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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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独立的经营场所。 <WESTBANK> (10) It shall have relatively independent business premises that are appropriate for the scope and scale of the imported medical instruments. 第七条三类进口单位包括： <WESTBANK> Article 7 The importers in Category C shall comprise: （一）从事进口医疗器械业务不满3年的进口单位； <WESTBANK> (1) Importers that have been engaged in the import business of medical instrument for less than three years; （二）从事进口医疗器械业务已满3年，但未提出分类管理申请的进口单位； <WESTBANK> (2) Importers that have been engaged in the import business of the medical instrument for three years but fails to bring an application for the classified management; and （三）提出分类申请，经考核不符合一、二类进口单位条件，未列入一、二类分类管理的进口单位。 <WESTBANK> (3) Importers that have brought an application for the classified management but not listed in the Category A or B management because of failing to satisfy the requirements for the importers in Category A or B upon examination. 第八条申请一类进口单位或者二类进口单位的医疗器械进口单位（以下简称申请单位），应当向所在地直属检验检疫局提出申请，并提交以下材料： <WESTBANK> Article 8 Where a medical instrument importer applies for a Category A or B importer (hereinafter referred to as the applicant), it shall submit an application to the administration of inspection and quarantine directly under the GAQSIQ at the place where the applicant is situated, and submit the materials as follows: （一）书面申请书，并有授权人签字和单位盖章； <WESTBANK> (1) An application in written form with a signature of the authorized person and the official seal thereon; （二）法人营业执照、医疗器械经营企业许可证； <WESTBANK> (2) Legal person business license and medical instrument business enterprise permit; （三）质量管理体系认证证书、质量管理文件； <WESTBANK> (3) Quality management system (QMS) certificate and quality management documents; （四）质量管理人员经检验检疫机构培训合格的证明文件； <WESTBANK> (4) Certificate documents as granted by an IQ organ to the quality management staff after training; （五）近2年每年进口批次的证明材料； <WESTBANK> (5) Certificate materials on the number of import batches in the last two years; and （六）遵守国家相关法律法规以及提供资料真实性的承诺书（自我声明）。 <WESTBANK> (6) Statement as promised to observe the relevant laws and administrative regulations of the state and the principle of providing true materials (self-statement). 第九条直属检验检疫局应当在5个工作日内完成对申请单位提交的申请的书面审核。申请材料不齐的，应当要求申请单位补正。 <WESTBANK> Article 9 The administration of inspection and quarantine directly under the GAQSIQ shall complete the assessment on written application as submitted by an applicant within five workdays; in case the application materials are incomplete, the applicant shall make supplement as required. 申请一类进口单位的，直属检验检疫局应当在完成书面审核后组织现场考核，考核合格的，将考核结果和相关材料报国家质检总局。 <WESTBANK> As for an application for a Category A importer, the administration of inspection and quarantine directly under the GAQSIQ shall arrange the spot assessment after completing the assessment on written application, and shall submit the result of assessment and relevant materials to the GAQSIQ if the assessment is passed. 国家质检总局对符合一类进口单位条件的申请单位进行核准，并定期对外公布一类进口单位名单。 <WESTBANK> The GAQSIQ shall verify and approve an applicant that satisfies the requirements for a Category A importer, and publicize the list of Category A importers at regular intervals. 申请二类进口单位的，直属检验检疫局完成书面审核后，可以自行或者委托进口单位所在地检验检疫机构组织现场考核。 <WESTBANK> As for an application for a Category B importer, the administration of inspection and quarantine directly under the GAQSIQ may arrange the spot assessment by itself or entrusting the IQ organ at the place where the importer is situated after completing the assessment of written application. 考核合格的，由直属检验检疫局予以核准并报国家质检总局备案，直属检验检疫局负责定期对外公布二类进口单位名单。 <WESTBANK> If the assessment is passed, the applicant shall be verified and approved by the administration of inspection and quarantine directly under the GAQSIQ shall and shall be submitted to the GAQSIQ for filing. The administration of inspection and quarantine directly under the GAQSIQ shall take the responsibilities of publicizing the list of Category B importers at regular intervals. 第三章 进口医疗器械风险等级及检验监管 <WESTBANK> Chapter III Risk Levels and Inspection Supervision of Imported Medical Instruments 第十条检验检疫机构按照进口医疗器械的风险等级、进口单位的分类情况，根据国家质检总局的相关规定，对进口医疗器械实施现场检验，以及与后续监督管理（以下简称监督检验）相结合的检验监管模式。 <WESTBANK> Article 10 In accordance with the relevant provisions of the GAQSIQ, an IQ organ shall take the spot inspection and supervision on the imported medical instruments combining with the follow-up surveillance and management (hereinafter referred to as the surveillant inspection) on the basis of the risk levels of the imported medical instruments and the categories of the importers. 第十一条国家质检总局根据进口医疗器械的结构特征、使用形式、使用状况、国家医疗器械分类的相关规则以及进口检验管理的需要等，将进口医疗器械产品分为：高风险、较高风险和一般风险三个风险等级。 <WESTBANK> Article 11 The GAQSIQ shall divide the risks of the imported medical instruments into three risk levels: high risk, relatively high risk and ordinary risk in light of the structural features, use forms and use conditions of the imported medical instruments as well as relevant rules on the categorization of medical instruments of the state, requirements for the import inspection management, etc.. 进口医疗器械产品风险等级目录由国家质检总局确定、调整，并在实施之日前60日公布。 <WESTBANK> The GAQSIQ shall make adjust the catalogue of the risk levels of the imported medical instruments and shall publicize it 60 days prior to the date of implementation of the catalogue. 第十二条符合下列条件的进口医疗器械产品为高风险等级： <WESTBANK> Article 12 Any imported medical instrument that satisfy the following requirements shall be at a level of high risk: （一）植入人体的医疗器械； <WESTBANK> (1) Any medical instrument implanted into the human body; （二）介入人体的有源医疗器械； <WESTBANK> (2) Any powered medical instrument intervening in the human body; （三）用于支持、维持生命的医疗器械； <WESTBANK> (3) Any medial instrument used for the life support or life maintenance; （四）对人体有潜在危险的医学影像设备及能量治疗设备； <WESTBANK> (4) Any medical image equipment and energy treatment equipment that may have potential dangers to the human body; and （五）产品质量不稳定，多次发生重大质量事故，对其安全性有效性必须严格控制的医疗器械。 <WESTBANK> (5) Any medical instrument that are unstable in product quality, have led to major quality accidents for several times, and must be controlled rigidly in product safety and effectiveness. 第十三条符合下列条件的进口医疗器械产品为较高风险等级： <WESTBANK> Article 13 Any imported medical instrument that satisfy the following requirements shall be at a level of relatively high risk: （一）介入人体的无源医疗器械； <WESTBANK> (1) Any unpowered medical instrument intervening in the human body; （二）不属于高风险的其他与人体接触的有源医疗器械； <WESTBANK> (2) Any other powered medical instrument contacting the human body but not at the level of high risk; and （三）产品质量较不稳定，多次发生质量问题，对其安全性有效性必须严格控制的医疗器械。 <WESTBANK> (3) Any medical instrument that are unstable in product quality, have led to quality problems for several times, and must be controlled rigidly in product safety and effectiveness. 第十四条未列入高风险、较高风险等级的进口医疗器械属于一般风险等级。 <WESTBANK> Article 14 Any other imported medial instruments that are not listed in the levels of high risk and relatively high risk shall be at the level of ordinary risk. 第十五条进口高风险医疗器械的，按照以下方式进行检验管理： <WESTBANK> Article 15 With respect to the import of high risk medical instruments, the inspection and management shall be performed in the modes as follows: （一）一类进口单位进口的，实施现场检验与监督检验相结合的方式，其中年批次现场检验率不低于50%； <WESTBANK> (1) As for the import by a Category A importer, the spot inspection shall be performed combining with surveillant inspection, and the annual rate of spot inspection of batches shall not be lower than 50 percent; and （二）二、三类进口单位进口的，实施批批现场检验。 <WESTBANK> (2) As for the import by a Category B or C importer, the spot inspection of each batch shall be performed. 第十六条进口较高风险医疗器械的，按照以下方式进行检验管理： <WESTBANK> Article 16 With respect to the import of relatively high risk medical instruments, the inspection and management shall be performed in the following modes as follows: （一）一类进口单位进口的，年批次现场检验率不低于30%； <WESTBANK> (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; （二）二类进口单位进口的，年批次现场检验率不低于50%； <WESTBANK> (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 50 percent; and （三）三类进口单位进口的，实施批批现场检验。 <WESTBANK> (3) As for the import by a Category C importer, the spot inspection of each batch shall be performed. 第十七条进口一般风险医疗器械的，实施现场检验与监督检验相结合的方式进行检验管理，其中年批次现场检验率分别为： <WESTBANK> Article 17 With respect to the import of ordinary risk medical instruments, the spot inspection shall be performed combining with surveillant inspection, and the annual rates of spot inspection of batches shall be as follows respectively: （一）一类进口单位进口的，年批次现场检验率不低于10%； <WESTBANK> (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 10 percent; （二）二类进口单位进口的，年批次现场检验率不低于30%； <WESTBANK> (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; and （三）三类进口单位进口的，年批次现场检验率不低于50%。 <WESTBANK> (3) As for the import by a Category C importer, the annual rate of spot inspection of batches shall not be lower than 50 percent. 第十八条根据需要，国家质检总局对高风险的进口医疗器械可以按照对外贸易合同约定，组织实施监造、装运前检验和监装。 <WESTBANK> Article 18 The GAQSIQ may, as required, arrange the production supervis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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