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进口医疗器械检验监督管理办法           ★★★

进口医疗器械检验监督管理办法

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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  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  Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments
第一章 总则  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。  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:  Article 2 These Measures shall be applicable to:
(一)对医疗器械进口单位实施分类管理;  (1) classified management of the medical instrument importers;
(二)对进口医疗器械实施检验监管;  (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。  (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。  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。  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  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。  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。  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:  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;  (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;  (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;  (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;  (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;  (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;  (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;  (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;  (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;  (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。  (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:  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;  (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;  (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;  (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;  (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;  (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;  (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;  (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;  (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;  (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、相对独立的经营场所。  (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:  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;  (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;  (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。  (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:  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;  (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;  (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;  (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;  (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;  (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)。  (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。  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。  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。  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。  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。  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  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。  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。  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。  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:  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;  (1) Any medical instrument implanted into the human body;
(二)介入人体的有源医疗器械;  (2) Any powered medical instrument intervening in the human body;
(三)用于支持、维持生命的医疗器械;  (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;  (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。  (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:  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;  (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;  (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。  (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。  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:  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%;  (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。  (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:  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%;  (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%;  (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。  (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:  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%;  (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%;  (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%。  (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。  Article 18 The GAQSIQ may, as required, arrange the production supervision, 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:  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;  (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;  (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;  (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。  (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。  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。  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。  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。  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。  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。  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:  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;  (1) Verifications on the consistency between the products and the relating certificates;
(二)数量、规格型号、外观的检验;  (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;  (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;  (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;  (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;  (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;  (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;  (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。  (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。  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》。  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。  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。  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  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。  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。  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。  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。  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。  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。  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。  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  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。  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。  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。  Article 34 Where any defect in the medical instrument is found by the producer, importer or user thereof, it 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:  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;  (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;  (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;  (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。  (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:  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;  (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;  (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;  (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;  (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。  (5) other necessary measures.
第六章 监督管理  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:  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;  (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;  (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%;  (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;  (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。  (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。  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:  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;  (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;  (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。  (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。  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。  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。  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。  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。  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  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。  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。  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。  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。  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。  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  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。  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。  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。  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区域的医疗器械,按照本办法执行。  Article 46 These Measures shall be applicable to the medical instruments that are brought into bonded area or export procession zone or other customs supervision areas for use from outside the territory of China, and the medical instruments that are brought into other areas within the territory of China from bonded area or export procession zone or other customs supervision areas.
第四十七条用于动物的进口医疗器械参照本办法执行。  Article 47 The imported medical instruments for animals shall be governed by these Measures by analogy.
第四十八条进口医疗器械中属于锅炉压力容器的,其安全监督检验还应当符合国家质检总局其他相关规定。  Article 48 In case any imported medical instruments are the boiler pressure vessels, the safety surveillant inspection thereof shall observe other relevant provisions of the GAQSIQ.
属于《中华人民共和国进口计量器具型式审查目录》内的进口医疗器械,还应当符合国家有关计量法律法规的规定。  The imported medical instruments within the Catalogue for the Model Examination of the Imported Measurement Instruments of the People's Republic of China shall follow the laws and administrative regulations on measurement of the state.
第四十九条本办法由国家质检总局负责解释。  Article 49 The power to interpret these Measures shall remain with the GAQSIQ.
第五十条本办法自2007年12月1日起施行。  Article 50 These Measures shall come into force as of December 1, 2007.
 
 
 

 

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