| Regulations on the Safety and Protection of Radioisotopes and Radiation Devices | | 放射性同位素与射线装置安全和防护条例 |
| (Promulgated by the Order No. 449 of the State Council of the People's Republic of China on September 14, 2005; revised for the first time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014; and revised for the second time in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) | | （2005年9月14日中华人民共和国国务院令第449号公布 根据2014年7月29日《国务院关于修改部分行政法规的决定》第一次修订 根据2019年3月2日《国务院关于修改部分行政法规的决定》第二次修订 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is formulated for purposes of strengthening the supervision and administration of the safety and protection of radioisotopes and radiation devices, promoting the safe application of radioisotopes and radiation devices, safeguarding the human health and protecting the environment. | | 第一条 为了加强对放射性同位素、射线装置安全和防护的监督管理，促进放射性同位素、射线装置的安全应用，保障人体健康，保护环境，制定本条例。 |
| Article 2 The production, sale and use of radioisotopes and radiation devices as well as the transfer, import and export of radioisotopes within the territory of the People's Republic of China shall be governed by this Regulation. | | 第二条 在中华人民共和国境内生产、销售、使用放射性同位素和射线装置，以及转让、进出口放射性同位素的，应当遵守本条例。 |
| The term “radioisotopes” as mentioned in this Regulation shall include radioactive sources and unsealed radioactive substances. | | 本条例所称放射性同位素包括放射源和非密封放射性物质。 |
| Article 3 The department of ecology and environment of the State Council shall conduct the unified supervision and administration on the safety and protection of radioisotopes and radiation devices throughout this country. | | 第三条 国务院生态环境主管部门对全国放射性同位素、射线装置的安全和防护工作实施统一监督管理。 |
| The public security department, health department and other departments of the State Council shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of relevant radioisotopes and radiation devices. | | 国务院公安、卫生等部门按照职责分工和本条例的规定，对有关放射性同位素、射线装置的安全和防护工作实施监督管理。 |
| The departments of ecology and environment and other relevant departments of the local people's governments at and above the county level shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of radioisotopes and radiation devices within their respective administrative areas. | | 县级以上地方人民政府生态环境主管部门和其他有关部门，按照职责分工和本条例的规定，对本行政区域内放射性同位素、射线装置的安全和防护工作实施监督管理。 |
| Article 4 The state shall implement the classified administration of radioactive sources and radiation devices. In accordance with the degree of potential harm of radioactive sources and radiation devices to human health and environment, radioactive sources may be divided, from high to low, into Class I, Class II, Class III, Class IV and Class V, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council; radiation devices may be divided into Class I, Class II and Class III, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council in consultation with the competent department of health of the State Council. | | 第四条 国家对放射源和射线装置实行分类管理。根据放射源、射线装置对人体健康和环境的潜在危害程度，从高到低将放射源分为Ⅰ类、Ⅱ类、Ⅲ类、Ⅳ类、Ⅴ类，具体分类办法由国务院生态环境主管部门制定；将射线装置分为Ⅰ类、Ⅱ类、Ⅲ类，具体分类办法由国务院生态环境主管部门商国务院卫生主管部门制定。 |
| Chapter II Licensing and Filing | | 第二章 许可和备案 |
| Article 5 The entities producing, selling and using radioisotopes and radiation devices shall obtain the relevant licenses in accordance with the provisions of this Chapter. | | 第五条 生产、销售、使用放射性同位素和射线装置的单位，应当依照本章规定取得许可证。 |
| Article 6 Except for entities using Class I radioactive sources for medical purposes or preparing radioactive pharmaceuticals for positron emission tomography for their own use, the licenses for entities producing radioisotopes, selling and using Class I radioactive sources or selling and using Class I radiation devices shall be issued by the department of ecology and environment of the State Council upon examination and approval. | | 第六条 除医疗使用Ⅰ类放射源、制备正电子发射计算机断层扫描用放射性药物自用的单位外，生产放射性同位素、销售和使用Ⅰ类放射源、销售和使用Ⅰ类射线装置的单位的许可证，由国务院生态环境主管部门审批颁发。 |
| The licenses for entities other than those whose licenses shall be issued by the department of ecology and environment of the State Council upon examination and approval shall be issued by the departments of ecology and environment of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government upon examination and approval. | | 除国务院生态环境主管部门审批颁发的许可证外，其他单位的许可证，由省、自治区、直辖市人民政府生态环境主管部门审批颁发。 |
| The department of ecology and environment of the State Council shall, before issuing a license to an entity producing radioisotopes, print and submit the application materials to the competent industry department governing the applicant for opinions. | | 国务院生态环境主管部门向生产放射性同位素的单位颁发许可证前，应当将申请材料印送其行业主管部门征求意见。 |
| The department of ecology and environment shall notify the public security department and competent department of health at the same level about the examination and approval of license applications and issuance of licenses. | | 生态环境主管部门应当将审批颁发许可证的情况通报同级公安部门、卫生主管部门。 |
| Article 7 To apply for a license, an entity producing, selling or using radioisotopes or radiation devices shall meet the following conditions: | | 第七条 生产、销售、使用放射性同位素和射线装置的单位申请领取许可证，应当具备下列条件： |
| (1) having the professional technicians appropriate for its scale of production, sale or use, who have the corresponding expertise and protection knowledge and meet the health conditions; | | （一）有与所从事的生产、销售、使用活动规模相适应的，具备相应专业知识和防护知识及健康条件的专业技术人员； |
| (2) having the places, facilities and equipment meeting the national environmental protection standards, occupational health standards and safety and protection requirements; | | （二）有符合国家环境保护标准、职业卫生标准和安全防护要求的场所、设施和设备； |
| (3) having a special safety and protection management body or full-time or part-time safety and protection managers, equipped with necessary protective equipment and monitoring instruments; | | （三）有专门的安全和防护管理机构或者专职、兼职安全和防护管理人员，并配备必要的防护用品和监测仪器； |
| (4) having sound safety and protection management regulations and rules and emergency response measures for radiation accidents; and | | （四）有健全的安全和防护管理规章制度、辐射事故应急措施； |
| (5) If generating radioactive waste gas, waste liquid or solid waste, having the treatment capacity or having a feasible treatment plan to ensure that the radioactive waste gas, waste liquid or solid waste are discharged up to the standard. | | （五）产生放射性废气、废液、固体废物的，具有确保放射性废气、废液、固体废物达标排放的处理能力或者可行的处理方案。 |
| Article 8 An entity producing, selling or using radioisotopes or radiation devices shall apply, in advance, for a license to the department of ecology and environment with the examination and approval power, and submit the evidential materials meeting the conditions as prescribed in Article 7 of this Regulation. | | 第八条 生产、销售、使用放射性同位素和射线装置的单位，应当事先向有审批权的生态环境主管部门提出许可申请，并提交符合本条例第七条规定条件的证明材料。 |
| A medical or health institution using radioisotopes or radiation devices for radiation diagnosis and therapy shall also obtain an institutional license for radioactive source diagnosis and therapy technologies and medical radiation. | | 使用放射性同位素和射线装置进行放射诊疗的医疗卫生机构，还应当获得放射源诊疗技术和医用辐射机构许可。 |
| Article 9 The department of ecology and environment shall, within 20 workdays from the acceptance of an application, complete the examination. If the conditions are met, it shall issue a license to the applicant and make an announcement; otherwise, shall notify the applicant in writing and give reasons. | | 第九条 生态环境主管部门应当自受理申请之日起20个工作日内完成审查，符合条件的，颁发许可证，并予以公告；不符合条件的，书面通知申请单位并说明理由。 |
| Article 10 A license shall mainly contain: | | 第十条 许可证包括下列主要内容： |
| (1) the name, address and legal representative of the entity; | | （一）单位的名称、地址、法定代表人； |
| (2) the types and scope of activities of the entity; | | （二）所从事活动的种类和范围； |
| (3) the term of validity; and | | （三）有效期限； |
| (4) the date of issuance and serial number of the license. | | （四）发证日期和证书编号。 |
| Article 11 Where an entity holding a license changes its name, address or legal representative, it shall, within 20 days from the date of modification registration, apply to the original license-issuing authority for conducting the license modification formalities. | | 第十一条 持证单位变更单位名称、地址、法定代表人的，应当自变更登记之日起20日内，向原发证机关申请办理许可证变更手续。 |
| Article 12 Under any of the following circumstances, an entity holding a license shall, under the original application procedures, reapply for a license: | | 第十二条 有下列情形之一的，持证单位应当按照原申请程序，重新申请领取许可证： |
| (1) changing the types or scope of its activities; or | | （一）改变所从事活动的种类或者范围的； |
| (2) newly constructing, reconstructing or expanding any facility or place for production, sale or use. | | （二）新建或者改建、扩建生产、销售、使用设施或者场所的。 |
| Article 13 A license shall be valid for five years. If the term of validity of a license needs to be renewed at the expiry of it, the entity holding the license shall, 30 days prior to the expiry of the term of validity of the license, submit an application for renewal to the original license-issuing authority. The original license-issuing authority shall, from the day of acceptance of the renewal application and before the expiry of the term of validity of the license, complete the examination. If the conditions are met, the original license-issuing authority shall renew the license; otherwise, shall notify the applicant in writing and give reasons. | | 第十三条 许可证有效期为5年。有效期届满，需要延续的，持证单位应当于许可证有效期届满30日前，向原发证机关提出延续申请。原发证机关应当自受理延续申请之日起，在许可证有效期届满前完成审查，符合条件的，予以延续；不符合条件的，书面通知申请单位并说明理由。 |
| Article 14 Where an entity holding a license terminates, partially or wholly, its activities of production, sale or use of radioisotopes or radiation devices, it shall submit an application to the original license-issuing authority for partial modification or cancellation of the license, and the original license-issuing authority shall modify or cancel the license upon verification. | | 第十四条 持证单位部分终止或者全部终止生产、销售、使用放射性同位素和射线装置活动的，应当向原发证机关提出部分变更或者注销许可证申请，由原发证机关核查合格后，予以变更或者注销许可证。 |
| Article 15 It shall be prohibited to be engaged in the production, sale or use of radioisotopes or radiation devices without a license or in violation of the types and scope as specified in a license. | | 第十五条 禁止无许可证或者不按照许可证规定的种类和范围从事放射性同位素和射线装置的生产、销售、使用活动。 |
| It shall be prohibited to forge, tamper or transfer a license. | | 禁止伪造、变造、转让许可证。 |
| Article 16 The competent department of foreign trade of the State Council shall, jointly with the department of ecology and environment of the State Council, the General Administration of Customs and the competent industry department governing the entities producing radioisotopes, formulate and publish a catalogue of radioisotopes restricted from import and export and a catalogue of radioisotopes prohibited from import and export. | | 第十六条 国务院对外贸易主管部门会同国务院生态环境主管部门、海关总署和生产放射性同位素的单位的行业主管部门制定并公布限制进出口放射性同位素目录和禁止进出口放射性同位素目录。 |
| For the import of any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the competent department of foreign trade of the State Council shall, after the examination and approval of the department of ecology and environment of the State Council, issue an import license according to the relevant provisions of the state on foreign trade. For the import of any radioisotope outside the catalogue of radioisotopes restricted from import and export and the catalogue of radioisotopes prohibited from import and export, the import formalities shall be handled according to the relevant provisions of the state on foreign trade. | | 进口列入限制进出口目录的放射性同位素，应当在国务院生态环境主管部门审查批准后，由国务院对外贸易主管部门依据国家对外贸易的有关规定签发进口许可证。进口限制进出口目录和禁止进出口目录之外的放射性同位素，依据国家对外贸易的有关规定办理进口手续。 |
| Article 17 To apply for importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the applicant shall meet the following requirements: | | 第十七条 申请进口列入限制进出口目录的放射性同位素，应当符合下列要求： |
| (1) The importing entity has obtained a license corresponding to its activities; | | （一）进口单位已经取得与所从事活动相符的许可证； |
| (2) The importing entity has a plan for disposing of the imported radioisotopes after the expiry of their usage period; if Class I, Class II or Class III radioactive sources are imported, it shall have a document of commitment that the original exporter is responsible for recovery; | | （二）进口单位具有进口放射性同位素使用期满后的处理方案，其中，进口Ⅰ类、Ⅱ类、Ⅲ类放射源的，应当具有原出口方负责回收的承诺文件； |
| (3) The imported radioactive sources shall have clear labels and necessary descriptive documents; the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of the radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents; and | | （三）进口的放射源应当有明确标号和必要说明文件，其中，Ⅰ类、Ⅱ类、Ⅲ类放射源的标号应当刻制在放射源本体或者密封包壳体上，Ⅳ类、Ⅴ类放射源的标号应当记录在相应说明文件中； |
| (4) If the imported radioisotopes are sold to any other entity for use, the importing entity shall have a written agreement concluded with the entity using them and a photocopy of the license obtained by the entity using them. | | （四）将进口的放射性同位素销售给其他单位使用的，还应当具有与使用单位签订的书面协议以及使用单位取得的许可证复印件。 |
| Article 18 An entity importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export shall submit an import application to the department of ecology and environment of the State Council, and provide the evidential materials meeting the requirements of Article 17 of this Regulation. | | 第十八条 进口列入限制进出口目录的放射性同位素的单位，应当向国务院生态环境主管部门提出进口申请，并提交符合本条例第十七条规定要求的证明材料。 |
| The department of ecology and environment of the State Council shall, within 10 workdays from the day of acceptance of an application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. | | 国务院生态环境主管部门应当自受理申请之日起10个工作日内完成审查，符合条件的，予以批准；不符合条件的，书面通知申请单位并说明理由。 |
| The customs office shall handle the relevant import formalities based on the import license for radioisotopes. Where the packaging materials of the imported radioisotopes are subject to quarantine according to law, the quarantine shall be implemented in accordance with the relevant laws and administrative regulations of the state on quarantine. | | 海关验凭放射性同位素进口许可证办理有关进口手续。进口放射性同位素的包装材料依法需要实施检疫的，依照国家有关检疫法律、法规的规定执行。 |
| For any imported radioactive source, the department of ecology and environment of the State Council shall determine the radioactive source code corresponding to its label at the same time. | | 对进口的放射源，国务院生态环境主管部门还应当同时确定与其标号相对应的放射源编码。 |
| Article 19 To apply for transferring radioisotopes, the applicant shall meet the following requirements: | | 第十九条 申请转让放射性同位素，应当符合下列要求： |
| (1) The entities as the transferor and transferee shall hold the licenses corresponding to their activities; | | （一）转出、转入单位持有与所从事活动相符的许可证； |
| (2) The entity as the transferee shall have a plan for disposing of the radioisotopes after the expiry of their usage period; and | | （二）转入单位具有放射性同位素使用期满后的处理方案； |
| (3) Both parties to the transfer shall have concluded a written agreement on the transfer. | | （三）转让双方已经签订书面转让协议。 |
| Article 20 To transfer radioisotopes, the entity as the transferee shall submit an application to the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and provide the evidential materials meeting the requirements of Article 19 of this Regulation. | | 第二十条 转让放射性同位素，由转入单位向其所在地省、自治区、直辖市人民政府生态环境主管部门提出申请，并提交符合本条例第十九条规定要求的证明材料。 |
| The department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 15 workdays from the day of acceptance of the application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. | | 省、自治区、直辖市人民政府生态环境主管部门应当自受理申请之日起15个工作日内完成审查，符合条件的，予以批准；不符合条件的，书面通知申请单位并说明理由。 |
| Article 21 The entities as the transferor and transferee of radioisotopes shall, within 20 days from the day of completion of the transfer, file a report on the transfer respectively with the departments of ecology and environment of the people's governments of provinces, autonomous regions or municipalities direct under the Central Government where they are located. | | 第二十一条 放射性同位素的转出、转入单位应当在转让活动完成之日起20日内，分别向其所在地省、自治区、直辖市人民政府生态环境主管部门备案。 |
| Article 22 An entity producing radioisotopes shall maintain an account book of radioisotope products, and in accordance with the coding rules of the department of ecology and environment of the State Council, uniformly code its produced radioactive sources. The account book of radioisotope products and the coding list of radioactive sources shall be filed with the department of ecology and environment of the State Council. | | 第二十二条 生产放射性同位素的单位，应当建立放射性同位素产品台账，并按照国务院生态环境主管部门制定的编码规则，对生产的放射源统一编码。放射性同位素产品台账和放射源编码清单应当报国务院生态环境主管部门备案。 |
| The produced radioactive sources shall have clear labels and necessary descriptive documents. In particular, the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents. | | 生产的放射源应当有明确标号和必要说明文件。其中，Ⅰ类、Ⅱ类、Ⅲ类放射源的标号应当刻制在放射源本体或者密封包壳体上，Ⅳ类、Ｖ类放射源的标号应当记录在相应说明文件中。 |
| The department of ecology and environment of the State Council shall be responsible for establishing a radioisotope filing information management system to share information with the relevant departments. | | 国务院生态环境主管部门负责建立放射性同位素备案信息管理系统，与有关部门实行信息共享。 |
| The radioisotopes not included in the product account book and uncoded radioactive sources shall not leave factory and be sold. | | 未列入产品台账的放射性同位素和未编码的放射源，不得出厂和销售。 |
| Article 23 Where an entity holding radioactive sources returns any waste or used radioactive source to the production entity or the original exporter or delivers it for storage to an entity engaged in the centralized storage of radioactive wastes, it shall, within 20 days from the day of completion of the said activity, file a report on it with the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located. | | 第二十三条 持有放射源的单位将废旧放射源交回生产单位、返回原出口方或者送交放射性废物集中贮存单位贮存的，应当在该活动完成之日起20日内向其所在地省、自治区、直辖市人民政府生态环境主管部门备案。 |
| Article 24 For the radioisotopes produced and imported before the implementation of this Regulation, the entity holding the radioisotopes shall, within 6 months from the day when this Regulation comes into force, handle the filing formalities at the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government shall uniformly code the radioactive sources. | | 第二十四条 本条例施行前生产和进口的放射性同位素，由放射性同位素持有单位在本条例施行之日起6个月内，到其所在地省、自治区、直辖市人民政府生态环境主管部门办理备案手续，省、自治区、直辖市人民政府生态环境主管部门应当对放射源进行统一编码。 |
| Article 25 Where an entity using radioisotopes needs to displace the radioisotopes to another province, autonomous region or municipality directly under the Central Government for use, it shall handle the filing formalities at the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where the radioisotopes are to be used on the basis of a photocopy of its license, and accept the supervision and administration by the local department of ecology and environment. | | 第二十五条 使用放射性同位素的单位需要将放射性同位素转移到外省、自治区、直辖市使用的，应当持许可证复印件向使用地省、自治区、直辖市人民政府生态环境主管部门备案，并接受当地生态环境主管部门的监督管理。 |
| Article 26 To export any radioisotope included in the catalogue of radioisotopes restricted from import and export, the evidential materials indicating that the importer may legally hold the radioisotopes shall be provided, and the department of ecology and environment of the State Council shall, in accordance with the relevant laws and international treaties and agreements concluded or acceded to by China, handle the relevant formalities. | | 第二十六条 出口列入限制进出口目录的放射性同位素，应当提供进口方可以合法持有放射性同位素的证明材料，并由国务院生态环境主管部门依照有关法律和我国缔结或者参加的国际条约、协定的规定，办理有关手续。 |
| The export of radioisotopes shall be governed by the relevant provisions of the state on foreign trade. | | 出口放射性同位素应当遵守国家对外贸易的有关规定。 |
| Chapter III Safety and Protection | | 第三章 安全和防护 |
Article 27 An entity producing, selling or using radioisotopes or radiation devices shall be responsible for the safety and protection of its radioisotopes or radiation devices, and be liable for the radioactive hazards caused by it according to law.
．．．．．． | | 第二十七条 生产、销售、使用放射性同位素和射线装置的单位，应当对本单位的放射性同位素、射线装置的安全和防护工作负责，并依法对其造成的放射性危害承担责任。
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