Home Traffic

Traffic

ANNOUNCEMENT OF OPEN MARKET OPERATIONS

Announcement of Open Market Operations

[2004] No. 9

Circular concerning the Change of the List Time of the Bank Notes of the Central Bank

With a view to enhancing the fluidity of the bank notes of the Central Bank, it is hereby decided, as of August 4, 2004, that the
time for the bank notes of the Central Bank to be listed and circulated in the inter-bank securities market and to be the tools of
open market operations of the People’s Bank of China is changed into the “T+1”, namely, the second working day as of the date of
issue (Wednesday).

The Operation Office of Open Market Operations of the People’s Bank of China

The People’s Bank of China

July 28, 2004



 
The People’s Bank of China
2004-07-28

 







MEASURES FOR THE ADMINISTRATION OF THE SAFETY AND HEALTH OF THE FEED PRODUCTS FROM ANIMAL SOURCES

Ministry of Agriculture

Order of the Ministry of Agriculture of the People’s Republic of China

No.40

The Measures for the Administration of the Safety and Health of the Feed Products from Animal Sources, examined and adopted at the
25th executive meeting of the Ministry of Agriculture on July 14th, 2004, are hereby promulgated and shall be implemented as of October
1st, 2004.

Du Qinglin, Minister of the Ministry of Agriculture

August 2nd, 2004

Measures for the Administration of the Safety and Health of the Feed Products from Animal Sources

Chapter I General Provisions

Article 1

With a view to strengthening the administration of the safety and health of the feed products from animal sources, the present Measures
are enacted in accordance with the Regulation on the Administration of Feed and Feed Additives.

Article 2

The Ministry of Agriculture shall be responsible for the administration of the safety and health of the feed products from animal
sources of the whole country.

The feed administration departments of local people’s governments at the county level or above shall be responsible for the administration
of the safety and health of the feed products from animal sources within their own administrative areas.

Article 3

The feed product from animal sources as mentioned in the present Measures refers to the single feed which takes the animals or byproducts
of animals as raw materials and is processed and manufactured through industrialization.

The catalogue of the feed products from animal sources shall be promulgated by the Ministry of Agriculture.

Chapter II Examination and Approval of the Establishment of Enterprises

Article 4

To establish a production enterprise of feed products from animal sources, one shall apply to the feed administrative department of
the people’s government at the provincial level where the enterprise is to be established. One can handle the enterprise registration
formalities only after being examined as eligible and obtaining the Certificate of Quality of Safety and Health of the Production
Enterprise of the Feed Products from Animal Sources.

Article 5

When establishing the production enterprise of feed products from animal sources, one shall possess the following conditions:

(1)

Factory building and facilities

a.

The factory building shall not be in a bad condition, and the factory building and the attached facilities shall be easy for cleaning
and disinfection;

b.

Relevant equipment for preventing flies, mice, birds and dust and relevant storage facilities; and

c.

Relevant dressing rooms, toilets, and washing grooves.

(2)

Production technology and equipment

a.

The production technology and equipment shall fulfill the requirements of safety and health and quality standards of the products;
and

b.

Relevant facilities for washing, disinfection, drying and grinding.

(3)

Personnel

a.

The persons in charge of techniques shall have an educational background of junior college or higher or a middle-level technical post_title
or higher, be familiar with the production technology and have engaged in the corresponding professional work for more than two years;

b.

The persons in charge of quality control and the persons in charge of quality testing organ shall have an educational background of
junior college or higher or a middle-level technical post_title or higher and have engaged in the corresponding professional work for
more than three years; and

c.

The employees of special types of work shall have the corresponding professional certificates.

(4)

Quality testing organ and equipment

a.

establishment of the quality-testing organ;

b.

establishment of the instrument room (section), checking and manipulation room (section) and room (section) for keeping samples and
observing; and

c.

the basic equipment needed for the quality testing.

(5)

Production circumstances

a.

The place of the enterprise shall be far from the feeding field of animals, with the minimum distance of 1,000 meters. In case the
enterprise is close to the slaughterhouse, the indispensable isolation measures shall be needed;

b.

No animal may be fed within the factory;

c.

The layout of production factory shall be reasonable, the areas for sorting out the raw materials, production and processing, preserving
the finished products shall be separated, and the finished products and raw materials must be stored separately to prevent cross
contamination.

(6)

Measures against pollution

The system for collecting and disposing of the waste and the equipment for preventing and eliminating pollution shall be complete,
and the discharge thereof shall fulfill the requirements for protection of the environment.

Article 6

To apply for establishing the production enterprises of feed products from animal sources, one shall fill in and submit the Written
Application for Producing the Feed Products from Animal Sources and offer the pertinent materials in conformity with the conditions
stipulated in Article 5 .

The Written Application for Producing the Feed Products from Animal Sources can be got, free of charge, from the feed administrative
department of the people’s government at the provincial level where the enterprise is located or downloaded at the website of chinafeed￿￿website:
http￿￿//www.chinafeed.org.cn￿￿.

Article 7

After receiving the Written Application for Producing the Feed Products from Animal Sources and the related materials, the feed administrative
department of people’s government at the provincial level shall finish examining and verifying the materials of the enterprise within
fifteen working days and submit them to the panel of appraisal for examination and appraisal, and it shall make the examination decision
within five working days after receiving the appraisal opinions. When it decides not to approve the issuance, it shall notify the
applicant in writing and explain the reasons.

In case the application materials are not complete or not in conformity with the prescribed conditions, the applicant shall be notified
just once of the complete contents that should be supplemented and corrected within five working days.The form of Certificate of
Quality of the Safety and Health of Feed Products from Animal Sources shall be worked out by the Ministry of Agriculture.

Article 8

The panel of appraisal shall be composed of three to five appraisers and technology experts. The appraisers shall be trained to be
eligible by the Ministry of Agriculture.

The panel of appraisal shall carry out on-spot inspections on the production conditions of the applicant.

Chapter III Production Management

Article 9

The enterprise shall establish the following systems:

(1)

system of post responsibility;

(2)

system of production management

(3)

system of checking and testing;

(4)

system of standards and quality guarantee;

(5)

system of safety and health;

(6)

system of keeping products’ samples for observing; and

(7)

system of measurement management.

Article10

The management of the raw materials of the enterprise shall fulfill the following requirements:

(1)

The purchase and getting-out of warehouse of raw materials shall be completely recorded, and the records shall be kept for two years
at least. No decayed, contaminated animal materials and the animal materials from the animal epidemic-stricken areas may be purchased;

(2)

The raw materials shall be piled up in light of the categories and be marked definitely; and the qualified and disqualified materials,
materials from the mammals and from other animals shall be guaranteed to be separated. No material may be placed outdoors; and

(3)

The use of raw materials shall follow the principle of ￿￿first in, first out￿￿. They shall be filtrated before the use, and the disqualified
shall be removed and made harmless.

Article 11

The management of production process of the enterprise shall fulfill the following requirements:

(1)

No unnecessary equipment and goods may be piled up within the plant, for fear of propagation of the harmful organism;

(2)

The equipment and instruments for manufacturing, packaging, storing and transporting shall be cleaned and disinfected periodically;

(3)

Before using the same equipment for producing different feed products from animal sources, the equipment shall be thoroughly cleaned
for fear of the cross contamination;

(4)

The operating personnel shall possess the health certificate, and the personnel of the special task shall have a physical examination
every half a year;

(5)

The production shall be conducted in strict conformity with the production technological process; and

(6)

The production record, including the categories and quantity of materials, the production date, the quantity of the products and the
conditions of the production technology, shall be made and kept for two years at least.

Article 12

The management of finished products of the enterprise shall fulfill the following requirements:

(1)

The finished products shall be checked as eligibility, and the inspection record and report shall be made. The inspection items shall
include the total number of bacteria, colon bacillus, salmonella, heavy metal, bacteria of special cause of disease and other indexes
of safety and health;

(2)

In case the finished products are contaminated by the harmful and poisonous substances or the quality of the finished products is
destroyed due to other reasons, they shall be destroyed immediately, and the reasons thereof shall be found out and a record shall
be made; and

(3)

The finished products shall be piled up in accordance with the categories to prevent wrong and mixed loading.

Article 13

The package of the products shall not be broken and damaged and be attached by the definite and eye-catching signs and labels.

If the package is in need of being used again, it shall be cleaned, washed and sterilized.

Article 14

The label of products shall accord with the standards of the national feed labels and indicate the names of the animal sources and
the serial number of the Certificate of Quality of the Safety and Health of Feed Products from Animal Sources.

With the exception of milk and diary products, the feed products from animal sources shall be indicated with the words of ￿￿this product
may not be fed to the ruminants￿￿ on the label in addition.

Chapter IV Management of Operation, Import and Use

Article 15

Where a products operator purchases the feed products from animal sources, he shall check the label and quality certificate of the
products.

No feed product from animal sources, whose business label is not in accordance with the prescription of Article 14 of the present
Measures, may be dealt in.

Article 16

One should obtain the registration certificate for importing products in conformity with the prescription of the Administrative Measures
for the Registration of Imported Feed and Feed Additives for importing the feed products from animal sources.

No feed products from animal sources from the countries (regions) stricken with animals’ plague may be imported.No feed products from
animal sources, which are transited through the third country (region) from the countries and regions stricken with animals’ plague,
may be imported.

Article 17

In terms of the feed products from animal sources which have been given the registration certificate of products, the registration
certificate of products shall become invalid as of the prohibition day, once the Ministry of Agriculture announces their prohibition.
The enterprises that have obtained the certificate shall return the registration certificate of products to the Ministry of Agriculture,
and the Ministry of Agriculture shall cancel them and make a notice.

In terms of the feed products from animal sources whose import has been announced to be suspended by the Ministry of Agriculture,
the registration certificates of products thereof shall cease to be used within the suspension period.

Article 18

No feed product from animal sources may be used in the feed of the ruminants apart from milk and diary products.

Article 19

No imported feed product from animal sources without the registration certificate of products may be dealt in and used. No feed products
from animal sources without the Certificate of Quality of the Safety and Health of Feed Products from Animal Sources may be dealt
in and used.

Chapter V Supervision and Inspection

Article 20

The production enterprise shall fill in the record-keeping form of the conditions of production and operation and submit it to the
feed administrative department of the people’s government at the provincial level for the record-keeping purpose.

The record-keeping form shall be offered, free of charge, by the feed administrative department of the people’s government at the
provincial level, and the enterprises also can download it at the website of chinafeed (website: http￿￿//www.chinafeed.org.cn ).

The Ministry of Agriculture shall carry out supervisions over the record-keeping work aperiodically.

Article 21

The feed administrative department of the local people’s government at the county level or above shall carry out the on-spot inspection
to the production enterprise of feed products from animal sources aperiodically, but it may not disturb the normal business activities
of the enterprises, neither seek for or accept money or goods, and nor seek for other interests.

Article 22

During the periods of putting-on-record and carrying out the on-spot inspection, where the feed administrative department of the local
people’s government at the county level or above finds that the production conditions of the production enterprise of the feed products
from animal sources have experienced great changes, or that the production enterprise has serious hidden danger of safety and health
or safety problem of products’ quality, or has other circumstances contrary to the present Measures, it shall conduct the investigation
according to the law and in time make the decision on how to handle them.

Article 23

The feed administrative department of the people’s government at the provincial level shall take back and cancel the Certificate of
Quality of the Safety and Health of Feed Products from Animal Sources and make an announcement, in case the production enterprise
is under any of the following circumstances:

(1)

The fundamental conditions have undergone relatively great changes, and it hasn’t possessed the basic production and sanitary conditions
yet;

(2)

It has stopped production for more than two years;

(3)

It has gone bankrupt or has been merged;

(4)

It doesn’t notify the competent department when it changes the place of plant;

(5)

It buys, sells, transfers, leases or lends the Certificate of Quality of the Safety and Health of Feed Products from Animal Sources;
or

(6)

It hasn’t submitted the record-keeping materials for two consecutive years, and refuses to correct after being supervised and urged.

Chapter VI Penalty Provisions

Article 24

Where anyone obtains the Certificate of Quality of the Safety and Health of Feed Products from Animal Sources through such illicit
means as deceiving or giving the bribery, the feed administrative department of the people’s government at the provincial level shall
cancel the Certificate of Quality of the Safety and Health of Feed Products from Animal Sources and make a public notice, and it
shall not accept any application put forward by this applicant within three years.

Article 25

Where anyone buys, sells, transfers, leases or lends the Certificate of Quality of the Safety and Health of Feed Products from Animal
Sources, he/it shall be imposed upon a fine of within three times the illegal proceeds if there are illegal proceeds, with the highest
fine of not more than 30,000 yuan. In case there are no illegal proceeds, he/it shall be fined not more than 10,000 yuan.

Article 26

Where anyone manufactures the feed products from animal sources without obtaining, or by counterfeiting or forging the Certificate
of Quality of the Safety and Health of Feed Products from Animal Sources, he/it shall be imposed upon a fine within three times the
illegal proceeds if there are illegal proceeds, with the highest fine of not more than 30,000 yuan. In case there are no illegal
proceeds, he/it shall be fined not more than 10,000 yuan.

Article 27

Whoever violates the prescription of Article 10 , Article 11 , and Article 12 shall be warned and ordered to correct within a time
limit. Anyone who doesn’t correct within a time limit or commits the same illegal conducts again shall be fined 1,000 yuan up to
10,000 yuan.

Article 28

Whoever deals in and uses the feed products from animal sources without obtaining the Certificate of Quality of the Safety and Health
of Feed Products from Animal Sources shall be ordered to rectify. Where there are illegal proceeds, he/it shall be imposed upon a
fine of twice the illegal proceeds but with the highest fine of not more than 30,000 yuan. In case there are no illegal proceeds,
he/it shall be fined not more than 10,000 yuan.

Article 29

Other violations of the present Measures shall be punished according to the pertinent prescriptions of the Measures for the Administration
of Feed and Feed Additives.

Chapter VII Supplementary Provisions

Article 30

Any enterprise of feed products from animal sources established before the implementation of the present Measures shall obtain the
Certificate of Quality of the Safety and Health of Feed Products from Animal Sources within six months as of the date of the implementation
of the present Measures.

Article 31

The present Measures shall be implemented as of October 1st, 2004.

Attachment:Catalogue of the Feed Products from Animal Sources

1.

meat meal (livestock and poultry), flesh bone dust (livestock and poultry)

2.

fish flour, fish oil, fish ointment, prawn flour, squid liver flour, squid flour, cuttlefish ointment, cuttlefish flour, fish concentrated
flour, dried scallop concentrated flour

3.

blood meal, plasma meal, blood cell meal, blood corpuscle meal, serum meal, fermented blood meal

4.

dust of leftover bits and pieces of animals, feather dust, hydrolyzed feather dust, hydrolyzed hair protein dust, leather protein
dust, hoof dust, horn dust, chicken giblets dust, intestinal mucosa protein meal, gelatin

5.

whey powder, milk powder, chocolate milk powder, egg powder

6.

silkworm chrysalis, maggot, stewed worm egg

7.

bone dust, bone ash, boneblack, bony calcium phosphate, prawn shell dust, egg shell dust, bone glue

8.

animal oil residue, animal fat, feed mixed oil



 
Ministry of Agriculture
2004-08-02

 







ANNOUNCEMENT OF THE MINISTRY OF COMMERCE

Ministry of Commerce

Announcement of the Ministry of Commerce

[2004] No. 38

August 3rd, 2004

Ministry of Commerce issued an announcement on December 17, 2003 according to Anti-dumping Regulations of the People’s Republic of
China, starting an anti-dumping investigation on imported Hydrazine hydrate originated in Japan, ROK, USA and France.

Ministry of Commerce made original arbitration according to the investigation that dumping of the imported Hydrazine hydrate originated
in above countries exists, Hydrazine hydrate industry in China has been injured and there is a causal relationship between dumping
and the injury.

In accordance with Article 28 and 29 of Anti-dumping Regulations of the People’s Republic of China, Ministry of Commerce decided
to take temporary anti-dumping measures by levying cash deposit. As of August 3, 2004, the import dealers should pay cash deposit
to General Administration of Customs of the People’s Republic of China when they import the investigated product originated in above
countries.

The tariff number of the investigated product is 28251010 in Customs Import-Export Tariffs 2003 and 2004.

The rate of cash deposit levied from each company is as follows:

Japanese Companies:108%

The companies of ROK

1.

KOC Co., Ltd.: 28%

2.

All others: 35%

The companies of USA: 184%

The companies of France

1.

ATOFINA S.A.: 118%

2.

All others: 120%

The interested parties may submit written comments with enclosed related evidence to the Ministry of Commerce within 20 days as of
the day when the announcement is issued. Ministry of Commerce will consider it according to laws.



 
Ministry of Commerce
2004-08-03

 







REPLY OF THE STATE ADMINISTRATION OF TAXATION ON ISSUES CONCERNING THE APPLICATION OF PREFERENTIAL TAX POLICY BY FOREIGN-FUNDED ENTERPRISES FOR THEIR UNDERTAKING OF TAXI BUSINESS AND OTHER PASSENGER TRANSPORTATION BUSINESSES

State Administration of Taxation

Reply of the State Administration of Taxation on Issues concerning the Application of Preferential Tax Policy by Foreign-funded Enterprises
for Their Undertaking of Taxi Business and Other Passenger Transportation Businesses

GuoShuiHan[2004] No. 945

August 3rd, 2004

The Administration of State Taxes of Guangxi Zhuang Autonomous Region:

Your Request for Instructions on the Nanning KangFu Communications Limited Company’ Request for Enjoying Preferential Income Tax Policy
on the Development of Western Areas (No.143 [2003] of the Guangxi Administration of State Taxes) and the Request for Instructions
on Issues regarding the Nanning White Horse Public Traffic Limited Company’s Application for Enjoying Preferential Tax Policy on
the Development of Western Areas (No.130 [2003] of the Guangxi Administration of State Tax) have been received, we hereby make the
following reply:

The “communications and transportation industry” that enjoys the treatment of a production-oriented foreign-funded enterprise as stipulated
in Item (8) of Article 72 of the Detailed Rules for the Implementation of the Income Tax Law of the People’s Republic of China on
Foreign-funded Enterprises and Foreign Enterprises (hereinafter referred to as the Detailed Rules for the Implementation of Tax Law)
shall not include the foreign-funded enterprises engaging in the passenger transportation business; the “traffic enterprises” newly
established in the western areas, which enjoy the exemption of enterprise income tax for two years and collection of half the rate
for three more consecutive years as stipulated in Item (2) of Article 3 of the Notice of the State Council on the Implementation
of Several Policies and Measures for the Development of Western Areas (No.33 [2000] of the State Council) shall refer to the enterprises
engaging in the investment and construction of such traffic infrastructure as roads and bridges. Therefore, the Nanning KangFu Traffic
Limited Company and the Nanning White Horse Public Traffic Limited Company that engage in the taxi business and urban public passenger
transportation business do not fall within the scope of application of the aforesaid preferential enterprise income tax. Please dispose
the issue by referring to other relevant tax provisions.



 
State Administration of Taxation
2004-08-03

 







MEASURES FOR THE SUPERVISION OVER AND ADMINISTRATION OF PHARMACEUTICAL PRODUCTION






State Food and Drug Administration

Order of the State Food and Drug Administration

No.16

The Measures for the Supervision over and Administration of Pharmaceutical Production, deliberated and adopted at the executive meeting
of the State Food and Drug Administration on May 28th 2004, is hereby promulgated, and shall be implemented as of the date of promulgation.

Zheng Xiaoyu, Director General of the State Food and Drug Administration

August 5th, 2004

Measures for the Supervision over and Administration of Pharmaceutical Production

Chapter I General Provisions

Article 1

With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated
pursuant to the Pharmaceutical Administration Law of the People’s Republic of China, Regulation on the Implementation of the Pharmaceutical
Administration Law of the People’s Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, Regulation
on the Implementation of the Pharmaceutical Administration Law).

Article 2

The supervision over and administration of pharmaceutical production shall refer to the activities of the food and drug supervision
and administration departments who make examination, licensing, supervision and inspection on pharmaceutical production conditions
and process and other administrative activities.

Article 3

The State Food and Drug Administration shall be in charge of the work of supervision over and administration of pharmaceutical production
nationwide. The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities
directly under the Central Government are responsible for the supervision over and administration of pharmaceutical production within
their own administrative regions.

Chapter II Application for and Examination and Approval of Launching Pharmaceutical Production Enterprises

Article 4

When launching a pharmaceutical production enterprise, the following conditions shall also be satisfied in addition to meeting the
pharmaceutical industry development plan and industrial policies of the state:

1.

Having technicians in pharmacology, engineers and technicians and corresponding technical workers whose qualifications have been certified;
and the legal representative or responsible person of the enterprise and the person in charge of quality having no circumstances
as stipulated in Article 76 of the Pharmaceutical Administration Law;

2.

Having workshops, facilities and sanitation environment fitting in with pharmaceutical production;

3.

Having institutions, personnel that are able to make quality control of and inspection on the pharmaceuticals produced, and necessary
apparatus and equipment; and

4.

Having regulations that can ensure the pharmaceutical quality.

Where the relevant state laws and regulations have different provisions on the production of narcotic pharmaceuticals, psychotropic
pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive pharmaceuticals, precursor chemicals of the pharmaceutical
category, etc., those provisions shall apply.

Article 5

Any applicant, who intends to launch a pharmaceutical production enterprise, shall file an application to the food and drug supervision
and administration department of the province, autonomous region, or municipality directly under the Central Government at his/its
locality, and submit the following documents:

1.

Basic information of the applicant and the pertinent certificate documents;

2.

Basic conditions of the enterprise to be launched, including the name of the enterprise to be launched, varieties of production, type
of medicament, equipment, technics and throughput; statements on the site of the enterprise, environment around the sites, and infrastructures,
etc., as well as the statements on investment scale and other conditions;

3.

Notice of pre-approval on the name of the enterprise to be launched issued by the department of industry and commerce administration,
production address and registration address, type of the enterprise, legal representative or responsible person of the enterprise;

4.

Plan of the organizations of the enterprise to be launched (indicating the functions of each sector and their correlations, responsible
person of each sector);

5.

Resumes, educational backgrounds and post_title certificates of the legal representative, responsible person of the enterprise to be launched
and the responsible person of each sector of the enterprise; registration form for the technicians of pharmacology and relevant professionals,
engineers and technicians, technical workers whose qualifications have been certified ipso jure with the indication of the sectors
and posts they are in; the proportion statement of the senior, medium and preliminary technicians;

6.

The map for the environment around the enterprise to be launched, general plane figure, storage plane figure, plane figure of quality
inspection place;

7.

Plan for the arrangement of production technics of the enterprise (including dressing room, water closet, passage for stream of people
and material circulation, and air brake, etc., and indicating the flowing direction of the people and materials and the grade of
air cleanliness factor), plan of the blow, return and ventilation of air cleansing system, and the plan for arrangement of technics
and equipment;

8.

The scope, type of medicament, varieties, quality standard and basis of the pharmaceuticals to be produced;

9.

The technical flow chart of the type of medicament and varieties of pharmaceuticals to be produced, with the major quality reference
points and items indicated;

10.

General situation on the validation of air cleansing system, water treatment system and the major equipment; conditions of checkout
of the production and inspection apparatus, instruments, and weighing apparatus;

11.

Lists of major production equipment and inspection apparatus; and

12.

Contents of documents on the production management and quality control of the enterprise to be launched.

The applicant shall be responsible for the truthfulness of all the contents of the application documents.

Article 6

Where a pharmaceutical production enterprise divides part of the production workshops and forms an independent pharmaceutical production
enterprise, it shall handle the Pharmaceutical Production License in conformity with the provisions of Articles 4 and 5 of the present
Measures.

Article 7

The food and drug supervision and administration departments of the provinces, autonomous regions, and municipalities directly under
the Central Government shall, after receiving the application, make handling in accordance with the following circumstances respectively:

1.

Where the matters applied for do not fall within the scope of functions and powers of the corresponding department ipso jure, the
department shall make decision on not accepting it, and notify the applicant to apply to the relevant administrative department;

2.

Where the application documents have mistakes that can be corrected on the spot, the applicant shall be allowed to correct on the
spot;

3.

Where the application documents are incomplete or do not comply with the requirements for the examination on the format, the department
shall issue the Notice on Supplementing and Correcting the Documents to the applicant on the spot or within 5 workdays, and notify
the applicant of all the contents to be supplemented and corrected. If it fails to notify within the time limit, the date of acceptance
shall be the date when the department has received the application documents; and

4.

If the application documents are complete and comply with the examination requirements, or the applicant has submitted all the supplementary
documents as required, the application shall be accepted.

Where any food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly
under the Central Government accepts or does not accept the application for the establishment of the pharmaceutical production enterprise,
it shall issue a Notice of Acceptance or Notice of Not Acceptance, which is sealed by the special seal of the corresponding department
and indicated with the date thereof.

Article 8

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make a decision within 30 workdays after the application is accepted.

If the application fulfills the requirements after examination, the department shall grant approval, and verify and issue the Pharmaceutical
Production License within 10 workdays as of the date when the decision on written approval has been made. If the application does
not fulfill the requirements, the department shall make a written decision on not approval, and explain the reasons, meanwhile notify
the applicant of his right to apply for administrative reconsideration or institute an administrative proceeding ipso jure.

Article 9

In case of launching a new pharmaceutical production enterprise, or a pharmaceutical production enterprise builds a new pharmaceutical
production workshop or newly adds production form of prepared pharmaceuticals, the enterprise shall file an application for certification
of Pharmaceutical Production Quality Control Criterions to the corresponding food and drug supervision and administration department
in accordance with the provisions of the State Food and Drug Administration within 30 days as of the date of obtaining pharmaceutical
production certificate documents or as of the date when it is approved to make production officially.

Article 10

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make a public notice on the website or at the office place of the administrative department on the conditions,
procedures and time limit for applying for the Pharmaceutical Production License, the whole documents to be submitted and the model
text of the application letter, etc.

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall open the relevant information on the issuance of Pharmaceutical Production License. The general public
shall be enpost_titled to consult.

Article 11

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make an announcement on the process and result of examination and approval when making examination on
the application of the pharmaceutical production enterprise. The applicant and the interested parties may submit written opinions
to make statements and defense on the matters directly pertaining to their major interests.

Article 12

Where the application for the establishment of any pharmaceutical production enterprise directly involves major interest relations
between the applicant and others, the food and drug supervision and administration department of the provinces, autonomous regions,
and municipalities directly under the Central Government shall notify the applicant and the interested parties that they may enjoy
the right to apply for hearing pursuant to laws and regulations and other provisions of State Food and Drug Administration. When
making examination on the application for establishment of pharmaceutical production enterprises, the food and drug supervision and
administration department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make
an announcement to the society on the major licensing matters concerning the public interests, and hold hearings.

Chapter III Administration on Pharmaceutical Production License

Article 13

The Pharmaceutical Production License shall have the original copy and the duplicate, the duplicate shall possess the same legal effect
as the original one, and the period of validity shall be five years.

The Pharmaceutical Production License shall be printed exclusively by the State Food and Drug Administration.

Article 14

The Pharmaceutical Production License shall bear the serial number of the License, name of the enterprise, legal representative, enterprise
type, registration address, production address, production scope, license issuing organ, date for license issuance, period of validity,
and other items, etc.. Among them the licensing matters that are subject to the approval of the food and drug supervision and administration
department shall be: responsible person of the enterprise, scope of production, and production address.

Such items as the name of the enterprise, legal representative, registration address, and enterprise type shall conform to the relevant
contents as specified in the business license issued by the administrative department for industry and commerce.The name of an enterprise
shall follow the principle of classified administration of pharmaceutical production enterprises. The production address shall be
filled in according to the actual pharmaceutical production address. The serial number of the License and the production scope shall
be filled in according to the methods and classes as stipulated by the State Food and Drug Administration.

Article 15

The alteration of Pharmaceutical Production License shall cover the alteration of the licensing matters and alteration of registration
matters.

The alteration of licensing matters shall refer to the alteration of the responsible person of the enterprise, production scope and
production address.

The alteration of the registration matters shall refer to the alteration of the matters as listed in paragraph 2 of Article 14 of
the present Measures.

Article 16

Where a pharmaceutical production enterprise alters the licensing matters in the Pharmaceutical Production License, it shall file
an alteration application to the original license issuing organ 30 days prior to the occurrence of alteration of the original licensing
matters. No enterprise may alter the licensing matters at will without authorization.

The original license-issuing organ shall make a decision on whether to approve the alteration or not within 15 workdays as of the
date when the application for alteration of an enterprise is received. If it does not grant the alteration, it shall explain the
reason in writing, and notify the applicant of his/its rights to apply for administrative reconsideration or to institute an administrative
proceeding ipso jure.

In case of alteration of production scope or production address, a pharmaceutical production enterprise shall submit the relevant
documents pertaining to the contents of alteration as stipulated in Article 5 of the present Measures, and report to the food and
drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government
at its locality for examination and determination.

After a pharmaceutical production enterprise has gone through formalities for alteration of licensing matters in the Pharmaceutical
Production License, it shall handle formalities for the alteration of the enterprise registration to the administrative department
for industry and commerce in time.

Article 17

Where a pharmaceutical production enterprise alters the registration matters in the Pharmaceutical Production License, it shall apply
for alteration registration on Pharmaceutical Production License to the original license issuing organ within 30 days after the alteration
is approved by the administrative department for industry and commerce.

Article 18

After the alteration of the Pharmaceutical Production License, the original license issuing organ shall record the contents and time
of alteration on the duplicate of the Pharmaceutical Production License, and reissue the original copy of the Pharmaceutical Production
License in accordance with the contents altered, and take back the former original copy of the Pharmaceutical Production License.
The period of validity of the Pharmaceutical Production License shall remain unchanged.

Article 19

Where the period of validity of the Pharmaceutical Production License expires and it is necessary to continue to produce pharmaceuticals,
the pharmaceutical production enterprise shall file an application for changing of the Pharmaceutical Production License to the original
license issuing organ 6 months prior to the expiry of the period of validity.

The original license issuing organ shall, in combination with the situations of the enterprises on their observance of laws and regulations,
and the Pharmaceutical Production Quality Control Criterions and operation of quality system, make examination on the procedures
and requirements for the establishment of pharmaceutical production enterprises as prescribed by the present Measures, and make decision
on whether to grant the change of the Pharmaceutical Production License or not before the expiry of the period of validity. In case
the requirements are fulfilled and the change of license is granted, the original license shall be taken back, and a new license
shall be issued. If the requirements are not fulfilled, the organ shall make a decision in writing on not granting the change of
license, and explain the reason, meanwhile, notify the applicant of his/its rights to file application for administrative reconsideration
or constitute an administrative proceeding ipso jure. In case the organ fails to make decision within the prescribed time limit,
it shall be deemed as agreeing to the change of license, and go through the corresponding due formalities.

Article 20

Where a pharmaceutical production enterprise terminates pharmaceutical production or is closed, the original license issuing organ
shall revoke its Pharmaceutical Production License, and notify the administrative department for industry and commerce.

Article 21

Where the Pharmaceutical Production License is lost, the pharmaceutical production enterprise shall file an application to the original
license issuing organ for reissue, and publish a lost license statement in the media designated by the original license issuing organ,
who shall then reissue the Pharmaceutical Production License within 10 workdays in accordance with the original approval matters
at the date when the enterprise has published the loss license statement for one full month.

Article 22

No entity or individual may forge, alter, sell or purchase, lease, or lend Pharmaceutical Production License.

Article 23

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall report to and put on archives the issuance, change, alteration, reissue, revocation, withdrawal and
capture, writing off of the Pharmaceutical Production License to the State Food and Drug Administration within 20 workdays after
completing the work for the handling them.

Chapter IV Administration on Production of Pharmaceuticals by Entrustment

Article 24

The entrusting party of pharmaceutical production by entrustment shall be the pharmaceutical production enterprise that has obtained
the registered number of approval for the pharmaceutical.

Article 25

The entrusted party of pharmaceutical production by entrustment shall be the pharmaceutical production enterprise that has the certification
certificate of Pharmaceutical Production Quality Control Criterions corresponding with the production conditions of such pharmaceuticals.

Article 26

The entrusting party shall be responsible for the quality and sale of the pharmaceuticals produced through entrustment. The entrusting
party shall make scrutiny on the production conditions, production technical level and quality control status of the entrusted party,
and shall provide the technology and quality documents to the entrusted party on pharmaceuticals produced through entrustment, and
make guidance to and supervision over the whole process of production.

The entrusted party shall make production in accordance with the Pharmaceutical Production Quality Control Criterions and keep all
the documents and records on the production through entrustment as required.

Article 27

The two parties of pharmaceutical production through entrustment shall sign a contract. The contents of the contract shall include
the rights and obligations of both parties, and stipulate the rights and obligations of the two parties in the technology, quality
control and other aspects of the pharmaceutical production through entrustment, and shall abide by the relevant pharmaceutical administrative
laws and regulations of the state.

Article 28

The application for the production of injections, biological products (with an exception of bacterin products, and blood products)
and for the trans-province, trans-autonomous region, and trans-municipality pharmaceuticals production through entrustment shall
be accepted and subject to the examination and approval of the State Food and Drug Administration.

The bacterin products, blood products and other pharmaceuticals as provided for by the State Food and Drug Administration may not
be produced through entrustment.

The production of narcotic pharmaceuticals, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive
pharmaceuticals, precursor chemicals of the pharmaceutical category through entrustment shall be conducted according to the relevant
laws and regulations.

Article 29

The application for the production through entrustment of other pharmaceuticals which are not included in Article 28 of the present
Measures shall be accepted by and subject to the examination and approval of the food and drug supervision and administrative department
of the provinces, autonomous regions, and municipalities directly under the Central Government at the locality of both parties of
the production through entrustment.

Article 30

Where a pharmaceutical is produced through entrustment, the entrusting party shall file an application to the State Food and Drug
Administration or the food and drug supervision and administration department of the provinces, autonomous regions, or municipalities
directly under the Central Government, and submit the application documents as stipulated in Article 34 of the present Measures.
The food and drug supervision and administration department shall accept it by referring to the provisions of Article 7 of the present
Measures.

Article 31

The food and drug supervision and administration department that accepts the application shall, within 20 workdays as of the date
of accepting the application, make examination on the application for pharmaceutical production through entrustment in conformity
with the conditions as prescribed by the present Chapter, and make decisions on it. In case it cannot make decisions within 20 workdays,
it may extend 10 workdays upon the approval of the responsible person of its own department, and notify the entrusting party of the
reasons for the extension.

Where, after examination, the application fulfills the requirements, an approval shall be granted, and the entrusting party shall
be issued the Document of Approval for Pharmaceutical Production through Entrustment within 10 workdays as of the date when the decision
on written approval has been made. In case it does not fulfill the requirements, the department shall notify the entrusting party
in writing and state the reason, and meanwhile notify the entrusting party of its right to apply for administrative reconsideration
or to institute an administrative proceeding ipso jure.

Article 32

The period of validity of the Documents of Approval for Pharmaceutical Production through Entrustment may not exceed two years, and
may not exceed the effective time as prescribed by the certificate documents of approval of the pharmaceutical.

Article 33

Where the period of validity of the Document of Approval of Pharmaceutical Production through Entrustment expires and it is necessary
to continue to produce pharmaceuticals through entrustment, the entrusting party shall submit the relevant documents in conformity
with the provisions of Article 34 of the present Measures, and go through formalities for extension.

Where the contract of production through entrustment terminates, the entrusting party shall go through the formalities for write-off
of the Document of Approval for Pharmaceutical Production through Entrustment in time.

Article 34

Items of application documents for pharmaceutical production through entrustment:

1.

The photocopies of the Pharmaceutical Production License and the business license of the entrusting party and the entrusted party;

2.

Photocopy of the certification certificate of the Pharmaceutical Production Quality Control Criterions of the entrusted party;

3.

The conditions concerning the entrusting party’s examination on the production and quality guaranty conditions of the entrusted party;

4.

Photocopy of the certificate documents of approval for pharmaceutical production through entrustment with the attachments of quality
standard, production technics, and the actual samples of packaging, label, and the instructions;

5.

The pattern of the packaging, label, and the instructions and the color labels to be adopted for the pharmaceutical produced through
entrustment;

6.

Contract of production through entrustment;

7.

The product testing report of three consecutive batches of the products issued by the pharmaceutical testing offices at the level
of province at the locality of the entrusted party. Where of producing biological products through entrustment, the three batches
of samples shall be taken out and sealed up for keeping by the pharmaceutical testing offices at the level of province at the locality
of the entrusted party. And the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible
for the testing and issue the testing report;

8.

The food and drug supervision and administration department of the province, autonomous region, and municipality directly under the
Central Government at the locality of the entrusted party shall put forward opinions on the enterprise technicians, workshops, facilities,
equipment and other production conditions and abilities, and the examination on the quality inspection organs, testing equipment
and other quality guaranty systems.

The items of application documents as required for the application for extension of pharmaceutical production through entrustment:

1.

Photocopies of the Pharmaceutical Production License and business license of the entrusting party and the entrusted party;

2.

Photocopy of the certification certificate of the Pharmaceutical Production Quality Control Criterions of the entrusted party;

3.

Photocopy of the Document of Approval for Pharmaceutical Production through Entrustment approved in the last time;

4.

Summaries of the periods, production and quality conditions of the production through entrustment of the last time; and

5.

Certificate documents on the changes compared with the Document of Approval for Pharmaceutical Production through Entrustment of the
last time.

Article 35

The national pharmaceutical quality standard shall be carried out for the quality standards for pharmaceuticals produced through entrustment,
and the prescriptions, production technics, packaging specifications, labels, instructions for the use, registered number of approval,
etc., shall be in conformity with the contents approved originally. The name, registration address of the entrusting enterprise and
the name and production address of the entrusted enterprise shall be indicated in the packaging, labels, and instructions of the
pharmaceutical produced through entrustment.

Article 36

The food and drug supervision and administration department shall refer to the relevant provisions of Articles 10 through 12 of Chapter
II of the present Measures when making examination on the application for pharmaceutical production through entrustment.

Article 37

Where any pharmaceutical production enterprise accepts the entrustment of any overseas pharmaceutical factory to process pharmaceuticals
within the territory of China, it shall put it on archives at the food and drug supervision and administration department of the
province, autonomous region, and municipality directly under the Central Government at its locality within 30 days after signing
the contract of production through entrustment. The pharmaceuticals processed may not be sold and used in any forms within the territory
of China.

Article 38

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall report the conditions for the approval and archival filing of pharmaceutical production through entrustment
to State Food and Drug Administration.

Chapter V Supervision and Inspection

Article 39

The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall be responsible for the supervision over and inspection on pharmaceutical production enterprises within
their own administrative regions, and shall establish an operation mechanism and administration system for the implementation of
supervision and inspection, clarify the functions of supervision over and inspection on food and drug supervision and administration
organs at the level of cities divided into districts and the food and drug supervision and administration organs at the county level.

State Food and Drug Administration may make supervision over and inspection on pharmaceutical production enterprises directly, and
make supervision over and selective examination on the supervision and inspection work of the food and drug supervision and administration
department of the provinces, autonomous regions, and municipalities directly under the Central Government and on the implementation
of the Pharmaceutical Production Quality Control Criterions on the production enterprises that have passed the certification.

Article 40

The major contents of supervision and inspection shall include: conditions concerning the implementation of the relevant laws, regulations
and the implementation of the Pharmaceutical Production Quality Control Criterions. Supervision and inspection includes the on-the-spot
inspection on the change of Pharmaceutical Production License, the follow-up inspection on Pharmaceutical Production Quality Control
Criterions and ordinary supervision and inspection, etc..

Article 41

The food and drug supervision and administration departments at all levels shall formulate inspection plans when organizing supervision
and inspection, clarify inspection standards, and record on-site inspection conditions according to the facts. The ins

NOTICE OF THE OFFICE OF THE STATE ADMINISTRATION OF FOREIGN EXPERTS AFFAIRS AND THE CONSULAR DEPARTMENT OF THE MINISTRY OF FOREIGN AFFAIRS ON THE USE AND ADMINISTRATION OF THE PERMIT FOR FOREIGN EXPERTS WORKING IN CHINA






the Office of the State Administration of Foreign Experts Affairs, the Consular Department of the Ministry of Foreign Affairs

Notice of the Office of the State Administration of Foreign Experts Affairs and the Consular Department of the Ministry of Foreign
Affairs on the Use and Administration of the Permit for Foreign Experts Working in China

No.105 [2004] of the Office of the State Administration of Foreign Experts Affairs

The foreign affairs offices and administrations of foreign experts affairs of the people’s governments of all provinces, autonomous
regions and municipalities directly under the Central Government, all the ministries and commissions of the State Council, organs
directly under the State Council, institutions, and international cooperative departments (foreign affairs departments) of special
parent companies:

For the purpose of implementing the Administrative License Law of the People’s Republic of China and the Decision of the State Council
on Establishing Administrative License for Administrative Examination and Approval Projects That Really Need to Be Reserved (Order
No. 412 of the State Council), and strengthening management on the work of our country for introduction of foreign talents and foreign
experts through specialized departments, we decide to adopt the measures on the Permit for Foreign Experts Working in China when
foreign experts apply for vocational (Z) visa on working in China. And relevant issues concerned are noticed hereby:

I.

All the foreign experts, who are invited to work in China in accordance with the relevant provisions of the Central Committee of the
Communist Party of China and the State Council on introducing intellects and strengthening foreign experts administration, shall
be exempted from obtaining employment licenses and employment permits. From October 1st, 2004, any of the aforesaid foreign experts,
who needs to draw a vocational visa, shall apply for the vocational (Z) visa at Chinese embassy or consulate in the foreign country
upon the strength of the Permit for Foreign Experts Working in China (For the format, see Attachment I) issued by the State Administration
of Foreign Experts Affairs, the letter of notice of visa issued by the authorized entity and the effective passport of his domestic
country or other certificates that can substitute the passport.

II.

Pursuant to the provisions of Order No.412 of the State Council, the State Administration of Foreign Experts Affairs and the specialized
departments for managing foreign experts affairs under the people’s governments at the provincial level shall issue the Permit for
Foreign Experts Working in China. The Chinese embassies or consulates in foreign countries shall keep the originals of the Permits
for Foreign Experts Working in China after checking and issuing vocational (Z) visas for foreign experts.

III.

The specialized departments of all people’s governments at the provincial level for managing foreign experts affairs shall strictly
administer and issue the Permit for Foreign Experts Working in China, and shall not issue work permits for entities and foreign personnel
that fall short of the invitation requirements. When issuing work permits, the said departments shall well do the work for classified
registration and statistic.

IV.

No specialized department of any of the people’s governments at the provincial level for managing foreign experts affairs may charge
fees when issuing Permits for Foreign Experts Working in China, nor shall it transfer the power for issuing permits to a department
at lower level or transfer it to the subordinate institution for handling. The State Administration of Foreign Experts Affairs shall
make regular examinations on the requirements for issuing work permits.

V.

The Permit For Foreign Experts Working in China shall be printed and distributed by the State Administration of Foreign Experts Affairs
uniformly, and shall be numbered by the issuing entities.

VI.

Any problem encountered in the implementation of the Permit for Foreign Experts Working in China, please be reported to the office
of the State Administration of Foreign Experts Affairs in time.

VII.

The original Confirmation Document for Inviting Foreign Experts shall be stopped using from October 1st, 2004, and the Notice of the
Office of the State Administration of Foreign Experts Affairs and the Consular Department of the Ministry of Foreign Affairs on the
Use and Administration of the Confirmation Document for Inviting Foreign Experts ([1996] No.16 of the Office of the State Administration
of Foreign Experts Affairs) shall be abolished simultaneously.

Attachment:

1.

the Format of the Permit for Foreign Experts Working in China

2.

the List of the Specialized Departments of the People’s Governments at the Provincial Level for Managing Foreign Experts Affairs

the Office of the State Administration of Foreign Experts Affairs

the Consular Department of the Ministry of Foreign Affairs

August 8, 2004 htm/e03947.htmAttachment I

￿￿

￿￿

Attachment I:

the Sequence Number of Printing:

the Counterfoil of the Permit for Foreign Experts Working in China (This page shall be kept by the Permit handling department.)

 

Type: Economy and Technology ( ) Culture and Education ( )                                                                                                                                                                     
Serial Number: _________

Embassy or Consulate in ________________:

Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____, Year _____), please help issue a vocational (Z) visa.

The relatives following him /her are _________ persons altogether.

 

Issuer: ____________

Month ____Date ____,Year _____

 

the Sequence Number of Printing:

 the Counterfoil of the Permit for Foreign Experts Working in China (This page shall be kept by the applicant)

 

Type: Economy and Technology ( ) Culture and Education ( )                                                                                                                                                                   
     
Serial Number: _________

Embassy or Consulate in ___________________:

Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____,  Year_____), please help issue a vocational (Z) visa.

The relatives following him /her are _________ persons altogether.

 

Issuer: ____________

Month ____Date ____,  Year_____

 

the Sequence Number of Printing:

 Permit of the People￿￿s Republic of China for Foreign Experts Working in China

 

The State Administration Of Foreign Experts Affairs, P.R.C. requests that foreign expert presents this Working Permit￿￿along with the invitation letter to have his/her Z visa processed at the nearest Chinese Embassy or Consulate.

Type: Economic and Technology ( ) Cultural and Education ( )      Serial Number: _________

Signing and issuing department (with seal):___________________ Issuer: __________________

Signing and issuing date: Month ______ Date ______, Year _______

 

Embassy or Consulate in ____________________

Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____, Year _____), please help issue a vocational (Z) visa.

The relatives following him /her are _________ persons altogether.

Name of his/her spouse: ______________________

Name of his/her children: _____________________

(The period of validity of the permit shall be six months)

 

the State Administration of Foreign Experts Affairs.(with seal)

 

Attachment II.:

the List of the Specialized Departments of the People￿￿s Governments at the Provincial Level for Managing Foreign Experts Affairs

 




the People￿￿s Governments at the Province Level

the List of the Specialized Departments for Managing Foreign Experts Affairs

Provinces (Districts or Cities)

Specialized Departments for Managing Foreign Experts Affairs

Beijing Municipality

Beijing Administration of Foreign Experts Affairs (Office for the Introduction of Oversea Intellects)

Tianjin Municipality

Tianjin Administration of Foreign Experts Affairs (Office for the Introduction of Overseas Intellects)

Shanghai Municipality

Shanghai Administration of Foreign Experts Affairs

Chongqing Municipality

Chongqing Administration of Foreign Experts Affairs

Hebei Province

Hebei Provincial Administration of Foreign Experts Affairs

Shanxi Province

Shanxi Provincial Administration of Foreign Experts Affairs

Inner Mongolia Autonomous Region

Administration of Foreign Experts Affairs of Inner Mongolia Autonomous Region

Liaoning Province

Liaoning Provincial Administration of Foreign Experts Affairs

Jilin Province

Jilin Provincial Administration of Foreign Experts Affairs

 
Ministry of Commerce
2004-08-09

 




INTERIM MEASURES FOR THE CONTROL OF OVERSEAS USE OF INSURANCE-RELATED FOREIGN EXCHANGE FUNDS

China Insurance Regulatory Commission

Order of China Insurance Regulatory Commission

No.9

The Interim Measures for the Control of Overseas Use of Insurance-related Foreign Exchange Funds as formulated jointly by China Insurance
Regulatory Commission and the People’s Bank of China are hereby promulgated and shall be implemented as of the date of promulgation.

Wu Dingfu, Chairman of China Insurance Regulatory Commission

Zhou Xiaochuan, President of the People’s Bank of China

August 9th, 2004

Interim Measures for the Control of Overseas Use of Insurance-related Foreign Exchange Funds

Chapter I General Provisions

Article 1

With a view to strengthening the control of overseas use of insurance-related funds, preventing risks and safeguarding the interests
of the insured, these Measures are formulated in conformity with the Insurance Law of the People’s Republic of China, Regulations
of the People’s Republic of China on Foreign Exchange Control and other pertinent laws and regulations.

Article 2

An insurance company mentioned in the present Measures refers to a Chinese capital insurance company, foreign capital insurance company,
Chinese-foreign joint venture insurance company or a branch of any foreign insurance company, set up with the approval of China Insurance
Regulatory Commission (hereinafter referred to as CIRC) and registered according to the law in the People’s Republic of China.

The insurance-related foreign exchange fund as mentioned in the present Measures refers to the sum of capital, public reserve fund,
undistributed profits, various reserves and guarantee deposits received in foreign currencies of an insurance company.

Article 3

In the overseas use of its foreign exchange fund, the insurance company shall follow the principles of security, liquidity and profitability
and be prudent in making investment and shall operate independently at its own risk.

Article 4

In the overseas use of its foreign exchange fund, the insurance company shall accord with the present Measures and other laws and
regulations concerning insurance and foreign exchange control, as well as the pertinent foreign laws and regulations.

Article 5

CIRC and the State Administration of Foreign Exchange (hereinafter referred to as SAFE) shall carry out supervision over and control
of the overseas use of insurance-related foreign exchange funds.

Chapter II Qualification Requirements

Article 6

An insurance company engaging in overseas use of its foreign exchange fund shall fulfill the following requirements:

(1)

possessing a license for engaging in foreign exchange;

(2)

its total assets at the end of the previous year being not less than RMB5 billion yuan;

(3)

its foreign exchange fund at the end of the previous year being not less than US$15 million or its equivalent in other freely convertible
currencies;

(4)

its solvency margin conforming to the pertinent provisions of CIRC;

(5)

possessing a professional fund use department or a pertinent insurance asset management company;

(6)

its internal management system and risk control system conforming to the provisions of the Guidelines for Risk Control in the Use
of Insurance Funds;

(7)

the number of its professional and managerial personnel with at least two years of experience in overseas investment conforming to
the pertinent provisions; and

(8)

other requirements as may be provided by CIRC and SAFE.

Article 7

In terms of the overseas use of its foreign exchange fund, the insurance company shall, within the amount of its foreign exchange
balance at the previous yearend, apply to SAFE for foreign exchange remittance and payment for investment outside China by submitting
the following documents and materials in triplicate:

(1)

a written application containing at least the background of the applicant, the amount of foreign exchange applied for to be paid for
investment and the investment plan;

(2)

its financial statements and balance sheet in foreign currencies at the previous yearend as audited by an accounting firm;

(3)

reports on its solvency positions at the end of last year and at the end of last quarter as audited by an accounting firm and notes
to such reports;

(4)

a brief of its internal professional fund use department or of pertinent insurance asset management company;

(5)

its internal management system and risk control system;

(6)

resumes of its professionals engaging in overseas investment;

(7)

materials concerning its domestic custodian and the draft custody agreement;

(8)

materials concerning its external trustee and the draft asset management entrustment agreement, if it has an external trustee; and

(9)

other materials as prescribed by CIRC and SAFE.The SAFE shall make a decision as whether or not to approve the application within
20 days as of the receipt of all necessary application documents. In the case of approval, the amount of foreign exchange payment
for investment as approved shall be notified in writing to the applicant; in the case of disapproval, such disapproval shall be notified
in writing to the applicant with reasons stated. A copy of such decision for either approval or disapproval shall also be sent to
CIRC.

Article 8

When its foreign exchange fund increases due to its capital increase or shares expansion or overseas listing, the insurance company
may apply to the SAFE for an increase of the specified amount of foreign exchange payment for investment for the current year by
submitting to the SAFE the pertinent documents and materials.The SAFE shall make a decision in conformity with Article 7 of the
present Measures.

Chapter III Investment Scope and Proportion

Article 9

The overseas use of insurance-related foreign exchange funds shall be limited to the following investment types and instruments:

(1)

bank deposits;

(2)

bonds of a foreign government, international financial organization or foreign company;

(3)

bonds issued outside China by the Chinese government or a Chinese enterprise;

(4)

money market derivatives, such as bank’s bills and large negotiable certificates of deposit; and

(5)

other investment types and instruments within the scope specified by the State Council.

The ￿￿bank￿￿ as referred to in item (1) of the preceding paragraph means either an external branch of a Chinese capital commercial
bank or a foreign bank with at least grade A or its equivalent of long-term credit as assessed by an internationally accepted rating
agency for the past three years.

The ￿￿bond￿￿ as referred to in item (2) of the preceding paragraph means that of at least grade A or its equivalent as assessed by
an internationally accepted rating agency.

The ￿￿money market derivatives￿￿ as referred to in item (4) of the preceding paragraph mean money market fixed income derivatives
of at least grade AAA or its equivalent as assessed by an internationally accepted rating agency.

Article 10

Any overseas use of insurance-related foreign exchange fund shall accord with the proportions as follows:

(1)

the total amount of the insurance company that may be used in investment may not be more than 80% of its foreign exchange balance
at the end of last year or, in the case of any circumstances under Article 8 herein, it may not be more than 80% of the sum of its
foreign exchange balance at the end of last year and the increased fund;

(2)

the actual total amount of investment of the insurance company may not be more than the amount of foreign exchange payment for investment
as approved by the SAFE;

(3)

the insurance company’s deposit in one bank may not be more than 30% of the amount of foreign exchange payment for investment as approved
by the SAFE, however, the balance in the account for settlement of overseas use of foreign exchange fund shall not be subject to
this limit;

(4)

the balance of all bonds of grade A of credit that the insurance company invested in, apart from those issued overseas by the Chinese
government or a Chinese enterprise, as calculated at their cost prices, may not be more than 30% of the amount of foreign exchange
payment for investment as approved by the SAFE;

(5)

the balance of all bonds below grade AA of credit that the insurance company invested in, apart from those issued overseas by the
Chinese government or a Chinese enterprise, as calculated at their cost prices, may not be more than 70% of the amount of foreign
exchange payment for investment as approved by the SAFE;

(6)

the balance of bonds issued by one company or enterprise, which the insurance company invested in, as calculated at their cost prices,
may not be more than 10% of the amount of foreign exchange payment for investment as approved by the SAFE; and

(7)

the balance of bonds issued overseas by the Chinese government or Chinese enterprises, which the insurance company invested in, as
calculated at their cost prices, may not be more than the amount of foreign exchange payment for investment as approved by the SAFE.

Chapter IV Investment Management

Article 11

In terms of overseas use of its insurance-related foreign exchange fund, the head office of the insurance company shall carry out
a unified strategic allocation of assets, and the internal professional fund use department or the pertinent insurance asset management
company shall be in charge of the operation and management.

No branch of an insurance company may undertake any overseas use of foreign exchange fund.

Article 12

Any overseas use of insurance-related foreign exchange fund must be made in conformity with the Guideline for Risk Control in the
Use of Insurance Funds and under a well-established risk control system.

The risk control system shall at least contain the investment decision-making procedure, investment authorization system, research
and reporting system, and risk assessment and performance appraisal index systems.

Article 13

In the overseas use of its foreign exchange fund, an insurance company may entrust the investment management to an external professional
investment institution satisfying the requirements prescribed in Article 14 herein.

Article 14

The external professional investment institution to which an insurance company entrust its investment management must fulfill the
following requirements:

(1)

being allowed to engage in asset management business according to the law of the country or district concerned;

(2)

its risk control index conforming to the pertinent provisions of the regulatory authority of the country or district concerned;

(3)

both its paid-in capital and net assets being not less than US$60 million respectively or its equivalent in other freely convertible
currencies, and the assets under its management being not less than US$50 billion or its equivalent in other freely convertible currencies;

(4)

possessing a sound corporate governance structure and well-established internal management system and risk control mechanism, and
having no record of any major illegal or irregular act in the country or district concerned in the past three years;

(5)

having at least ten years of experience in international asset management business, and having professional investment personnel of
a corresponding number;

(6)

committing in writing to a promise that, if necessary, it shall, at the request of CIRC, provide the exact state of transactions relating
to the overseas use of insurance-related foreign exchange fund;

(7)

the country or district concerned having a well-defined financial regulatory system, and there being a memorandum of understanding
concerning regulatory cooperation and effective regulatory cooperation relations between financial regulatory authority of the country
or district concerned and the Chinese financial regulatory authority; and

(8)

other requirements for prudence as prescribed by CIRC.The provisions concerning professional investment institutions established overseas
by domestic financial institutions, to which the management of insurance-related foreign exchange fund is entrusted, shall be separately
formulated by CIRC.

Article 15

When an insurance company entrusts its investment management to an external trustee, its internal professional fund use department
or related insurance asset management company shall be in charge of the delegation matters, and appraise the risk level of the trusted
assets, investment performance and management ability of the external trustee.

When selecting an external trustee for the management of insurance-related foreign exchange fund, the risk of management shall be
fully taken into consideration, and the foreign exchange fund under trusteeship management shall be decentralized properly.

Article 16

In the overseas use of its insurance-related foreign exchange fund, an insurance company shall lay stress on that the use matches
its liabilities in foreign exchange in terms of term structures and currency structures.

When undertaking overseas use of its insurance-related foreign exchange fund, the insurance company shall give priority to the bonds
issued overseas by the Chinese government and Chinese enterprises.

Chapter V Asset Custody

Article 17

In the overseas use of its foreign exchange fund, an insurance company shall entrust the custody of all its assets used overseas to
a domestic commercial bank.

The ￿￿commercial bank￿￿ as in the preceding paragraph means any Chinese capital bank, branch of a foreign bank, Chinese-foreign joint
venture bank or foreign capital bank in the territory of China.

Article 18

A commercial bank to be a domestic custodian of an insurance company shall fulfill the following requirements:

(1)

having been a designated foreign exchange bank for more than three years;

(2)

its paid-in capital being not less than RMB8 billion yuan, of which, there must be foreign exchange capital in freely convertible
currencies at the value of RMB1 billion yuan for a Chinese capital bank; the paid-in capital of the branch of a foreign bank shall
be calculated in light of its head office;

(3)

having obtained qualifications for domestic securities investment fund custody business;

(4)

having a sound corporate governance structure and well-established internal management system and risk control system;

(5)

having a special custody department and personnel of corresponding number who are familiar with global custody business;

(6)

having a safe and efficient clearing and settlement system and emergency mechanism;

(7)

having no record of any major illegal or irregular act, and neither the head office nor the branch having been heavily punished by
the regulatory authority of the country or district concerned, in the past three years; and

(8)

other requirements as prescribed by CIRC and SAFE.

The branch of a foreign bank shall not be subject to item (3) of the preceding paragraph, on condition that its head office has a
custody scale of at least US$100 billion.

Article 19

The domestic custodian of an insurance company shall perform the following obligations:

(1)

to manage the foreign exchange fund and securities entrusted by the insurance company;

(2)

to open a domestic custody account, external foreign exchange use settlement account and securities custody account in respect of
insurance-related foreign exchange fund;

(3)

to conduct outward and inward remittance of foreign exchange fund and the pertinent exchange formalities;

(4)

to supervise the overseas investment operation by the insurance company, insurance asset management company and external trustee,
jointly with the external custody agent;

(5)

to promptly notify the insurance company of any illegal or irregular investment directions whenever they find any;

(6)

to supervise the external custody agent and make sure that the insurance-related foreign exchange fund is in safe custody;

(7)

to keep for at least 15 years the records, vouchers and other pertinent materials of inward and outward remittance and transactions
of foreign exchange fund and transactions of securities;

(8)

to conduct the declarations for statistics of the international balance of payment in conformity with such provisions as the Measures
for Declarations for Statistics of International Balance of Payment, Operation Rules for Financial Institutions’ Handling Declarations
for Statistics of International Balance of Payment, and Operation Rules for Financial Institutions’ Handling Declarations of External
Asset Balance and Profit and Loss;

(9)

to assist CIRC and SAFE in inspecting the overseas use of insurance-related foreign exchange funds; and

(10)

other obligations as prescribed by CIRC and SAFE.

Article 20

The domestic custodian of an insurance company shall submit the pertinent reports pursuant to the following provisions:

(1)

a report on the opening of the insurance company’s domestic custody account, external foreign exchange use settlement account and
securities custody account shall be made to CIRC and SAFE within five days as of the day when they are opened;

(2)

a report on the insurance company’s outward remittance of principal and inward remittance of principal and earnings shall be made
to SAFE with a copy thereof to CIRC within two days as of the day of remittance;

(3)

a report on the receipt and payment in the domestic custody account of the insurance company shall be made to CIRC and SAFE within
five days from the end of each month;

(4)

a statement of the overseas use of insurance-related foreign exchange fund shall be submitted to CIRC and SAFE within ten days as
of the end of each quarter;

(5)

a statement of the overseas use of foreign exchange fund of the insurance company for the last year shall be submitted to CIRC and
SAFE within one month as of the end of each fiscal year;

(6)

it shall promptly report to CIRC and SAFE any illegal or irregular investment directions of the insurance company, insurance asset
management company or external trustee whenever it finds them; and

(7)

it shall report other matters to CIRC and SAFE as prescribed by them.

Article 21

After receiving the approval document from SAFE for the amount of foreign exchange payment for investment, an insurance company shall
conclude a custody agreement with the domestic custodian by producing such approval document, and open a domestic custody account.

Article 22

The insurance company shall submit the following documents to CIRC and SAFE within five days as of the opening of its domestic custody
account:

(1)

a copy of the custody agreement; and

(2)

a written commitment of the domestic custodian that it shall, pursuant to the pertinent provisions, supervise the use by the insurance
company of its domestic custody account, external foreign exchange use settlement account and securities custody account.

The custody agreement must state the obligations of the domestic custodian as prescribed in Articles 19 and 20 herein. The insurance
company is enpost_titled to terminate the agreement earlier if, in the case of any violation by the domestic custodian of the said obligations,
CIRC or SAFE requires the insurance company to replace the domestic custodian with another one.

Article 23

The following funds fall with the receipts of the domestic custody account of an insurance company:

(1)

foreign exchange fund transferred to the account by the insurance company;

(2)

insurance-related foreign exchange fund remitted to the account from overseas;

(3)

bank deposit principal and interest income;

(4)

interest income from bonds and revenue from sale of bonds;

(5)

interest income from money market derivatives and revenue from the sale thereof; and

(6)

other receipts.

Article 24

The following expenditures fall within the payment of the domestic custody account of an insurance company:

(1)

fund transferred to the external foreign exchange use settlement account;

(2)

insurance-related foreign exchange fund remitted back to the insurance company;

(3)

bank deposit;

(4)

cost paid for the purchase of bonds, including tax payment, such as stamp tax and capital gains tax;

(5)

currency exchange fee, custody fee and asset management fee;

(6)

various service charges; and

(7)

other expenditures.

Article 25

Any overseas commercial bank chosen by a domestic custodian to be its external custody agent shall fulfill the requirements concluded
in the custody agreement.

The domestic custodian shall open an external foreign exchange use settlement account and a securities custody account in respect
of the insurance-related foreign exchange fund with its external custody agent for fund settlement and securities custody business.

Article 26

The domestic custodian shall choose an overseas commercial bank satisfying the following requirements as its external custody agent:

(1)

its paid-in capital being not less than US$2.5 billion or its equivalent in other freely convertible currencies;

(2)

having been of at least grade A or its equivalent of long-term credit as assessed by an internationally accepted rating agency for
the past three years;

(3)

being qualified for a custodian as determined by the regulatory authority of the country or district concerned, or having cooperative
relations with the domestic custodian;

(4)

having a sound corporate governance structure and well-established internal management system and risk control mechanism;

(5)

having a special custody department and personnel of corresponding number who are familiar with the custody business in the country
or district concerned;

(6)

having a safe and efficient clearing and settlement system and emergency mechanism;

(7)

having no record of any heavy punishment in the country or district concerned in the past three years;

(8)

the country or district concerned having a well-defined financial regulatory system, and there being a memorandum of understanding
regarding regulatory cooperation and effective regulatory cooperation relations between the financial regulatory authority of the
country or district concerned and the Chinese financial regulatory authority; and

(9)

other requirements for prudence as prescribed by CIRC and SAFE.

Article 27

The insurance company’s domestic custodian and its external custody agent shall strictly separate their own assets from those under
trust, and set up accounts respectively for, and make separate management of, the overseas use of foreign exchange fund of each insurance
company.

Chapter VI Supervision and Management

Article 28

SAFE may adjust the approved amount of overseas use of insurance-related foreign exchange fund for investment in light of the overall
state of international balance of payment.

Article 29

Any overseas use of foreign exchange fund by an insurance company shall be limited to the provisions of Articles 9 and 10 herein,
and the insurance company may not commit any of the following acts:

(1)

granting a loan to or providing guarantee for others;

(2)

money laundering;

(3)

conspiring with its external trustee, domestic custodian and external custody agent to obtain illegal gains; or

(4)

other acts as prohibited by the pertinent laws or provisions of China or any other country or district concerned.

Article 30

When concluding a pertinent agreement respectively with its external trustee and domestic custodian, an insurance company shall expressly
require the external trustee and domestic custodian to promptly provide the related statements and relevant materials to CIRC and
SAFE.

Article 31

CIRC and SAFE may require the insurance company and its domestic custodian to provide the materials concerning the overseas use of
insurance-related foreign exchange fund and, if necessary, conduct on- site inspection on the insurance company or entrust such inspection
to a professional agency.

Article 32

No overseas commercial bank entrusted with the management of insurance-related foreign exchange fund may concurrently be the domestic
custodian or external custody agent.

Article 33

If any of the following circumstances occurs, the insurance company shall report it to SAFE within five days as of the occurrence:

(1)

any change of its external trustee, domestic custodian or external custody agent;

(2)

any significant change in its registered capital and shareholding structure;

(3)

being involved in any major litigation, subject to any heavy punishment or any other serious matters; and

(4)

other circumstances as prescribed by SAFE.

The insurance company shall also report the occurrence of circumstances under items (1) and (3) of the preceding paragraph to CIRC.

Article 34

If any of the following circumstances occurs, the insurance company’s domestic custodian shall report it to CIRC and SAFE within five
days as of the occurrence:

(1)

any significant change in its registered capital and shareholding structure;

(2)

being involved in any major litigation or subject to any heavy punishment; and

(3)

other matters as prescribed by CIRC and SAFE.

Article 35

Any insurance company and its domestic custodian in violation of the present Measures or any other provisions concerning insurance
and foreign exchange control shall be given by the pertinent regulatory authorities administrative penalties according to their respective
authorities and regulatory functions.

In the case of any gross violation by an insurance company of the present Measures, CIRC may limit the company’s scope of business,
order the company to cease accepting new business or revoke the company’s license for insurance business.

In the case of any gross violation by the domestic custodian of the present Measures, CIRC may order the insurance company to replace
the domestic custodian.

Article 36

If the external trustee entrusted with the management of insurance-related foreign exchange fund breached the pertinent provisions,
CIRC and SAFE may require the insurance company to replace such external trustee.

Chapter VII Supplementary Provisions

Article 37

For the materials submitted to CIRC and SAFE under the present Measures, those in Chinese shall be regarded as the authentic ones.

Article 38

The use by an insurance company of foreign exchange fund in Hong Kong Special Administrative Region and Macao Special Administrative
Region shall be carried out by following the pertinent provisions of the present Measures.

Article 39

The overseas use of foreign exchange fund by an insurance management company shall be carried out by following the present Measures.

Article 40

In the present Measures, ￿￿day￿￿ means a working day not including any festival or holiday.

Article 41

The power of interpretation of the present Measures shall be vested in CIRC and the People’s Bank of China.

Article 42

The present Measures shall be implemented as of the date of promulgation.

 
China Insurance Regulatory Commission
2004-08-09

 




INTERIM MEASURES OF THE MINISTRY OF COMMERCE FOR THE ADMINISTRATION OF SPECIAL FUNDS FOR STANDARDIZATION SYSTEM CONSTRUCTION OF DOMESTIC TRADE

The Ministry of Commerce

Interim Measures of the Ministry of Commerce for the Administration of Special Funds for Standardization System Construction of Domestic
Trade

August 9, 2004

Chapter 1 General Provisions

Article 1

These Measures are formulated with a view to strengthening the administration of special funds for standardization system construction
of domestic trade (hereinafter referred to as special funds for standardization system construction), ensuring the rational and effective
use of such funds in accordance with the Interim Provisions of the Ministry of Commerce for the Administration of Budget, the Interim
Measures of the Ministry of Commerce for the Administration of Expenditure Budget for Projects of Organs under the Ministry of Commerce
and the Interim Provisions for the Administration of Projects Funds for Drafting and Revising National Standard System (Guo Zhi Jian
Cai [2003] No. 30) as enacted by AQSIQ .

Article 2

Standardization system construction of domestic trade as mentioned herein shall refer to the research on and preparation of development
programs for standardization system construction of domestic trade, formulation of or amendment to standards in connection with the
production and circulation of products (commodities), service industry as well as market operating conditions, management along with
service during the construction of market system.

Article 3

The Department of Market System Development of the Ministry of Commerce, acting as a functional department of the Ministry of Commerce
responsible for exercising unified administration of and organizing and coordinating the standardization of domestic trade, shall,
in conjunction with the Department of Commercial Reform and Development and the Department of Market Operation and Coordination,
be in charge of presenting an annual plan (including a supplement plan) for drafting and revising standard projects of domestic trade
industry and preparing as well as submitting the expenditure budget for standardization system construction projects of domestic
trade (hereinafter referred to as expenditure budget for projects).

Article 4

The Department of Planning and Finance of the Ministry of Commerce shall be the competent department in charge of special funds for
standardization construction. Principles of laying stress on the key points, giving an overall consideration, implementing strict
control and tracing for efficiency shall be adhered to in the arrangement and management of such funds.

Article 5

The range of expenditure of special funds for standardization construction shall cover documentation fees (material costs) directly
concerning the standardization construction of domestic trade, expenses of investigation and research, experiment, conference, technical
examination, announcement and printing as well as reexamination.

Chapter 2 Budget Preparation and Submission

Article 6

The Department of Market System Development shall, according to the arrangement of standardization on a yearly basis and in conjunction
with related departments and bureaus, bring forward a plan for formulating and revising the annual standards; it shall, under the
unified arrangement of the Ministry of Commerce, produce a expenditure budget for market standardization construction projects and
submit such budget to the Department of Planning and Finance.

Article 7

The Department of Planning and Finance shall, after departmental budgets of the Ministry of Commerce have been approved officially
by the Ministry of Finance, notify the Department of Market System Development according to the official reply given by the Ministry
of Commerce in terms of the expenditure budget for standardization system construction projects of domestic trade.

Article 8

The Department of Market System Development shall, according to expenditure budget of projects that are officially approved by the
Department of Planning and Finance, organize relevant departments and bureaus to carry out the standardization system construction
of domestic trade, examine and confirm funds necessary for single standards item by item, choose an entity to undertake projects
on the basis of competitive selection by tenders or other means after such choice has been adopted at the director’s meeting of its
department and conclude a project entrustment contract with the said entity.

Article 9

The project entrustment contract shall explicitly specify contents and time of entrustment, quantity requirements, forms of results,
payment terms, intellectual property rights and liabilities for breach of a contract and etc..

Article 10

No project fund shall be directly appropriated to the entity undertaking such project (or the leading entity) until draft for examination
of standard projects has passed the experts’ review.

Article 11

No subsidy shall be granted to the standard project that fails to be listed in the annual project plan (including a supplement plan)
for formulating and revising standards in principle.

Article 12

Application for collecting project funds and appropriation thereof shall conform to the Interim Measures of the Ministry of Commerce
for the Administration of Expenditure Budget for Projects.

Chapter 3 Supplementary Provisions

Article 13

The Department of Planning and Finance under the Ministry of Commerce shall be responsible for the interpretation of the present Measures.

Article 14

These Measures shall go into effect as of the date of promulgation.

 
The Ministry of Commerce
2004-08-09

 




MEASURES FOR THE ADMINISTRATION OF LICENSE FOR MEDICAL APPLIANCE OPERATION ENTERPRISES

CONSTITUTION ACT, 1982 – page 22

NOTES (1) The enacting clause was repealed by the Statute Law Revision Act, 1893, 56-57 Vict., c. 14 (U.K.). It read as...

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.