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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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t shall be reported to the IQ organ, and assistance shall be made in the risk warning measures and fast response measures taken by the IQ organ. 第三十五条对缺陷进口医疗器械的风险预警措施包括： <WESTBANK> Article 35 As for any defective imported medical instrument, the risk warning measures shall include: （一）向检验检疫机构发布风险警示通报，加强对缺陷产品制造商生产的和进口单位进口的医疗器械的检验监管； <WESTBANK> (1) releasing the risk warning bulletin to the IQ organs, and intensifying the inspection supervision on the medical instruments as produced by the defective product producers and imported by the importers; （二）向缺陷产品的制造商、进口单位发布风险警示通告，敦促其及时采取措施，消除风险； <WESTBANK> (2) releasing the risk warning bulletin to the producers and importers of the defective products, and pressing them to take relevant measures to avoid the risks in a timely manner; （三）向消费者和使用单位发布风险警示通告，提醒其注意缺陷进口医疗器械的风险和危害； <WESTBANK> (3) releasing the risk warning bulletin to the consumers and users, and giving them a warning of the risks and troubles of the defective imported medical instruments; and （四）向国内有关部门、有关国家和地区驻华使馆或者联络处、有关国际组织和机构通报情况，建议其采取必要的措施。 <WESTBANK> (4) reporting relevant information to the related domestic authorities, China embassies or liaison offices in relevant countries and regions, and to relevant international organizations and institutions, and proposing necessary measures. 第三十六条对缺陷进口医疗器械的快速反应措施包括： <WESTBANK> Article 36 As for the defective imported medical instruments, the fast response measures shall include: （一）建议暂停使用存在缺陷的医疗器械； <WESTBANK> (1) suggesting the suspension of using the defective medical instruments; （二）调整缺陷进口医疗器械进口单位的分类管理的类别； <WESTBANK> (2) adjusting the category of the importer of the defective medical instruments in the classified management; （三）停止缺陷医疗器械的进口； <WESTBANK> (3) stopping the import of the defective medical instruments; （四）暂停或者撤销缺陷进口医疗器械的国家强制性产品认证证书； <WESTBANK> (4) suspending or invalidating the certificates of state compulsory product certification for the defective imported medical instruments; and （五）其他必要的措施。 <WESTBANK> (5) other necessary measures. 第六章 监督管理 <WESTBANK> Chapter VI Supervision and Management 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： <WESTBANK> 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: （一）进口单位出现不良诚信记录的； <WESTBANK> (1) The importer has a bad credibility record; （二）所进口的医疗器械存在重大安全隐患或者发生重大质量问题的； <WESTBANK> (2) The medical instruments as imported by this importer have severe potential risks in safety or serious quality problem; （三）经检验检疫机构检验，进口单位年进口批次中出现不合格批次达10%； <WESTBANK> (3) The unqualified import batches of the importer are up to 10 percent of the annual import batches upon inspections by an IQ organ,; （四）进口单位年进口批次未达到要求的； <WESTBANK> (4) The annual import batches of the importer fails to satisfy the requirements; or （五）进口单位有违反法律法规其他行为的。 <WESTBANK> (5) Otherwise the importer is in violation of any law or administrative regulation. 降类的进口单位必须在12个月后才能申请恢复原来的分类管理类别，且必须经过重新考核、核准、公布。 <WESTBANK> The degraded importer may lodge an application for resuming the original category in the classified management only after 12 months, and it must be reexamined, checked and approved, and publicized. 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： <WESTBANK> 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: （一）属于禁止进口的； <WESTBANK> (1) prohibited importations; （二）存在安全卫生缺陷或者可能造成健康隐患、环境污染的； <WESTBANK> (2) any defectiveness in safety and sanitation or any possible potential health risks or environmental pollution; or （三）可能危害医患者生命财产安全，情况紧急的。 <WESTBANK> (3) any possible circumstance that may harm the life or property safety of the doctor or patient or any emergency. 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。 <WESTBANK> 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. 未经考核合格的人员不得从事进口医疗器械的检验监管工作。 <WESTBANK> The staff without examination to be qualified shall not conduct the administration of inspection and supervision on imported medical instruments. 第四十条用于科研及其他非作用于患者目的的进口旧医疗器械，经国家质检总局及其他相关部门批准后，方可进口。 <WESTBANK> Article 40 The used medical instruments for scientific research or other non-applied-to-patient purposes may be imported only upon the approvals of the GAQSIQ and other relevant authorities. 经原厂再制造的进口医疗器械，其安全及技术性能满足全新医疗器械应满足的要求，并符合国家其他有关规定的，由检验检疫机构进行合格评定后，经国家质检总局批准方可进口。 <WESTBANK> With respect to any medical instrument as reproduced by the original factory, if it satisfies the requirements that new medical instruments shall satisfy in safety and technology and comply with other relevant provisions of the state, may be imported only upon the qualification assessment by the IQ organ and the approval of the GAQSIQ. 禁止进口前两款规定以外的其他旧医疗器械。 <WESTBANK> The used medical instruments other than those in the two preceding paragraphs shall be prohibited from being imported. 第七章 法律责任 <WESTBANK> Chapter VII Legal Liability 第四十一条擅自销售、使用未报检或者未经检验的属于法定检验的进口医疗器械，或者擅自销售、使用应当申请进口验证而未申请的进口医疗器械的，由检验检疫机构没收违法所得，并处商品货值金额5%以上20%以下罚款；构成犯罪的，依法追究刑事责任。 <WESTBANK> Article 41 Where any importer sells or uses the imported medical instruments that is subject to the statutory inspection and fails to apply for the inspection or to go through the inspection, or it sells or uses the imported medical instruments that fails to be applied for the import verification that it should be, it shall be confiscated of the illegal income by an IQ organ, and be imposed upon a fine of 5 percent or not more than 20 percent of the value of commodities; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws. 第四十二条销售、使用经法定检验、抽查检验或者验证不合格的进口医疗器械的，由检验检疫机构责令停止销售、使用，没收违法所得和违法销售、使用的商品，并处违法销售、使用的商品货值金额等值以上3倍以下罚款；构成犯罪的，依法追究刑事责任。 <WESTBANK> Article 42 Where any importer sells or uses the imported medical instruments that are unqualified after the statutory inspection, sample inspection or verification, it shall be ordered by an IQ organ to stop sales or use, its illegal income and illegally sold or used commodities shall be confiscated, and it shall be imposed upon a fine of the value or not more than three times the value of commodities as sold or used illegally; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws. 第四十三条医疗器械的进口单位进口国家禁止进口的旧医疗器械的，按照国家有关规定予以退货或者销毁。 <WESTBANK> Article 43 Where any importer of medical instruments imports the used medical instruments that are forbidden from being imported by the state, it shall return or destroy the said instruments in accordance with the relevant provisions of the state. 进口旧医疗器械属机电产品的，情节严重的，由检验检疫机构并处100万元以下罚款。 <WESTBANK> In case the imported used medical instruments are electromechanical products and the circumstances are severe, it shall be concurrently imposed upon a fine of not more than RMB one million yuan by an IQ organ. 第四十四条检验检疫机构的工作人员滥用职权，故意刁难的，徇私舞弊，伪造检验结果的，或者玩忽职守，延误检验出证的，依法给予行政处分；构成犯罪的，依法追究刑事责任。 <WESTBANK> Article 44 Where any staff of an IQ organ abuses his/her powers, deliberately creates difficulties, plays favoritism and commits irregularities, forges inspection results, neglects their duties or delays the inspection and issuance of certificate, it shall be imposed upon an administrative punishment; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws. 第八章 附则 <WESTBANK> Chapter VIII Supplementary Rules 第四十五条本办法所指的进口医疗器械，是指从境外进入到中华人民共和国境内的，单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所配套使用的软件，其使用旨在对疾病进行预防、诊断、治疗、监护、缓解，对损伤或者残疾进行诊断、治疗、监护、缓解、补偿，对解剖或者生理过程进行研究、替代、调节，对妊娠进行控制等。 <WESTBANK> Article 45 The imported medical instruments as referred to in these Measures are the machineries, equipments, apparatuses, materials or other articles, including the relevant software, that are brought into the territory of People's Republic of China from overseas and applied separately or in combination to the human body, in order to do the prevention, diagnosis, treatment, care or mitigation of diseases, the diagnosis, treatment, care, mitigation and repair of injuries and disabilities, the research, substitution and adjustment in anatomy or physiological process, the control over pregnancy, etc. 本办法所指的缺陷进口医疗器械，是指不符合国家强制性标准的规定的，或者存在可能危及人身、财产安全的不合理危险的进口医疗器械。 <WESTBANK> The defective imported medical instruments as referred to in these Measures are the imported medical instruments that fail to comply with the provisions of state compulsory standards or have unreasonable dangers to the human body or property safety. 本办法所指的进口单位是指具有法人资格，对外签订并执行进口医疗器械贸易合同或者委托外贸代理进口医疗器械的中国境内企业。 <WESTBANK> The importer as referred to in these Measures is an enterprise within the territory of China that shall be qualified as a legal person and has signed and implemented a foreign trade contract on medical instrument import or has entrusted a foreign-trade agent to import medical instruments. 第四十六条从境外进入保税区、出口加工区等海关监管区域供使用的医疗器械，以及从保税区、出口加工区等海关监管区域进入境内其他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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