MEASURES FOR THE IMPLEMENTATION OF THE REGULATIONS OF THE PEOPLE’S REPUBLIC OF CHINA ON THE ADMINISTRATION ON PRODUCTION LICENSE FOR INDUSTRIAL PRODUCTS

State Administration of Quality Supervision, Inspection and Quarantine

Order of the State Administration of Quality Supervision, Inspection and Quarantine

No.80

The Measures for the Implementation of the Regulations of the People’s Republic of China on the Administration on Production License
for Industrial Products, which were adopted through discussion at the executive meeting of the State Administration of Quality Supervision,
Inspection and Quarantine on August 31st, 2005, are hereby promulgated, and shall come into force as of November 1st, 2005. The Measures
for the Administration on Production License for Industrial Products as promulgated by the State Administration of Quality Supervision,
Inspection and Quarantine on March 27, 2002 shall be abolished simultaneously.

The Director General Li Changjiang

September 15, 2005

Measures for the Implementation of the Regulations of the People’s Republic of China on the Administration on Production License for
Industrial Products

Chapter I General Provisions

Article 1

The present Measures are formulated according to the Regulations of the People’s Republic of China on the Administration on Production
License for Industrial Products (hereinafter referred to as the Administration Regulations)

Article 2

The state shall adopt the administration system of production license to important industrial products.

Article 3

The present Measures shall be abided by when undertaking the production or sale of or using during business activities any product
subject to the production license administration within the territory of the People’s Republic of China.

No enterprise that has not obtained a production license may produce any product subject to production license administration. No
entity or individual may sell or use during business activities any product without obtaining a production license.

Article 4

The administration of production license for industrial products shall adhere to the principles of science and justness, openness
and transparency, legitimacy in procedures, facilitating people and high efficiency.

Article 5

The State Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the SAQSIQ) shall take charge
of the unified administration of production licenses for industrial products nationwide, and for the products subject to the production
license administration, unify the product catalogue, the examination requirements, the certificate symbols and the supervision and
administration.

The SAQSIQ shall establish a National Office of Production License for Industrial Products (hereinafter referred to as the National
License Office) to take charge of the routine work of the administration on production license for industrial products nationwide,
formulate detailed implementation rules for the issuance of license for products, verify the examination institutions of products
subject to production licensing for industrial products (hereinafter referred to as the examination institution), appoint production
inspection institutions to undertake the task of inspection on license issuance, and manage the qualification of checkers, and the
examination and approval for license issuance uniformly, and other work.

Article 6

The quality and technical supervision bureaus of a province, autonomous region, and municipality directly under the Central Government
(hereinafter referred to as the provincial quality and technical supervision bureaus) may, in case it is necessary, take charge of
the work of examination and issuance of production license for some of the products. And the concrete product catalogue shall be
determined and publicized by the SAQSIQ.

Article 7

A provincial quality and technical supervision bureaus shall take charge of the work of supervision and administration on production
license for industrial products within its own administrative region, and shall, in accordance with the Administration Regulations
and the provisions of the SAQSIQ, conduct the work for the examination and issuance of production license for some products.

A provincial quality and technical supervision bureaus shall establish an office of production license for industrial products (hereinafter
referred to as the provincial license office) to take charge of the routine work of the administration on production license for
industrial products within its own administrative region.

The local quality and technical supervision bureaus at or above the county level shall take charge of the supervision and inspection
on the production license within their own administrative regions.

Article 8

The examination organ shall, upon the entrustment of the SAQSIQ, undertake the drafting of detailed implementation rules for the issuance
of license for relevant products, organizing on-site examination and technical training to checkers, and other work.

Article 9

Any institution or personnel undertaking the production license work shall make administration by law, perform his duties faithfully,
serve the people warm-heartedly, and reinforce supervision and administration strictly.

Article 10

The SAQSIQ and the provincial quality and technical supervision bureaus shall plan the information construction of production license
work uniformly, publicize production licensing items, so as to facilitate the consultation of the general public and the application
of enterprises for handling licenses and realize the examination and approval through internet step by step.

Chapter II Production Licensing Procedures

Section I Application and Acceptance

Article 11

An enterprise shall meet the following qualifications for obtaining a production license:

1.

Possessing a business license;

2.

Having professional technicians qualified for the products it produces;

3.

Having the production conditions and means of inspection and quarantine, which are suitable for the products it produces;

4.

Having technical documents and technique documents matching the products it produces;

5.

Having sound and effective quality control system and responsibility system;

6.

Its products can meet the relevant national standards, industrial standards and requirements for ensuring personal health and personal
and property safety; and

7.

According with the provisions of state industrial policies, and not being a project of backward techniques, with high energy consumption,
environmental pollution, or waste of resources, and etc., which are to be stated out by public proclamation of the state and prohibited
from being invested in and constructed.

In case there are otherwise provisions by any law or administrative regulation, such provisions shall be accorded with as well.

Article 12

An examination organ shall, upon the entrustment of the SAQSIQ, and in pursuance of the characteristics of the relevant products,
developing conditions of certain industry and the relevant policies of the state, organize the drafting of detailed implementation
rules for products.

The SAQSIQ shall, in accordance with the relevant provisions of the Administration Regulations, approve and publicize the detailed
implementation rules for products. The special provisions in the detailed implementation rules for products, when necessary, shall
be formulated and promulgated by the SAQSIQ together with the relevant departments of the State Council.

The provincial license offices and the examination organs shall, in accordance with the provisions of the detailed implementation
rules for products, take charge of organizing or cooperating with the work for the publicity and implementation of the detailed implementation
rules for products.

Article 13

The provincial quality and technical supervision bureaus shall, in light of the arrangement for the progress of the issuance of production
licenses, inform the production enterprises within their own administrative regions by ways of publishing on newspapers or internet
websites, and shall take charge of the work of enterprise application. The examination organs shall actively provide assistance to
well do the relevant work.

Article 14

An enterprise, when producing the products listed in the catalogue, shall file an application to the provincial quality and technical
supervision bureaus at the place where it is located.

In case any product being produced by an enterprise is listed into the catalog, the enterprise shall apply for obtaining a production
license within the time as prescribed by the SAQSIQ.

Article 15

After receiving an application filed by an enterprise, the provincial quality and technical supervision bureaus shall grant the acceptance
if the application materials meet the requirements of the detailed implementation rules, and shall send a Letter of Determination
on the Acceptance of Application for Administrative License (See Attachment I) to the enterprise within 5 days as of the day of accepting
the application of the enterprise.

Article 16

After receiving an application by an enterprise, the provincial quality and technical supervision bureaus may, in case the application
materials fail to meet the requirements of the detailed implementation rules and may meet the requirements after supplementation,
send a Letter of Notification on Supplementing Application Materials for Administrative License (See Attachment II) to the enterprise
on the spot or within 5 days to notify the enterprise once for all. If it fails to notify the enterprise at the expiration of the
time limit, the day when the application materials are received shall be regarded as the day of acceptance.

After receiving an application by an enterprise, which fails to meet the requirements of the Administrative License Law and the Administration
Regulations, the provincial quality and technical supervision bureaus shall make a decision on rejecting the application, and issue
a Letter of Determination on Rejecting the Application for Administrative License (See Attachment III).

Article 17

No provincial quality and technical supervision bureaus or any other department may add any additional requirement on any enterprise
in its effort to obtain a production license.

Section II Examination and Determination

Article 18

After a provincial quality and technical supervision bureaus has accepted the application by an enterprise, the provincial license
office or the examination organ shall conduct an examination on the enterprise, which shall include the on-site examination on the
enterprise and the inspection on the products. If it is found to be unqualified in either the examination or inspection, the enterprise
shall be determined as failing the examination.

Article 19

Where the examination shall be organized by a provincial quality and technical supervision bureaus as provided for by the detailed
implementation rules, the provincial license office shall, within 30 days as of accepting the application of an enterprise, finish
the on-site examination on the enterprise and the selection and seal of the samples, and inform the enterprise subject to inspection
of the conclusion of the on-site examination in written form.

Where the examination shall be organized by an examination organ as provided for by the detailed implementation rules, the provincial
license office shall submit all the application materials to the examination organ within 5 days as of the day of accepting the application
of the enterprise. The examination organ shall, within 30 days as of the day of accepting the application of the enterprise, finish
the on-site examination on the enterprise and the selection and seal of the samples, and inform the enterprise subject to inspection
of the conclusion of the on-site examination in written form, and notify the provincial license office at the same time.

Article 20

In case any enterprise does not pass the on-site inspection, the spot examination on its products shall not be carried out any longer,
and the enterprise examination shall be terminated.

Article 21

The examination organ or provincial license office shall formulate an on-site examination plan for enterprises and notify the enterprises
five days before the examination.

If the examination is organized by an examination organ as provided for by the detailed implementation rules, a copy of the on-site
examination plan for enterprises shall be sent to the provincial license office at the place where the enterprises are located at
the same time.

Article 22

The examination organ or a provincial license office shall assign 2-4 examiners to constitute an examination group, which shall conduct
on-site examination on enterprises, and the enterprises shall provide assistance.

Article 23

The examination group shall, pursuant to the requirements of the detailed implementation rules, conduct on-site examinations on enterprises,
and the time for the inspection shall be 1-3 days in general. The examination group shall take charge of the result of on-site examination
on enterprises, and shall apply the group leader responsibility system.

Article 24

Where an enterprise has passed the on-site examination, the examination group shall seal the samples in light of the requirements
of the detailed implementation rules, and inform the enterprise of the name list of the inspection institutions that will undertake
the task of inspection on the production license for products and the contact information for the enterprise to make a selection
by itself.

If an enterprise has passed the examination and it is necessity to send samples for inspection, the enterprise shall be informed to
serve the samples to the inspection institution within 7 days as of the day of sealing the samples. If it is necessity to make an
on-site inspection, the checkers shall notify the enterprise to choose an inspection institution by itself to conduct the on-site
inspection.

Article 25

The inspection institution shall complete the inspection within the time as provided for by the detailed implementation rules, and
shall issue an inspection report.

Article 26

Where the examination is organized by a provincial license office, it shall submit the application materials to the examination organ
within 30 days as of the day of accepting the application of an enterprise. And the examination organ shall gather the application
materials within 40 days as of the day of accepting the application of the enterprise and submit them to the National License Office.

Where the examination is organized by an examination organ, it shall gather the application materials within 40 days as of the day
of accepting the application of an enterprise and submit them to the National License Office.

Article 27

The SAQSIQ shall, within 60 days as of the day of accepting the application of an enterprise, make a decision on whether or not to
grant to it a license. If the enterprise meets the conditions for license issuance, the SAQSIQ shall issue a certificate of production
license within 10 days as of the day of making a decision on granting a license; if the enterprise does not satisfy the conditions
for license issuance, it shall issue a Letter of Determination on Not Granting An Administrative License (See the Attachment IV)
to the enterprise within 10 days as of the day of making the decision.

Article 28

Pursuant to the provisions of Article 18 of the present Measures, if a provincial license office or an examination organ determines
that an enterprise fails to pass the examination, it shall report it to the SAQSIQ in written form in a timely manner, and the SAQSIQ
shall issue to the enterprise a Letter of Determination on Not Granting An Administrative License.

Article 29

The SAQSIQ shall make public the name list of enterprises that have obtained a license to the general public on internet or newspapers
and periodicals or in other ways. Meanwhile, it shall also provide a report on the license issuance of the relevant products to the
department of national development and reform, the competent department of health and the administrative department of industry and
commerce.

Article 30

The valid period of a production license shall be five years. Where an enterprise continues production at the expiry of the valid
period, it shall, six months before the expiry of the production license, file an application for changing the license to the provincial
quality and technical supervision bureaus at the place where it is located.

Article 31

Where an enterprise needs to add any item after obtaining a production license, it shall go through the formalities for adding items
in pursuance of the procedures as prescribed in the detailed implementation rules. If the enterprise satisfies the conditions, it
may change the certificate of production license but with the valid period of the license unchanged.

Article 32

Where, during the valid period of a production license, the detailed implementation rules are revised due to any big change of relevant
laws and regulations, product standards and technical requirements of the state, the National License Office shall organize, when
necessary, on-site examinations and product inspections.

Article 33

Where, during the valid period of a production license, there occurs any big change on the production conditions, means of inspection,
production technology or techniques of an enterprise (including the alteration of the production address, and the major technical
renovation on production lines), the enterprise shall file an application to the provincial quality and technical supervision bureaus
at the place where it is located in a timely manner. And the examination organ or the provincial license office shall re-organize
an on-site examination and product inspection according to the provisions of the detailed implementation rules.

Article 34

The provincial license offices, examination organs and the National License Office shall file the relevant materials for obtaining
a production license submitted by enterprises in a timely manner. And the general public shall have the right to consult such materials.
The archival materials of an enterprise shall be kept for five years.

Section III Supervision and Inspection of the Examination Work

Article 35

The National License Office shall organize the supervision and inspection on the quality of the enterprise examination work.

Where the on-site examination on an enterprise is organized by a provincial license office, the National License Office shall organize
the examination organ to conduct a spot test; where the on-site examination on an enterprise is organized by an examination organ,
the National License Office shall organize the provincial license office to conduct a spot test.

Article 36

When conducting a supervision and inspection, the supervision and inspection plan shall be made, which shall include the constitution
of the inspection group, the specific time for inspection, the enterprise to be inspected and other contents.

Article 37

The provincial quality and technical supervision bureaus at the place where an enterprise is located shall be informed of the inspection
plan beforehand, and shall provide assistance in the inspection work.

Article 38

After finishing the supervision and inspection work, the inspection group shall work out a written report and handling suggestion,
and report them to the National License Office.

Article 39

The National License Office shall make a supervision and inspection on whether or not the inspection process and inspection report
of an inspection institution is objective, just and timely through consulting the inspection report, comparing the inspection conclusions
and in other ways.

Section IV Production Licensing on Group Companies

Article 40

A group company and its subsidiaries, branches or production bases (hereinafter jointly referred to as the subordinated entities),
which have the legal person status, may apply for a production license independently; if any of these entities has no legal person
status, it cannot apply for a production license independently in the name of their subordinated entities.

All the subordinated entities, no matter whether or not they have the status of a legal person, may file an application for obtaining
a production license along with the group company.

Article 41

When any subordinated entity applies for a production license along with its group company, it shall file an application to the provincial
quality and technical supervision bureaus at the place where the group company is located. If the on-site examination on the enterprise
is organized by a provincial license office as required, the provincial license office at the locality of the group company may appoint
an examination group directly, or may entrust in written form the provincial license office at the place where the subordinated entity
is located to organize the examination. The provincial license office at the place where the group company is located shall take
charge of reporting the relevant materials according to the prescribed procedures.

Article 42

Where, after a group company has obtained a production license, any of its newly established subordinated entities needs to apply
for a production license along with the group company, the newly established subordinated entity may change its certificate of production
license after passing the examination but with the valid period of the production license unchanged.

Article 43

Where a subordinated entity applies for a production license along with its group company, the subordinated entity that has been examined
and its group company shall pay the examination fees and the production inspection fees respectively. And the fees for public notice
shall be collected pursuant to the number of the certificates issued.

Article 44

The procedures for obtaining a certificate by a group company shall be applicable by analogy to the application of other economic
communities and the subordinated entities for obtaining production licenses.

Section V Archival Filing for Processing under Entrustment

Article 45

The entrusting enterprise which undertakes the processing of any product subject to the production license administration upon entrustment
and the entrusted enterprise, shall apply for archival filing respectively to the provincial license office at their localities.

Article 46

The entrusting enterprise shall be an enterprise engaging in lawful operation. And the enterprise being entrusted shall hold a lawful
and effective production license.

Article 47

The entrusting enterprise and the entrusted enterprise shall, when applying for archival filing to the provincial license office at
their localities, provide the following materials:

1.

The photocopies of the business licenses of the entrusting enterprise and the entrusted enterprise;

2.

The photocopy of the production license of the entrusted enterprise;

3.

The photocopy of the notarized contract of processing under entrustment;

4.

The contract of processing under entrustment shall clarify that the entrusting enterprise shall take charge of the sale of all the
products; and

5.

The format of marking on the products processed under entrustment.

Article 48

A provincial license office shall, within 5 days after receiving the application for archival filing of processing under entrustment,
make necessary verification, and put on archives of the enterprise that meets conditions. For the enterprise that does not meet the
conditions, it shall not put on archives and shall explain the reasons.

Article 49

An entrusted processing enterprise shall perform its commitment for archival filing, and shall not alter the entrustment contract
and the way of marking the products at will.

Article 50

No one may charge fees to any enterprise for putting on archives of the processing under entrustment.

Chapter III Administration on Checkers

Article 51

A checker shall not undertake the work for on-site examination on enterprises until he/she has obtained the corresponding qualification.

Article 52

The checkers shall include the examiners for the registration of production license for industrial products (hereinafter referred
to as the examiners), senior examiners and technical experts.

Article 53

An examiner shall meet the following conditions:

1.

Being at the age of 65 or below;

2.

Having a junior college degree or above or middle technical post_title or above;

3.

Being familiar with the production techniques, quality standards for production and quality control system of relevant products; and

4.

Having undertaken the quality work for five full years.

Article 54

The National License Office shall make examination and registration on the personnel trained by provincial license offices or examination
organs, and issue to an approved examiner a registration certificate with the valid period of three years.

Article 55

Within 3 months before the expiry of the valid period of a registration certificate, the examiner shall apply for changing the registration
certificate as required, and shall comply with the following conditions:

1.

Being at the age of 65 or below;

2.

Having completed at least 6 on-site examinations on enterprises with a production license for industrial products within the valid
period of the certificate;

3.

Having participated in at least 15 hours relevant work training on the production license for industrial products each year; and

4.

Observing the behavior criterions on examiners, and having no illegal act or act violating regulations.

Where a senior examiner meets the conditions as prescribed in the preceding paragraph within the valid period of the certificate,
and acts as the leader of an examination group for at least three times, he/she may change for a registration certificate of a senior
examiner as required; if he/she only meets the conditions as prescribed in the preceding paragraph, he/she may change for a certificate
of an examiner.

Article 56

The provincial license offices or examination organs shall take charge of the work of organizing the application for changing certificates
at the expiry of the tenure of an examiner. And the National License Office shall take charge of changing the certificates for personnel
who meet the conditions for changing the certificate.

Article 57

Where an examiner applies for upgrading to a senior examiner, he/she shall meet the following conditions:

1.

Having completed on-site examinations on enterprises with a production license for at least 10 times and acting as the leader of an
examination group for more than 6 times within the valid period of the registration certificate;

2.

Having participated in the relevant work training on production license for more than 20 hours each year; and

3.

Observing the behavior criterions on examiners, and having no illegal act or act violating regulations.

Article 58

Any personnel who applies for upgrading shall file an application to the provincial license office or the examination organ. The National
License Office shall make examination on the applicants for upgrading reported by the provincial license office or the examination
organ, and issue a registration certificate of a senior examiner to an examiner who meets the requirements for upgrading and upon
the approval of the National License Office. And the valid period of the certificate shall be three years.

Article 59

The technical experts shall refer to the relevant personnel, who have not obtained the registration certificate of an examiner, but
may provide technical advice to the on-site examinations on the enterprises with a production license when necessary.

Article 60

Any person who applies for the qualification of a technical expert shall meet the following conditions:

1.

Having a bachelor’s degree of college or above or a senior technical post_title;

2.

Having undertaken the relevant professional work for 10 full years; and

3.

Being familiar with the professional knowledge on relevant products and being the technical authority of the relevant fields.

Article 61

A provincial license office or an examination organ may, when necessary, file an application to the National License Office for putting
on archives the technical experts who may participate in the on-site examination work of enterprises upon the approval of the National
License Office.

Article 62

Where a technical expert participates in an on-site examination on an enterprise, he/she shall not act as a member of the examination
group, and may not take part in drawing examination conclusions.

Article 63

The registration certificate holder shall properly keep its certificate, and shall apply for a new one in a timely manner in case
the certificate is lost or damaged.

Article 64

A checker shall carry out on-site examinations on enterprises in accordance with the provisions of the detailed implementation rules
for products. When conducting an examination, the checker shall show the relevant certificate to the enterprise under examination.

Article 65

When conducting an on-site examination on any enterprise, a checker may not create difficulties for the enterprise, and may not seek
for or take the property of the enterprise or figure for other illicit interests.

Chapter IV Administration on Examination Organs

Article 66

An examination organ shall meet the following basic conditions:

1.

Having a sound management system and an effective operating mechanism;

2.

Having staff members suitable for carrying out the work of examination on relevant products;

3.

Having a suitable place of business and office facilities;

4.

Having mastered the relevant laws and regulations and provisions on production license, and knowing the mechanism and procedures for
production license;

5.

Knowing the present situation of the industry concerned and the national industrial policies of relevant products; and

6.

Having no acts of undertaking the production, sale, and supervision over the manufacture and sale of the relevant products.

Article 67

Any entity that meets the conditions as provided for in Article 66 may apply to the National License Office for working as an examination
organ on relevant products, and submit the following materials:

1.

the written application for working as an examination organ on relevant products;

2.

the certificate of organization code of the application institution, business license of the legal person or the registration certificate
of the legal person of a social body;

3.

the basic information on the application entity;

4.

the industrial development level of the relevant products, enterprise distribution, and the basic information on the prod

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