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关于止鼾器等产品分类界定的通知

作者:法律资料网 时间:2024-05-13 22:38:50  浏览:9111   来源:法律资料网
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关于止鼾器等产品分类界定的通知

国家食品药品监督管理局


关于止鼾器等产品分类界定的通知

国食药监械[2004]331号


各省、自治区、直辖市食品药品监督管理局(药品监督管理局):

  近期,我局陆续收到一些省级食品药品监督管理部门和进口企业对部分产品进行分类界定的请示。为适应各地对医疗器械监督管理工作的需要,现将止鼾器等产品的分类界定通知如下:

  一、非植入式止鼾器:作为II类医疗器械管理。

  二、药粉吸入器:用于药粉的口腔吸入。作为I类医疗器械管理。

  三、颈椎固定带:用于外伤后的固定。作为I类医疗器械管理。

  四、光鼻器:用于治疗过敏性鼻炎。作为II类医疗器械管理。

  五、排龈线:用于退缩牙龈组织及牙龈毛细血管止血和口腔组织出血时的止血。作为II 类医疗器械管理。

  六、卵母细胞采集器:包含一个单腔穿刺针。作为II 类医疗器械管理。

  七、胚胎移植管:用于将胚胎移植到宫腔内。作为II 类医疗器械管理。

  八、囊胚培养液:用于体外授精的培养,提供胚胎细胞在各个时期的生长环境。作为III类医疗器械管理。

  九、胚胎冷冻液:用于冷冻期及复苏期的胚胎。作为III类医疗器械管理。

  十、精子处理洗涤液:用于体外授精中精子的洗涤。作为III类医疗器械管理。

  十一、胃肠道造影显影剂:用于B超、CT、MRI的胃肠道造影显像。作为III类医疗器械管理。

  十二、婴儿吸氧罩:用于婴儿在高压氧舱内呼吸纯氧。作为II类医疗器械管理。

  十三、骨质疏松治疗系统:利用电磁螺线圈对患者的骨头进行物理治疗。作为II类医疗器械管理。

  十四、快速过敏皮试仪:供临床用作青霉素等药物皮肤过敏反应的快速试验用。作为III类医疗器械管理。

  十五、助眠器:用于帮助失眠患者入眠。作为II类医疗器械管理。

  十六、IgG抗A抗体快速检测试剂盒:用于诊断新生儿溶血和黄疸发生机率和严重程度。作为III类医疗器械管理。

  十七、尿微量白蛋白测试卡:采用胶体金法半定量测试尿中白蛋白,用于肾功能异常高危人群的筛选。作为III类医疗器械管理。

  十八、检查灯:在检查室内用于医生对病人近距离检查时用作照明,不能用于手术室。不作为医疗器械管理。

  十九、多功能试管架:不作为医疗器械管理。

  二十、显微镜专用液晶显示器:不作为医疗器械管理。

  二十一、阴冷理疗器:用于已婚女性性功能冷淡者使用。不作为医疗器械管理。

  二十二、凹面镜近视防治仪:由一凹面镜及其框架等组成,用于锻炼睫状肌、预防近视等。不作为医疗器械管理。

  二十三、微生物反应产物显色指示剂:微生物与不同地物反应会产生不同的产物,有的产物需外加显色剂来显色,显色剂的主要成份均为化学试剂,本身不具备微生物鉴定作用。不作为医疗器械管理。

  二十四、信息工作站:有电脑主机、显示器、键盘和鼠标组成,通过数据网线连接医院相应的设备和PACS系统,将一些生命指征参数、发射影像及其它实时医疗设备的数据进行集成显示,本身不具有诊断作用。不作为医疗器械管理。

  二十五、美容笔:用于消除眼角鱼尾纹或眼袋纹,延缓皱纹产生。不作为医疗器械管理。上述凡界定为医疗器械的产品,从2005年1月1日起执行调整后的类别。


                            国家食品药品监督管理局
                             二○○四年七月七日



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汕头市市级渔业龙头企业评定管理办法

广东省汕头市人民政府


印发《汕头市市级渔业龙头企业评定管理办法》的通知

汕府〔2004〕152号

各区县人民政府,市政府各部门、各直属机构:
  现将《汕头市市级渔业龙头企业评定管理办法》印发给你们,请认真贯彻执行。



汕头市人民政府
二○○四年十月九日




汕头市市级渔业龙头企业评定管理办法

第一条 为促进本市渔业产业化经营,提高渔业整体效益,规范渔业龙头企业的评定和运行监测,做好对渔业龙头企业的服务与扶持工作,根据有关法律、法规、政策,结合本市实际,制定本办法。
第二条 本办法所称渔业龙头企业,是指以水产品养殖、捕捞、加工或流通为主业,通过各种利益联结机制与渔户相联系,带动渔户进入市场,使水产品生产、加工、销售有机结合、相互促进,并依据本办法被评定为龙头的渔业企业。
第三条 渔业龙头企业的评定和运行监测,应遵循市场经济规律,引进竞争淘汰机制,发挥中介组织和专家作用,坚持公开、公平、公正原则,不干预企业经营自主权。
第四条 凡在本市行政区域内从事的市级渔业龙头企业的申报、评定及相关的管理工作,适用本办法。
第五条 市海洋与渔业行政主管部门负责市级渔业龙头企业的评定的组织、管理工作,具体实施本办法。
第六条 申报市级渔业龙头企业,应符合以下基本标准和条件:
(一)企业组织形式。依法设立的、具有独立法人资格的企业,包括依照《公司法》设立的公司,其他形式的国有、集体、民营企业以及中外合资经营、中外合作经营、外商独资企业,或直接在工商行政管理部门登记开办的水产品专业贸易市场等。
(二)企业经营的产品。企业中水产品的产值或销售额 (生产经营值连续3年)占企业总产值或销售额的60%以上。
(三)企业规模:
1、水产加工流通企业:总资产3000万元以上;年销售收入8000万元以上,税利500万元以上。
2、水产养殖企业:养殖面积50公顷以上或集约化养殖面积10公顷以上或工厂化养殖8000立方米水体以上,总资产500万元以上,年销售收入1000万元以上,税利100万元以上;或被评为省级以上(含省级)良种场、示范单位,年销售收入800万以上。
3、水产品专业贸易市场:年交易额3亿元以上,税利500万元以上。
(四)企业效益。企业的总资产收益率高于或接近同期银行贷款利率;企业不欠税、不欠工资、不欠社会保险费、不欠折旧,不亏损。
(五)企业负债与信用。企业资产负债率一般应低于60%(含60%);企业银行信用等级在A级(或相似级别)以上(含A级)。在未进行信用等级评定的银行业金融机构贷款的企业必须没有逃废债务的行为。
(六)企业带动能力。通过合同或其它合法约定建立可靠、稳定的利益联结机制带动渔户的数量(包括养殖户、捕捞船)一般应达到200户以上或捕捞渔船50艘以上,每户年从中获取纯收入1000元以上;或企业通过订立合同、入股和合作方式采购的原料或购进的货物占所需原料量或所购进(销售)货物量的 70%以上(含70%)。
(七)企业产品竞争力。在同行业中企业的产品质量、产品科技含量、新产品开发能力居领先水平,主营产品符合国家或进口国的质量安全标准,符合国家产业政策、环保政策,产销率达93%以上。
申报企业吸纳50名以上转产转业渔民或直系亲属就业,前款规定的年销售收入和税利评定标准可适当降低。
第七条 市级渔业龙头企业每年评定一次,每年3月底前申报。
第八条 区(县)属及以下企业申报市级渔业龙头企业,按以下程序办理:
(一)向所在区(县)海洋与渔业行政主管部门提出申请并提供以下申报材料:
1、企业的基本情况。
2、符合本办法第六条要求的书面证明材料。其中,企业的资产和效益情况由有资质的中介机构(会计师事务所)提供审计报告;企业的资信情况由其开户银行提供证明;企业的带动能力和利益联结关系情况由县级以上海洋与渔业行政主管部门提供说明。
(三)所在区(县)海洋与渔业行政主管部门对企业所报材料的真实性进行审核;
(四)区(县)海洋与渔业行政主管部门报经区县人民政府同意,以书面形式向市海洋与渔业行政主管部门推荐,并附审核意见和相关材料。
第九条 市属企业直接向市海洋与渔业行政主管部门申报。申报应提供的申报材料参照本办法第八条第一款第(一)项的规定执行。
第十条 市海洋与渔业行政主管部门成立市级渔业龙头企业评定和运行监测评价专家组(以下简称专家组),负责对申报市级渔业龙头的企业进行审核评定和对已评定企业进行监测评价。
第十一条 市级渔业龙头企业评定程序和办法:
(一)市海洋与渔业行政主管部门对区(县)海洋与渔业行政主管部门上报的区(县)属以下企业有关材料,以及市属企业直接报送的有关材料进行初审或组织专家对企业进行核查后,符合条件的交专家组进行综合评定,提出评定结论。
(二)市海洋与渔业行政主管部门根据专家组评审意见综合审核,确定评定名单。
(三)由市海洋与渔业行政主管部门将评定结果报市人民政府批准后,授予被评定企业“汕头市渔业龙头企业”称号,颁发证书,并向社会公开公布。
第十二条 经评定公布的市级渔业龙头企业,享受国家、省、市对渔业龙头企业的优惠和扶持。
第十三条 市级渔业龙头企业实行动态管理。
市海洋与渔业行政主管部门应建立市级渔业龙头企业动态监测制度,及时了解企业的经营发展情况,并进行运行监测评价,为企业的进出提供依据。
第十四条 对市级渔业龙头企业实行两年一次的监测评价,第一次监测是在企业被评定为汕头市渔业龙头企业开始的第三个年份,以后类推。
第十五条 市级渔业龙头企业的监测评价具体程序和办法为:
(一)企业报送基础材料。在进行监测年份的2月底前,企业将反映企业变化情况的基础材料按企业归属,分别报企业所在区(县)海洋与渔业行政主管部门或市海洋与渔业行政主管部门。材料包括:经有资质会计师事务所审定的企业情况统计表,主要是资产负债表、损益表、现金流量表等;开户银行提供的资信证明;县级以上海洋与渔业主管部门提供的企业与渔户利益联结关系的说明;享受优惠政策的落实情况等。
(二)材料汇总与核查。在进行监测年份的3月份,各区(县)海洋与渔业行政主管部门对所辖市级渔业龙头企业所报基础材料进行汇总、核查。核查无误后,报市海洋与渔业行政主管部门;市属企业的,由海洋与渔业行政主管部门直接核查。
(三)专家评价。市海洋与渔业行政主管部门对企业报送的基础数据材料进行初审或组织专家对企业进行核查,合格的交专家组提出评价意见。
(四)提出监测情况报告。市海洋与渔业行政主管部门根据专家组的评价意见和企业的情况,对龙头企业的运行状况进行综合审核、确认。
(五)市海洋与渔业行政主管部门向社会公布监测结果。
第十六条 经动态监测合格的市级渔业龙头企业企业,继续享受有关优惠和扶持政策;对监测不合格者,收回证书,取消汕头市渔业龙头企业资格,不再享受有关优惠政策。
第十七条 在不属监测评价的年份,各区(县)海洋与渔业行政主管部门将所辖市级渔业龙头企业的基本情况按有关报表制度统计汇总,于当年的3月底之前报市海洋与渔业行政主管部门;属市属企业的,企业应将企业的基本情况于当年的3月底之前直接报市海洋与渔业行政主管部门。
第十八条 市级渔业龙头企业及申报市级渔业龙头企业的企业应按要求如实提供有关材料,不得弄虚作假。如果存在舞弊行为,一经查实,已经评定的企业取消其市级渔业龙头企业资格;未经评定的企业取消其申报资格,2年内不得再行申报。
第十九条 对在市级渔业龙头企业申报、评定、监测评价过程中不能坚持公开、公平、公正原则,存在徇私舞弊行为的工作人员,由其所在单位或上级主管部门依法追究其行政责任;构成犯罪的,依法追究刑事责任。
第二十条 市级渔业龙头企业更改企业名称,需要对其市级渔业龙头企业称号予以重新确认的,企业应出具工商行政管理部门的营业执照等更名材料,按企业归属由所在区县海洋与渔业行政主管部门提出审查意见或直接报市海洋与渔业行政主管部门,报市海洋与渔业行政主管部门审核确认。
第二十一条 本办法由市海洋与渔业行政主管部门负责解释。
第二十二条 本办法自颁布之日起施行。






LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE PROCEDURE OF THECONCLUSION OF TREATIES ——附加英文版

The Standing Committee of the National People's Congress


LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE PROCEDURE OF THECONCLUSION OF TREATIES

(Adopted at the 17th Meeting of the Standing Committee of the
Seventh National People's Congress on December 28, 1990, promulgated by
Order No. 37 of the President of the People's Republic of China on
December 28, 1990, and effective as of the same date)

Article 1
The present Law is enacted in accordance with the Constitution of the
People's Republic of China.
Article 2
This Law shall be applicable to bilateral or multilateral treaties and
agreements and other instruments of the nature of a treaty or agreement
concluded between the People's Republic of China and foreign states.
Article 3
The State Council, that is, the Central People's Government, of the
People's Republic of China shall conclude treaties and agreements with
foreign states.
The Standing Committee of the National People's Congress of the People's
Republic of China shall decide on the ratification and abrogation of
treaties and important agreements concluded with foreign states.
The President of the People's Republic of China shall, in accordance with
decisions of the Standing Committee of the National People's Congress,
ratify and abrogate treaties and important agreements concluded with
foreign states.
The Ministry of Foreign Affairs of the People's Republic of China shall,
under the leadership of the State Council, administer the specific affairs
concerning the conclusion of treaties and agreements with foreign states.
Article 4
The People's Republic of China shall conclude treaties and agreements with
other states in the name of:
(1) the People's Republic of China;
(2) the Government of the People's Republic of China;
(3) the governmental departments of the People's Republic of China.
Article 5
The decision to negotiate and sign treaties and agreements shall be made
according to the following procedures:
(1) in the case of a treaty or agreement to be negotiated and signed in
the name of the People's Republic of China, the Ministry of Foreign
Affairs or the department concerned under the State Council in conjunction
with the Ministry of Foreign Affairs shall make a recommendation and draw
up a draft treaty or agreement of the Chinese side and submit it to the
State Council for examination and decision;
(2) in the case of a treaty or agreement to be negotiated and signed in
the name of the Government of the People's Republic of China, the Ministry
of Foreign Affairs or the department concerned under the State Council
shall make a recommendation and draw up a draft treaty or agreement of the
Chinese side and, after consultation with the Ministry of Foreign Affairs,
submit it to the State Council for examination and decision. In the case
of an agreement concerning a specific line of business, its Chinese draft
shall, with the consent of the State Council, be examined and decided upon
by the department concerned under the State Council or when necessary in
consultation with the Ministry of Foreign Affairs;
(3) agreements to be negotiated and signed in the name of a governmental
department of the People's Republic of China concerning matters within the
scope of functions and powers of the department concerned shall be decided
upon by the department itself or after consultation with the Ministry of
Foreign Affairs. In the case of an agreement relating to matters of major
importance or matters falling within the functions and powers of other
departments under the State Council, the department concerned shall submit
it by itself or after consultation with the other departments concerned
under the State Council, to the State Council for decision. The draft
agreement of the Chinese side shall be examined and decided upon by the
department concerned or when necessary in consultation with the Ministry
of Foreign Affairs.
When major modification in the Chinese draft of a treaty or agreement
already examined and decided upon by the State Council are necessary as a
result of negotiation, the revised draft shall be submitted to the State
Council for examination and decision.
Article 6
Representatives for negotiating and signing treaties or agreements shall
be appointed according to the following procedures:
(1) In the case of a treaty or agreement to be concluded in the name of
the People's Republic of China or the Government of the People's Republic
of China, the Ministry of Foreign Affairs or the department concerned
under the State Council shall submit a report to the State Council for the
appointment of a representative. The full powers of the representative
shall be signed by the Premier of the State Council, but may also be
signed by the Minister of Foreign Affairs.
(2) In the case of an agreement to be concluded in the name of a
governmental department of the People's Republic of China, a
representative shall be appointed by the head of the department concerned.
The letter of authorization for the representative shall be signed by the
head of the department. Where the head of a department signs an agreement
concluded in the name of the governmental department, and where the
contracting parties agree that it is necessary for the head of the
department to produce full powers, the full powers shall be signed by the
Premier of the State Council, but may also be signed by the Minister of
Foreign Affairs.
The following persons shall dispense with full powers for negotiating and
signing treaties and agreements:
(1) the Premier of the State Council, the Minister of Foreign Affairs;
(2) the head of a diplomatic mission of the People's Republic of China who
negotiates and signs treaties and agreements concluded between China and
the state to which he is accredited, unless it is otherwise agreed by the
contracting parties;
(3) the head of a governmental department of the People's Republic of
China who negotiates and signs the agreements concluded in the name of his
department, unless it is otherwise agreed by the contracting parties;
(4) the person, dispatched to an international conference or accredited to
an international organization by the People's Republic of China, who is at
the same time the representative for negotiating treaties or agreements in
that conference or organization, unless it is otherwise agreed by the
conference or otherwise provided for in the constitution of the
organization.
Article 7
The ratification of treaties and important agreements shall be decided
upon by the Standing Committee of the National People's Congress.
The treaties and important agreements referred to in the preceding
paragraph are as follows:
(1) treaties of friendship and cooperation, treaties of peace and similar
treaties of a political nature;
(2) treaties and agreements relating to territory and delimitation of
boundary lines;
(3) treaties and agreements relating to judicial assistance and
extradition;
(4) treaties and agreements which contain stipulations inconsistent with
the laws of the People's Republic of China;
(5) treaties and agreements which are subject to ratification as agreed by
the contracting parties; and
(6) other treaties and agreements subject to ratification.
After the signing of a treaty or an important agreement, the Ministry of
Foreign Affairs or the department concerned under the State Council in
conjunction with the Ministry of Foreign Affairs shall submit it to the
State Council for examination and verification; the State Council shall
then refer it to the Standing Committee of the National People's Congress
for decision on ratification; the President of the People's Republic of
China shall ratify it in accordance with the decision of the Standing
Committee of the National People's Congress.
After the ratification of a bilateral treaty or an important bilateral
agreement, the Ministry of Foreign Affairs shall execute the formalities
for the exchange of the instruments of ratification with the other
contracting party. After the ratification of a multilateral treaty or an
important multilateral agreement, the Ministry of Foreign Affairs shall
execute the formalities for the deposit of the instrument of ratification
with the depositary state or international organization. The instrument of
ratification shall be signed by the President of the People's Republic of
China and countersigned by the Minister of Foreign Affairs.
Article 8
After the signing of the agreements and other instruments of the nature of
a treaty which do not fall under paragraph 2, Article 7 of this Law and
which are subject to approval as prescribed by the State Council or as
agreed by the contracting parties, the Ministry of Foreign Affairs or the
departments concerned under the State Council in conjunction with the
Ministry of Foreign Affairs shall submit them to the State Council for
approval. After the approval of agreements and other instruments of the
nature of a treaty, in the case of a bilateral one, the Ministry of
Foreign Affairs shall execute the formalities for the exchange of the
instruments of approval with the other contracting party or for mutual
notification of the approval by diplomatic notes. In the case of a
multilateral one, the Ministry of Foreign Affairs shall execute the
formalities for the deposit of the instrument of approval with the
depositary state or international organization concerned. The instrument
of approval shall be signed by the Premier of the State Council, but may
also be signed by the Minister of Foreign Affairs.
Article 9
After the signing of the agreements which need no decision on ratification
by the Standing Committee of the National People's Congress or approval by
the State Council, the agreements shall be submitted by the departments
concerned under the State Council to the State Council for the record,
except those agreements concluded in the name of the governmental
departments of the People's Republic of China which are to be submitted by
these departments to the Ministry of Foreign Affairs for registration.
Article 10
If the two contracting parties need to go through different domestic legal
procedures for the entry into force of the same treaty or agreement, the
said treaty or agreement shall enter into force after the accomplishment
by the two parties of their respective legal procedures and the mutual
notification by diplomatic notes.
After the signing of the treaties and agreements listed in the preceding
paragraph, the formalities of ratification, approval, entry on the record
or registration shall be executed as the case requires in accordance with
Articles 7, 8 or 9 of this Law. The formalities of notification by note
shall be completed by the Ministry of Foreign Affairs.
Article 11
The decision to accede to multilateral treaties or agreements shall be
made by the Standing Committee of the National People's Congress or the
State Council as the case requires. The procedures for acceding to
multilateral treaties and agreements shall be as follows:
(1) to accede to a multilateral treaty or an important multilateral
agreement listed in Paragraph 2, Article 7 of this Law, the Ministry of
Foreign Affairs or the department concerned under the State Council in
conjunction with the Ministry of Foreign Affairs shall make a
recommendation after examination and submit it to the State Council for
examination and verification; the State Council shall then refer it to the
Standing Committee of the National People's Congress for decision on
accession. The instrument of accession shall be signed by the Minister of
Foreign Affairs, and the specific formalities executed by the Ministry of
Foreign Affairs;
(2) to accede to a multilateral treaty or agreement other than those
listed in Paragraph 2, Article 7 of this Law, the Ministry of Foreign
Affairs or the department concerned under the State Council in conjunction
with the Ministry of Foreign Affairs shall make a recommendation after
examination and submit it to the State Council for decision on accession.
The instrument of accession shall be signed by the Minister of Foreign
Affairs, and the specific formalities executed by the Ministry of Foreign
Affairs.
Article 12
The decision to accept a multilateral treaty or an agreement shall be made
by the State Council.
In the case of a multilateral treaty or agreement containing clauses of
acceptance which is signed by the Chinese representative or does not
require any signature, the Ministry of Foreign Affairs or the department
concerned under the State Council in conjunction with the Ministry of
Foreign Affairs shall make a recommendation after examination and submit
it to the State Council for decision on acceptance. The instrument of
acceptance shall be signed by the Minister of Foreign Affairs, and the
specific formalities executed by the Ministry of Foreign Affairs.
Article 13
A bilateral treaty or agreement concluded by the People's Republic of
China with a foreign state shall be done in the Chinese language and the
official language of the other contracting party, both texts being equally
authentic. When necessary, a text in the language of a third state agreed
upon by the two contracting parties may be executed in addition as a
third, equally authentic, official text or an unofficial text for
reference. It may be stipulated by agreement of the two contracting
parties that the third text shall prevail in case of divergence of
interpretation of the treaty or agreement.
For agreements on specific lines of business and treaties and agreements
concluded with international organizations, a single language fairly
commonly used internationally may also be used by agreement of the two
contracting parties or in accordance with the provisions of the
constitutions of the international organizations concerned.
Article 14
Signed originals of bilateral treaties and agreements concluded in the
name of the People's Republic of China or the Government of the People's
Republic of China and copies of multilateral treaties and agreements
certified as true by the depositary states or international organizations
concerned shall be deposited with the Ministry of Foreign Affairs. Signed
originals of bilateral agreements concluded in the name of the
governmental departments of the People's Republic of China shall be
deposited with these departments.
Article 15
A treaty or an important agreement of which the Standing Committee of the
National People's Congress has decided on ratification or accession shall
be published in the bulletin of the Standing Committee of the National
People's Congress. The measures for publishing other treaties and
agreements shall be made by the State Council.
Article 16
Treaties and agreements concluded by the People's Republic of China shall
be compiled by the Ministry of Foreign Affairs into a collection of the
Treaties of the People's Republic of China.
Article 17
Treaties and agreements concluded by the People's Republic of China shall
be registered with the Secretariat of the United Nations by the Ministry
of Foreign Affairs in accordance with the relevant provisions of the
United Nations Charter. Treaties and agreements concluded by the People's
Republic of China that require registration with other international
organizations shall be registered by the Ministry of Foreign Affairs or
the departments concerned under the State Council in accordance with the
respective constitutions of the international organizations.
Article 18
The procedures for the conclusion of a treaty or an agreement with an
international organization by the People's Republic of China shall follow
this Law and the constitution of the relevant international organization.
Article 19
The procedures for amendment to, abrogation of and withdrawal from
treaties and agreements concluded by the People's Republic of China shall
follow mutatis mutandis the procedures for the conclusion of the treaties
and agreements in question.
Article 20
The State Council may make regulations in accordance with this Law for its
implementation.
Article 21
This Law shall enter into force as of the date of promulgation.


Important Notice:
This English document is coming from "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.


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