| Regulation on the Supervision and Management of Civil Nuclear Safety Equipment | | 民用核安全设备监督管理条例 |
| (Promulgated by Order No. 500 of the State Council of the People's Republic of China on July 11, 2007; revised for the first time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and revised for the second time in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) | | （2007年7月11日中华人民共和国国务院令第500号公布 根据2016年2月6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 made to strengthen the supervision and management of civil nuclear safety equipment, guarantee the safe operation of civil nuclear facilities, prevent nuclear accidents, protect the health of working staff and the general public, protect the environment, and promote the smooth development of the nuclear power cause. | | 第一条 为了加强对民用核安全设备的监督管理，保证民用核设施的安全运行，预防核事故，保障工作人员和公众的健康，保护环境，促进核能事业的顺利发展，制定本条例。 |
| Article 2 The civil nuclear safety equipment as mentioned in this Regulation shall refer to the equipment performing the nuclear safety functions, which is used in the civil nuclear facilities, including the nuclear safety machinery equipment and nuclear safety electrical equipment. | | 第二条 本条例所称民用核安全设备，是指在民用核设施中使用的执行核安全功能的设备，包括核安全机械设备和核安全电气设备。 |
| The catalogue of civil nuclear safety equipment shall be made and issued by the nuclear safety regulatory authority of the State Council in consultation with the relevant authorities of the State Council. | | 民用核安全设备目录由国务院核安全监管部门商国务院有关部门制定并发布。 |
| Article 3 The design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment shall be subject to this Regulation. | | 第三条 民用核安全设备设计、制造、安装和无损检验活动适用本条例。 |
| The maintenance of civil nuclear safety equipment carried away from the sites of civil nuclear facilities shall be subject to the relevant provisions on the manufacturing of civil nuclear safety equipment. | | 民用核安全设备运离民用核设施现场进行的维修活动，适用民用核安全设备制造活动的有关规定。 |
| Article 4 The nuclear safety regulatory authority of the State Council shall conduct the supervision and management of the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment. | | 第四条 国务院核安全监管部门对民用核安全设备设计、制造、安装和无损检验活动实施监督管理。 |
| The competent nuclear industry authority and other relevant authorities of the State Council shall be responsible for the relevant work according to the division of responsibilities as provided for by this Regulation and the State Council. | | 国务院核行业主管部门和其他有关部门依照本条例和国务院规定的职责分工负责有关工作。 |
| Article 5 The entities engaging in the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment shall establish and enhance a responsibility system, strengthen the quality control, and assume the full responsibility for such design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment. | | 第五条 民用核安全设备设计、制造、安装和无损检验单位，应当建立健全责任制度，加强质量管理，并对其所从事的民用核安全设备设计、制造、安装和无损检验活动承担全面责任。 |
| The entities operating the civil nuclear facilities shall examine, test, inspect and maintain the civil nuclear safety equipment in service, and assume the full responsibility for the use and operating safety of civil nuclear safety equipment. | | 民用核设施营运单位，应当对在役的民用核安全设备进行检查、试验、检验和维修，并对民用核安全设备的使用和运行安全承担全面责任。 |
| Article 6 The design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment shall be in conformity with the relevant industrial policies of the state. | | 第六条 民用核安全设备设计、制造、安装和无损检验活动应当符合国家有关产业政策。 |
| The state shall encourage the science and technology research on the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment to improve the safety level. | | 国家鼓励民用核安全设备设计、制造、安装和无损检验的科学技术研究，提高安全水平。 |
| Article 7 Any entity or individual shall have the right to inform the nuclear safety regulatory authority of the State Council of any violation of the provisions of this Regulation. After receiving such information, the nuclear safety regulatory authority of the State Council shall timely investigate and dispose of it, and keep the informer confidential. | | 第七条 任何单位和个人对违反本条例规定的行为，有权向国务院核安全监管部门举报。国务院核安全监管部门接到举报，应当及时调查处理，并为举报人保密。 |
| Chapter II Standards | | 第二章 标 准 |
| Article 8 The standards for civil nuclear safety equipment shall be the technical basis for the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment. | | 第八条 民用核安全设备标准是从事民用核安全设备设计、制造、安装和无损检验活动的技术依据。 |
| Article 9 The state shall establish and enhance a system of standards for civil nuclear safety equipment. In the making of the standards for civil nuclear safety equipment, full consideration shall be given to the technological development and use requirements of civil nuclear safety equipment, in combination with the industrial basis and technological level of our country, so as to make it safe and reliable, technologically mature and economically reasonable. | | 第九条 国家建立健全民用核安全设备标准体系。制定民用核安全设备标准，应当充分考虑民用核安全设备的技术发展和使用要求，结合我国的工业基础和技术水平，做到安全可靠、技术成熟、经济合理。 |
| The standards for civil nuclear safety equipment shall include the national standards, industrial standards and enterprise standards. | | 民用核安全设备标准包括国家标准、行业标准和企业标准。 |
| Article 10 The nuclear safety regulatory authority of the State Council shall organize the drafting of the national standards for civil nuclear safety equipment involving the basic principles and technical requirements for nuclear safety, which shall be jointly issued by the competent standardization authority and the nuclear safety regulatory authority of the State Council. The competent nuclear industry authority of the State Council shall organize the drafting of other national standards for civil nuclear safety equipment, which shall be issued by the competent standardization authority of the State Council after being accepted by the nuclear safety regulatory authority of the State Council. | | 第十条 涉及核安全基本原则和技术要求的民用核安全设备国家标准，由国务院核安全监管部门组织拟定，由国务院标准化主管部门和国务院核安全监管部门联合发布；其他的民用核安全设备国家标准，由国务院核行业主管部门组织拟定，经国务院核安全监管部门认可，由国务院标准化主管部门发布。 |
| The competent nuclear industry authority of the State Council shall organize the drafting of the industrial standards for civil nuclear safety equipment, which shall be issued by the competent nuclear industry authority of the State Council after being accepted by the nuclear safety regulatory authority of the State Council and shall be submitted to the competent standardization authority of the State Council for archival purposes. | | 民用核安全设备行业标准，由国务院核行业主管部门组织拟定，经国务院核安全监管部门认可，由国务院核行业主管部门发布，并报国务院标准化主管部门备案。 |
| In the making of the national and industrial standards for civil nuclear safety equipment, the opinions of the relevant authorities and experts shall be fully heeded. | | 制定民用核安全设备国家标准和行业标准，应当充分听取有关部门和专家的意见。 |
| Article 11 In the absence of the relevant national and industrial standards, the entities engaging in the design, manufacturing, installation and nondestructive inspection shall adopt the standards as accepted by the nuclear safety regulatory authority of the State Council. | | 第十一条 尚未制定相应国家标准和行业标准的，民用核安全设备设计、制造、安装和无损检验单位应当采用经国务院核安全监管部门认可的标准。 |
| Chapter III Licenses | | 第三章 许 可 |
| Article 12 The entities engaging in the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment shall apply for the licenses as provided for in this Regulation. | | 第十二条 民用核安全设备设计、制造、安装和无损检验单位应当依照本条例规定申请领取许可证。 |
| Article 13 An entity applying for a license for the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall meet the following conditions: | | 第十三条 申请领取民用核安全设备设计、制造、安装或者无损检验许可证的单位，应当具备下列条件： |
| 1. Having a legal person status; | | （一）具有法人资格； |
| 2. Having work performance related or similar to the proposed activity for at least five years; | | （二）有与拟从事活动相关或者相近的工作业绩，并且满5年以上； |
| 3. Having the specialized technical staff who are qualified after examination and suitable for the proposed activity, of whom those engaging in the weld and nondestructive inspection of civil nuclear safety equipment shall have obtained the relevant certificates of qualification; | | （三）有与拟从事活动相适应的、经考核合格的专业技术人员，其中从事民用核安全设备焊接和无损检验活动的专业技术人员应当取得相应的资格证书； |
| 4. Having the work places, facilities and equipment suitable for the proposed activity; and | | （四）有与拟从事活动相适应的工作场所、设施和装备； |
| 5. Having a complete management system, a sound quality assurance system, and a quality assurance program consistent with the nuclear safety regulatory rules. | | （五）有健全的管理制度和完善的质量保证体系，以及符合核安全监督管理规定的质量保证大纲。 |
| An entity applying for a license for manufacturing or a license for installation of civil nuclear safety equipment shall also make a representative simulation. | | 申请领取民用核安全设备制造许可证或者安装许可证的单位，还应当制作有代表性的模拟件。 |
| Article 14 An entity applying for a license for the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall file a written application with the nuclear safety regulatory authority of the State Council, and submit the evidential materials that it meets the conditions as set forth in Article 13 of this Regulation. | | 第十四条 申请领取民用核安全设备设计、制造、安装或者无损检验许可证的单位，应当向国务院核安全监管部门提出书面申请，并提交符合本条例第十三条规定条件的证明材料。 |
| Article 15 The nuclear safety regulatory authority of the State Council shall finish the examination of an application within 45 working days as of the date of acceptance of the application, issue a license and make an announcement, if the conditions are met; or notify in writing the applicant of reasons for denial, if the conditions are not met. | | 第十五条 国务院核安全监管部门应当自受理申请之日起45个工作日内完成审查，并对符合条件的颁发许可证，予以公告；对不符合条件的，书面通知申请单位并说明理由。 |
| In the examination, the nuclear safety regulatory authority of the State Council shall organize experts to conduct technical review, and solicit opinions from the competent nuclear industry authority and other relevant authorities of the State Council. The time necessary for a technical review shall not be counted in the time limit as set forth in the preceding paragraph. | | 国务院核安全监管部门在审查过程中，应当组织专家进行技术评审，并征求国务院核行业主管部门和其他有关部门的意见。技术评审所需时间不计算在前款规定的期限内。 |
| Article 16 A license for the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall expressly state the following contents: | | 第十六条 民用核安全设备设计、制造、安装和无损检验许可证应当载明下列内容： |
| 1. Name, address and legal representative of an entity; | | （一）单位名称、地址和法定代表人； |
| 2. Types and extent of activities as approved; | | （二）准予从事的活动种类和范围； |
| 3. Term of validity; and | | （三）有效期限； |
| 4. Issuing authority, issuing date and license number. | | （四）发证机关、发证日期和证书编号。 |
| Article 17 An entity engaging in the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment, which modifies its name, address or legal representative, shall apply to the nuclear safety regulatory authority of the State Council for conducting the license modification formalities within 20 days as of the date of modification registration with the industrial and commercial authority. | | 第十七条 民用核安全设备设计、制造、安装和无损检验单位变更单位名称、地址或者法定代表人的，应当自变更工商登记之日起20日内，向国务院核安全监管部门申请办理许可证变更手续。 |
| An entity engaging in the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment, which intends to modify the types or extent of activities as stated in a license, shall reapply for a license to the nuclear safety regulatory authority of the State Council according to the original application procedures. | | 民用核安全设备设计、制造、安装和无损检验单位变更许可证规定的活动种类或者范围的，应当按照原申请程序向国务院核安全监管部门重新申请领取许可证。 |
| Article 18 The term of validity of a license for the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall be five years. | | 第十八条 民用核安全设备设计、制造、安装和无损检验许可证有效期为5年。 |
| An entity engaging in the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment, which needs to continue the relevant activities at the expiration of the term of validity of a license, shall file an extension application with the nuclear safety regulatory authority of the State Council six months before the expiration of the term of validity of a license. | | 许可证有效期届满，民用核安全设备设计、制造、安装和无损检验单位需要继续从事相关活动的，应当于许可证有效期届满6个月前，向国务院核安全监管部门提出延续申请。 |
| The nuclear safety regulatory authority shall make a decision on whether or not to approve the extension before the expiration of the term of validity of a license; and shall be deemed as having approved the extension, if it fails to make a decision within the time limit. | | 国务院核安全监管部门应当在许可证有效期届满前作出是否准予延续的决定；逾期未作决定的，视为准予延续。 |
| Article 19 It shall be prohibited to engage in any activities of the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment without a license or not in conformity with the types and extent of activities as stated in a license. | | 第十九条 禁止无许可证擅自从事或者不按照许可证规定的活动种类和范围从事民用核安全设备设计、制造、安装和无损检验活动。 |
| It shall be prohibited to delegate the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment to an entity having not obtained the relevant license. | | 禁止委托未取得相应许可证的单位进行民用核安全设备设计、制造、安装和无损检验活动。 |
| It shall be prohibited to forge, alter or transfer a license. | | 禁止伪造、变造、转让许可证。 |
| Chapter IV Design, Manufacturing, Installation and Nondestructive Inspection | | 第四章 设计、制造、安装和无损检验 |
| Article 20 An entity engaging in the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall improve its awareness of nuclear safety, establish a sound quality assurance system, and ensure the quality and reliability of civil nuclear safety equipment. | | 第二十条 民用核安全设备设计、制造、安装和无损检验单位，应当提高核安全意识，建立完善的质量保证体系，确保民用核安全设备的质量和可靠性。 |
| An entity operating civil nuclear facilities shall conduct quality and process control over the design, manufacturing, installation and nondestructive inspection of civil nuclear safety equipment, and do a good job in the manufacture supervision, inspection and acceptance. | | 民用核设施营运单位，应当对民用核安全设备设计、制造、安装和无损检验活动进行质量管理和过程控制，做好监造和验收工作。 |
| Article 21 An entity engaging in the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment shall compile a project quality assurance subprogram before the design, manufacturing, installation or nondestructive inspection of civil nuclear safety equipment begins, and subject it to the examination and approval of the entity operating civil nuclear facilities, according to its quality assurance program and the requirements of the entity operating civil nuclear facilities. | | 第二十一条 民用核安全设备设计、制造、安装和无损检验单位，应当根据其质量保证大纲和民用核设施营运单位的要求，在民用核安全设备设计、制造、安装和无损检验活动开始前编制项目质量保证分大纲，并经民用核设施营运单位审查同意。 |
Article 22 An entity engaging the design of civil nuclear safety equipment shall submit the following documents to the nuclear safety regulatory authority of the State Council for archival purposes at least 30 days before the design begins:
．．．．．． | | 第二十二条 民用核安全设备设计单位，应当在设计活动开始30日前，将下列文件报国务院核安全监管部门备案：
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