国家技术监督局


中华人民共和国进口计量器具监督管理办法(附英文)

（一九八九年十月十一日国务院批准）

第一章 总 则
第一条 为加强进口计量器具的监督管理，根据《中华人民共和国计量法》和《中华人民共和国计量法实施细则》的有关规定，制定本办法。
第二条 任何单位和个人进口计量器具，以及外商（含外国制造商、经销商，下同）或其代理人在中国销售计量器具，都必须遵守本办法。
第三条 进口计量器具的监督管理，由国务院计量行政部门主管，具体实施由国务院和地方有关部门分工负责。

第二章 进口计量器具的型式批准
第四条 凡进口或外商在中国境内销售列入本办法所附《中华人民共和国进口计量器具型式审查目录》内的计量器具的，应向国务院计量行政部门申请办理型式批准。
属进口的，由外商申请型式批准。
属外商在中国境内销售的，由外商或其代理人申请型式批准。
国务院计量行政部门可根据情况变化对《中华人民共和国进口计量器具型式审查目录》作个别调整。
第五条 外商或其代理人申请型式批准，须向国务院计量行政部门递交型式批准申请书、计量器具样机照片和必要的技术资料。
国务院计量行政部门应根据外商或其代理人递交的资料进行计量法制审查。
第六条 国务院计量行政部门接受申请后，负责安排授权的技术机构进行定型鉴定，并通知外商或其代理人向承担定型鉴定的技术机构提供样机和以下技术资料：
（一）计量器具的技术说明书；
（二）计量器具的总装图、结构图和电路图；
（三）技术标准文件和检验方法；
（四）样机测试报告；
（五）使用说明书。
定型鉴定所需的样机由外商或其代理人无偿提供。海关凭国务院计量行政部门的保函验放并免收关税。样机经鉴定后退还申请人。
第七条 定型鉴定按鉴定大纲进行。鉴定大纲由承担鉴定的技术机构，根据国务院计量行政部门发布的《计量器具定型鉴定技术规范》的要求制定。主要内容包括：外观检查、计量性能考核以及安全性、环境适应性、可靠性和寿命试验等。
第八条 定型鉴定的结果由承担鉴定的技术机构报国务院计量行政部门审核。经审核合格的，由国务院计量行政部门向申请人颁发《中华人民共和国进口计量器具型式批准证书》，并准予在相应的计量器具和包装上使用中华人民共和国进口计量器具型式批准的标志和编号。
第九条 承担定型鉴定的技术机构及其工作人员，对申请人提供的技术资料必须保密。
第十条 有下列情况之一的，经国务院计量行政部门同意，可申请办理临时型式批准，具体办法由国务院计量行政部门规定：
（一）展览会留购的；
（二）确属急需的；
（三）销售量极少的；
（四）国内暂无定型鉴定能力的。
第十一条 外国制造的计量器具经我国型式批准后，由国务院计量行政部门予以公布。

第三章 进口计量器具的审批
第十二条 申请进口计量器具，按国家关于进口商品的规定程序进行审批。
负责审批的有关主管部门和归口审查部门，应对申请进口《中华人民共和国依法管理的计量器具目录》内的计量器具进行法定计量单位的审查，对申请进口本办法第四条规定的计量器具审查是否经过型式批准。经审查不合规定的，审批部门不得批准进口，外贸经营单位不得办理订货手续。
海关对进口计量器具凭审批部门的批件验放。
第十三条 因特殊需要，申请进口非法定计量单位的计量器具和国务院禁止使用的其他计量器具，须经国务院计量行政部门批准。
第十四条 申请进口非法定计量单位的计量器具和国务院禁止使用的其他计量器具的单位，应向国务院计量行政部门提供以下材料和文件：
（一）申请报告；
（二）计量器具的性能及技术指标；
（三）计量器具的照片和使用说明；
（四）本单位上级主管部门的批件。

第四章 进口计量器具的检定
第十五条 进口以销售为目的的列入《中华人民共和国依法管理的计量器具目录》内的计量器具，在海关验放后，订货单位必须向所在的省、自治区、直辖市人民政府计量行政部门申请检定。当地不能检定的，向国务院计量行政部门申请检定。
第十六条 接受进口计量器具检定申请的政府计量行政部门，应指定计量检定机构及时进行检定。对检定合格的，应由政府计量行政部门出具检定证书、检定合格证或加盖检定合格印，并准予销售。
第十七条 订货单位应将计量行政部门对进口计量器具的检定结果报告所在地区的商检机构。检定不合格，需要向外索赔的，订货单位应及时向所在地区商检机构申请复验出证。
第十八条 进口不以销售为目的的计量器具，按照国家关于一般进口商品检验工作的管理办法办理。

第五章 法律责任
第十九条 违反本办法规定，进口非法定计量单位的计量器具或国务院禁止使用的其他计量器具的，按照《中华人民共和国计量法实施细则》第四十四条规定追究法律责任。
第二十条 进口计量器具未经省级以上人民政府计量行政部门指定的计量检定机构检定合格而销售的，按照《中华人民共和国计量法实施细则》第五十条规定追究法律责任。
第二十一条 违反本办法第四条规定，进口或销售未经国务院计量行政部门型式批准的计量器具的，计量行政部门有权封存其计量器具，责令其补办型式批准手续，并可处以相当于进口或销售额百分之三十以下的罚款。
第二十二条 承担进口计量器具定型鉴定的技术机构违反本办法第九条规定的，按照《中华人民共和国计量法实施细则》第五十八条规定追究法律责任。

第六章 附 则
第二十三条 引进成套设备中配套的计量器具以及不以销售为目的的计量器具的监督管理，按国家有关规定办理。
第二十四条 与本办法有关的申请书、证书和标志式样，由国务院计量行政部门统一制定。
第二十五条 申请进口计量器具的型式批准、定型鉴定和计量检定，应按国家有关规定缴纳费用。
第二十六条 进口用于统一量值的标准物质的监督管理，可参照本办法执行。
第二十七条 本办法由国务院行政部门负责解释。
第二十八条 本办法自发布之日起施行。

中华人民共和国进口计量器具型式审查目录
1．衡器（含天平）
2．传感器
3．声级计
4．三座标测量机
5．表面粗糙度测量仪
6．大地测量仪器
7．热量计
8．流量计（含水表、煤气表）
9．压力计（含血压计）
10．温度计
11．数字电压表
12．场强计
13．心、脑电图仪（机）
14．有害气体、粉尘、水质污染监测仪
15．电离辐射防护仪
16．分光光度计（含紫外、红外、可见光光度计）
17．气相、液相色谱仪
18．温度、水份测量仪
(附英文)

MEASURES OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE SUPERVISION ANDADMINISTRATION OF IMPORTED INSTRUMENTS OF MEASUREMENT

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
MEASURES OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE SUPERVISION AND
ADMINISTRATION OF IMPORTED INSTRUMENTS OF MEASUREMENT
(Approved by the State Council on October 11, 1989 and promulgated
by the Decree No. 3 of the State Bureau of Technology Supervision on
November 4, 1989)

Chapter I General Provisions
Article 1
These Measures are formulated, in accordance with the pertinent
stipulations of the Metrology Law of the People's Republic of China and
the Rules for the Implementation of the Metrology Law of the People's
Republic of China, for the purpose of strengthening the supervision over
the administration of imported instruments of measurement.
Article 2
Any units and individuals that are engaged in the importation of
instruments of measurement and any foreign businessmen (including foreign
manufacturers, salesmen, the same hereinafter) or their agents who are
engaged in the sales of instruments of measurement in China must abide by
these Measures.
Article 3
The competent administrative department under the State Council shall be
responsible for the supervision over and administration of imported
instruments of measurement. The departments concerned under the State
Council and in the local governments shall be responsible for the actual
implementation in keeping with the division of responsibility.

Chapter II Model Approval of Imported Instruments of Measurement
Article 4
Anyone who wants to import the instruments of measurement listed in the
Catalogue of Model Examination of the People's Republic of China for
Imported Instruments of Measurement attached to these Measures or any
foreign businessman who wants to sell these instruments in China must
apply to the competent department in charge of measurement under the State
Council for model approval.
Applications for model approval for imported instruments should be
submitted by foreign businessmen.
Applications for model approval for instruments sold by foreign
businessmen in China should be submitted by the foreign businessmen or
their agents.
The competent department in charge of measurement under the State Council
may, according to changes of circumstances, make minor adjustments of the
Catalogue of Model Examination of the People's Republic of China for
Imported Instruments of Measurement.
Article 5
In applying for model approval, foreign businessmen or their agents must
submit model approval application, photographs or the sample instruments
and necessary technical data to the competent department in charge of
measurement under the State Council. The competent department under the
State Council shall conduct examination of the materials submitted by
foreign businessmen or their agents according to the relevant provisions
of the measurement law and regulations.
Article 6
After receiving applications, the competent department under the State
Council shall arrange for an authorized technical agency to conduct design
appraisement and inform the foreign businessmen or their agents that they
should provide the technical agency with sample instruments and the
following technical data:
(1) the technical manuals of the instruments;
(2) the assembly diagrams, structural drawings and circuit diagrams of the
instruments;
(3) the documents of technical standards and the methods for examination;
(4) the testing reports on the sample instruments;
(5) the operation instructions.
The sample instruments needed in the design appraisement should be
provided free of charge by the foreign businessmen or their agents.
Customs authorities shall inspect and release the instruments on the
strength of the letters of guarantee issued by the competent department in
charge of measurement under the State Council and shall impose no customs
duties. The sample instruments shall be returned to the applicants after
the appraisements.
Article 7
Design appraisement shall be conducted in accordance with the requirements
laid down in the appraisement outline which is drawn up by the technical
agency responsible for the appraisement according to the Technical
Specifications of Design Appraisement for Instruments of Measurement
issued by the competent administrative department under the State Council.
Its main content includes inspection of the exterior assessment of
measurement functions, safety, adaptability to environment, reliability
and service life.
Article 8
The results of the design appraisement shall be reported by the technical
agency responsible for the appraisement to the competent administrative
department under the State Council for verification. Those applicants
whose instruments have passed such examination and verification shall be
issued with the Certificate of Approval of the People's Republic of China
for Designs of Imported Instruments of Measurement by the competent
administrative department under the State Council and shall be allowed to
use the marks and serial numbers of the People's Republic of China for
design approval on the corresponding instruments and their packages.
Article 9
The technical agencies responsible for design appraisement and their
personnel must keep secret the technical data provided by applicants.
Article 10
Applications for temporary model approvals for instruments, which fall
into any of the following categories, can be made with prior consent of
the competent administrative department under the State Council, which
shall stipulate the relevant procedures:
(1) those instruments reserved for sale after exhibitions;
(2) those instruments which are indeed urgently needed;
(3) those instruments whose sales volume is extremely small;
(4) those instruments for which China is incapable of carrying out design
appraisement for the time being.
Article 11
Those instruments of measurement produced in foreign countries which have
obtained design approvals in our country shall be made public by the
competent department under the State Council.

Chapter III Examination and Approval of Imported Instruments of Measurement
Article 12
Applications to import instruments of measurement must be examined and
approved according to the procedures stipulated by the state concerning
imported commodities. The relevant competent administrative departments
for examination and approval and the special departments in charge of
examination shall conduct examination of official measures for instruments
of measurement to be imported, which are listed in the Catalogue of the
People's Republic of China Concerning Instruments of Measurement
Controlled by Law and must ensure that the instruments of measurement to
be imported according to the provisions of Article 4 of these Measures
pass model approval. If the relevant instruments fail to pass the
examination, the departments responsible for examination and approval may
not approve of import of them and foreign trade departments may not order
the goods.
The Customs shall inspect and release imported instruments of measurement
on the strength of the documents of approval issued by the department
responsible for examination and approval.
Article 13
Applications, as required by special needs, to import instruments of non-
official measures or those instruments which have been prohibited by the
State Council must be subject to approval of the administrative department
for measurement under the State Council.
Article 14
The units which apply to import instruments of non-official measures or
those instruments which have been prohibited by the State Council should
provide the following materials and documents to the administrative
department for measurement under the State Council:
(1) applications;
(2) the functions and technical standards of the instruments;
(3) the photographs and operation instructions of the instruments;
(4) the documents of approval issued by the competent authorities above
the applying units.

Chapter IV Examination and Determination of Imported Instruments of Measurement
Article 15
Those units which import, for sale on the domestic market, instruments as
listed in the Catalogue of the People's Republic of China Concerning the
Instruments of Measurement Controlled by Law must, after the inspection
and release by the Customs, apply for examination and determination to the
administrative departments for measurement in the people's governments of
their respective provinces, autonomous regions or municipalities directly
under the Central Government. If it cannot be done locally, they may apply
to the administrative department for measurement under the State Council
for examination and determination.
Article 16
The government administrative departments for measurement which deal with
applications for examination and determination of imported instruments of
measurement shall appoint agencies for prompt measurement examination and
determination. If the instruments pass the examination and determination,
the government administrative departments shall issue certificates of
examination and determination and certificates of quality or affix stamps
and allow their sales.
Article 17
The units ordering such instruments shall report the result of examination
and determination to the local commodity inspection agencies. In case the
instruments fail to pass the examination and determination and therefore
give rise to the necessity to claim compensation from foreign suppliers,
the units should apply in time to the local commodity inspection agencies
for re-inspection certificates.
Article 18
Those instruments of measurement which are imported for purposes other
than sales shall be dealt with according to the measures stipulated by the
State concerning inspection of ordinary imported commodities.

Chapter V Legal Liability
Article 19
Those who violate the provisions of these Measures by importing
instruments of measurement of non-official measures or other instruments
prohibited by the State Council shall be investigated for legal
liabilities in accordance with the provisions of Article 44 of the Rules
for the Implementation of the Metrology Law of the People's Republic of
China.
Article 20
Those who import and sell the instruments of measurements which have not
been examined and determined by the agencies for measurement examination
and determination designated by the administrative departments in charge
of measurement in the people's governments above provincial level shall be
investigated for legal liabilities in accordance with the provisions of
Article 50 of the Rules for the Implementation of the Metrology Law of the
People's Republic of China.
Article 21
If anyone or any units violate the provisions of Article 4 of these
Measures by importing or selling those instruments of measurement which
have not obtained the model approval by the administrative department for
measurement under the State Council, the administrative departments in
charge of measurement have the right to seal up their instruments, order
them to go through the formalities for model approval and may also impose
a fine of less than 30% of the import volume or the sales volume.
Article 22
Technical agencies responsible for design appraisement for imported
instruments of measurement that have violated the provisions of Article 9
of these Measures shall be investigated for legal liabilities in
accordance with the provisions of Article 58 of the Rules for the
Implementation of the Metrology Law of the People's Republic of China.

Chapter VI Supplementary Provisions
Article 23
The supervision over and administration of the instruments of measurement
which form a part of complete sets of equipment introduced from abroad and
the instruments imported for purposes other than sale on the domestic
market shall be conducted according to the relevant stipulations of the
state.
Article 24
The applications, certificates and types of marks related to these
Measures shall all be formulated by the competent department under the
State Council.
Article 25
Fees for model approval, design appraisement and measurement examination
and determination for imported instruments of measurement should be paid
in accordance with the relevant stipulations of the state.
Article 26
The supervision over and administration of imported standard substances
used in unifying measure values may be conducted with reference to these
Measures.
Article 27
These Measures shall be interpreted by the administrative department for
measurement under the State Council.
Article 28
These Measures shall go into effect as of the date of promulgation.
Appendix: The Catalogue of Model Examination of the People's Republic of
China for Imported Instruments of Measurement:
1. Weighing apparatus (including scales);
2. Sensors;
3. Sound meters;
4. Surveying machines with three coordinates;
5. Surveying instruments for roughness of surface;
6. Geodesic instruments;
7. Calorimeters;
8. Flowmeters (including water meters and gas meters);
9. Pressure gauges (including sphygmomanometers);
10. Thermometers;
11. Digital voltmeters;
12. Field intensity meters;
13. Electrocardiographs and electroencephalographs;
14. Monitors for toxic gases, dust and water pollution;
15. Ionospheric radiation protectors;
16. Spectrometers (including meters for ultraviolet rays, infrared rays
and visible lights);
17. Gaseous phase and liquid phase chromatographs;
18. Instruments for measuring temperature and moisture content.


国家食品药品监督管理局


关于贯彻落实党中央国务院西部大开发战略若干措施的通知


国药管办[2000]238号



各省、自治区、直辖市药品监督管理局或卫生厅（局）、医药管理部门，国家药品监督管理
局各直属单位：
　　实施西部大开发，加快中西部地区发展，是党中央总揽全局、面向新世纪作出的重大决
策，关系到民族团结、社会稳定和边防巩固，关系到东西部地区的协调发展和最终实现共同
富裕，具有重要的现实意义和深远的历史意义。江泽民总书记在党的十五届四中全会和1999
年中央经济工作会议上作了全面系统的阐述。2000年，国务院成立了以朱镕基总理为组长
的西部开发工作领导小组。 实施西部大开发已是全党、全国的一项重大战略任务。
　　为了认真贯彻落实党中央、国务院制定的西部大开发战略，从药品监督管理工作的角度，
按照“以监督为中心，监、帮、促相结合”的工作方针，全力支持和帮助西部地区提高药品
监督管理工作水平，促进西部地区医药经济的健康发展， 经局党组研究，特制定以下措施：

　　一、积极支持和帮助西部地区建立、完善药品研究、评价监督管理体系，促进西部地区
医药科研开发的发展
　　（一）从西部地区实际出发，特别是要结合西部地区的地方病、多发病新药研究的要求，
支持和帮助有条件的省（区）建立临床药理基地。组织专家有针对地进行指导，帮助培训相
关人员。
　　（二）根据西部地区的需要，支持和帮助西部地区有条件的省（区）建立医疗器械临床
试验基地。
　　（三）支持西部地区有条件的省（区）筹建医疗器械质量检测机构，加强西部地区医疗
器械检测工作，提高西部地区医疗器械产品质量。

　　二、优先安排西部地区药品项目审评，加快西部地区药品科研成果向生产力转化
　　（四）对西部地区申报的二类以上化学药品、生物制品、中药新药和利用当地药材资源
生产的三类中药新药，给予加快审评政策待遇。
　　（五）优先安排西部地区医疗器械三类产品注册和准产体系考核工作。

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　　（六）积极支持并鼓励医药企业利用西部地区药材资源建立工业原料基地和商业货源基
地，促进西部地区按照保护和开发并重的原则，合理利用西部药材资源，走持续发展的道路。
使用西部地区野生药材生产药品的，必须建立相应药材人工种植、养殖基地。
　　（七）积极引导西部地区药材基地实施药材种植质量管理规范（GAP），提高药材生产质
量。
　　（八）根据西部地区需要，组织专家帮助西部地区进行药材资源、质量标准研究，并指
导西部地区合理规划药材生产的品种、区域等。

　　四、积极支持西部地区发展具有地区特点的民族药
　　（九）做好西部地区民族药地方标准转为国家标准的工作。在具有国家标准的西部地区
民族药中，遴选部分品种进入国家基本药物目录，遴选部分品种成为非处方药品。

　　五、加大支持、帮助西部地区药品生产企业实施质量管理规范的力度，提高西部地区药
品生产企业质量管理水平
　　（十）组织专家对西部地区部分药品生产企业进行现场指导，帮助和指导企业进行GMP
改造。
　　（十一）优先安排对西部地区药品生产企业的GMP认证检查工作，按照认证程序，加快
认证步伐。
　　（十二）支持和帮助西部地区有条件的省（区）建立医疗器械ISO9000系列认证分支机
构。
　　（十三）优先安排西部地区医疗器械生产企业ISO9000系列认证工作。

　　六、大力帮助西部地区加快执业药师队伍建设，提高西部地区药品从业人员的素质
　　（十四）组织内地优秀师资力量，为西部地区免费提供执业药师资格考试师资培训。
　　（十五）根据西部地区的实际需要，在部分省（区）组织执业药师资格考前培训。

　　七、加强对西部地区药品监督管理队伍的培训，开展与西部省（区）药品监督管理部门
的干部交流活动
　　（十六）根据西部地区的实际需要，对部分省（区）的药品监督管理部门和技术监督部
门关键岗位的工作人员进行业务培训。
　　（十七）局机关、部分在京直属单位和东部地区药品监督管理部门要创造条件，开展与
西部地区药品监督管理部门的干部交流活动，为西部地区培养药品监督管理业务骨干。按照
国家有关干部管理政策，鼓励干部到西部地区药品监督管理部门挂职锻炼，同时，鼓励西部
地区药品监督管理干部到局机关、直属单位和东部地区药品监督管理部门挂职锻炼。

　　八、不断扩大西部地区药品监督管理部门对外交流
　　（十八）有重点地安排西部地区药品监督管理部门进行出国培训和考察。同时，创造条
件扩大西部地区药品监督管理部门的对外交流与合作。
　　
　　各级药品监督管理部门、各有关单位必须充分认识实施西部大开发战略的重大意义，坚
决贯彻党中央、国务院的部署，把支持和帮助西部大开发作为责无旁贷的重要任务，根据以
上部署，制定本地、本部门支持和帮助西部大开发的具体办法，实事求是，扎实工作，为西
部开发作出贡献。请各省、自治区、直辖市药品监督管理部门和各有关单位将制定的具体办
法及时报告我局。
　　特此通知


　　 国家药品监督管理局
　　 二○○○年六月十四日