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THE GOVERNMENT
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
No.: 154/2018/ND-CP Hanoi, November 09, 2018
DECREE
AMENDING, SUPPLEMENTING AND REPEALING CERTAIN REGULATIONS ON
INVESTMENT AND BUSINESS CONDITIONS IN SECTORS UNDER MANAGEMENT OF
MINISTRY OF SCIENCE AND TECHNOLOGY AND CERTAIN REGULATIONS ON
SPECIALIZED INSPECTIONS
Pursuant to the Law on government organization dated June 19, 2015;
Pursuant to the Law on investment dated November 26, 2014 and the Law on amendments to
Article 6 and Appendix 4 regarding the list of conditional business lines of the Law on
investment dated November 22, 2016;
Pursuant to the Law on intellectual property dated November 29, 2005 and the Law on
amendments to certain articles of the Law on intellectual property dated June 19, 2009;
Pursuant to the Law on technical regulations and standards dated June 29, 2006;
Pursuant to the Law on quality of goods and products dated November 21, 2007;
Pursuant to the Law on measurement dated November 11, 2011;
At the request of the Minister of Science and Technology;
The Government promulgates a Decree amending, supplementing and repealing certain
regulations on investment and business conditions in sectors under the management of the
Ministry of Science and Technology and certain regulations on specialized inspections.
Article 1. Amendments to Clause 2 Article 42 of the Government’s Decree No.
105/2006/ND-CP dated September 22, 2006 elaborating and guiding the implementation of
the Law on intellectual property with respect to intellectual property protection and state
management of intellectual property (as amended in Clause 10 Article 1 of the
Government’s Decree No. 119/2010/ND-CP dated December 30, 2010)
“2. A provider of intellectual property assessment services is allowed to provide intellectual
property assessment services when it employs at least an intellectual property assessor.".
Article 2. Amending, supplementing and repealing certain articles of the Government’s
Decree No. 105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for
MEDGATE TECHNOLOGY AND
INVESTMENT JOINT STOCK COMPANY
Hotline: 098.546.1894
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operation to be satisfied by providers of inspection, calibration and testing services of
measuring instruments and standards
1. Point a Clause 2 and Clause 5 Article 3 are abrogated.
2. Point b Clause 2 Article 3 is amended as follows:
“b) Have sufficient measuring standards and instruments, and environmental conditions for
performing inspection, calibration and testing activities according to the corresponding
inspection, calibration and testing procedures. Inspection, calibration and testing procedures
must be conformable with the Ministry of Science and Technology’s guidelines or the
international advices provided by the International Organization of Legal Metrology, the
standards of the International Electrotechnical Commission, the standards of the International
Organization for Standardization, and relevant documents of manufacturers. These measuring
standards and instruments must be periodically inspected, calibrated and tested, and maintained,
managed and used according to regulations adopted by the head of the inspection, calibration and
testing service provider; inspection, calibration and/or testing certificate must be unexpired.".
3. Clause 3 Article 3 is amended as follows:
“3. Have established inspection, calibration and testing procedures which must be suitable for the
registered operations.”
4. Clause 4 Article 3 is amended and supplemented as follows:
“4. Employ at least 01 technician for each operating sector. A technician is required to meet the
following requirements:
a) Possess an intermediate education diploma or equivalent or higher level;
b) Have completed a training course in inspection, calibration and testing suitable for the
registered operating sectors and according to the Ministry of Science and Technology’s
guidelines.”.
5. Clause 6 Article 3 is amended as follows:
“5. Have a management system established and maintained in conformity with TCVN ISO/IEC
17025 for managing inspection, calibration and testing of measuring instruments and standards.
The document stipulating the management of certificates of inspection, calibration and testing
(including stamps, seals and certifications) made by the head of the inspection, calibration and
testing service provider must be also available.”.
6. Clause 1 Article 4 is amended and supplemented as follows:
“1. Fulfill regulatory requirements for operation as stated in Article 3 hereof.”
7. Clause 2 Article 4 is amended and supplemented as follows:
“2. Working standards and reference materials directly used for inspecting group-2 measuring
instruments in the designated operating sector must meet the requirements set forth in
corresponding technical documents on measurement of Vietnam, be calibrated, tested or
compared by the designated calibration/testing service providers operating in relevant sectors in
Vietnam or by the accredited or designated foreign inspection, calibration and/or testing service
providers operating in relevant sectors, and be certified according to Article 14 and Article 15 of
the Law on measurement.”.
8. Clause 3 Article 4 is abrogated.
9. Clause 4 Article 4 is amended as follows:
“4. Employ at least 01 inspector who must be certified and granted the metrology inspector’s
card in order to engage in the inspection of designated group-2 measuring instruments.”.
10. Clause 5 Article 4 is abrogated.
11. Clause 5 Article 5 is amended as follows:
“5. The document stipulating the management of inspection, calibration and testing certificates,
which must specify: Contents and format of the certificate; production, management and use of
the certificate; size and position of the registration number on the certificate, which should be
identified easily with naked eyes; documents stipulating the maintenance, management and use
of measuring standards and instruments serving the performance of inspection, calibration and
test activities.”.
12. The Form No. 02 provided in the Appendix enclosed with the Government’s Decree No.
105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for operation to be
satisfied by providers of inspection, calibration and testing services of measuring instruments
and standards is replaced by the Form No. 02 provided in the Appendix I enclosed herewith.
Article 3. Amending, supplementing and repealing certain articles of the Government’s
Decree No. 107/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements to be
satisfied by conformity assessment service providers
1. Clause 4 Article 5, Point d Clause 2 Article 6, Point c Clause 3 Article 17 and regulations on
provision of information concerning working period and experience of assessors and assessment
experts in Point c Clause 2 Article 14, Point c Clause 2 Article 18 and Point g Clause 2 Article
22 are abrogated.
2. The second paragraph of Point dd Clause 2 and Point d Clause 3 Article 6 are amended and
supplemented as follows:
“If a testing body has been accredited by an accreditation body as prescribed in Article 21 hereof
or a foreign accreditation body as prescribed in Article 25 hereof but wishes to apply for
registration of testing services other than the accredited ones, it shall submit the copy of the
Certificate of accreditation, accompanied by the list of accredited testing services, and testing
procedures/documents, and other relevant documents proving its conformity of the competence
to provide the requested testing services with corresponding standards as stated in Clause 2
Article 5 hereof.”
3. Point dd Clause 2 and Point c Clause 3 Article 10 are amended and supplemented as follows:
“If an inspection body has been certified to be conformable with the standards set forth in TCVN
ISO 9001:2008 or ISO 9001:2008 but wishes to apply for registration of inspection services
other than the certified ones, it shall submit the copy of the Certificate of conformity with TCVN
ISO 9001:2008 or ISO 9001:2008, and inspection procedures/ documents and other relevant
documents proving its conformity of the competence to provide the requested inspection services
with corresponding standards as stated in Clause 2 Article 9 hereof.”
4. Point c Clause 3 Article 13 is amended as follows:
“c) Have at least 02-year experience in the quality assessment for products and goods.
If a provider of quality assessment services for products and goods wishes to apply for
registration of an additional assessment service, it must employ at least 02 official assessors
(who are public employees or employees working under labour contracts with a term of at least
12 months or an indefinite term) for take charge of the requested additional assessment service;
these assessors must also meet relevant requirements specified in this Clause."
5. Point d Clause 2 and Point c Clause 3 Article 14 are amended and supplemented as follows:
“If a provider of quality assessment services for products and goods has been accredited by an
accreditation body as prescribed in Article 21 hereof or a foreign accreditation body as
prescribed in Article 25 hereof but wishes to apply for registration of an operating scope larger
than the accredited one, it shall submit the copy of the Certificate of accreditation stating the
accredited quality assessment services, and quality assessment procedures/documents, and other
relevant documents proving its conformity of the competence to provide the requested quality
assessment services for products and goods with corresponding standards as stated in Clause 2
Article 13 hereof.”
6. Point a Clause 3 Article 17 is amended as follows:
“a) Hold a university degree or higher;”
7. Point d Clause 3 Article 17 is amended as follows:
“d) Have at least 20-working-day experience in assessment in connection with the relevant
certification program.
If a certification body wishes to apply for registration of additional certification services, it must
employ at least 02 official experts (who are public employees or employees working under
labour contracts with a term of at least 12 months or an indefinite term) for each requested
certification service; these experts are required to meet relevant requirements specified in this
Clause."
8. Point d Clause 2 and Point c Clause 3 Article 18 are amended and supplemented as follows:
“If a certification body has been accredited by an accreditation body as prescribed in Article 21
hereof or a foreign accreditation body as prescribed in Article 25 hereof but wishes to apply for
registration of an operating scope larger than the accredited one, it shall submit the copy of the
Certificate of accreditation stating the accredited certification services, and certification
procedures/documents, and other relevant documents proving its conformity of the competence
to provide the requested certification services with corresponding standards as stated in Clause 2
Article 17 hereof.”
9. Clause 4 Article 21 is amended and supplemented as follows:
“Meet a regional or international accreditation body’s requirements and conditions for
accreditation services in connection with the registered accreditation program.
Within 04 years from the date of establishment, the accreditation body must prove its fulfillment
of competence requirements prescribed in this Clause so as to be eligible to become a signatory
of agreements on mutual recognition of conformity assessment results of regional or
international accreditation bodies with respect to relevant accreditation programs."
10. Point a Clause 5 Article 21 is amended as follows:
“a) Hold a university degree or higher, and have at least 02-year experience in quality
management and/or assessment of competence of relevant conformity assessment bodies, for the
chief assessor, or have at least 01-year experience in quality management and/or assessment of
competence of relevant conformity assessment bodies, for assessors;".
11. The second paragraph of Point e Clause 2 Article 22 is amended and supplemented as
follows:
“If the accreditation body does not yet become a signatory of any agreement on mutual
recognition of conformity assessment results of a regional or international accreditation body, it
must submit the written commitment to its fulfillment of competence requirements to be eligible
to become a signatory of an agreement on mutual recognition of conformity assessment results of
a regional or international accreditation body within a period of 04 years after its establishment.”
12. Article 26 is supplemented as follows:
“The conformity assessment body whose certificate is revoked may only apply for re-issuance
of the certificate at least 06 months after the notice of revocation of the certificate is made and
after it has taken all required corrective actions."
13. Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12 provided in the
Appendix enclosed with the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016
shall be replaced by Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12
provided in the Appendix II enclosed herewith.
Article 4. Amending and supplementing the Government’s Decree No. 132/2008/ND-CP
dated December 31, 2008 providing specific guidance on enforcement of the Law on quality
of products and goods (as amended in the Government’s Decree No. 74/2018/ND-CP dated
May 15, 2018)
1. Point a Clause 2a Article 7 is amended and supplemented as follows:
“a) Register the regulatory inspection of quality of imported goods, and commitment on the
quality of these goods conforming to applied technical regulations and standards as prescribed in
Form No.01 in the Appendix to this Decree, with bodies authorized to inspect quality of goods
and products (hereinafter referred to as “inspecting agency”), and attach the following
documents: Copy of the contract, packing list (if any); copy (bearing the importer’s
confirmation) of the bill of lading, commercial invoice, cargo manifest (if any); warranty of
quality issued in the exporting country (certificate of quality, test result) (if any); certificate of
origin (if any), photographs or description of goods with mandatory information to be displayed
on primary labels and secondary labels (if the primary label contains insufficient information as
prescribed); and certificates of free sale (CFS) (if any). Importer shall be fully responsible before
the law for the quality of their imported goods;”
2. Point d and Point g Clause 7 Article 7 are amended as follows:
“d) Goods temporarily imported for display or advertisement at trade fairs or exhibitions;
g) Goods, supplies, machinery and equipment which are temporarily imported for re-export, and
not consumed and used in Vietnam;”
3. Clause 8 Article 7 is amended and supplemented as follows:
“8. Reduction or exemption of inspection of quality of group-2 commodities shall be applied,
subject to the following provisions:
a) The imported goods have the same name, usage, brand, type, technical specifications, are
made by a manufacturer, are of the same origin, and are imported by the same importer, and,
after 03 consecutive imports, gain the results of conformity with the national technical
regulations based on which the inspecting agency has issued a written document confirming the
exemption from the regulatory quality inspection within a period of 02 years.
b) An application for the exemption from the regulatory quality inspection includes:
- The application form for the exemption from the regulatory quality inspection, specifying such
information as commodity name, brand, type, technical specifications, origin, manufacturer,
quantity and volume of imported goods as registered, and unit of measurement.
- Copied results of assessment of conformity with national technical regulation carried out in 03
consecutive imports.
c) The importer applying for reduction or exemption from the regulatory quality inspection shall
prepare and submit 01 set of application to the inspecting agency. To be specific:
- With respect to direct submission of the application, if the required documents referred to in
Point b of this Clause are not yet authenticated, original shall be needed for comparison;
- With respect to submission of the application by post, the importer needs to include
authenticated copies or certified true copies (signature and stamp is required) of the documents
stipulated in Point b of this Clause.
d) Within 03 days of receipt of the application, if the application documentation is incomplete or
invalid as per law, the inspecting agency informs the importer in writing to submit a complete
application;
Within 05 days from the receipt of the valid application, the inspecting agency shall issue a
written document confirming the exemption from the regulatory quality inspection, including the
following information: commodity name, brand, type, technical specifications, origin,
manufacturer, quantity and volume of imported goods as registered, and unit of measurement. In
case of refusal to confirm the exemption from the regulatory quality inspection, the inspecting
agency must notify the reasons in writing to the importer.
dd) During duration of such exemption or reduction:
- Every 03 months, the importer must report on the import status enclosed with the results of
assessment of conformity with national technical regulations and applied standards to the
inspecting agency for its supervision and conduct of post-inspection activities.
- The inspecting agency has the rights to conduct a surprise inspection of shipments when
finding out or receiving complaints upon the quality of the imported goods (if necessary).
e) During the reduction or exemption period, if the imported goods sold on the market are found
not conformable with the national technical regulations or applied standards or if the complaints
or denunciations upon results of the assessment of conformity are verified as true or when the
importer fail to pass the surprise inspection of conformity, the inspecting agency shall send out a
notification of suspension of the exemption.
Annually, the inspecting agency conducts the inspection at the storage facility of the importer.
The Ministry of Science and Technology promulgates procedures and contents of the inspection
of quality of products and goods during the production process.”
4. Point b Clause 1 Article 18a is amended and supplemented as follows:
“b) Must carry out the proficiency testing or inter-laboratory comparison with respect to test
methods applied to goods and products specified in its application for designation.
As regards tests for which there is no proficiency testing body available or in which the inter-
laboratory comparison cannot be conducted because no domestic testing laboratory carries out
the analysis, the requesting testing body must supplement its test method dossier, give
confirmation of useful value of the test method and reference materials to control the testing
quality.”
5. Clause 1a Article 18b is supplemented as follows:
“1a. For the temporary designation, the application shall comprise:
a) Application for designation as a conformity assessment body made according to Form No. 4
provided in the Appendix enclosed herewith;
b) The copy of the decision on designation of testing body;
c) Documents about test methods and confirmation of useful value of test methods and reference
materials to control the testing quality.”
6. Clause 5 Article 18dd is supplemented as follows:
“5. Ministries and sectoral administrations shall decide the temporary designation of testing
bodies for a period of 06 months so as to serve the testing for new products and those to which
no national technical regulation applies or for which test methods are not prescribed in relevant
national technical regulations or to perform the state management in their assigned sectors, and
shall assume responsibility for their decisions."
7. Article 18g is supplemented as follows:
“The conformity assessment body having the decision on designation revoked may only submit
an application for designation at least 06 months after the notice of revocation of the decision is
made and after it has taken all required corrective actions.”
8. The second dash of Point b Clause 2 Article 32 of the Government’s Decree No.
132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the
Law on quality of products and goods, as amended and supplemented in Clause 14 Article 1 of
the Government’s Decree No. 74/2018/ND-CP is amended as follows:
“Fertilizers; pesticides; veterinary drugs; animal feeds and aqua feeds; salt.”
9. Form No. 01, Form No. 04 and Form No. 08 provided in the Appendix enclosed to the
Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing
the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific
guidance on enforcement of the Law on quality of products and goods are replaced by Form No.
01, Form No. 04 and Form No. 08 provided in the Appendix III enclosed herewith.
Article 5. The Government’s Decree No. 87/2016/ND-CP dated July 01, 2016 prescribing
conditions for motorcycle helmet business is repealed.
Article 6. Transition provisions
Any certificates of registration of conformity assessment services issued to conformity
assessment bodies shall remain effective till the end of validity period note thereon.
Any of such conformity assessment bodies wishing to expand its operating scope is required to
meet relevant requirements set forth in this Decree.
Article 7. Effect
1. This Decree comes into force as from the date on which it is signed.
2. Ministers, heads of ministerial agencies, heads of the Governmental agencies and
Chairpersons of People’s Committees of provinces and central-affiliated cities shall implement
this Decree./.
ON BEHALF OF THE GOVERNMENT
THE PRIME MINISTER
Nguyen Xuan Phuc
APPENDIX I
(Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018)
Amending Form No. 02 provided in the Appendix enclosed with the Government’s Decree
No. 105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for
operation to be satisfied by providers of inspection, calibration and testing services of
measuring instruments and standards
Form No. 02
THE GOVERNING
AUTHORITY
(if any)
NAME OF ORGANIZATION
----------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
No.: ………………… …………...............[place], ……....................[date]
REPORT ON FACILITIES AND PERSONNEL
1. List of applied inspection/ calibration/ testing procedures
No.
Name of inspection/
calibration/ testing
procedure
Number,
sign
Year of
promulgation
Promulgating
authority1
Inspection/
calibration/ testing
activities
(1
): With respect to the applicant itself formulates and promulgates the inspection/ calibration/
testing procedure: It must submit the copy of the corresponding inspection/ calibration/ testing
procedure in the first registration or additional registration of operating services.
2. List of measuring standards and instruments used for performing inspection/ calibration/
testing activities
No
.
Name of
measuring
standard/
instrumen
t used for
performin
g
inspection/
calibratio
n/ testing
activities
Manufacturin
g country
Manufacturin
g number
Measurin
g scope
Precisio
n level/
degree
Place of
inspection/
calibratio
n/ testing
Validit
y
period
Applied
procedure
2
(2
) Specify number, sign of the applied inspection/ calibration/ testing procedure as stated in
Section 1.
3. Environmental conditions
- Temperature, humidity, pressure, etc.
- Voltage, power supply frequency, monitoring of vibration and interference from
electromagnetic energy, etc.
4. List of inspection/ calibration/ testing employees
- Name of inspection/ calibration/ testing department:……………………………..
- Telephone: …………………………………….; Fax: .....................................................
No. Full name
Date of
birth
Level of
education
Public
employee/
employee
working
under
labour
contract
Completed
training courses
in inspection/
calibration/
testing
Training
institution
Inspection/
calibration/
testing sectors
Enclosed documents:
1. The copies of the inspection/ calibration/ testing certificates of measuring standards and
instruments used to perform inspection/ calibration/ testing activities.
2. Documents proving the employee’s completion of training course(s) in inspection/ calibration/
testing.
HEAD OF ORGANIZATION
(Full name, signature and seal)
APPENDIX II
(Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018)
Replacing Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12
provided in the Appendix enclosed with the Government’s Decree No. 107/2016/ND-CP
dated July 01, 2016
Form No. 01
Application form for registration of certification/ testing/ assessment/ inspection
services
Form No. 02 List of lab analysts/ assessors/ inspectors/ assessment experts
Form No. 03 Statement of assessment experience
Form No. 10 Certificate of registration of certification/ testing/ assessment/ inspection services
Form No. 12 List of chief assessors, assessors, technical experts, technical assessors of
accreditation body
Form No. 01
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
……………….[place], on………[date]
APPLICATION FORM FOR REGISTRATION OF CERTIFICATION/ TESTING/
ASSESSMENT/ INSPECTION SERVICES
To: ………………………..……………………………………..
1. Name of organization: ....................................................................................................
2. Address: ...............................................................................................................
Telephone: ……………………………. Fax:…………………….. E-mail: ............................
3. Establishment decision/ Enterprise registration certificate/ Investment certificate
No.:………………. Issuing authority: …………….Issued on:………………………..
at………………
4. After study into the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016
prescribing regulatory requirements to be satisfied by conformity assessment service providers
and the Government’s Decree No……………………… dated………………. amending,
supplementing and repealing certain regulations on investment and business conditions in sectors
under the management of the Ministry of Science and Technology and certain regulations on
specialized inspections, we believe that we are eligible to provide ……………. (certification/
testing/ assessment/ inspection) service in the sector.................... (name of specialized sectors)2
.
5. Templates of Certificate/ Test report/ Assessment certificate/ Inspection certificate.
6. Template of certification stamp (for certification body)
(Name of the issuing authority) is kindly requested to consider this application and issue the
Certificate of registration of ……………… (certification/ testing/ assessment/ inspection)
service mentioned herein. We shall fully and strictly comply with laws in the sectors for which
we provide conformity assessment services, relevant regulations, and legally assume liability for
information stated herein./.
HEAD OF ORGANIZATION
(Signature and seal)
____________________
1
Specify the operating service requiring registration certification (E.g. if providing testing
service, "Application for registration of testing service” shall be specified).
2
Information shall be specified as follows:
- For testing service: (name of testing sector such as Chemistry/ Biology/ Physical Mechanics/
Pharmaceutical Products/ Electricity – Electronics/ Building materials/ Non-destructive testing/
Bio-safety, etc. shall be specified and accompanied with name of product, and name of
corresponding test method or approach). If there is so much information to be provided, it should
be stated in an Appendix attached to the application.
- For certification service: The product is conformable with the standard (name of product and
applied standard/ technical regulation (if any)/ management system (TCVN ISO 9001/ISO 9001,
TCVN ISO 14001/ISO 14001...) shall be specified. If there is so much information to be
provided, it should be stated in an Appendix attached to the application.
- For quality assessment service (name of product and applied standard/ technical regulation/
assessment procedure shall be specified). If there is so much information to be provided, it
should be stated in an Appendix attached to the application.
- For quality inspection service (name of product and inspection procedure/ applied standard/
technical regulation shall be specified). If there is so much information to be provided, it should
be stated in an Appendix attached to the application.
Form No. 02
NAME OF ORGANIZATION: ……………………
LIST OF ASSESSMENT EXPERTS/ LAB ANALYSTS/ ASSESSORS/ INSPECTORS OF
CONFORMITY ASSESSMENT BODY
List of assessment experts/ assessors/ inspectors (for certification body/ assessment body or
inspection body):
No. Full name
Training
discipline
Trained
management
system
Working
experience2
Type of
signed labour
contract
Notes
1
2
....
List of lab analysts (for testing body)
No. Full name
Training
discipline
Trained
management
system
Working
experience
(number of
years)
Type of
signed labour
contract
Notes
1
2
....
(Name of organization) shall submit documents proving the capacity of…………………..
(assessment expert/ lab analyst/ assessor/ inspector) meeting the requirements set forth in the
Government's Decree No. 107/2016/ND-CP dated July 01, 2016 prescribing regulatory
requirements to be satisfied by conformity assessment service providers and the Government’s
Decree No……………………… dated………………. amending, supplementing and repealing
certain regulations on investment and business conditions in sectors under the management of
the Ministry of Science and Technology and certain regulations on specialized inspections, and
confirm that the information stated herein is accurate and shall be legally responsible for the
provided information./.
……................[place], ……....................[date]
HEAD OF ORGANIZATION
(Signature and seal)
___________________
1
The list of personnel in the registered sector shall be specified (E.g. The list of lab analysts of
the testing body).
2
Information shall be specified as follows: Total years shall be specified for personnel working in
assessment or inspection sector; number of working days shall be specified for personnel
working in certification sector.
Form No. 03
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
STATEMENT OF ASSESSMENT EXPERT/ ASSESSOR'S ASSESSMENT
EXPERIENCE
1. Full name: ......................................................................................................................
Address: ....................................................................................................................
Telephone: ……………………………………. Fax:……………………….. E-mail:
.........................................
2. Assessment experience:
No. Period
Name of
organization/
enterprise to
be assessed
Address,
telephone, fax,
representative
of the assessed
organization/
enterprise
Assessed
sector1
Assessment
result
Other information: ..................................................................................................................
I assure that the information stated herein is accurate and shall be legally responsible for the
provided information./.
……................[place], ……....................[date]
MADE BY
(Signature and full name)
____________________
1
Information shall be specified as follows:
- For the certification of products, name of the product and applied standards/ technical
regulations shall be specified; for the certification of management system, the management
system standard shall be specified.
- For the assessment service, name of product and applied standard/ technical regulation/
assessment procedure shall be specified.
Form No. 10
(NAME OF ISSUING
AUTHORITY)
---------
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
No.: ………………….. …………………[place], …………..………..[date]
CERTIFICATE OF REGISTRATION OF CERTIFICATION/ TESTING/
ASSESSMENT/ INSPECTION SERVICE
Pursuant to the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 on eligibility
requirements to be satisfied to provide conformity assessment services, and the Government’s
Decree No……………………… dated……………….;
Pursuant to the Decree/ Decision No………………………. defining the functions, tasks, powers
and organizational structure of (name of the issuing authority);
At the request of (name of the authority assigned to appraise the application), (name of the
issuing authority) hereby certifies:
1. (Name of conformity assessment body):
…………………………………………………………….
Address: ................................................................................................................................
Telephone: ……………………………………. Fax:……………………………….. E-mail:
...........................................
Has registered its provision of …………………. (certification/ testing/ assessment/ inspection
service) in the sector……………………2
with respect to ..............................3
2. Registration number: ....................................................................................................................
3. This certificate is valid for……………….year(s) from the date on which it is signed./.4
HEAD OF THE ISSUING
AUTHORITY
(Signature and seal)
___________________
1
Name of the service to which the registration certificate is issued shall be specified (E.g.
Certificate of registration of testing service).
2
Name of sector/ industry shall be specified (E.g. construction, industry and trade,
transportation, etc.)
3
Information shall be specified as follows:
- For testing service (name of testing sectors such as Chemistry/ Biology/ Physical Mechanics/
Pharmaceutical products/ Electricity – Electronics/ Building materials/ Non-destructive testing/
Bio-safety, etc. shall be specified and accompanied with name of product, and name of
corresponding test method or approach). If there is so much information to be provided, it should
be stated in an Appendix attached to the certificate.
- For certification service: The product is conformable with the standard (name of product and
applied standard/ technical regulation (if any)/ management system (TCVN ISO 9001/ISO 9001,
TCVN ISO 14001/ISO 14001...) shall be specified. If there is so much information to be
provided, it should be stated in an Appendix attached to the certificate.
- For quality assessment service (name of product and applied standard/ technical regulation/
assessment procedure shall be specified). If there is so much information to be provided, it
should be stated in an Appendix attached to the certificate.
- For quality inspection service (name of product and inspection procedure/ applied standard/
technical regulation shall be specified). If there is so much information to be provided, it should
be stated in an Appendix attached to the certificate.
4
Information shall be specified as follows:
- For issuance of a new certificate: “This certificate is valid for ………… year(s) from the date
on which it is signed” shall be specified.
- For modification of the certificate: “This certificate is re-issued for the……….. (second/ third/
fourth, etc.) time and valid until……………….” shall be specified. (The validity of the re-issued
certificate shall follow that of the issued certificate. E.g. If a certificate is issued on June 20,
2018 and valid for 05 years, the validity of a certificate to be reissued due to modification or
changes shall be June 19, 2023).
Form No. 12
NAME OF ORGANIZATION:……………………….
LIST OF CHIEF ASSESSORS, ASSESSORS, TECHNICAL EXPERTS OF AN
ACCREDITATION BODY
1. List of experts:
No. Full name
Training
discipline
Trained
management
system
Qualification
level (Chief
assessor/ assessor/
technician)
Assessment
experience
(total working
days)
Type of signed
labour
contract
1
2
3
4
5
….
....
2. Actual experience of each expert:
No. Full name
Assessment
standard
Accredited
sector
Assessment
period
Name and address of
the conformity
assessment body to
be assessed
Supervisor
1
2
3
4
5
….
....
(Name of the organization) confirms that the information stated herein is accurate and shall be
legally responsible for the provided information./.
……................[place], ……....................[date]
HEAD OF ORGANIZATION
(Signature and seal)
APPENDIX III
(Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018)
Amending and supplementing Form No. 01, Form No. 04 and Form No. 08 provided in the
Appendix enclosed to the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018
amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated
December 31, 2008 providing specific guidance on enforcement of the Law on quality of
products and goods
Form No.
01
Registration of regulatory inspection of quality of imported goods
Form No.
04
Application for designation as conformity assessment body
Form No.
08
Decision on designation of testing body/ certification body/ assessment body/
inspection body
Form No. 01
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
REGISTRATION OF REGULATORY INSPECTION OF QUALITY OF IMPORTED
GOODS
To: ………………………..…………………………………….. (Name of the inspecting
agency)……………………….
Importer: ...............................................................................................................
Address: ................................................................................................................................
Telephone: …………………….. Fax: ………………………… Email: ...................................
Registers for the inspection of quality of the following imported goods:
No.
Name of good,
brand, type
Technical
specifications
Origin,
manufacturer
Volume/
quantity
Import
checkpoint
Time of
import
Goods gathering place: ...................................................................................................
Import dossier includes: ......................................................................................................
Contract No.: ....................................................................................................
- Packing list (if any): ...................................................................
- Certificate of conformity or certificate of quality of import shipment or certificate of quality
assessment of the import shipment:
.........................................................................................................
Issued by……………………..on……………………..at……………………….
- Certificate of management system (if any) No.: ………………Issued by
……………………………on…………………..at………………………..
- Invoice (if any) No.: ........................................................................................
Bill of Lading (if any) No.: . .............................................................................
Cargo manifest (if any) No.: .......................................................................
C/O (if any) No.: .....................................................................
CFS (if any) No.: .......................................................
- Photographs or description of goods with mandatory information to be displayed on primary
labels and secondary labels (if the primary label contains insufficient information as prescribed).
We confirm and assume legal liability for the validity and legality of the provided information
concerning the import shipment, and also confirm that the quality of the shipment is conformable
with the technical regulation…………………………… and the applied
standard………………….
(NAME OF INSPECTING AGENCY) ………[place], ……………[date]
Registration No.: ………../(Abbreviated name of
the inspecting agency)
……………[place], ………………………[date]
(Signature of representative and seal of the
inspecting agency)
(IMPORTER)
(Signature and seal)
Form No. 04
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
…………..……….……………[place], ……………………[date]
APPLICATION FOR DESIGNATION AS CONFORMITY ASSESSMENT BODY
To: ……………………………….(name of the in-charge agency assigned by the ministry,
sectoral administration, or provincial-level people’s committee)
1. Name of organization: ...................................................................................................................
2. Address: ...............................................................................................................
Telephone: …………………….. Fax: …………………….. Email: ..........................................
3. Establishment decision/ Enterprise registration certificate/ Investment certificate
No.:………………. Issued
by………………….on………………………at……………………….
4. Certificate of registration of testing/ assessment/ inspection/ certification service No
………………….. issued by……………………… issued on……………………………..
5. Enclosed documents:
..........................................................................................................................................
6. After study into the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending
and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008
providing specific guidance on enforcement of the Law on quality of products and goods, and the
Government’s Decree No……………………… dated………………. amending, supplementing
and repealing certain regulations on investment and business conditions in sectors under the
management of the Ministry of Science and Technology and certain regulations on specialized
inspections, we believe that we are eligible to be designated as testing/ assessment/ inspection/
certification body for products, goods, processes, environmental conditions (name of product,
good, process, environmental condition, technical regulation, test method or approach shall be
specified)1
.
(Name of the in-charge agency assigned by the ministry, sectoral administration, or provincial-
level people’s committee) is requested to consider designating (name of organization) as testing/
assessment/ inspection/ certification body for corresponding sectors/ subjects.
We shall fully and strictly comply with laws in the sectors for which we provide conformity
assessment services as designated, and legally assume liability for information stated herein./.
HEAD OF ORGANIZATION
(Signature and seal)
__________________
1
The conformity assessment service requiring designation shall be specified (E.g. If applying for
designation as certification body, “…….to be designated as the certification body” shall be
specified). If there is so much information to be provided, it should be stated in an Appendix
attached to the application. In case of application for temporary designation as testing body, such
temporary designation must be specified.
Form No. 08
(Name of ministry, sectoral
administration, or provincial-
level people’s committee)
(Name of the in-charge agency
assigned by the ministry,
sectoral administration, or
provincial-level people’s
committee)
--------------
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
--------------
…..(Decision No.)……………. ………...............[place], ……....................[date]
DECISION
on designation of testing body/ certification body/ assessment body/ inspection body
…………..(Position of the person signing the decision)
……. (Name of the in-charge agency assigned by the ministry, sectoral administration, or
provincial-level people’s committee)
Pursuant to the Law on quality of goods and products dated November 21, 2007;
Pursuant to the Decree/ Decision No…………….defining the functions, tasks, powers and
organizational structure of……………….. (name of the in-charge agency assigned by the
ministry, sectoral administration, or provincial-level people’s committee);
Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing
specific guidance on enforcement of the Law on quality of products and goods, the
Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing
the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific
guidance on enforcement of the Law on quality of products and goods, and the Government’s
Decree No……………………… dated………………. amending, supplementing and repealing
certain regulations on investment and business conditions in sectors under the management of
the Ministry of Science and Technology and certain regulations on specialized inspections;
Pursuant to the Official Dispatch/ Decision
No………………dated…………….of……………………. (name of the ministry, sectoral
administration, or provincial-level people’s committee) providing guidance on conditions for
provision of testing/ assessment/ inspection/ certification service and competence conditions
prescribed in technical regulations (if any);
At the request of………………… (name of the agency assigned to appraise the application for
designation);
DECIDES:
Article 1. (Name of conformity assessment body) affiliated to………………. (name of the
governing body, if any) (address, telephone, fax, email) is designated as testing/ assessment/
inspection/ certification body for products, goods, processes, environmental conditions (name of
product, good, process, environmental condition, technical regulation, test method or approach
shall be specified)2
.
Article 2. This Decision is valid for ……… year(s) from the date of signing.
Article 3. (Name of conformity assessment body)………….shall provide testing/ assessment/
inspection/ certification service serving the state management as requested, comply with
competent authorities’ regulations and/or guidelines, and be responsible for conformity
assessment results provided.
Article 4. (Name of conformity assessment body)…………………..and relevant authorities and
organizations shall implement this Decision./.
HEAD OF DESIGNATING
AUTHORITY
(Signature and seal)
___________________
1
. Name of the service to be designated shall be specified (E.g. If the testing body is designated,
“decision on designation of testing body" shall be specified).
2
. Information shall be specified as follows:
- For certification/ assessment/ inspection service: Name of product, good, process,
environmental condition and technical regulation shall be specified. If there is so much
information to be provided, it should be stated in an Appendix attached to the decision.
- For testing service: Name of product, good, test method or approach shall be specified. If
there is so much information to be provided, it should be stated in an Appendix attached to the
decision. If a testing body is temporarily designated, such temporary designation must be
specified.

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Decree 154/2018/ND-CP: AMENDING, SUPPLEMENTING AND REPEALING CERTAIN REGULATIONS ON INVESTMENT AND BUSINESS CONDITIONS IN SECTORS UNDER MANAGEMENT OF MINISTRY OF SCIENCE AND TECHNOLOGY AND CERTAIN REGULATIONS ON SPECIALIZED INSPECTIONS

  • 1. THE GOVERNMENT ------- THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- No.: 154/2018/ND-CP Hanoi, November 09, 2018 DECREE AMENDING, SUPPLEMENTING AND REPEALING CERTAIN REGULATIONS ON INVESTMENT AND BUSINESS CONDITIONS IN SECTORS UNDER MANAGEMENT OF MINISTRY OF SCIENCE AND TECHNOLOGY AND CERTAIN REGULATIONS ON SPECIALIZED INSPECTIONS Pursuant to the Law on government organization dated June 19, 2015; Pursuant to the Law on investment dated November 26, 2014 and the Law on amendments to Article 6 and Appendix 4 regarding the list of conditional business lines of the Law on investment dated November 22, 2016; Pursuant to the Law on intellectual property dated November 29, 2005 and the Law on amendments to certain articles of the Law on intellectual property dated June 19, 2009; Pursuant to the Law on technical regulations and standards dated June 29, 2006; Pursuant to the Law on quality of goods and products dated November 21, 2007; Pursuant to the Law on measurement dated November 11, 2011; At the request of the Minister of Science and Technology; The Government promulgates a Decree amending, supplementing and repealing certain regulations on investment and business conditions in sectors under the management of the Ministry of Science and Technology and certain regulations on specialized inspections. Article 1. Amendments to Clause 2 Article 42 of the Government’s Decree No. 105/2006/ND-CP dated September 22, 2006 elaborating and guiding the implementation of the Law on intellectual property with respect to intellectual property protection and state management of intellectual property (as amended in Clause 10 Article 1 of the Government’s Decree No. 119/2010/ND-CP dated December 30, 2010) “2. A provider of intellectual property assessment services is allowed to provide intellectual property assessment services when it employs at least an intellectual property assessor.". Article 2. Amending, supplementing and repealing certain articles of the Government’s Decree No. 105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for MEDGATE TECHNOLOGY AND INVESTMENT JOINT STOCK COMPANY Hotline: 098.546.1894 Website: medgate.vn
  • 2. operation to be satisfied by providers of inspection, calibration and testing services of measuring instruments and standards 1. Point a Clause 2 and Clause 5 Article 3 are abrogated. 2. Point b Clause 2 Article 3 is amended as follows: “b) Have sufficient measuring standards and instruments, and environmental conditions for performing inspection, calibration and testing activities according to the corresponding inspection, calibration and testing procedures. Inspection, calibration and testing procedures must be conformable with the Ministry of Science and Technology’s guidelines or the international advices provided by the International Organization of Legal Metrology, the standards of the International Electrotechnical Commission, the standards of the International Organization for Standardization, and relevant documents of manufacturers. These measuring standards and instruments must be periodically inspected, calibrated and tested, and maintained, managed and used according to regulations adopted by the head of the inspection, calibration and testing service provider; inspection, calibration and/or testing certificate must be unexpired.". 3. Clause 3 Article 3 is amended as follows: “3. Have established inspection, calibration and testing procedures which must be suitable for the registered operations.” 4. Clause 4 Article 3 is amended and supplemented as follows: “4. Employ at least 01 technician for each operating sector. A technician is required to meet the following requirements: a) Possess an intermediate education diploma or equivalent or higher level; b) Have completed a training course in inspection, calibration and testing suitable for the registered operating sectors and according to the Ministry of Science and Technology’s guidelines.”. 5. Clause 6 Article 3 is amended as follows: “5. Have a management system established and maintained in conformity with TCVN ISO/IEC 17025 for managing inspection, calibration and testing of measuring instruments and standards. The document stipulating the management of certificates of inspection, calibration and testing (including stamps, seals and certifications) made by the head of the inspection, calibration and testing service provider must be also available.”. 6. Clause 1 Article 4 is amended and supplemented as follows: “1. Fulfill regulatory requirements for operation as stated in Article 3 hereof.”
  • 3. 7. Clause 2 Article 4 is amended and supplemented as follows: “2. Working standards and reference materials directly used for inspecting group-2 measuring instruments in the designated operating sector must meet the requirements set forth in corresponding technical documents on measurement of Vietnam, be calibrated, tested or compared by the designated calibration/testing service providers operating in relevant sectors in Vietnam or by the accredited or designated foreign inspection, calibration and/or testing service providers operating in relevant sectors, and be certified according to Article 14 and Article 15 of the Law on measurement.”. 8. Clause 3 Article 4 is abrogated. 9. Clause 4 Article 4 is amended as follows: “4. Employ at least 01 inspector who must be certified and granted the metrology inspector’s card in order to engage in the inspection of designated group-2 measuring instruments.”. 10. Clause 5 Article 4 is abrogated. 11. Clause 5 Article 5 is amended as follows: “5. The document stipulating the management of inspection, calibration and testing certificates, which must specify: Contents and format of the certificate; production, management and use of the certificate; size and position of the registration number on the certificate, which should be identified easily with naked eyes; documents stipulating the maintenance, management and use of measuring standards and instruments serving the performance of inspection, calibration and test activities.”. 12. The Form No. 02 provided in the Appendix enclosed with the Government’s Decree No. 105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for operation to be satisfied by providers of inspection, calibration and testing services of measuring instruments and standards is replaced by the Form No. 02 provided in the Appendix I enclosed herewith. Article 3. Amending, supplementing and repealing certain articles of the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements to be satisfied by conformity assessment service providers 1. Clause 4 Article 5, Point d Clause 2 Article 6, Point c Clause 3 Article 17 and regulations on provision of information concerning working period and experience of assessors and assessment experts in Point c Clause 2 Article 14, Point c Clause 2 Article 18 and Point g Clause 2 Article 22 are abrogated. 2. The second paragraph of Point dd Clause 2 and Point d Clause 3 Article 6 are amended and supplemented as follows:
  • 4. “If a testing body has been accredited by an accreditation body as prescribed in Article 21 hereof or a foreign accreditation body as prescribed in Article 25 hereof but wishes to apply for registration of testing services other than the accredited ones, it shall submit the copy of the Certificate of accreditation, accompanied by the list of accredited testing services, and testing procedures/documents, and other relevant documents proving its conformity of the competence to provide the requested testing services with corresponding standards as stated in Clause 2 Article 5 hereof.” 3. Point dd Clause 2 and Point c Clause 3 Article 10 are amended and supplemented as follows: “If an inspection body has been certified to be conformable with the standards set forth in TCVN ISO 9001:2008 or ISO 9001:2008 but wishes to apply for registration of inspection services other than the certified ones, it shall submit the copy of the Certificate of conformity with TCVN ISO 9001:2008 or ISO 9001:2008, and inspection procedures/ documents and other relevant documents proving its conformity of the competence to provide the requested inspection services with corresponding standards as stated in Clause 2 Article 9 hereof.” 4. Point c Clause 3 Article 13 is amended as follows: “c) Have at least 02-year experience in the quality assessment for products and goods. If a provider of quality assessment services for products and goods wishes to apply for registration of an additional assessment service, it must employ at least 02 official assessors (who are public employees or employees working under labour contracts with a term of at least 12 months or an indefinite term) for take charge of the requested additional assessment service; these assessors must also meet relevant requirements specified in this Clause." 5. Point d Clause 2 and Point c Clause 3 Article 14 are amended and supplemented as follows: “If a provider of quality assessment services for products and goods has been accredited by an accreditation body as prescribed in Article 21 hereof or a foreign accreditation body as prescribed in Article 25 hereof but wishes to apply for registration of an operating scope larger than the accredited one, it shall submit the copy of the Certificate of accreditation stating the accredited quality assessment services, and quality assessment procedures/documents, and other relevant documents proving its conformity of the competence to provide the requested quality assessment services for products and goods with corresponding standards as stated in Clause 2 Article 13 hereof.” 6. Point a Clause 3 Article 17 is amended as follows: “a) Hold a university degree or higher;” 7. Point d Clause 3 Article 17 is amended as follows: “d) Have at least 20-working-day experience in assessment in connection with the relevant certification program.
  • 5. If a certification body wishes to apply for registration of additional certification services, it must employ at least 02 official experts (who are public employees or employees working under labour contracts with a term of at least 12 months or an indefinite term) for each requested certification service; these experts are required to meet relevant requirements specified in this Clause." 8. Point d Clause 2 and Point c Clause 3 Article 18 are amended and supplemented as follows: “If a certification body has been accredited by an accreditation body as prescribed in Article 21 hereof or a foreign accreditation body as prescribed in Article 25 hereof but wishes to apply for registration of an operating scope larger than the accredited one, it shall submit the copy of the Certificate of accreditation stating the accredited certification services, and certification procedures/documents, and other relevant documents proving its conformity of the competence to provide the requested certification services with corresponding standards as stated in Clause 2 Article 17 hereof.” 9. Clause 4 Article 21 is amended and supplemented as follows: “Meet a regional or international accreditation body’s requirements and conditions for accreditation services in connection with the registered accreditation program. Within 04 years from the date of establishment, the accreditation body must prove its fulfillment of competence requirements prescribed in this Clause so as to be eligible to become a signatory of agreements on mutual recognition of conformity assessment results of regional or international accreditation bodies with respect to relevant accreditation programs." 10. Point a Clause 5 Article 21 is amended as follows: “a) Hold a university degree or higher, and have at least 02-year experience in quality management and/or assessment of competence of relevant conformity assessment bodies, for the chief assessor, or have at least 01-year experience in quality management and/or assessment of competence of relevant conformity assessment bodies, for assessors;". 11. The second paragraph of Point e Clause 2 Article 22 is amended and supplemented as follows: “If the accreditation body does not yet become a signatory of any agreement on mutual recognition of conformity assessment results of a regional or international accreditation body, it must submit the written commitment to its fulfillment of competence requirements to be eligible to become a signatory of an agreement on mutual recognition of conformity assessment results of a regional or international accreditation body within a period of 04 years after its establishment.” 12. Article 26 is supplemented as follows:
  • 6. “The conformity assessment body whose certificate is revoked may only apply for re-issuance of the certificate at least 06 months after the notice of revocation of the certificate is made and after it has taken all required corrective actions." 13. Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12 provided in the Appendix enclosed with the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 shall be replaced by Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12 provided in the Appendix II enclosed herewith. Article 4. Amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods (as amended in the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018) 1. Point a Clause 2a Article 7 is amended and supplemented as follows: “a) Register the regulatory inspection of quality of imported goods, and commitment on the quality of these goods conforming to applied technical regulations and standards as prescribed in Form No.01 in the Appendix to this Decree, with bodies authorized to inspect quality of goods and products (hereinafter referred to as “inspecting agency”), and attach the following documents: Copy of the contract, packing list (if any); copy (bearing the importer’s confirmation) of the bill of lading, commercial invoice, cargo manifest (if any); warranty of quality issued in the exporting country (certificate of quality, test result) (if any); certificate of origin (if any), photographs or description of goods with mandatory information to be displayed on primary labels and secondary labels (if the primary label contains insufficient information as prescribed); and certificates of free sale (CFS) (if any). Importer shall be fully responsible before the law for the quality of their imported goods;” 2. Point d and Point g Clause 7 Article 7 are amended as follows: “d) Goods temporarily imported for display or advertisement at trade fairs or exhibitions; g) Goods, supplies, machinery and equipment which are temporarily imported for re-export, and not consumed and used in Vietnam;” 3. Clause 8 Article 7 is amended and supplemented as follows: “8. Reduction or exemption of inspection of quality of group-2 commodities shall be applied, subject to the following provisions: a) The imported goods have the same name, usage, brand, type, technical specifications, are made by a manufacturer, are of the same origin, and are imported by the same importer, and, after 03 consecutive imports, gain the results of conformity with the national technical regulations based on which the inspecting agency has issued a written document confirming the exemption from the regulatory quality inspection within a period of 02 years.
  • 7. b) An application for the exemption from the regulatory quality inspection includes: - The application form for the exemption from the regulatory quality inspection, specifying such information as commodity name, brand, type, technical specifications, origin, manufacturer, quantity and volume of imported goods as registered, and unit of measurement. - Copied results of assessment of conformity with national technical regulation carried out in 03 consecutive imports. c) The importer applying for reduction or exemption from the regulatory quality inspection shall prepare and submit 01 set of application to the inspecting agency. To be specific: - With respect to direct submission of the application, if the required documents referred to in Point b of this Clause are not yet authenticated, original shall be needed for comparison; - With respect to submission of the application by post, the importer needs to include authenticated copies or certified true copies (signature and stamp is required) of the documents stipulated in Point b of this Clause. d) Within 03 days of receipt of the application, if the application documentation is incomplete or invalid as per law, the inspecting agency informs the importer in writing to submit a complete application; Within 05 days from the receipt of the valid application, the inspecting agency shall issue a written document confirming the exemption from the regulatory quality inspection, including the following information: commodity name, brand, type, technical specifications, origin, manufacturer, quantity and volume of imported goods as registered, and unit of measurement. In case of refusal to confirm the exemption from the regulatory quality inspection, the inspecting agency must notify the reasons in writing to the importer. dd) During duration of such exemption or reduction: - Every 03 months, the importer must report on the import status enclosed with the results of assessment of conformity with national technical regulations and applied standards to the inspecting agency for its supervision and conduct of post-inspection activities. - The inspecting agency has the rights to conduct a surprise inspection of shipments when finding out or receiving complaints upon the quality of the imported goods (if necessary). e) During the reduction or exemption period, if the imported goods sold on the market are found not conformable with the national technical regulations or applied standards or if the complaints or denunciations upon results of the assessment of conformity are verified as true or when the importer fail to pass the surprise inspection of conformity, the inspecting agency shall send out a notification of suspension of the exemption.
  • 8. Annually, the inspecting agency conducts the inspection at the storage facility of the importer. The Ministry of Science and Technology promulgates procedures and contents of the inspection of quality of products and goods during the production process.” 4. Point b Clause 1 Article 18a is amended and supplemented as follows: “b) Must carry out the proficiency testing or inter-laboratory comparison with respect to test methods applied to goods and products specified in its application for designation. As regards tests for which there is no proficiency testing body available or in which the inter- laboratory comparison cannot be conducted because no domestic testing laboratory carries out the analysis, the requesting testing body must supplement its test method dossier, give confirmation of useful value of the test method and reference materials to control the testing quality.” 5. Clause 1a Article 18b is supplemented as follows: “1a. For the temporary designation, the application shall comprise: a) Application for designation as a conformity assessment body made according to Form No. 4 provided in the Appendix enclosed herewith; b) The copy of the decision on designation of testing body; c) Documents about test methods and confirmation of useful value of test methods and reference materials to control the testing quality.” 6. Clause 5 Article 18dd is supplemented as follows: “5. Ministries and sectoral administrations shall decide the temporary designation of testing bodies for a period of 06 months so as to serve the testing for new products and those to which no national technical regulation applies or for which test methods are not prescribed in relevant national technical regulations or to perform the state management in their assigned sectors, and shall assume responsibility for their decisions." 7. Article 18g is supplemented as follows: “The conformity assessment body having the decision on designation revoked may only submit an application for designation at least 06 months after the notice of revocation of the decision is made and after it has taken all required corrective actions.” 8. The second dash of Point b Clause 2 Article 32 of the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods, as amended and supplemented in Clause 14 Article 1 of the Government’s Decree No. 74/2018/ND-CP is amended as follows:
  • 9. “Fertilizers; pesticides; veterinary drugs; animal feeds and aqua feeds; salt.” 9. Form No. 01, Form No. 04 and Form No. 08 provided in the Appendix enclosed to the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods are replaced by Form No. 01, Form No. 04 and Form No. 08 provided in the Appendix III enclosed herewith. Article 5. The Government’s Decree No. 87/2016/ND-CP dated July 01, 2016 prescribing conditions for motorcycle helmet business is repealed. Article 6. Transition provisions Any certificates of registration of conformity assessment services issued to conformity assessment bodies shall remain effective till the end of validity period note thereon. Any of such conformity assessment bodies wishing to expand its operating scope is required to meet relevant requirements set forth in this Decree. Article 7. Effect 1. This Decree comes into force as from the date on which it is signed. 2. Ministers, heads of ministerial agencies, heads of the Governmental agencies and Chairpersons of People’s Committees of provinces and central-affiliated cities shall implement this Decree./. ON BEHALF OF THE GOVERNMENT THE PRIME MINISTER Nguyen Xuan Phuc APPENDIX I (Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018) Amending Form No. 02 provided in the Appendix enclosed with the Government’s Decree No. 105/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements for
  • 10. operation to be satisfied by providers of inspection, calibration and testing services of measuring instruments and standards Form No. 02 THE GOVERNING AUTHORITY (if any) NAME OF ORGANIZATION ---------- THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- No.: ………………… …………...............[place], ……....................[date] REPORT ON FACILITIES AND PERSONNEL 1. List of applied inspection/ calibration/ testing procedures No. Name of inspection/ calibration/ testing procedure Number, sign Year of promulgation Promulgating authority1 Inspection/ calibration/ testing activities (1 ): With respect to the applicant itself formulates and promulgates the inspection/ calibration/ testing procedure: It must submit the copy of the corresponding inspection/ calibration/ testing procedure in the first registration or additional registration of operating services. 2. List of measuring standards and instruments used for performing inspection/ calibration/ testing activities No . Name of measuring standard/ instrumen t used for performin g inspection/ calibratio n/ testing activities Manufacturin g country Manufacturin g number Measurin g scope Precisio n level/ degree Place of inspection/ calibratio n/ testing Validit y period Applied procedure 2 (2 ) Specify number, sign of the applied inspection/ calibration/ testing procedure as stated in Section 1.
  • 11. 3. Environmental conditions - Temperature, humidity, pressure, etc. - Voltage, power supply frequency, monitoring of vibration and interference from electromagnetic energy, etc. 4. List of inspection/ calibration/ testing employees - Name of inspection/ calibration/ testing department:…………………………….. - Telephone: …………………………………….; Fax: ..................................................... No. Full name Date of birth Level of education Public employee/ employee working under labour contract Completed training courses in inspection/ calibration/ testing Training institution Inspection/ calibration/ testing sectors Enclosed documents: 1. The copies of the inspection/ calibration/ testing certificates of measuring standards and instruments used to perform inspection/ calibration/ testing activities. 2. Documents proving the employee’s completion of training course(s) in inspection/ calibration/ testing. HEAD OF ORGANIZATION (Full name, signature and seal) APPENDIX II (Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018) Replacing Form No. 01, Form No. 02, Form No. 03, Form No. 10, and Form No. 12 provided in the Appendix enclosed with the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016
  • 12. Form No. 01 Application form for registration of certification/ testing/ assessment/ inspection services Form No. 02 List of lab analysts/ assessors/ inspectors/ assessment experts Form No. 03 Statement of assessment experience Form No. 10 Certificate of registration of certification/ testing/ assessment/ inspection services Form No. 12 List of chief assessors, assessors, technical experts, technical assessors of accreditation body Form No. 01 SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- ……………….[place], on………[date] APPLICATION FORM FOR REGISTRATION OF CERTIFICATION/ TESTING/ ASSESSMENT/ INSPECTION SERVICES To: ………………………..…………………………………….. 1. Name of organization: .................................................................................................... 2. Address: ............................................................................................................... Telephone: ……………………………. Fax:…………………….. E-mail: ............................ 3. Establishment decision/ Enterprise registration certificate/ Investment certificate No.:………………. Issuing authority: …………….Issued on:……………………….. at……………… 4. After study into the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements to be satisfied by conformity assessment service providers and the Government’s Decree No……………………… dated………………. amending, supplementing and repealing certain regulations on investment and business conditions in sectors under the management of the Ministry of Science and Technology and certain regulations on specialized inspections, we believe that we are eligible to provide ……………. (certification/ testing/ assessment/ inspection) service in the sector.................... (name of specialized sectors)2 . 5. Templates of Certificate/ Test report/ Assessment certificate/ Inspection certificate. 6. Template of certification stamp (for certification body)
  • 13. (Name of the issuing authority) is kindly requested to consider this application and issue the Certificate of registration of ……………… (certification/ testing/ assessment/ inspection) service mentioned herein. We shall fully and strictly comply with laws in the sectors for which we provide conformity assessment services, relevant regulations, and legally assume liability for information stated herein./. HEAD OF ORGANIZATION (Signature and seal) ____________________ 1 Specify the operating service requiring registration certification (E.g. if providing testing service, "Application for registration of testing service” shall be specified). 2 Information shall be specified as follows: - For testing service: (name of testing sector such as Chemistry/ Biology/ Physical Mechanics/ Pharmaceutical Products/ Electricity – Electronics/ Building materials/ Non-destructive testing/ Bio-safety, etc. shall be specified and accompanied with name of product, and name of corresponding test method or approach). If there is so much information to be provided, it should be stated in an Appendix attached to the application. - For certification service: The product is conformable with the standard (name of product and applied standard/ technical regulation (if any)/ management system (TCVN ISO 9001/ISO 9001, TCVN ISO 14001/ISO 14001...) shall be specified. If there is so much information to be provided, it should be stated in an Appendix attached to the application. - For quality assessment service (name of product and applied standard/ technical regulation/ assessment procedure shall be specified). If there is so much information to be provided, it should be stated in an Appendix attached to the application. - For quality inspection service (name of product and inspection procedure/ applied standard/ technical regulation shall be specified). If there is so much information to be provided, it should be stated in an Appendix attached to the application. Form No. 02 NAME OF ORGANIZATION: …………………… LIST OF ASSESSMENT EXPERTS/ LAB ANALYSTS/ ASSESSORS/ INSPECTORS OF CONFORMITY ASSESSMENT BODY
  • 14. List of assessment experts/ assessors/ inspectors (for certification body/ assessment body or inspection body): No. Full name Training discipline Trained management system Working experience2 Type of signed labour contract Notes 1 2 .... List of lab analysts (for testing body) No. Full name Training discipline Trained management system Working experience (number of years) Type of signed labour contract Notes 1 2 .... (Name of organization) shall submit documents proving the capacity of………………….. (assessment expert/ lab analyst/ assessor/ inspector) meeting the requirements set forth in the Government's Decree No. 107/2016/ND-CP dated July 01, 2016 prescribing regulatory requirements to be satisfied by conformity assessment service providers and the Government’s Decree No……………………… dated………………. amending, supplementing and repealing certain regulations on investment and business conditions in sectors under the management of the Ministry of Science and Technology and certain regulations on specialized inspections, and confirm that the information stated herein is accurate and shall be legally responsible for the provided information./. ……................[place], ……....................[date] HEAD OF ORGANIZATION (Signature and seal) ___________________ 1 The list of personnel in the registered sector shall be specified (E.g. The list of lab analysts of the testing body). 2 Information shall be specified as follows: Total years shall be specified for personnel working in assessment or inspection sector; number of working days shall be specified for personnel working in certification sector.
  • 15. Form No. 03 SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- STATEMENT OF ASSESSMENT EXPERT/ ASSESSOR'S ASSESSMENT EXPERIENCE 1. Full name: ...................................................................................................................... Address: .................................................................................................................... Telephone: ……………………………………. Fax:……………………….. E-mail: ......................................... 2. Assessment experience: No. Period Name of organization/ enterprise to be assessed Address, telephone, fax, representative of the assessed organization/ enterprise Assessed sector1 Assessment result Other information: .................................................................................................................. I assure that the information stated herein is accurate and shall be legally responsible for the provided information./. ……................[place], ……....................[date] MADE BY (Signature and full name) ____________________ 1 Information shall be specified as follows:
  • 16. - For the certification of products, name of the product and applied standards/ technical regulations shall be specified; for the certification of management system, the management system standard shall be specified. - For the assessment service, name of product and applied standard/ technical regulation/ assessment procedure shall be specified. Form No. 10 (NAME OF ISSUING AUTHORITY) --------- SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- No.: ………………….. …………………[place], …………..………..[date] CERTIFICATE OF REGISTRATION OF CERTIFICATION/ TESTING/ ASSESSMENT/ INSPECTION SERVICE Pursuant to the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 on eligibility requirements to be satisfied to provide conformity assessment services, and the Government’s Decree No……………………… dated……………….; Pursuant to the Decree/ Decision No………………………. defining the functions, tasks, powers and organizational structure of (name of the issuing authority); At the request of (name of the authority assigned to appraise the application), (name of the issuing authority) hereby certifies: 1. (Name of conformity assessment body): ……………………………………………………………. Address: ................................................................................................................................ Telephone: ……………………………………. Fax:……………………………….. E-mail: ........................................... Has registered its provision of …………………. (certification/ testing/ assessment/ inspection service) in the sector……………………2 with respect to ..............................3 2. Registration number: .................................................................................................................... 3. This certificate is valid for……………….year(s) from the date on which it is signed./.4
  • 17. HEAD OF THE ISSUING AUTHORITY (Signature and seal) ___________________ 1 Name of the service to which the registration certificate is issued shall be specified (E.g. Certificate of registration of testing service). 2 Name of sector/ industry shall be specified (E.g. construction, industry and trade, transportation, etc.) 3 Information shall be specified as follows: - For testing service (name of testing sectors such as Chemistry/ Biology/ Physical Mechanics/ Pharmaceutical products/ Electricity – Electronics/ Building materials/ Non-destructive testing/ Bio-safety, etc. shall be specified and accompanied with name of product, and name of corresponding test method or approach). If there is so much information to be provided, it should be stated in an Appendix attached to the certificate. - For certification service: The product is conformable with the standard (name of product and applied standard/ technical regulation (if any)/ management system (TCVN ISO 9001/ISO 9001, TCVN ISO 14001/ISO 14001...) shall be specified. If there is so much information to be provided, it should be stated in an Appendix attached to the certificate. - For quality assessment service (name of product and applied standard/ technical regulation/ assessment procedure shall be specified). If there is so much information to be provided, it should be stated in an Appendix attached to the certificate. - For quality inspection service (name of product and inspection procedure/ applied standard/ technical regulation shall be specified). If there is so much information to be provided, it should be stated in an Appendix attached to the certificate. 4 Information shall be specified as follows: - For issuance of a new certificate: “This certificate is valid for ………… year(s) from the date on which it is signed” shall be specified. - For modification of the certificate: “This certificate is re-issued for the……….. (second/ third/ fourth, etc.) time and valid until……………….” shall be specified. (The validity of the re-issued certificate shall follow that of the issued certificate. E.g. If a certificate is issued on June 20, 2018 and valid for 05 years, the validity of a certificate to be reissued due to modification or changes shall be June 19, 2023).
  • 18. Form No. 12 NAME OF ORGANIZATION:………………………. LIST OF CHIEF ASSESSORS, ASSESSORS, TECHNICAL EXPERTS OF AN ACCREDITATION BODY 1. List of experts: No. Full name Training discipline Trained management system Qualification level (Chief assessor/ assessor/ technician) Assessment experience (total working days) Type of signed labour contract 1 2 3 4 5 …. .... 2. Actual experience of each expert: No. Full name Assessment standard Accredited sector Assessment period Name and address of the conformity assessment body to be assessed Supervisor 1 2 3 4 5 …. .... (Name of the organization) confirms that the information stated herein is accurate and shall be legally responsible for the provided information./.
  • 19. ……................[place], ……....................[date] HEAD OF ORGANIZATION (Signature and seal) APPENDIX III (Enclosed with the Government’s Decree No. 154/2018/ND-CP dated November 09, 2018) Amending and supplementing Form No. 01, Form No. 04 and Form No. 08 provided in the Appendix enclosed to the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods Form No. 01 Registration of regulatory inspection of quality of imported goods Form No. 04 Application for designation as conformity assessment body Form No. 08 Decision on designation of testing body/ certification body/ assessment body/ inspection body Form No. 01 SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- REGISTRATION OF REGULATORY INSPECTION OF QUALITY OF IMPORTED GOODS To: ………………………..…………………………………….. (Name of the inspecting agency)………………………. Importer: ............................................................................................................... Address: ................................................................................................................................ Telephone: …………………….. Fax: ………………………… Email: ...................................
  • 20. Registers for the inspection of quality of the following imported goods: No. Name of good, brand, type Technical specifications Origin, manufacturer Volume/ quantity Import checkpoint Time of import Goods gathering place: ................................................................................................... Import dossier includes: ...................................................................................................... Contract No.: .................................................................................................... - Packing list (if any): ................................................................... - Certificate of conformity or certificate of quality of import shipment or certificate of quality assessment of the import shipment: ......................................................................................................... Issued by……………………..on……………………..at………………………. - Certificate of management system (if any) No.: ………………Issued by ……………………………on…………………..at……………………….. - Invoice (if any) No.: ........................................................................................ Bill of Lading (if any) No.: . ............................................................................. Cargo manifest (if any) No.: ....................................................................... C/O (if any) No.: ..................................................................... CFS (if any) No.: ....................................................... - Photographs or description of goods with mandatory information to be displayed on primary labels and secondary labels (if the primary label contains insufficient information as prescribed). We confirm and assume legal liability for the validity and legality of the provided information concerning the import shipment, and also confirm that the quality of the shipment is conformable with the technical regulation…………………………… and the applied standard…………………. (NAME OF INSPECTING AGENCY) ………[place], ……………[date]
  • 21. Registration No.: ………../(Abbreviated name of the inspecting agency) ……………[place], ………………………[date] (Signature of representative and seal of the inspecting agency) (IMPORTER) (Signature and seal) Form No. 04 SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- …………..……….……………[place], ……………………[date] APPLICATION FOR DESIGNATION AS CONFORMITY ASSESSMENT BODY To: ……………………………….(name of the in-charge agency assigned by the ministry, sectoral administration, or provincial-level people’s committee) 1. Name of organization: ................................................................................................................... 2. Address: ............................................................................................................... Telephone: …………………….. Fax: …………………….. Email: .......................................... 3. Establishment decision/ Enterprise registration certificate/ Investment certificate No.:………………. Issued by………………….on………………………at………………………. 4. Certificate of registration of testing/ assessment/ inspection/ certification service No ………………….. issued by……………………… issued on…………………………….. 5. Enclosed documents: .......................................................................................................................................... 6. After study into the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods, and the Government’s Decree No……………………… dated………………. amending, supplementing and repealing certain regulations on investment and business conditions in sectors under the management of the Ministry of Science and Technology and certain regulations on specialized inspections, we believe that we are eligible to be designated as testing/ assessment/ inspection/ certification body for products, goods, processes, environmental conditions (name of product,
  • 22. good, process, environmental condition, technical regulation, test method or approach shall be specified)1 . (Name of the in-charge agency assigned by the ministry, sectoral administration, or provincial- level people’s committee) is requested to consider designating (name of organization) as testing/ assessment/ inspection/ certification body for corresponding sectors/ subjects. We shall fully and strictly comply with laws in the sectors for which we provide conformity assessment services as designated, and legally assume liability for information stated herein./. HEAD OF ORGANIZATION (Signature and seal) __________________ 1 The conformity assessment service requiring designation shall be specified (E.g. If applying for designation as certification body, “…….to be designated as the certification body” shall be specified). If there is so much information to be provided, it should be stated in an Appendix attached to the application. In case of application for temporary designation as testing body, such temporary designation must be specified. Form No. 08 (Name of ministry, sectoral administration, or provincial- level people’s committee) (Name of the in-charge agency assigned by the ministry, sectoral administration, or provincial-level people’s committee) -------------- SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- …..(Decision No.)……………. ………...............[place], ……....................[date] DECISION on designation of testing body/ certification body/ assessment body/ inspection body
  • 23. …………..(Position of the person signing the decision) ……. (Name of the in-charge agency assigned by the ministry, sectoral administration, or provincial-level people’s committee) Pursuant to the Law on quality of goods and products dated November 21, 2007; Pursuant to the Decree/ Decision No…………….defining the functions, tasks, powers and organizational structure of……………….. (name of the in-charge agency assigned by the ministry, sectoral administration, or provincial-level people’s committee); Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods, the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending and supplementing the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 providing specific guidance on enforcement of the Law on quality of products and goods, and the Government’s Decree No……………………… dated………………. amending, supplementing and repealing certain regulations on investment and business conditions in sectors under the management of the Ministry of Science and Technology and certain regulations on specialized inspections; Pursuant to the Official Dispatch/ Decision No………………dated…………….of……………………. (name of the ministry, sectoral administration, or provincial-level people’s committee) providing guidance on conditions for provision of testing/ assessment/ inspection/ certification service and competence conditions prescribed in technical regulations (if any); At the request of………………… (name of the agency assigned to appraise the application for designation); DECIDES: Article 1. (Name of conformity assessment body) affiliated to………………. (name of the governing body, if any) (address, telephone, fax, email) is designated as testing/ assessment/ inspection/ certification body for products, goods, processes, environmental conditions (name of product, good, process, environmental condition, technical regulation, test method or approach shall be specified)2 . Article 2. This Decision is valid for ……… year(s) from the date of signing. Article 3. (Name of conformity assessment body)………….shall provide testing/ assessment/ inspection/ certification service serving the state management as requested, comply with competent authorities’ regulations and/or guidelines, and be responsible for conformity assessment results provided. Article 4. (Name of conformity assessment body)…………………..and relevant authorities and organizations shall implement this Decision./.
  • 24. HEAD OF DESIGNATING AUTHORITY (Signature and seal) ___________________ 1 . Name of the service to be designated shall be specified (E.g. If the testing body is designated, “decision on designation of testing body" shall be specified). 2 . Information shall be specified as follows: - For certification/ assessment/ inspection service: Name of product, good, process, environmental condition and technical regulation shall be specified. If there is so much information to be provided, it should be stated in an Appendix attached to the decision. - For testing service: Name of product, good, test method or approach shall be specified. If there is so much information to be provided, it should be stated in an Appendix attached to the decision. If a testing body is temporarily designated, such temporary designation must be specified.