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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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ion, pre-shipment inspection and installment surveillance over the imported high risk medical instruments as agreed in a foreign trade contract. 第十九条进口医疗器械进口时，进口医疗器械的收货人或者其代理人（以下简称报检人）应当向报关地检验检疫机构报检，并提供下列材料： <WESTBANK> Article 19 Where the medical instruments are imported, the consignee or its agent of the imported medial instruments (hereinafter referred to as the inspection applicants) shall apply for inspection to the IQ organ at the place where the customs declaration is made, and file the following materials as well: （一）报检规定中要求提供的单证； <WESTBANK> (1) Documents as required in the rules of inspection application; （二）属于《实施强制性产品认证的产品目录》内的医疗器械，应当提供中国强制性认证证书； <WESTBANK> (2) Certificate of China Compulsory Certification for the medical instruments within the Catalogue of Products Subject to the Compulsory Product Certification system; （三）国务院药品监督管理部门审批注册的进口医疗器械注册证书； <WESTBANK> (3) Registration certificate of imported medical instruments as examined, approved and registered by the administrative authority of drug supervision of the State Council; and （四）进口单位为一、二类进口单位的，应当提供检验检疫机构签发的进口单位分类证明文件。 <WESTBANK> (4) Certificate documents concerning importer category as issued by an IQ organ for a Category A or B importer. 第二十条口岸检验检疫机构应当对报检材料进行审查，不符合要求的，应当通知报检人；经审查符合要求的，签发《入境货物通关单》，货物办理海关报关手续后，应当及时向检验检疫机构申请检验。 <WESTBANK> Article 20 A customs IQ organ shall examine the inspection application materials, and inform the inspection applicants if the requirements are not satisfied; in the case of any satisfied requirements upon examination, it shall issue a Circular of Customs Clearance of Inbound Goods, and the importer shall timely apply for inspection to the IQ organ after the goods have gone through the formalities of customs declaration. 第二十一条进口医疗器械应当在报检人报检时申报的目的地检验。 <WESTBANK> Article 21 The imported medical instruments shall be inspected at the destination where the inspection declaration is made by the inspection applicants. 对需要结合安装调试实施检验的进口医疗器械，应当在报检时明确使用地，由使用地检验检疫机构实施检验。 <WESTBANK> With respect to the imported medical instruments that require the inspection combining with their installments and adjustments, the use place thereof shall be specified when the inspection declaration is made, and the inspection shall be implemented by the IQ organ at the use place. 需要结合安装调试实施检验的进口医疗器械目录由国家质检总局对外公布实施。 <WESTBANK> The GAQSIQ shall publicize and implement the catalogue of imported medical instruments that require the inspection combining with their installments and adjustments. 对于植入式医疗器械等特殊产品，应当在国家质检总局指定的检验检疫机构实施检验。 <WESTBANK> The inspection of the special products such as the implanted medical instruments shall be performed by an IQ organ as appointed by the GAQSIQ. 第二十二条检验检疫机构按照国家技术规范的强制性要求对进口医疗器械进行检验；尚未制定国家技术规范的强制性要求的，可以参照国家质检总局指定的国外有关标准进行检验。 <WESTBANK> Article 22 An IQ organ shall implement the inspection on imported medical instruments in accordance with the compulsory requirements of the state technical specifications; in case the said requirements have not been constituted yet, it may perform the inspection with reference to the relevant foreign criterions as designated by the GAQSIQ. 第二十三条检验检疫机构对进口医疗器械实施现场检验和监督检验的内容可以包括： <WESTBANK> Article 23 The spot inspection and surveillant inspection of imported medical instruments by an IQ organ may include: （一）产品与相关证书一致性的核查； <WESTBANK> (1) Verifications on the consistency between the products and the relating certificates; （二）数量、规格型号、外观的检验； <WESTBANK> (2) Examinations on the quantity, specifications and type, and appearance; （三）包装、标签及标志的检验，如使用木质包装的，须实施检疫； <WESTBANK> (3) Inspections on packaging, labels and signs, and quarantine if wooden packaging is adopted; （四）说明书、随机文件资料的核查； <WESTBANK> (4) Examinations on user's manuals and documents and materials attached to the instruments; （五）机械、电气、电磁兼容等安全方面的检验； <WESTBANK> (5) Inspections on machinery, electric and electromagnetic compatibility and other aspects of safety; （六）辐射、噪声、生化等卫生方面的检验； <WESTBANK> (6) Inspections on radiation, noise, biochemistry and other aspects of sanitation; （七）有毒有害物质排放、残留以及材料等环保方面的检验； <WESTBANK> (7) Inspections on emission, residue and materials of toxic and hazardous substances and other aspects of environmental protection; （八）涉及诊断、治疗的医疗器械性能方面的检验； <WESTBANK> (8) Inspections on performance of medical instruments involving the diagnosis and treatment; and （九）产品标识、标志以及中文说明书的核查。 <WESTBANK> (9) Examinations on product logos, signs and user's manuals in Chinese. 第二十四条检验检疫机构对实施强制性产品认证制度的进口医疗器械实行入境验证，查验单证，核对证货是否相符，必要时抽取样品送指定实验室，按照强制性产品认证制度和国家规定的相关标准进行检测。 <WESTBANK> Article 24 With respect to the imported medical instruments that are subject to the compulsory product certification system, an IQ organ shall perform an inbound inspection on the certificates, examine the documents, check the consistency between the certificates and goods, and draw a sample of the goods, if necessary, which shall be sent to the designated laboratory for testing in light of the compulsory product certification system and relevant standards of the state. 第二十五条进口医疗器械经检验未发现不合格的，检验检疫机构应当出具《入境货物检验检疫证明》。 <WESTBANK> Article 25 In case no unqualified imported medical instrument is found in the inspection, a Certificate of Inspection and Quarantine of Inbound Goods shall be issued by an IQ organ. 经检验发现不合格的，检验检疫机构应当出具《检验检疫处理通知书》，需要索赔的应当出具检验证书。 <WESTBANK> If any unqualified imported medical instrument is found in the inspection, an IQ organ shall issue a Circular of Inspection and Quarantine Treatment, and shall issue an inspection certificate if a claim for damage is necessary. 涉及人身安全、健康、环境保护项目不合格的，或者可以技术处理的项目经技术处理后经检验仍不合格的，由检验检疫机构责令当事人销毁，或者退货并书面告知海关，并上报国家质检总局。 <WESTBANK> Where any item involving the human safety, health or environmental protection is unqualified or any item that may be technically treated remains unqualified upon the technical treatment, the party concerned shall be ordered by an IQ organ to destroy the item or return the goods, the customs shall be notified in written form, and it shall be reported to the GAQSIQ. 第四章 进口捐赠医疗器械检验监管 <WESTBANK> Chapter IV Inspection Supervision on Imported Donated Medical Instruments 第二十六条进口捐赠的医疗器械应当未经使用，且不得夹带有害环境、公共卫生的物品或者其他违禁物品。 <WESTBANK> Article 26 The imported donated medical instruments shall not be used before, and shall not carry any article harmful to the environment or to the sanitation, or any other illegal imports. 第二十七条进口捐赠医疗器械禁止夹带列入我国《禁止进口货物目录》的物品。 <WESTBANK> Article 27 No article within the Catalogue of Goods Prohibited from Being Imported of China may be carried with any imported donated medical instruments. 第二十八条向中国境内捐赠医疗器械的境外捐赠机构，须由其或者其在中国的代理机构向国家质检总局办理捐赠机构及其捐赠医疗器械的备案。 <WESTBANK> Article 28 Any donating institution outside the territory of China that donates medical instruments to China by itself or by its agent in the territory of China must apply to the GAQSIQ for going through the formalities of filing the donating institution and donated medical instruments. 第二十九条国家质检总局在必要时可以对进口捐赠的医疗器械组织实施装运前预检验。 <WESTBANK> Article 29 The GAQSIQ may arrange the pre-inspection on the imported donated medical instruments before the shipment thereof, if necessary. 第三十条接受进口捐赠医疗器械的单位或者其代理人应当持相关批准文件向报关地的检验检疫机构报检，向使用地的检验检疫机构申请检验。 <WESTBANK> Article 30 Any entity or its agent that accepts the imported donated medical instruments shall make an inspection application to the IQ organ at the place where the declaration to customs is made upon relevant approving documents, and apply for inspection to the IQ organ at the place where the said instruments are used. 检验检疫机构凭有效的相关批准文件接受报检，实施口岸查验，使用地检验。 <WESTBANK> The IQ organ shall accept the inspection application upon the relevant valid approving documents, and shall perform the customs inspection and use place inspection accordingly. 第三十一条境外捐赠的医疗器械经检验检疫机构检验合格并出具《入境货物检验检疫证明》后，受赠人方可使用；经检验不合格的，按照商检法及其实施条例的有关规定处理。 <WESTBANK> Article 31 After the IQ organs inspect the medical instruments donated from outside the territory of China have been inspected to be qualified and a Certificate for Inspection and Quarantine of Inbound Goods has been issued by, the donee may use the said instruments; in the case of any unqualified inspection, they shall be handled in accordance with the relevant provisions in the Inspection Law and the implementation regulations thereof. 第五章 风险预警与快速反应 <WESTBANK> Chapter V Risk Warning and Fast Response 第三十二条国家质检总局建立对进口医疗器械的风险预警机制。通过对缺陷进口医疗器械等信息的收集和评估，按照有关规定发布警示信息，并采取相应的风险预警措施及快速反应措施。 <WESTBANK> Article 32 The GAQSIQ shall set up a risk warning mechanism for imported medical instruments, it shall issue warning information under relevant provisions and adopt corresponding risk warning measures and fast response measures by collecting and assessing the information concerning the defective imported medical instruments. 第三十三条检验检疫机构需定期了解辖区内使用的进口医疗器械的质量状况，发现进口医疗器械发生重大质量事故，应及时报告国家质检总局。 <WESTBANK> Article 33 An IQ organ shall be aware of the information relating to the quality of imported medical instruments as used within its jurisdiction at regular intervals, and report to the GAQSIQ timely, if any major quality accident concerning imported medical instruments is found. 第三十四条进口医疗器械的制造商、进口单位和使用单位在发现其医疗器械中有缺陷的应当向检验检疫机构报告，对检验检疫机构采取的风险预警措施及快速反应措施应当予以配合。 <WESTBANK> Article 34 Where any defect in the medical instrument is found by the producer, importer or user thereof, i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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