支持； (9) It shall have the capabilities of the technical training and after sales service that are appropriate for the imported medical instruments, or have an agreement of obtaining technical support by a third party; and
- (i) 如保险期为一年，保单一经签发则没有保费退还予被保险人。 (i) For one-year contract, no refund of premium will be made once the insurance policy is issued.
- (ii) 如保险期为两年，被保险人于起保日起计算十二个月内要求取消此保险单，保险单将作为一年期保险单收费计算，其余未到期的保险费将退还予被保险人；如被保险人于起保日计算十二个月后要求取消此保险单，则没有保险费退还予被保险人。 (ii) For two-year contract, if the Insured cancels the insurance within 12 months from the commencement date of this Policy, the Company will treat this insurance as one-year contract, and charge the full premium, the balance of premium for the unexpired period of the insurance will be refund. If the insured cancels this Policy after 12 months from the commencement date of this insurance, no refund of premium will be made.
- 如保险期为三年，被保险人于起保日起计算十二个月内要求取消此保险单，或于起保日计算第十三个月至二十四个月内要求取消此保险单，本保险公司将分别以一年期保险费或两年期保险单收费计算，其余未到期的保险费将退还予被保险人；如被保险人于起保日计算第二十四个月后要求取消，则没有保险费退还予被保险人。 (iii) For three-year contract, if the Insured cancels this insurance within 12 months or after 12 months but within 24 months from the commencement date of this Policy, the company will treat this Policy as one-year contract or two-year contract respectively and charge the corresponding full one-year or two-year premium, the balance of premium for the unexpired period of the insurance will be refunded. If the Insured cancels this insurance after 24 months from the commencement of this Policy, no refund of premium will be made.
- （一）符合本市医疗机构设置规划； 1. In conformity to the Municipal Program of the Establishment of Medical Institutions;
- （二）未经市卫生行政部门批准，引进国外医学新技术、新项目； 2. Importing new medical technology or new medical project from abroad without approval of the Municipal Public Health Administrative Department; or
- （二）符合国家规定的医疗机构基本标准； 2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
- （二）符合国家规定的医疗机构基本标准； 2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
- （三）在职人员； 3. In-service employee(s);
- （四）未经国家或者市卫生行政部门批准，引进国外医学新技术、新项目或者从事婚前医学检查、遗传病诊断、产前诊断、人工授精等母婴保健专项技术服务； 4. Introducing new medical technology and new projects from abroad, or being engaged in such special technical services for mother child healthcare, such as medical examination before marriage, diagnosis on hereditary diseases, prenatal diagnosis, artificial insemination, etc. without approval of the State or Municipal Public Health Administrative Department;
- 医疗机构违反本办法规定，有下列行为之一的，由卫生行政部门责令其限期改正，并可处以1000元以上3000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》： If a medical institution commits one of the following acts in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 1,000 yuan up to no more than 3,000 yuan upon it; and may revoke its ""Practice License of Medical Institution""in serious case:
- 医疗机构违反本办法规定，使用无卫生技术资格证书的人员从事医疗卫生技术工作的，由卫生行政部门责令其限期改正，并可处以3000元以上5000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》。 If a medical institution employs persons without the qualification certificate of public health technique to carry out the medical and health technique work in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 3,000 yuan up to no more than 5,000 yuan upon it; and may revoke its ""Practice License of Medical Institution""in serious case.
- 医疗机构设置分支机构的，应当向原设置审批的卫生行政部门申请办理审批手续； If a medical institution intends to establish a branch, it shall apply for examination and approval with the original Public Health Administrative Department which has examined and approved the establishment of the medical institution.
- 医疗机构在本机构以外的场所组织卫生技术人员开展医疗执业活动，应当经卫生行政部门批准。 If a medical institution intends to organize public health technical persons to carry out medical practising activities in any places outside the institution, it shall obtain approval from the Public Health Administrative Department.
- 医疗机构因扩建、改建等原因，暂时歇业或者部分歇业的，应当事先向原执业登记的卫生行政部门办理歇业手续。 If a medical institution intends to suspend its practice temporarily or partly due to extension, or reconstruction, or other causes, it shall apply for the practice suspension procedures in advance with the original Public Health Administrative Department which has approved its practice registration.
- 医疗机构违反本办法规定，出具虚假疾病诊断书、健康证明书、死亡证明书、出生证明书、死产报告书的，由卫生行政部门予以警告，并可处以500元以下的罚款； If a medical institution issues a false diagnosis report on disease, health certificate, death certificate, birth certificate or dead-birth report in violation of the present Procedures, the Public Health Administrative Department shall give it a disciplinary warning, and may impose a fine of no more than 500 yuan upon it.
- 医疗机构违反本办法规定，出卖、出借、转让《医疗机构执业许可证》，或者借用、冒用其他医疗机构名义从事医疗执业活动的，由卫生行政部门没收其非法所得，并可处以2000元以上5000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》。 If a medical institution sell, lend or transfer the ""Practice License of Medical Institution"", or borrow or fraudulently use the name of other medical institution to carry out medical practising activities in violation of the present Procedures; the Public Health Administrative Department shall confiscate its illegal gains and may impose a fine of 2,000 yuan up to no more than 5,000 yuan upon the medical institution; and may revoke its ""Practice License of Medical Institution""in serious case.
- 违反本办法规定，有下列行为之一的，由卫生行政部门责令其停止执业活动，没收非法所得和药品、器械，并可以根据情节轻重处以4000元以上1万元以下的罚款： If a medical institution violates the present Procedures by doing any one of the following acts, the Public Health Administrative Department shall order the medical institution to suspend its practising activities, confiscate its illegal gains, medicines and apparatus, and may also impose a fine of 4,000 yuan up to no more than 10,000 yuan upon the medical institution according to the seriousness of the wrongdoing:
- 医疗机构违反本办法规定，逾期未办理《医疗机构执业许可证》校验手续仍从事医疗执业活动的，由卫生行政部门责令10日内补办校验手续； If a medical institution violates the provisions of the present Procedures, i.e. remains being engaged in medical practising activities without having the required inspection of the ""Practice License of Medical Institution""within the time limit, the Public Health Administrative Department shall order it to make up the inspection within 10 days;
- 医疗单位发现药品中毒事故，必须及时向当地卫生行政部门报止。 If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.
- 逾期不申请复议或者不提起诉讼又不履行的，做出处罚决定的卫生行政部门可以申请法院强制执行。 If a party neither applies for reconsideration nor brings a lawsuit before a court of law nor carries out the punishment decision within the prescribed time, the health administration department that has made the decision on punishment may apply to a court for compulsory execution.
- 药品监督管理部门对药品广告不依法履行审查职责，批准发布的广告有虚假或者其他违反法律、行政法规的内容的，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。 If a pharmaceutical supervisory or administrative department does not perform its duty of inspection on pharmaceutical advertisements which results in the publishing of advertisements containing falsehoods or other content against laws and administrative regulations, the directly liable person in charge and other responsible personnel shall be subject to administrative sanction. If their acts constitute a crime, they shall be investigated for criminal liabilities in conformity with relevant regulations.
- 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构的工作人员参与药品生产经营活动的，依法给予行政处分。 If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.
最后更新
