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(Adopted at the 7th Meeting of the Standing Committee of the Eighth National People’s Congress on May 12, 1994, revised
at the 8th Meeting of the Standing Committee of the Tenth National People’s Congress and promulgated by Order No. 15 of the President
of the People’s Republic of China on April 6, 2004)
Contents
Chapter I General Provisions
Chapter II Foreign Trade Dealers
Chapter III Import and Export of Goods and Technologies
Chapter IV International Trade in Services
Chapter V Protection of Trade-Related Aspects of Intellectual Property Rights
Chapter VI Foreign Trade Order
Chapter VII Foreign Trade Investigation
Chapter VIII Foreign Trade Remedies
Chapter IX Promotion of Foreign Trade
Chapter X Legal Responsibility
Chapter XI Supplementary Provisions
Chapter I
General Provisions
Article 1 This Law is enacted with a view to opening wider to the outside world, developing foreign trade, maintaining foreign
trade order, protecting the legitimate rights and interests of foreign trade dealers and promoting the sound development of the socialist
market economy.
Article 2 This Law is applicable to foreign trade and the protection of foreign-trade-related aspects of intellectual property
rights.
For purposes of this Law, foreign trade refers to the import and export of goods and technologies, and international service trade.
Article 3 The department for foreign trade under the State Council is in charge of foreign trade throughout the country pursuant
to this Law.
Article 4 The State applies a unified system of foreign trade, encourages the development of foreign trade and preserves a
fair and free foreign trade order.
Article 5 The People’s Republic of China, on the principle of equality and mutual benefit, promotes and develops trade relations
with other countries and regions, concludes or accedes to such regional economic and trade agreements as tariff alliances agreement
and free trade zone agreement, and joins regional economic organizations.
Article 6 In the field of foreign trade, the People’s Republic of China, in accordance with the international treaties and
agreements it has signed or acceded to, grants the other signatories or acceding parties most-favored-nation treatment or national
treatment, or on the principle of mutual benefit and reciprocity, grants the other party most-favored-nation treatment or national
treatment, etc.
Article 7 In the event that any country or region adopts prohibitive, restrictive or other similar measures that are discriminatory
in nature against the People’s Republic of China in trade, the People’s Republic of China may, in light of the actual conditions,
take countermeasures against the country or region accordingly.
Chapter II
Foreign Trade Dealers
Article 8 For purposes of this Law, foreign trade dealers refer to the legal persons, other organizations or individuals that
have gone through the formalities of industrial, commercial or other registration in accordance with law and engage in foreign trade
activities in compliance with the provisions of this Law and relevant laws and administrative regulations.
Article 9 A foreign trade dealer who intends to engage in the import and export of goods or technologies shall register with
the department for foreign trade under the State Council or the body it entrusts with the registration, unless otherwise prescribed
by laws, administrative regulations or by the said department. The specific measures for registration shall be formulated by the
department.
Where a foreign trade dealer fails to register as required by regulations, the Customs shall not process the procedures of declaration,
inspection and release for the import or export of goods.
Article 10 The units and individuals engaged in international trade in services shall observe the provisions of this Law, and
of the relevant laws and administrative regulations.
The units engaged in contracted construction of foreign projects or service cooperation with other countries shall have the necessary
eligibility or qualification. The specific measures in this regard shall be formulated by the State Council.
Article 11 The State may put the import and export of certain goods under the control of State- operated trading. Such goods
shall only be imported and exported by the authorized enterprises, expect the import and export of certain quantities of the goods
under State- operated trading which the State permits to be operated by unauthorized enterprises.
The catalogues of the goods under the control of State- operated trading and the authorized enterprises shall be determined, adjusted
and published by the department for foreign trade under the State Council in conjunction with the relevant department under the State
Council.
Where, in violation of the provisions in the first paragraph of this Article, the goods under State- operated trading are imported
or exported without authorization, the Customs shall not grant to them clearance.
Article 12 A foreign trade dealer may accept the entrustment by another person to engage in foreign trade as an agent within the
scope of its business operations.
Article 13 A foreign trade dealer shall, in accordance with the regulations laid down according to law by the department for foreign
trade under the State Council or any other relevant department under the State Council, submit to relevant departments the
documents and information related to its foreign trade activities. The latter shall keep the business secrets for the former.
Chapter III
Import and Export of Goods and Technologies
Article 14 The State permits free import and export of goods and technologies, except where otherwise provided for in laws and administrative
regulations.
Article 15 The department for foreign trade under the State Council may, based on the need to monitor imports and exports, implement
an automatic import and export licensing system for certain goods subject to free import and export and shall publish the catalogue
thereof.
Where the consignee or consigner, before going through the Customs declaration formalities, submits an application for automatic
licensing for the import or export of the goods under such licensing, the department for foreign trade under the State Council or
its authorized department shall grant permission to it . The Customs shall not grant clearance to the goods for which the formalities
for automatic licensing are not gone through.
In the case of importing or exporting technologies subject to free import and export, the contracts thereof shall be registered with
the department for foreign trade under the State Council or the authority it entrusts with such registration.
Article 16 For the following reasons, the State may restrict or prohibit the import or export of relevant goods and technologies:
(1) for safeguarding State security, and public interests and ethics, it is necessary to restrict or prohibit their import and export;
(2) for protecting human health or safety, the lives or health of animals and plants, or the environment, it is necessary to restrict
or prohibit their import or export;
(3) for implementing the measures related to the import and export of gold and silver, it is necessary to restrict or prohibit their
import or export;
(4) because of short supply on domestic market or for effective conservation of exhaustible natural resources, it is necessary to
restrict or prohibit their export;
(5) because of the limited market capacity of the importing country or region, it is necessary to restrict their export;
(6) because of serious chaos in export order, it is necessary to restrict their export;
(7) for establishing or speeding up the establishment of a particular domestic industry, it is necessary to restrict their import;
(8) it is necessary to restrict the import of agricultural, animal husbandry and fishery products of any form;
(9) for maintaining the State’s international financial position and the balance of international receipts and payments, it is necessary
to restrict their import;
(10) other goods the import or export of which needs to be restricted or prohibited, as required by laws and administrative regulations;
or
(11) other goods the import or export of which needs to be restricted or prohibited in accordance with the provisions of international
treaties or agreements signed or acceded to by the People’s Republic of China.
Article 17 With regard to the import and export of goods and technologies related to fissile and fusion material or the substances
from which such material is derived, and the imports and exports related to arms, ammunition or other military supplies, the State
may adopt any necessary measures to safeguard State security.
In wartime or for the purpose of preserving international peace and security, the State may adopt any necessary measures in respect
of the import and export of goods and technologies.
Article 18 The department for foreign trade under the State Council shall, in conjunction with other departments under the
State Council and in accordance with the provisions in Articles 16 and 17 of this Law, formulate, adjust and publish the catalogue
of goods and technologies that are restricted or prohibited for import or export.
With the approval of the State Council, the department for foreign trade under the State Council or the said department in conjunction
with other relevant departments under the State Council may, within the scope specified by the provisions in Article 16 and 17 of
this Law, decide on temporary restriction or prohibition on the import or export of specific goods and technologies other than the
ones listed in the catalogue mentioned in the preceding paragraph.
Article 19 The State exercises control of the goods subject to import or export restriction through quotas, licensing, etc;
with regard to the technologies the import or export of which is restricted, it exercises control through licensing.
The goods and technologies subject to control through quotas or licensing may only be imported or exported upon permission by the
department for foreign trade under the State Council, or upon permission jointly by the department and the relevant departments under
the State Council, as required by the regulations of the State Council.
The State exercises control of part of the imported goods through tariff-rate quota.
Article 20 Quotas for imported and exported goods and tariff-rate quotas shall be distributed by the department for foreign trade
under the State Council or the relevant departments under the State Council within the limits of their respective responsibilities,
on the principles of openness, fairness, impartiality and efficiency. The specific measures in this regard shall be formulated by
the State Council.
Article 21 The State implements a unified commodity assessment system and, in accordance with the provisions of relevant laws
and administrative regulations, carries out certification, inspection and quarantine in respect of imported and exported commodities.
Article 22 The State applies rules of origin to the imported and exported goods. The specific measures in this regard shall
be formulated by the State Council.
Article 23 Where the import or export of cultural relics, wild animals and plants and their products are prohibited or restricted
by the provisions of other laws or administrative regulations, the provisions of those laws and administrative regulations shall
prevail.
Chapter IV
International Trade in Services
Article 24 In respect of international trade in services, the People’s Republic of China shall, in accordance with its commitments
made in the international treaties or agreements it has signed or acceded to, grant the other signatories and acceding parties market
access and national treatment.
Article 25 The department for foreign trade under the State Council and the relevant departments under the State Council shall, pursuant
to the provisions of this Law and the relevant laws and administrative regulations, regulate international trade in services.
Article 26 For any of the following reasons, the State may restrict or prohibit the relevant international trade in services:
(1) restrictions or prohibitions are needed for safeguarding State security and public interests and ethics;
(2) restrictions or prohibitions are needed for protecting human health or safety, the lives or health of animals and plants, or
the environment;
(3) restrictions are needed for establishing or speeding up the establishment of a particular domestic service industry;
(4) restrictions are needed for maintaining the balance of receipts and payments of the State in foreign exchanges;
(5) restrictions or prohibitions are needed for other reasons, as laws and administrative regulations so provide; or
(6) restrictions or prohibitions are needed for other reasons, as required by the provisions of the international treaties or agreements
which China has signed or acceded to.
Article 27 With regard to military-related international trade in services, and international trade in services related to fissile
and fusion material or the substances from which such material is derived, the State may adopt any necessary measure to safeguard
State security.
In wartime or for the purpose of preserving international peace and security, the State may adopt any necessary measure in respect
of international trade in services.
Article 28 The department for foreign trade under the State Council shall, in conjunction with the relevant departments under the
State Council and in accordance with the provisions in Articles 26 and 27 of this Law and relevant laws and administrative regulations,
formulate, adjust and publish the market access catalogue of international trade in services.
Chapter V
Protection of Trade-Related Aspects of Intellectual Property Rights
Article 29 The State protects trade-related intellectual property rights in accordance with the laws and administrative regulations
concerning intellectual property rights.
Where any imported goods infringe upon intellectual property rights and impair foreign trade order, the department for foreign trade
under the State Council may take such measures as prohibiting, for a specified period of time, the import of the relevant goods produced
or sold by the infringer.
Article 30 Where the owner of a intellectual property right commits any of the acts, such as preventing the licensee from challenging
the validity of the intellectual property right in the licensing contract, imposing mandatory package licensing on the licensee or
incorporating exclusive grant-back conditions in the licensing contract, which undermines the order of fair competition in foreign
trade, the department for foreign trade under the State Council may take any necessary measures to eliminate the harm done.
Article 31 If any country or region fails to grant the legal persons, other organizations or individuals from the People’s Republic
of China national treatment in respect of protection of intellectual property rights, or cannot adequately and effectively protect
the intellectual property rights in respect of the goods, technologies or services from the People’s Republic of China, the department
for foreign trade under the State Council may, in accordance with the provisions of this Law and the relevant laws and administrative
regulations, and the international treaties or agreements which the People’s Republic of China has signed or acceded to, take any
necessary measures in respect of trade with the country or region in question.
Chapter VI
Foreign Trade Order
Article 32 In foreign trade activities, monopolistic behavior in violation of the provisions of the laws and administrative regulations
against monopoly is not allowed.
In foreign trade activities, any monopolistic behavior that jeopardizes fair market competition shall be dealt with in accordance
with the provisions of the laws and administrative regulations against monopoly.
In the event that violations as mentioned in the preceding paragraph are committed, which undermine foreign trade order, the department
for foreign trade under the State Council may take any necessary measures to eliminate the harm done.
Article 33 In foreign trade activities, no one may engage in unfair competition, such as selling commodities at unreasonably low
prices, colluding with another person in a tender, publishing false advertisements and practising commercial bribery.
Any unfair competition in foreign trade activities shall be dealt with in accordance with the provisions of laws and administrative
regulations against unfair competition.
In the event that violations as mentioned in the preceding paragraph are committed, which undermine foreign trade order, the department
for foreign trade under the State Council may take any measures such as prohibiting the dealer from importing and exporting relevant
goods and technologies to eliminate the harm done.
Article 34 In foreign trade activities, none of the following acts may be committed:
(1) forging or falsifying marks of origin of imported or exported goods; forging, falsifying or dealing in origin certificates
of imported or exported goods, import or export licenses, certificates of import or export quotas, or any other import or export
certificates;
(2) obtaining export tax refund by fraudulent means;
(3) smuggling;
(4) evading certification, inspection or quarantine which is required by laws and administrative regulations; or
(5) other acts in violation of the provisions of laws and administrative regulations.
Article 35 In foreign trade activities, foreign trade dealers shall act in compliance with the regulations of the State governing
foreign exchange control.
Article 36 The department for foreign trade under the State Council may make known to the public any violations of this Law, which
undermine foreign trade order.
Chapter VII
Foreign Trade Investigation
Article 37 To maintain foreign trade order, the department for foreign trade under the State Council may, on its own or jointly with
the relevant departments under the State Council, investigate the following matters in accordance with the provisions of laws and
administrative regulations:
(1) the impact on domestic industries and their competitiveness exerted by the imported and exported goods, imported or exported
technologies, and international trade in services;
(2) trade barriers erected by relevant countries or regions;
(3) matters needing to be investigated in order to determine whether such foreign trade remedies as anti-dumping, countervailing
duties and safeguards should be taken in accordance with law;
(4) acts circumventing foreign trade remedies;
(5) matters concerning State security and interests in foreign trade;
(6) matters needing to be investigated in order to enforce the provisions in Article 7, the second paragraph of Article 29, Articles
30 and 31, the third paragraph of Article 32 and of Article 33; and
(7) other matters that may have an impact on foreign trade order.
Article 38 The initiation of a foreign trade investigation shall be announced by the department for foreign trade under the State
Council.
The investigation may be conducted in the form of written questionnaire, hearing, on-the-spot investigation, entrusted investigation,
etc.
The department for foreign trade under the State Council shall, based on the findings, submit an investigation report or make a ruling,
and make the matter known to the public.
Article 39 The units and individuals concerned shall cooperate and assist in foreign trade investigation.
The department for foreign trade under the State Council and the relevant departments under the State Council and their staff members
shall have the obligation to keep confidential the State secrets and business secrets they come to know in the course of foreign
trade investigation.
Chapter VIII
Foreign Trade Remedies
Article 40 The State may, based on the findings of foreign trade investigation, take appropriate measures of foreign trade remedies.
Article 41 Where a product from another country or region is dumped into the domestic market at a price lower than its normal value,
thus causing or threatening to cause substantive damage to an established domestic industry, or presenting a substantive impediment
to the establishment of a domestic industry, the State may take anti-dumping measures to eliminate or mitigate such damage, threat
of damage, or impediment.
Article 42 Where a product from another country or region is exported to the market of a third country at a price lower than its
normal value, thus causing or threatening to cause substantive damage to an established domestic industry, or presenting a substantive
impediment to the establishment of a domestic industry, the department for foreign trade under the State Council may, in response
to the application submitted by the domestic industry, conduct consultations with the government of that third country and request
it to take appropriate measures.
Article 43 Where an imported product to which specific subsidies of any form are directly or indirectly granted by the exporting
country or region causes or threatens to cause substantive damage to an established domestic industry, or presents a substantive
impediment to the establishment of a domestic industry, the State may take countervailing measures to eliminate or mitigate such
damage or threat of damage, or impediment.
Article 44 Where the substantial increase in the quantities of an imported product causes or threatens to cause serious damage to
a domestic producer of like product or a manufacturer of a product directly competitive to the imported one, the State may take the
necessary safeguard measures to eliminate or mitigate such damage or threat of damage and, at the same time, provide the industry
concerned with the necessary support.
Article 45 Where the increase in the services provided to China by the service supplier of another country or region causes or threatens
to cause damage to the domestic industry that provides like or directly competitive services, the State may take the necessary remedies
measures to eliminate or mitigate such damage or threat of damage.
Article 46 Where the substantial increase in the quantities of a certain product imported into the domestic market, as a result of
the restrictions imposed by a third country on its import, causes or threatens to cause damage to an established domestic industry,
or presents a impediment to the establishment of a domestic industry, the State may take the necessary remedies measures to restrict
the import of the said product.
Article 47 Where a country or region that has signed or jointly acceded to the economic and trade treaties or agreements with the
People’s Republic of China violates the provisions of such treaties and agreements and thus causes losses or damage to the interests
the People’s Republic of China is enpost_titled to under these treaties and agreements, or impedes the achievement of the objectives set
in the treaties and agreements, the government of the People’s Republic of China has the right to request the government of the country
or region concerned to take appropriate remedies measures and may suspend or terminate its performance of relevant obligations in
compliance with the relevant treaties and agreements.
Article 48 The department for foreign trade under the State Council shall, in accordance with the provisions of this Law and relevant
laws, carry out bilateral or multilateral foreign trade consultations and negotiations and settle disputes over such trade.
Article 49 The department for foreign trade under the State Council and the relevant departments under the State Council shall establish
precaution and emergency mechanism for the import and export of goods and of technologies and for the international trade in services
to cope with unexpected and unusual situations in foreign trade and safeguard the economic security of the State.
Article 50 The State may take the necessary anti-circumvention measures against the activities that circumvent the foreign trade
remedies measures prescribed in this Law.
Chapter IX
Promotion of Foreign Trade
Article 51 The State formulates strategies for the development of foreign trade, and establishes and improves the mechanism for promoting
foreign trade.
Article 52 The State, in light of the need for the development of foreign trade, establishes and improves financial institutions
in the service of foreign trade and establishes development fund and risk fund for foreign trade.
Article 53 The State develops foreign trade by means of import and export credit, export credit insurance, export tax refund and
other means designed to promote foreign trade.
Article 54 The State establishes a system of public information service for foreign trade, providing foreign trade dealers and the
public with information services.
Article 55 The State takes measures to encourage foreign trade dealers to exploit international market, and extend foreign trade
by a variety of means such as investment abroad, contract for foreign construction projects and overseas labor service cooperation.
Article 56 Foreign trade dealers may establish or join relevant associations or chambers of commerce in accordance with law.
The relevant associations and chambers of commerce shall observe laws and administrative regulations; in compliance with their articles
of association, provide their members with foreign-trade-related services in production, marketing, information, training, etc.;
play the role of coordination and self-discipline; submit applications for foreign trade remedies measures according to law; safeguard
the interests of their members and the industry; report to relevant government departments suggestions made by their members regarding
foreign trade; and carry out activities for promotion of foreign trade.
Article 57 The organization for the promotion of international trade in China shall, in accordance with its articles of association,
develop external relations, hold exhibitions, provide information and advisory services and carry out other activities to promote
foreign trade.
Article 58 The State supports and facilitates small and medium-sized enterprises to develop foreign trade.
Article 59 The State supports and promotes the development of foreign trade in ethnic autonomous regions and economically under-developed
areas.
Chapter X
Legal Responsibility
Article 60 The department for foreign trade under the State Council or the relevant department under the State Council may impose
a fine of not more than RMB 50,000 yuan on enterprise that, in violation of the provisions in Article 11 of this Law and without
authorization, imports or exports the goods subject to control of State-operated trading, and if the circumstances are serious, it
may, within three years from the date the administrative penalty decision takes effect, refuse to accept the application submitted
by the offender for engaging in the business of import and export of the goods subject to control of State-operated trading , or
may withdraw the authorization granted to the offender for the import and export of other goods subject to control of State-operated
trading.
Article 61Any dealer who imports or exports the goods the import and export of which are prohibited or, without authorization, imports
or exports the goods import and export of which are restricted shall be dealt with and penalized by the Customs in accordance with
the provisions of relevant laws and administrative regulations; if its act constitutes a crime, it shall be investigated for criminal
responsibility according to law.
Any dealer who imports or exports the technologies the import and export of which are prohibited or, without authorization, imports
or exports the technologies the import and export of which are restricted shall be dealt with and penalized in accordance with the
provisions of relevant laws and regulations. Where there are no provisions in laws or administrative regulations to go by, the department
for foreign trade under the State Council shall order it to rectify, confiscate its unlawful gains and, in addition, impose a fine
of not less than the amount of the unlawful gains but not more than five times that amount. If there are no unlawful gains or such
gains are less than 10,000 yuan, a fine of not more than 10,000 yuan but not more than 50,000 yuan shall be imposed. If its act constitutes
a crime, it shall be investigated for criminal responsibility according to law.
Within three years from the date the administrative penalty decision or the criminal penalty judgment takes effect, as specified
in the preceding two paragraphs, the department for foreign trade under the State Council or the relevant department under the State
Council may refuse to accept the application submitted by the offender for import or export quotas or license, or prohibit the offender
from engaging in the import or export of relevant goods and technologies for a period of not less than one year but not more than
three years.
Article 62 Any dealer that engages in the international trade in services subject to prohibition or, without authorization, engages
in the international trade in services subject to restriction shall be penalized in accordance with the provisions of relevant laws
and administrative regulations. Where there are no provis
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State Food and Drug Administration
Order of the State Food and Drug Administration
No. 15
The Measures for the Administration of License for Medical Appliance Operation Enterprises, which were deliberated and adopted at
the executive meeting of the State Food and Drug Administration on June 25, 2004, are hereby promulgated and shall come into force
as of the date of promulgation.
Director General, Zheng Xiaoyu
August 9, 2004
Measures for the Administration of License for Medical Appliance Operation Enterprises
Chapter I General Provisions
Article 1
The present Measures are formulated in accordance with the Regulation on the Supervision and Administration of Medical Devices for
the purpose of strengthening the supervision and administration of the permission for medical appliance operation.
Article 2
The present Measures shall apply to the issuance, replacement, alteration, supervision and administration of the License for Medical
Appliance Operation Enterprises.
Article 3
An enterprise that operates medical appliances of Class 2 or Class 3 shall hold the License for the Medical Appliance Operation Enterprise.
However, an enterprise that operates certain small number of medical appliances of Class 2 and is able to guarantee the safety and
efficacy of such medical appliances in the process of circulation through conventional management does not have to file an application
for the License for the Medical Appliance Operation Enterprise. The List of the medical appliance products of Class 2 that do not
require the License for Medical Appliance Operation Enterprises shall be formulated by the State Food and Drug Administration.
Article 4
The State Food and Drug Administration shall be in charge of the supervision and administration of the License for Medical Appliance
Operation Enterprises within the country.
The administrative department of food/drug of all provinces, autonomous regions, and municipalities directly under the Central Government
shall be in charge of the issuance, replacement, alteration, supervision and administration of the License for Medical Appliance
Operation Enterprises within their own jurisdictions.
The food/drug administrative institutions at the municipal level or the food/drug administrative institutions at the county level
directly established by the food/drug administrative department of all provinces, autonomous regions, or municipalities directly
under the Central Government shall take charge of the daily supervision and administration of the License for Medical Appliance Operation
Enterprises within their own jurisdiction.
Article 5
The State Food and Drug Administration shall gradually put in force regulations on medical appliance operation quality management.
The criterion of the medical appliance operation quality management shall be formulated by the State Food and Drug Administration.
Chapter II Application conditions on the License for the Medical Appliance Operation Enterprise
Article 6
In order to apply for a License for the Medical Appliance Operation Enterprise, the applicant shall meet the following conditions
concurrently:
(1)
It shall have a quality management department or full-time quality management personnel in accordance with its operational scale and
business scope. The quality management personnel shall have State-accredited diplomas or professional post_title of relevant specialty;
(2)
It shall have a relatively independent business place in accordance with its operational scale and business scope;
(3)
Its storage conditions shall be suitable for its operational scale and business scope, including the storage facilities and equipment
meeting the requirements of the medical appliance products’ special features;
(4)
It shall establish and improve the product quality management systems, including the regulations on purchase, inspection and acceptance
of purchased goods, warehousing custody, re-check upon leaving the warehouse, follow-up supervision of the quality and report of
misconducts, etc.; and
(5)
It shall have the technical training and after-sale service capacities suitable for the medical appliance products it operates, or
have reached an agreement with a third party that provide technical supports.
Article 7
An enterprise that applies for a License for the Medical Appliance Operation Enterprise must pass the examination conducted by the
administrative department of food/drug.
In light of the actual situation of its own jurisdiction, the administrative departments of food/drug of all provinces, autonomous
regions, or municipalities directly under the Central Government shall formulate the standards for inspection and acceptance of
medical appliance operation enterprises, and submit such standards to the State Food and Drug Administration for archival filing
in accordance with the present Measures.
Article 8
The business scope stated in a License for the Medical Appliance Operation Enterprise shall be determined according to the management
class and classification code name prescribed in the catalogue of classification of medical appliances.
Chapter III Application procedures for the License of the Medical Appliance Operation Enterprise
Article 9
The administrative departments of food/drug of all provinces, autonomous regions, or municipalities directly under the Central Government
or the entrusted food/drug administrative institution at the municipal level where the to-be-established enterprise is located or
the entrusted shall take charge of processing the applications for the License of Medical Appliance Operation Enterprises.
Article 10
The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government
or the entrusted food/drug administrative institution at the municipal level shall announce the conditions, procedures, time limit,
catalogue of all necessary materials to be submitted for applying for the License of the Medical Appliance Operation Enterprise,
and a model text of the application letter as well on its administrative organ’s website or at its location.
Article 11
When applying for the License for the Medical Appliance Operation Enterprise, the applicant shall submit the following documents:
(1)
The Application Form for the License of the Medical Appliance Operation Enterprise;
(2)
The testimonial issued by the administrative department for industry and commerce on pre-ratification of the enterprise’s name;
(3)
The photocopies of the identity certificates, diplomas or professional post_title certificates and curriculum vitae of the quality management
personnel of the enterprise to be established;
(4)
The organizational structure and functions of the enterprise to be established;
(5)
The sketch map of the location and the ichnography (indicated with acreage) of the registered address of the enterprise to be established,
and those of the address of its warehouse, and a photocopy of premise ownership certificate (or lease agreement);
(6)
Documents on the product quality management system of the enterprise to be established, and a catalogue of its storage facilities
and equipment; and
(7)
The business scope of the enterprise to be established.
Article 12
An applicant shall file the application for the License of the Medical Appliance Operation Enterprise to the administrative department
of food/drug of the province, autonomous region, or municipality directly under the Central Government where the to-be-established
enterprise is located, or to the entrusted food/drug administrative institution at the municipal level.
As to the application filed by an applicant for issuance of the license of the Medical Appliance Operation Enterprise, the administrative
department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted
food/drug administrative institution at the municipal level shall deal separately according to the following circumstances:
(1)
If the application does not fall within the scope of powers of the abovementioned administration, a decision shall be made refusing
to accept the application and the Notification on Not Accepting the Application shall be issued. The applicant shall be informed
to file the application to other relevant department;
(2)
If the application materials contain any error that may be corrected on the spot, the applicant shall be allowed to correct the said
error immediately;
(3)
If the application materials are incomplete or do not conform to the legal form, the abovementioned administration shall send a Notification
for Supplement of Materials to the applicant, and inform the applicant of all the contents to be supplemented either on the spot
or within 5 working days. If it fails to so inform the applicant, it shall be deemed as having accepted the application as of receipt
of the application materials; or
(4)
If the application falls within the scope of powers of the abovementioned administration, and the application materials are complete
and conform to the legal form, or all the supplemented application materials are submitted as required, the said administration shall
issue the Notification on Accepting the Application, which shall be affixed with a special stamp for acceptance and be indicated
with the date of acceptance.
Article 13
According to the standards for inspection and acceptance of medical device operation enterprises, the administrative department of
food/drug of a province, autonomous region, or municipality directly under the Central Government or r entrusted food/drug administrative
institutions at the municipal level shall make an on-site check on the enterprise to be established, and shall examine the application
materials in accordance with the present Measures.
Article 14
The administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government
shall make a decision on whether or not to ratify the issuance of the License for the Medical Appliance Operation Enterprise within
30 working days as of acceptance of an application. If it considers that the application meets the requirements, it shall make a
decision on approving the issuance of the License for the Medical Appliance Operation Enterprise and issue the License for the Medical
Appliance Operation Enterprise to the applicant within 10 days as of making the decision. However, if it considers that the application
does not meet the requirements, it shall notify the applicant in writing form, stating the reason therefor and informing the applicant
of the legal right to apply for administrative reconsideration or bring an administrative lawsuit.
Article 15
When examining the application filed by an applicant, the administrative department of food/drug shall announce the examination process
and results. The applicant or an interested person may make its statement and defense by submitting written opinions regarding the
matter directly related to its major interests.
Where an application for a License for the Medical Appliance Operation Enterprise directly involves the major interest relationship
with the applicant or others, the administrative department of food/drug shall inform the applicant or the said other related person
of the legal right to apply for a hearing.
Where a administrative department of food/drug considers that a License for the Medical Appliance Operation Enterprise involves
public benefits, it shall make an announcement to the public and hold a hearing.
Article 16
The administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government
shall publish the relevant information on the issued License for Medical Appliance Operation Enterprises, and the right to inquire
about such information remains with the public.
Chapter IV Alteration and Replacement Issuance of License for Medical Appliance Operation Enterprises
Article 17
The alteration of items in a License for the Medical Appliance Operation Enterprise may be divided into alteration of permitted contents
and alteration of registered contents.
The alteration of permitted contents shall include alteration of the quality management personnel, the registered address, the business
scope, and the address of the warehouse (including adding or removal of a warehouse).
The alteration of registered contents shall mean the alteration of the contents other than those mentioned above.
Article 18
With a view to modifying a permitted content in a License for the Medical Appliance Operation Enterprise, the medical appliance operation
enterprise shall fill out the application letter for alteration of the License for the Medical Appliance Operation Enterprise, and
submit the photocopies of the Business License and the License for the Medical Appliance Operation Enterprise, which shall be affixed
with its stamp.
With a view to modifying the quality management personnel, the said enterprise shall meanwhile submit the photocopies of the identity
certificates of the newly appointed quality management personnel, their diplomas or professional post_title certificates; with a view
to modifying the registered address, the said enterprise shall meanwhile submit a photocopy of the ownership certificate of the modified
address or of the lease agreement, a sketch map of the location, an ichnography and a statement on storage conditions; with a view
to modifying the business scope, the said enterprise shall meanwhile submit a photocopy of the registration certificate for the product
under planned operation, and a statement on the corresponding storage conditions, as well; with a view to modifying the address of
the warehouse, the said enterprise shall meanwhile submit a photocopy of the ownership certificate of the modified address of the
warehouse or of the lease agreement, a sketch map of the location, an ichnography and a statement on storage conditions.
Article 19
Where a medical appliance operation enterprise applies for alteration of a permitted content, the administrative department of food/drug
of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative
institution at the municipal level shall examine the application according to the standards for inspection and acceptance of medical
device operation enterprises within 15 working days as of acceptance of the medical device operation enterprise’s application for
alteration of the permitted content, and the administrative department of food/drug of the province, autonomous region, or municipality
directly under the Central Government shall make a decision on whether or not to approve the alteration; if an on-site inspection
is needed, the said administration shall make a decision on approving or not approving the alteration within 20 working days as of
acceptance of the application.
Where the administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government
makes a decision on approving the alteration, it shall record the modified content and the time of alteration on the counterpart
of the License for the Medical Appliance Operation Enterprise; however, if it does not approve the alteration, it shall inform the
applicant in writing form stating the reason therefor and informing the applicant of the legal right to apply for administrative
reconsideration or bring an administrative lawsuit.
After alteration of a permitted content of the License for the Medical Appliance Operation Enterprise, a medical appliance operation
enterprise shall legally go through the relevant alteration procedures of enterprise registration in the administrative department
for industry and commerce. The valid term of the modified License for the Medical Appliance Operation Enterprise shall remain unchanged.
Article 20
Where a medical appliance operation enterprise’s operation in violation of law has been put on the file by the administrative department
of food/drug for investigation, but the case is not finalized; or the enterprise received an administrative penalty decision, but
has not implemented the penalty, the administrative department of food/drug of the province, autonomous region, or municipality
directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall suspend
accepting or examining the enterprise’s application for alteration of the permitted content in the License for the Medical Appliance
Operation Enterprise until the case is finalized.
Article 21
Where a medical appliance operation enterprise intends to have a registered content in the License for the Medical Appliance Operation
Enterprise modified, it shall fill out the application letter for alteration of the License for the Medical Appliance Operation
Enterprise within 30 days after the administrative department for industry and commerce approves the alteration, and apply to the
administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government
or the entrusted food/drug administrative institution at the municipal level for alteration registration of the License for the
Medical Appliance Operation Enterprise. The administrative department of food/drug of the province, autonomous region, or municipality
directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall, handle
the alteration formalities, and notify the applicant within 15 working days as of receipt of the application for alteration.
Article 22
After alteration of a registered content in the License for the Medical Appliance Operation Enterprise, the administrative department
of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug
administrative institution at the municipal level shall record the modified contents and time of alteration on the counterpart of
the License for the Medical Appliance Operation Enterprise. The valid term of the modified License for the Medical Appliance Operation
Enterprise shall remain unchanged.
Article 23
Where an enterprise is divided, merged, or moved to another jurisdiction, it shall re-apply for a License for the Medical Appliance
Operation Enterprise in accordance with the present Measures.
Article 24
The valid term of the License for a Medical Appliance Operation Enterprise shall be 5 years. At expiry of the valid term, if the
medical appliance operation enterprise needs to continue to operate the medical appliance products, it shall apply to the administrative
department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted
food/drug administrative institution at the municipal level for replacement issuance of the License for the Medical Appliance Operation
Enterprise 6 months prior to the expiry of the valid term,.
The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government
or the entrusted food/drug administrative institution at the municipal level shall examine the application for replacement issuance
of the license in accordance with the present Measures.
The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government
shall make a decision on whether or not to approve the replacement of the license prior to the expiry of valid term of the License
for the Medical Appliance Operation Enterprise,. If it fails to make the decision within the time limit, it shall be deemed as consenting
to the replacement of the license and shall handle the corresponding formalities.
Where the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government
considers that the application meets the requirements, it shall issue a new License for the Medical Appliance Operation Enterprise
and take back the former one at expiry of the License for the Medical Appliance Operation Enterprise; however, if, the application
does not meet the conditions, it shall order the applicant to make a rectification within a time limit; if the applicant still fails
to meet the conditions after rectification, the said administrative department shall nullify the former License for the Medical
Appliance Operation Enterprise at expiry of the valid term, inform the applicant in writing form, stating the reason therefor and
informing the applicant of the legal right to apply for administrative reconsideration or bring an administrative lawsuit.
Article 25
Where a medical device operation enterprise loses its License for the Medical Appliance Operation Enterprise, it shall immediately
report to the administrative department, of food/drug and make an announcement of the loss on a media designated by the administrative
department of food/drug of the province, autonomous region, or municipality directly under the Central Government. The administrative
department of food/drug of the province, autonomous region, or municipality directly under the Central Government shall re-issue
the License for the Medical Appliance Operation Enterprise on the basis of the original approved contents after 1 month as of the
enterprise’s publishing of the statement of loss. The valid term of the re-issued License for the Medical Appliance Operation Enterprise
shall be the same as that of the former License for the Medical Appliance Operation Enterprise.
Chapter V Supervisory Inspections
Article 26
A administrative department of food/drug at the higher level shall strengthen its supervisory inspections on the granting of medical
appliance operation permits by the administrative departments of food/drug at the lower levels, and shall timely correct the illegal
acts in granting administrative permits.
Article 27
A administrative department of food/drug shall set up the working archives on issuance, replacement, alteration, supervisory inspection,
etc. of the License for Medical Appliance Operation Enterprises, and shall report the information of the last quarter on issuance,
replacement, alteration, supervisory inspection, etc. of the License for Medical Appliance Operation Enterprises to the administrative
department of food/drug at the next higher level in the first of week of each quarter. As to the legally invalidated or recovered
License for Medical Appliance Operation Enterprises, the administrative department of food/drug of the province, autonomous region,
or municipality directly under the Central Government shall set up an archive and keep it for 5 years.
Article 28
A administrative department of food/drug shall strengthen its supervisory inspections on medical device operation enterprises. The
main contents of supervisory inspection shall include:
(1)
Name of the enterprise, change of the enterprise’s legal representative, person-in-charge and quality management personnel;
(2)
Change of the enterprise’s registered address and address of the warehouse;
(3)
Information on the business place, storage conditions and main storage facilities and equipment;
(4)
Implementation and change of the business scope and other important contents;
(5)
Implementation of the enterprise product quality management system; and
(6)
Other relevant contents to be inspected.
Article 29
A supervisory inspection may be conducted in the way of written inspection, on-site inspection, or combining the written inspection
with the on-site one. If a medical appliance operation enterprise is under any of the following circumstances, the administrative
department of food/drug must conduct an on-site inspection:
(1)
It is an enterprise newly established in the last year;
(2)
It has problems in the inspection of the last year;
(3)
It is an enterprise subject to any administrative penalty due to violation of any relevant law or regulation; or
(4)
Any other case where the food/drug administrative department considers an on-site inspection should be conducted.
Article 30
In the year when the License for the Medical Appliance Operation Enterprise is replaced, the supervisory inspection and the replacement
examination may be conducted simultaneously.
Article 31
When legally conducting a supervisory inspection on a medical appliance operation enterprise, a administrative department of food/drug
shall record the information on the supervisory inspection and the results, which shall be signed by the supervisory inspectors and
then be kept in archives. The administrative department of food/drug shall announce the on-site inspection results and record them
on the counterpart of the License for the Medical Appliance Operation Enterprise.
Article 32
In case any of the following circumstances arises, the License for the Medical Appliance Operation Enterprise shall be nullified
by the original administrative department that issued the license:
(1)
The valid term of the License for the Medical Appliance Operation Enterprise has expired and the enterprise fails to apply for replacement
issuance or is not approved for a new license ;
(2)
The medical appliance operation enterprise terminates its business or is legally closed up;
(3)
The License for the Medical Appliance Operation Enterprise is legally cancelled, withdrawn, revoked, recovered or invalidated;
(4)
The medical appliance operation enterprise is unable to carry out its normal business due to force majeure; or
(5)
Other circumstances under which the License for the Medical Appliance Operation Enterprise is required to be nullified by any law
or regulation.
Where a administrative department of food/drug nullifies the License for the Medical Appliance Operation Enterprise, it shall notify
the administrative department for industry and commerce and announce the nullification to the public within 5 working days as of
the nullification,.
Chapter VI Legal Liabilities
Article 33
Where a medical appliance operation enterprise unlawfully modifies any of its quality management personnel, it shall be ordered by
the administrative department of food/drug to make a correction within the time limit. If it fails to make a correction within the
time limit, it shall be fined 5,000 Yuan up to 10,000 Yuan.
Article 34
Where a medical appliance operation enterprise unlawfully modifies its registered address or address of the warehouse, it shall be
ordered by the administrative department of food/drug to make a correction within the time limit, imposed upon a circularized criticism,
and fined 5,000 Yuan up to 20,000 Yuan in addition.
Article 35
Where a medical appliance operation enterprise unlawfully enlarges its business scope or lowers its operational conditions, it shall
be ordered by the food/drug administrative department to make a correction within the time limit, imposed upon a circularized criticism,
be fined 10,000 Yuan up to 20,000 Yuan in addition.
Article 36
Where an applicant conceals the relevant information or provides false materials to apply for the License for the Medical Appliance
Operation Enterprise, the administrative department of food/drug of the province, autonomous region, or municipality directly under
the Central Government or the entrusted food/drug administrative institution at the municipal level shall refuse to accept the application
or refuse to ratify the issuance of the License for the Medical Appliance Operation Enterprise, and shall warn the application in
addition. The applicant may not apply for the License for the Medical Appliance Operation Enterprise again within 1 year.
Article 37
Where an applicant obtains the License for the Medical Appliance Operation Enterprise by fraud, by offering bribery, or by other
foul means, the administrative department of food/drug shall revoke its License for the Medical Appliance Operation Enterprise,
warn it, and fine it 10,000 Yuan up to 20,000 Yuan. The said applicant may not apply for the License for the Medical Appliance Operation
Enterprise again within 3 years.
Article 38
Where a medical appliance operation enterprise has any of the following acts, it shall be ordered by the administrative department
of food/drug to make a correction within the time limit, and be warned; if it refuses to make a correction within the time limit,
it shall be fined 10,000 Yuan up to 20,000 Yuan:
(1)
Altering, buying and selling for profit, leasing, or lending the license for the Medical Appliance Operation Enterprise, or illegally
assigning the License for the Medical Appliance Operation Enterprise in any other form;
(2)
Carrying out business activities out of the business scope stated in the License for the Medical Appliance Operation Enterprise;
or
(3)
Concealing the relevant information or providing false materials in supervisory inspection, or refusing to provide authentic materials
reflecting its business situation.
Article 39
Where an enterprise violates any relevant law or regulation under any other circumstance, in the issuance, replacement issuance, alteration,
supervision and administration of the License for the Medical Appliance Operation Enterprise, it shall be punished in accordance
with the relevant laws and regulations.
Chapter VII Supplementary Provisions
Article 40
The License for a Medical Appliance Operation Enterprise shall include the original copy and the counterpart. Both the original copy
and the counterpart of the License for the Medical Appliance Operation Enterprise shall have equal legal binding force. The original
copy of the License for the Medical Appliance Operation Enterprise shall be placed at an eye-catching position of the medical appliance
operation enterprise’s operation place.
The License for a Medical Appliance Operation Enterprise shall state the enterprise’s name and legal person, the names of the person-in-charge
and the quality management personnel, the business scope, the registered address, the address of the warehouse, the license number,
the serial number of the license, the administrative department that issued the license, the date of issuance and the valid term,
etc.
Article 41
The License for Medical Appliance Operation Enterprises shall be uniformly printed by the State Food and Drug Administration. The
specimens of the original copies and counterparts of the License for Medical Appliance Operation Enterprises and the numbering method
shall be uniformly formulated by the State Food and Drug Administration.
Article 42
The present Measures shall come into force as of the date of promulgation. The Measures for the Supervision and Administration of
Medical Appliance Operation Enterprises promulgated by the State Drug Administration by Order No. 19 shall be abolished simultaneously.
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China Securities Depository & Clearance Corporation Limited
Notice of China Securities Depository & Clearance Corporation Limited on Promulgating Rules for the Implementation of the Registry
and Clearance Business of Listed Open-end Fund
Every member bodies and fund management companies:
In order to standardize the registry and clearance business of listed open-end fund, the Rules for the Implementation of the Registry
and Clearance Business of Listed Open-end Fund enacted by China Securities Depository & Clearance Corporation Limited, are hereby
promulgated and shall come into force as of the day of promulgation.
China Securities Depository & Clearance Corporation Limited
August 20, 2004
Rules for the Implementation of the Registry and Clearance Business of Listed Open-end Fund
Chapter 1 General Provisions
1.1
This Rules is promulgated with a view to maintaining the order of securities investment fund market, protecting the legal rights of
investors and standardizing the registry and clearance business of listed open-end fund, in accordance with the Securities Investment
Fund Law of the People’s Republic of China and the relevant provisions of other laws, regulations, rules and those set forth by China
Securities Depository and Clearance Co., Ltd. (hereinafter referred to as this Company).
1.2
The listed open-end fund referred to in this Rules is the open-end fund replaced, listed and transacted in Stock Exchange. Listed
open-end fund may be subscribed and transacted through Stock Exchange, or subscribed, applied for and redeemed through fund manager
or its best effort institution.
1.3
This Rules applies to the registry and clearance business of listed open-end fund. Where this Rules does not have related provision
thereto, other related provisions of this Company will be applied.
Chapter 2 The Account Management
2.1
Investors holding common RMB securities account or securities investment fund account (hereinafter referred to as the securities account)
may subscribe and transact the listed open-end fund in Stock Exchange through securities institutions.
Investors may subscribe, apply for and redeem the listed open-end fund through fund manager or its best effort institution based on
the open-end fund account in this Company.
2.2
The open, cancellation, merger of the securities account or the change of information thereof, etc. shall be handled in accordance
with the Management Rules of Securities Account of this Company.
2.3
The investor who has had a securities account may apply through the fund manager or best effort institution to this Company for the
depository of a listed fund account based on the securities account.
The investor who has not had a securities account may apply through the fund manager or best effort institution to this Company for
the registry of a listed fund account, this Company will allocate new securities investment fund account and automatic registry of
an open-end fund account will be made.
The investor who has registered an open-end fund account through fund manager or best effort institution may apply directly for the
releasing of open-end fund business to these institutions.
The investor who has registered an open-end fund account through fund manager or best effort institution applying for the open-end
fund business through other best effort institution or fund manager shall, upon the strength of the open-end fund account, first
handle the open-end fund account registry confirmation procedures with that best effort institution or fund manager.
2.4
An investor may have only one Shanghai or Shenzhen open-end fund account, except otherwise provided for by laws, regulations, rules
or this Company.
Shanghai securities account and the Shanghai open-end fund account registered based on it may not conduct listed open-end fund business
for the time being.
2.5
Where the name of the investor, the type or number of valid identification document as stated in the registry information of open-end
fund account is changed, the investor shall make securities account information change application at the agency in which the securities
account is opened. The change of the registry information, except for the three items mentioned above, can be made in the fund manager
or its best effort institution.
2.6
The investor may inquire about the registry information of his open-end fund account in the fund manager or its best effort institution
as referred to in article 2 .5.
2.7
The cancellation of the open-end fund account by the investor shall be made in the fund manager or its best effort institution that
has formerly handled this open-end fund account and the following conditions shall be satisfied:
(1)
The fund unit in the open-end fund account is zero;
(2)
Where the registry confirmation of the open-end fund account has been made in more than one fund managers or best effort institutions,
the cancellation of the registry confirmation of the open-end fund account shall have been made.
Chapter 3 Registry Trusteeship
3.1
This Company adopts the principle of separated system of registry with respect to the unit of listed open-end fund. The fund unit
subscribed and purchased in Stock Exchange through securities institutions is registered within the securities registry and clearance
system of this Company (hereinafter referred to as the securities registry system) and is recorded as investor’s securities account
and trusted in the securities institutions; the fund unit subscribed or applied for through fund manager or its best effort institution
is registered within the open-end fund registry and clearance system of this Company (hereinafter referred to as the TA system) and
is recorded as the investor’s open-end fund account and trusted in the fund manger or its best effort institution.
3.2
The fund manager shall conclude the registry and clearance service contract with this Company before the replacement of listed open-end
fund unit.
3.3
The fund manager shall, within prescribed time limit after the establishment of the listed open-end fund succeeding to capital verification,
handle the primary registry of the raised listed open-end fund unit in the securities registry system and the TA system of this Company
separately.
3.4
The registry of the change of the fund unit concerning the transaction of listed open-end fund that is made through the Stock Exchange,
the ownership transfer that is not made because of transaction of the fund unit under the securities account and the judicial assistance
etc. shall be made through the securities registry system.
The registry of change of the fund unit of listed open-end fund concerning the application or redemption through the fund manager
and its best effort institution, the non-trading transfer of the fund unit under the open-end fund account, the judicial assistance
and other businesses shall be handled through the TA system.
3.5
Such data as the preliminary registry, registry of change and related account information of listed open-end fund shall be sent unified
to the fund manager by TA system.
Chapter 4 Transfer of Trusteeship
4.1
The transfer of trusteeship of the listed open-end fund unit is divided into transfer of trusteeship within system and transfer of
trusteeship across system (i.e. the transfer of registry across system as referred to in the Listed Open-end Fund Business Rules
of Shenzhen Stock Exchange).
4.2
The transfer of trusteeship within system means that investors transfer the trusteeship of listed open-end fund unit trusted in a
securities institution to other securities institution, or transfer the trusteeship of listed open-end fund unit trusted in a fund
manager or its best effort institution to other best effort institution or fund manager. The transfer of trusteeship within system
shall be handled in accordance with the relevant provisions of this Company.
In the same securities institution, the change of the operate business office shall be conducted in the light of relevant provisions
to “transfer of trusteeship within system”.
4.3
The transfer of trusteeship across system means that investors transfer the trusteeship of listed open-end fund unit under a securities
institution to a fund manager or best effort institution, or transfer the trusteeship of listed open-end fund unit under a fund manager
or its best effort institution to other securities institution.
4.4
The transfer of trusteeship across system of listed open-end fund unit can only be carried out between securities account and the
open-end fund account registered based on it.
4.5
Where investors redeem listed open-end fund unit under the trusteeship of a securities institution through a fund manager or its best
effort institution, the transfer of trusteeship across system shall be handled in accordance with the following procedures:
(1)
Before investors go through the formalities of transfer of trusteeship, they shall ensure that registry or registry confirmation of
open-end fund account has been handled successfully in the transferee fund manager or best effort institution.
(2)
The investors file the applications for transfer of trusteeship across system in transferor securities institution; they shall specify
the code of transferee fund manager or best effort institution, securities account number, fund code and the amount transferred.
(3)
With regard to the application for transfer of trusteeship across system that is qualified in examination, the securities registry
system makes debit to the fund unit in the securities account of the investor and the TA system makes corresponding credit to the
fund unit in the securities account of the investor.
With respect to the fund unit transferred in, the TA system starts to calculate the fund unit holding duration of the investor from
the day when the fund unit of open-end fund account is credited.
(4)
With respect to the application for transfer of trusteeship across system that has been handled successfully, investors may apply
for the redemption of fund unit in the transferee’s fund manager or best effort institution after two trading days from the application
date.
4.6
The investor who sells in a Stock Exchange through a security institution the listed open-end fund unit that is under the trusteeship
of a certain fund manager or its best effort institution shall handle the trusteeship transfer across system in accordance with the
following procedure:
(1)
Where the investor applies to the transferring fund manager or its best effort institution for trusteeship transfer across system,
he shall specify the chair number of the transferee securities institution, the number of the open-end fund account, the fund code,
and the amount to be transferred, of which, the amount to be transferred shall be in integer unit.
(2)
With respect to the trusteeship transfer across system application that is qualified in examination, TA system debits the fund unit
of the open-end fund account of the investor, and the security registry system makes corresponding credits to the fund unit of the
securities account.
(3)
With respect to the trusteeship transfer across system application that has been successfully processed, the investor may, after two
transaction days from the applying date, apply through the transferee security institution to the Stock exchange for sale of the
fund unit.
4.7
With respect to the transfer of trusteeship across system in that the transferor system has debited the fund unit of the investor’s
account while the system of the transferee can’t make credit thereto, the investor may conduct account adjustment in the system of
the transferee.
4.8
After the date when the open-end fund is listed, except for the equity allocation period (from date R-2 to date R, date R is the equity
registry date) when the trusteeship transfer across system is temporary suspended, the investor may, in the transaction day of the
Stock Exchange, apply for handling the trusteeship transfer across system.
4.9
The unit of the listed open-end fund that is frozen can’t be handled with the trusteeship transfer across system.
Chapter 5 Fund Clearance
5.1
This Company adopts the principle of separated system in clearance with respect to listed open-end fund. The clearance of the fund
concerning the subscription and transaction of listed open-end fund trough Stock Exchange is conducted in the securities registry
system; the clearance of the fund involved in the subscription, application for purchase and redemption of listed open-end fund through
fund manager or its best effort institution is conducted in the TA system.
5.2
This Company adopts the multilateral net clearance with respect to listed open-end fund. This Company may adopt other fund clearance
method with respect to listed open-end fund after relevant business rules are formulated by this Company and are submitted to and
approved by China Securities Regulatory Commission.
5.3
The clearance participants such as the securities institution, fund manager and its best effort institution, before participating
in the fund clearance business of listed open-end fund of this Company, shall open clearance-reserving account in this Company in
accordance with relevant provisions of this Company, and conclude fund clearance business agreement with this Company.
5.4
The delivery and receipt of the fund concerning the application for purchase listed open-end fund through Stock Exchange shall abide
by the principle that “delivery and receipt in secondary market is in priority to that in internet application”, the delivery and
receipt of the fund concerning the subscribe of listed open-end fund through fund manager and its best effort institution shall abide
by the principle that “the delivery and receipt of the fund of application and redemption is in priority to that of subscribed fund”.
5.5
The fund clearance in subscribing listed open-end fund:
(1)
The securities registry system, based on the applied data of listed open-end fund made through Stock Exchange in date T, conducts
fund clearance in that date and produces fund clearance data, and finishes fund delivery and receipt through the clearance reserve
account of its clearance participant in date T-1. Where the balance of the clearance reserve account of its clearance participant
is not sufficient for delivery and receipt, the securities registry system makes invalid the applied amount of the insufficient part
in date T-2.
(2)
The TA system, based on the applied data of listed open-end fund made through fund manager and its best effort institution in date
T, conducts fund clearance and produces fund clearance data in date T-1, and finishes fund delivery and receipt through the clearance
reserve account of its clearance participant in date T-2. Where the balance of the clearance reserve account of its clearance participant
is not sufficient for delivery and receipt, the TA system makes invalid the applied amount of the insufficient part in date T-3.
5.6
The fund clearance in daily transaction, application, redemption of listed open-end fund:
(1)
The securities registry system conducts fund clearance of the combination of the dealing data of the listed open-end fund and other
listed stocks in the Stock Exchange and other non-transaction data after the market is closed in date T, figures out the net receivable
and payable of the clearance participants and produces fund clearance data, and finishes fund delivery and receipt through the clearance
reserve account of its clearance participant in date T-1.
(2)
The TA system conducts fund clearance of the combination of the application in date T-1 and the redemption in T-N-1 working days (N
is the redemption payment cyclical period prescribed in advance by fund manager) of the listed open-end fund made through fund manager
and its best effort institution and the business data of the open-end fund of the day, figures out the net receivable and payable
of the clearance participants and produces fund clearance data, and finishes fund delivery and receipt through the clearance reserve
account of its clearance participant in date T-1.
Chapter 6 Risk Prevention and Control Measures
6.1
This Company and the clearance participants shall adopt the following measures to strengthen the risk control in registry and clearance
business:
(1)
To stipulate perfect risk prevention system and inner control system;
(2)
To establish perfect technical system, to abide by the agreed technical criteria and rules.
(3)
To make backups of the clearance data and technical system and stipulate business urgency solving procedures and operational procedures.
6.2
Based on the risk sharing principle, the clearance participants shall pay clearance deposit as prescribed to prevent risks in clearance.
The payment, adjustment, management and use of the clearance deposit shall be conducted in accordance with provisions of this Company.
6.3
The balance of the clearance reserve account of the clearance participants at the end of a day shall not be lower than the minimum
clearance reserve as verified by this Company. The payment rate of the minimum clearance reserve and the adjustment thereof shall
be carried out in accordance with the provisions of this Company.
6.4
Where the clearance participant violates contract in fund delivery and receipt, this Company may adopt the following measures:
(1)
To charge interest and fine for breach of contract as prescribed in the provisions of the People’s Bank of China and this Company
based on the breach amount of the clearance participants.
(2)
On the day of the overdraft, to detain the securities proprietary traded by the clearance participants that are equivalent to 100%
of the breach amount. Where the clearance participant who breaches the contract pay fully the capital and interest of the breach
amount and the fine for breach of contract, this Company returns back the securities detained. Otherwise this Company will sell out
the detained securities and compensate for the breach amount of the clearance participants with the amount gained in sale, where
the amount gained in sale can’t recover fully the capital and interest of the breach amount and the fine thereof, the difference
shall be recovered by recourse to the clearance participants.
(3)
To record the breach of the clearance participant in the bad record of the clearance participant as the proof in evaluating the risk
scope and determining the key supervision object.
(4)
To be enpost_titled to require the clearance participant that breaches the contract to provide an account of its financial status to this
Company and bring forward the specific measures for covering the breach amount, and to make the clearance participant as the key
supervision object and keep close supervision on its financial status.
6.5
This Company, where necessary to the clearance participant that has a relatively big risk in clearance, is enpost_titled to adopt such
measures as to increase the clearance deposit, adjust the payment rate and time of minimum clearance reserve, require it to provide
clearance credit guaranty or clearance mortgage, limit the business application or require it to trust other clearance participant
to conduct clearance, etc.
6.6
The fees and damages of this Company in dealing with the breach of the clearance participant in delivery and receipt are born by the
clearance participant.
Chapter 7 The Equity Allocation
7.1
The equity allocation of listed open-end fund shall be conducted by the security registry system and TA system based on respective
investor’s book thereof on the equity registry day (Date R).
The security registry system can only conduct cash dividend allocation, TA system can conduct cash dividend allocation or dividend
re-investing allocation as in the option of the investor.
7.2
The fund manager shall, before the announcement of the equity allocation, make equity allocation application to this Company in advance.
7.3
The fund manager shall, before the prescribed time point in date R, inform this Company of the finally determined dividend allocation
plan. Where the dividend allocation plan is amended after the prescribed time point, the equity registry date shall be re-determined.
7.4
The fund manager shall, before the prescribed time point in date R-2, appropriate the cash dividend to the bank account designated
by this Company. This Company will appropriate the cash dividend to the clearance reserve account of the securities institution,
fund manager and its best effort institution in date R-3.
Where the fund manager fails to appropriate fully the cash dividend before the prescribed time point, this Company will postpone the
allocation of the cash dividend.
Chapter 8 Supplementary Provisions
8.1
This Implementation Rules apply, for the time being, to registry and clearance business of the open-end securities investment fund
sold, listed and transacted in Shenzhen Stock exchange.
8.2
This Company is not liable to any damage to related parties caused by earthquake, typhoon, drought, fire, war and other force majeure
factors, and such contingent incidents as unpredictable or uncontrollable failure of system, equipment and telecommunication, electricity
power off, etc.
8.3
The meanings of the following wordings as used in this Rules are:
Purchase: The activity that within the raising period of open-end fund, the investor purchases fund unit in the Stock Exchange through
securities institution, or purchases through fund manager and its best effort institution.
Application for purchase: The activity that beyond the raising period of open-end fund, an investor buys fund unit through fund manager
and its best effort institution.
Transaction: The activity that after the open-end fund is listed in Stock Exchange, an investor buys or sells fund unit in Stock Exchange
by way of collective transaction and through securities institution.
Securities account: It is divided into Shanghai securities account and Shenzhen securities account. Shanghai securities account is
used to record the securities listed in Shanghai Stock exchange and other securities acknowledged by this Company; Shenzhen securities
account is used to record the securities listed in Shenzhen Stock exchange and other securities acknowledged by this Company.
The registry of open-end fund account: The business process in that an investor holding securities account applies to this Company
for opening the function of open-end fund business and gets the confirmation feedback from the TA system of this Company.
The confirmation of open-end fund account: The business process in that an investor who has registered to open open-end fund account
applies for, in order to conduct fund subscribe, application and redemption through more than one best effort institutions, the registered
open-end fund account through the proposed best effort institution and gets the confirmation feedback from the TA system of this
Company.
The Shanghai, Shenzhen open-end fund account: The open-end fund account that comes into being following the registration of Shanghai,
Shenzhen Securities Account.
Best effort institution: Such institutions as the commercial banks or securities institution etc. which have best effort institution
qualification of open-end fund authorized by the China Securities Regulatory Commission, sell fund unit upon delegation of fund manager,
and carry out the application and redemption of fund share.
Clearance participants: Securities institution, fund manager, best effort institution and other bodies which participate in the clearance
business of this Company after the consent of this Company in the electronic securities registry and clearance system established
and managed in this Company.
8.4
This company shall be responsible for the amendments and interpretation of the present Implementation Rules.
8.5
The present Implementation Rules shall be implemented as of the promulgation date.
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China Securities Depository & Clearance Corporation Limited
2004-08-23
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