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中英对照法律资源--进口医疗器械检验监督管理办法 |
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作者：无忧教育 文章来源：51education.net 点击数： 更新时间：2008-5-18 |
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国家质量监督检验检疫总局令第95号 《进口医疗器械检验监督管理办法》已经2007年5月30日国家质量监督检验检疫总局局务会议审议通过，现予公布，自2007年12月1日起施行。国家质量监督检验检疫总局局长李长江 二〇〇七年六月十八日 <WESTBANK> Decree of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China No.95 Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments, which have been deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on May 30, 2007, are hereby promulgated and shall come into force as of December 1, 2007. Director-general: Li Changjiang June 18, 2007 进口医疗器械检验监督管理办法 <WESTBANK> Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments 第一章 总则 <WESTBANK> Chapter I General Rules 第一条为加强进口医疗器械检验监督管理，保障人体健康和生命安全，根据《中华人民共和国进出口商品检验法》（以下简称商检法）及其实施条例和其它有关法律法规规定，制定本办法。 <WESTBANK> Article 1 These Measures are formulated according to the Law on the Inspection of Imported and Exported Commodities of the People's Republic of China (hereinafter referred to as the Inspection Law) and its implementing regulation and other relevant laws and administrative regulations for the purpose of strengthening the administration of inspection and supervision of the imported medical instruments and safeguarding the human health and life safety. 第二条本办法适用于： <WESTBANK> Article 2 These Measures shall be applicable to: （一）对医疗器械进口单位实施分类管理； <WESTBANK> (1) classified management of the medical instrument importers; （二）对进口医疗器械实施检验监管； <WESTBANK> (2) inspection surveillance of the imported medical instruments; and （三）对进口医疗器械实施风险预警及快速反应管理。 <WESTBANK> (3) risk warning and fast response management of the imported medical instruments. 第三条国家质量监督检验检疫总局（以下简称国家质检总局）主管全国进口医疗器械检验监督管理工作，负责组织收集整理与进口医疗器械相关的风险信息、风险评估并采取风险预警及快速反应措施。 <WESTBANK> Article 3 The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as the GAQSIQ) administers the inspection and supervision of the imported medical instruments all over the country, and shall take the responsibility of organizing, gathering and processing relevant risk information concerning the imported medical instruments, assessing the risks, and adopting the risk warning and fast response measures as well. 国家质检总局设在各地的出入境检验检疫机构（以下简称检验检疫机构）负责所辖地区进口医疗器械检验监督管理工作，负责收集与进口医疗器械相关的风险信息及快速反应措施的具体实施。 <WESTBANK> The local entry-exit inspection and quarantine organs as established by the GAQSIQ (hereinafter referred to as the IQ organs) shall administer the inspection and supervision of the imported medical instruments within their jurisdictions respectively, and shall take the responsibility of gathering relevant risk information concerning the imported medical instruments, and implementing fast response measures. 第二章 医疗器械进口单位分类监管 <WESTBANK> Chapter II Classified Surveillance of Medical Instrument Importers 第四条检验检疫机构根据医疗器械进口单位的管理水平、诚信度、进口医疗器械产品的风险等级、质量状况和进口规模，对医疗器械进口单位实施分类监管，具体分为三类。 <WESTBANK> Article 4 The IQ organs shall perform the classified surveillance over the medical instrument importers according to the level of management and credibility thereof and the risk level, quality and import scale of the imported medical instruments, and there are three categories specifically. 医疗器械进口单位可以根据条件自愿提出分类管理申请。 <WESTBANK> A medical instrument importer may voluntarily apply for classified management as required by their conditions. 第五条一类进口单位应当符合下列条件： <WESTBANK> Article 5 The importers in Category A shall satisfy the requirements as follows: （一）严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定，诚信度高，连续5年无不良记录； <WESTBANK> (1) It shall severely observe the Inspection Law and its implementing regulation, other relevant laws and administrative regulations of the state as well as the relevant provisions of the GAQSIQ, shall have high credibility without any bad record for five successive years; （二）具有健全的质量管理体系，获得ISO9000质量体系认证，具备健全的质量管理制度，包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度； <WESTBANK> (2) It shall have a sound management system quality, have already obtained a certification for the ISO9000 quality system, and have sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, etc.; （三）具有2名以上经检验检疫机构培训合格的质量管理人员，熟悉相关产品的基本技术、性能和结构，了解我国对进口医疗器械检验监督管理； <WESTBANK> (3) It shall have more than two quality management staff that have been through training by an IQ organ, are aware of basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China; （四）代理或者经营实施强制性产品认证制的进口医疗器械产品的，应当获得相应的证明文件； <WESTBANK> (4) It shall have obtained relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent; （五）代理或者经营的进口医疗器械产品质量信誉良好，2年内未发生由于产品质量责任方面的退货、索赔或者其他事故等； <WESTBANK> (5) It shall have a good quality reputation when engaging in the business of the imported medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the liability of product quality over the last two years; （六）连续从事医疗器械进口业务不少于6年，并能提供相应的证明文件； <WESTBANK> (6) It shall have been engaged in import business of the medical instrument for at least six successive years, and be able to provide relevant certificate documents; （七）近2年每年进口批次不少于30批； <WESTBANK> (7) It shall have no less than 30 batches of imports for each year in the last two years; （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； <WESTBANK> (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； <WESTBANK> (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 （十）具备与进口医疗器械产品范围与规模相适应的、相对独立的经营场所和仓储条件。 <WESTBANK> (10) It shall have relatively independent business premises and storage conditions that is appropriate for the scope and scale of the imported medical instruments. 第六条二类进口单位应当具备下列条件： <WESTBANK> Article 6 The importers in Category B shall satisfy the requirements as follows: （一）严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定，诚信度较高，连续3年无不良记录； <WESTBANK> (1) It shall be in strict accordance with the Inspection Law and its implementation rules, other relevant laws and regulations of the state and the relevant provisions of the GAQSIQ, have a relatively high credibility, and without any bad record for three successive years; （二）具有健全的质量管理体系，具备健全的质量管理制度，包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度； <WESTBANK> (2) It shall have a sound quality management system and sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, and etc.; （三）具有1名以上经检验检疫机构培训合格的质量管理人员，熟悉相关产品的基本技术、性能和结构，了解我国对进口医疗器械检验监督管理的人员； <WESTBANK> (3) It shall have more than one quality management staff that have been through training by an IQ organ, are aware of the basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China; （四）代理或者经营实施强制性产品认证制度的进口医疗器械产品的，应当获得相应的证明文件； <WESTBANK> (4) It shall have obtained the relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent; （五）代理或者经营的进口医疗器械产品质量信誉良好，1年内未发生由于产品质量责任方面的退货、索赔或者其他事故等； <WESTBANK> (5) It shall have a good quality reputation when engaging in the import business of the medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the product quality liability within a year; （六）连续从事医疗器械进口业务不少于3年，并能提供相应的证明文件； <WESTBANK> (6) It shall have been engaged in the import business of the medical instrument for at least three successive years, and be able to provide relevant certificate documents; （七）近2年每年进口批次不少于10批； <WESTBANK> (7) It shall have no less than 10 batches of imports for each year in the last two years; （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； <WESTBANK> (8) It shall have collected and preserved the national and industrial standards for relevant medical instruments and the regulations and rules and 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； <WESTBANK> (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 （十）具备与进口医疗器械产品范围与规模相适应的、相对实践证明经常访问无忧英语教育网 www.51education.net ,能迅速提高你的英语学习能力!积沙成塔,不断提高! 本站所提供的所有信息仅供学校课堂教学及英语学习者学习研究之用，其著作权归原作者及媒体所有。 |
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