Decree No. 105/2023/ND-CP detailing some articles and measures to implement the Law on Metrology, the Law on Product Quality, and the Decree on metrological activities and product quality. This Decree abolishes Decree No. 87/2016/ND-CP on business conditions for motorcycle helmets for motorcyclists.
Đối tượng áp dụng
Applies to organizations that have been granted a Registration Certificate for conformity assessment activities and relevant state management agencies.
Các điểm cốt lõi
- Detailed regulations on business conditions for motorcycle helmets for motorcyclists
- Adjusts the procedure for exempting or reducing product quality inspections for imported goods
- Adds provisions regarding the temporary designation of testing organizations in certain special cases.
- Transitional provisions and the effective date of the Decree.
- This Decree abolishes Decree No. 87/2016/ND-CP on business conditions for motorcycle helmets for motorcyclists.
🌐 Tác động xã hội từ văn bản này
- Strengthening the management of the quality of imported products and goods
- Improving the effectiveness of conformity assessment organizations' operations
- Reducing administrative procedures in product quality inspections for imported goods
❓ Câu hỏi thường gặp
When does this Decree take effect?
Decree No. 105/2023/ND-CP takes effect from the date of issuance.
Can conformity assessment organizations that have been granted a Registration Certificate continue their operations until when?
These organizations can continue their operations until the expiration date stated on the Registration Certificate.
Does this Decree abolish Decree No. 87/2016/ND-CP on business conditions for motorcycle helmets for motorcyclists?
Yes, Decree No. 105/2023/ND-CP has abolished Decree No. 87/2016/ND-CP.
What does this Decree stipulate about the temporary designation of testing organizations?
The competent ministry or sector decides on the temporary designation of testing organizations for up to six months to meet the testing needs of new products or those without national technical standards.
Toàn văn
DECREE
Provincial People's Committees set specific pricesto amend, supplement, and abolish certain provisions on investment and business conditions in the field of managementhsector
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CFebruary 10, 2017 on the functions, tasks, powers, and responsibilities of the Ministry of Transport; Law by the Government on June 19,amend2015;
On the basis of Law đthe Law on Investment dated November 26, 2014, and Law stipulating and guiding the implementation of content number 09 under component number 02 and content number 02 under component number 08 of the National Target Program on New Rural Development for the period 2021-2025. Article 6 and Appendix 4 on the list fields of industries and businesses subject to 1. NATIONAL UNIVERSITIES ARE PUBLIC HIGHER EDUCATION INSTITUTIONS MANAGED BY THE MINISTRY OF EDUCATION AND TRAINING, HAVE LEGAL PERSONALITY, SEPARATE ACCOUNTS, AND USE STAMPS WITH THE NATIONAL EMBLEM. conditions of Law đthe Law on Investment dated November 22, 2016;
Pursuant to the Law "7. A flexible power plant is a thermal power plant using reciprocating internal combustion engines (RICE) or aeroderivative gas turbines (Aero-GT) with fast start-up capabilities, designed in modular form to generate electricity for balancing capacity and maintaining power system stability."the Law on Intellectual Property dated November 29, 2005, and the Law amending and supplementing certain articles of the Law "7. A flexible power plant is a thermal power plant using reciprocating internal combustion engines (RICE) or aeroderivative gas turbines (Aero-GT) with fast start-up capabilities, designed in modular form to generate electricity for balancing capacity and maintaining power system stability."on Intellectual Property dated June 19, 2009;
Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006;
Pursuant to the Law on Product Quality and Goods Quality dated November 21, 2007;
Pursuant to the Law on Measurement dated November 11, 2011;
at the proposal of the Minister of Science and Technology;
The Government issues this Decree to amend, supplement, and abolish certain provisions on investment and business conditions in the field of management under the Ministry of Science and Technology.
Article 1. Amending Clause 2 of Article 42 of Decree No. 105/2006/NĐ-CP dated September 22, 2006 of the Government detailing and guiding the implementation of certain articles of the Law on Intellectual Property regarding the protection of intellectual property rights and state management of intellectual property (amended and supplemented at Clause 10 of Article 1 of Decree No. 119/2010/NĐ-CP dated December 30, 2010 of the Government).
"2. An intellectual property appraisal organization may only operate when it has at least one intellectual property appraiser."
Article 2. Amending, supplementing, and abolishing certain articles of Decree No. 105/2016/NĐ-CP dated July 1, 2016 of the Government on the conditions for the operation of organizations for calibration, verification, and testing of measuring instruments and standards.
1. Abolish Point a of Clause 2 and Clause 5 of Article 3.
2. Amend Point b of Clause 2 of Article 3 as follows:
"b) Possess sufficient measurement standards, equipment, and environmental conditions to perform calibration, verification, and testing according to the requirements of the corresponding calibration, verification, and testing procedures. These procedures must be consistent with the guidance of the Ministry of Science and Technology or international recommendations of the International Legal Metrology Service Organization, international standards of the International Electrotechnical Commission, international standards of the International Organization for Standardization, and relevant manufacturer documentation. The measurement standards and measuring instruments must be periodically calibrated, verified, tested, maintained, and used in accordance with the regulations of the organization's head; certificates of calibration, verification, and testing must still be valid."
3. To amend Clause 3 of Article 3 as follows:
"3. Possess sufficient calibration, verification, and testing procedures appropriate to the registered fields of activity."
4. Amend and supplement Clause 4 of Article 3 as follows:
"4. Have at least one technical staff member suitable for each field of activity. These technical staff members must meet the following requirements:
a) Graduated from a college or equivalent level or higher;
b) Completed the corresponding calibration, verification, and testing vocational training course in accordance with the guidance of the Ministry of Science and Technology."
5. Amend Clause 6 of Article 3 as follows:
"5. Established and maintained a management system in compliance with National Standard TCVN ISO/IEC 17025 for calibration, verification, and testing activities of measuring instruments and standards. There must be a document from the organization's head specifying the management of certification (seals, stamps, certificates) for calibration, verification, and testing."
6. Amend and supplement Clause 1 of Article 4 as follows:
"1. Meet the operational conditions stipulated in Article 3 of this Decree."
7. Amend and supplement Clause 2 of Article 4 as follows:
"2. Working standards and direct-use standards for calibrating group 2 measuring instruments within the designated field of activity must comply with the requirements specified in the corresponding Vietnamese Technical Measurement Documents, must be calibrated, tested, or compared at a domestic calibration and testing organization with a suitable designated field of activity or at an overseas calibration and testing organization with a suitable designated field of activity that has been recognized or designated, and must be certified in accordance with Articles 14 and 15 of the Law on Measurement."
8. Abolish Clause 3 of Article 4.
9. Amend Clause 4 of Article 4 as follows:
"4. Have at least one certified and licensed metrology inspector for each designated field of activity for calibrating group 2 measuring instruments."
10. Abolish Clause 5 of Article 4.
11. Amend Clause 5 of Article 5 as follows:
"5. Documentation on the management of calibration, verification, and testing certificates shall include the following main contents: Content and form of the certificate; production, management, and use of the certificate; size and location of the registration number on the certificate to ensure easy visual recognition; documentation on the maintenance, storage, and use of measurement standards and measuring instruments for calibration, verification, and testing."
12. Amend Model No. 02 of the Appendix issued together with Decree No. 105/2016/NĐ-CP dated July 1, 2016 of the Government on the conditions for the operation of organizations for calibration, verification, and testing of measuring instruments and standards by Model No. 02 of Appendix I issued together with this Decree.
Article 3. Amending, supplementing, and abolishing certain provisions of Decree No. 107/2016/NĐ-CP dated July 1, 2016 of the Government on conditions for operating conformity assessment services
1. Abolish Clause 4, Article 5, Point d, Clause 2, Article 6, Point c, Clause 3, Article 17, and the declaration content regarding work experience and work history of assessors and experts at Point c, Clause 2, Article 14, and Point c, Clause 2, Article 18, Point g, Clause 2, Article 22.
2. Amend and supplement the second part of Point đ, Clause 2, and Point d, Clause 3, Article 6 as follows:
"In cases where the testing organization has been recognized by the certification body specified in Article 21 of this Decree or foreign certification body specified in Article 25 of this Decree for testing activities but registers testing activities beyond the scope of recognition, the testing organization shall submit a copy of the Recognition Certificate along with the recognized scope and relevant documents, testing procedures, and other related documents to demonstrate its capability to meet the corresponding standard requirements set out in Clause 2, Article 5 of this Decree for the unregistered scope."
3. Amend and supplement Point đ, Clause 2, and Point c, Clause 3, Article 10 as follows:
"In cases where the inspection organization has been certified as compliant with TCVN ISO 9001:2008 or ISO 9001:2008 but registers inspection activities beyond the certified scope, the inspection organization shall submit a copy of the Compliance Certification for TCVN ISO 9001:2008 or ISO 9001:2008 and relevant documents, inspection procedures, and other related documents to demonstrate its capability to meet the corresponding standard requirements set out in Clause 2, Article 9 of this Decree for the unregistered scope."
4. Amend Point c, Clause 3, Article 13 as follows:
"c) Have at least two years of experience in product and goods quality inspection work.
In cases of expanding the scope of inspection activities, there must be at least two official inspectors of the organization (civil servants or employees under a fixed-term contract of at least twelve months or indefinite-term contract) corresponding to the expanded inspection field, meeting the conditions stipulated herein."
5. Amend and supplement Point d, Clause 2, and Point c, Clause 3, Article 14 as follows:
"In cases where the inspection organization has been recognized by the certification body specified in Article 21 of this Decree or foreign certification body specified in Article 25 of this Decree but registers inspection activities beyond the recognized scope, the inspection organization shall submit a copy of the Recognition Certificate along with the recognized scope and relevant documents, inspection procedures, and other related documents to demonstrate its capability to meet the corresponding standard requirements set out in Clause 2, Article 13 of this Decree for the unregistered scope."
6. Amend Point a, Clause 3, Article 17 as follows:
"a) Hold a bachelor's degree or higher;"
7. Amend Point d, Clause 3, Article 17 as follows:
"d) Have at least twenty working days of evaluation experience for the corresponding certification program.
In cases of expanding the scope of certification activities, there must be at least two official experts of the organization (civil servants or employees under a fixed-term contract of at least twelve months or indefinite-term contract) corresponding to each expanded certification field, meeting the conditions stipulated herein."
8. Amend and supplement Point d, Clause 2, and Point c, Clause 3, Article 18 as follows:
"In cases where the certification organization has been recognized by the certification body specified in Article 21 of this Decree or foreign certification body specified in Article 25 of this Decree but registers certification activities beyond the recognized scope, the certification organization shall submit a copy of the Recognition Certificate along with the recognized scope and relevant documents, certification procedures, and other related documents to demonstrate its capability to meet the corresponding standard requirements set out in Clause 2, Article 17 of this Decree for the unregistered scope."
9. Amend and supplement Clause 4, Article 21 as follows:
"Meet the requirements and conditions of one of the regional or international certification bodies specified for the corresponding accreditation activities.
Within four years from the date of establishment, the certification body must build its capacity to meet the conditions stipulated herein to become a signatory member participating in mutual recognition agreements on conformity assessment results of regional or international certification bodies for corresponding accreditation programs."
10. Amend Point a, Clause 5, Article 21 as follows:
"a) Hold a bachelor's degree or higher, wherein for lead assessors, have at least two years of experience related to quality management and assessment of the corresponding conformity assessment organization; for assessors, have at least one year of experience related to quality management and assessment of the corresponding conformity assessment organization;"
11. Amend and supplement the second part of Point e, Clause 2, Article 22 as follows:
"In cases where the certification body is not yet a signatory member of mutual recognition agreements on conformity assessment results of regional or international certification bodies, the certification body shall submit a commitment to build its capacity to meet the requirements and conditions of regional or international certification bodies to become a signatory member of these mutual recognition agreements within four years from the date of establishment."
12. Supplement Article 26 as follows:
"A conformity assessment organization whose certificate has been revoked may only be considered for reissuance of the certificate at least six months after the revocation notice and after rectifying the violations."
13. Replace Model No. 01, Model No. 02, Model No. 03, Model No. 10, and Model No. 12 of the Appendix issued together with Decree No. 107/2016/NĐ-CP dated July 1, 2016 of the Government on conditions for operating conformity assessment services with Model No. 01, Model No. 02, Model No. 03, Model No. 10, and Model No. 12 of Appendix II issued together with this Decree.
Article 4. Amending and supplementing some articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product and Goods Quality (amended and supplemented by Decree No. 74/2018/NĐ-CP dated May 15, 2018 of the Government).
1. Amending and supplementing Point a Clause 2a Article 7 as follows:
"a) Registering state quality inspection for imported goods and committing to the quality of goods in compliance with technical regulations and standards published for application according to Model No. 01 attached to this Decree at the product and goods quality inspection agency (hereinafter referred to as the inspection agency) and accompanied by the following documents: A copy of the Contract, Goods List (if any); a copy (certified by the importer) of the bill of lading, invoice, import declaration form (if any); certificate of quality from the exporting country (quality certificate, test result) (if any); certificate of origin (if any), photo or description of the goods containing mandatory information to be displayed on the product label and supplementary label (if the main label does not contain all required information); CFS free circulation certificate (if any). The importer shall bear full responsibility under the law for the quality of imported goods;"
2. Amending Point d and Point g Clause 7 Article 7 as follows:
"d) Goods temporarily imported for display and promotion at trade fairs and exhibitions;
g) Goods, materials, equipment, machinery temporarily imported for re-export without consumption or use in Vietnam;"
3. Amending and supplementing Clause 8 Article 7 as follows:
"8. Applying measures to exempt or reduce quality inspection for Group 2 imported goods
a) For imported goods having the same name, function, brand, type, technical characteristics produced by the same production facility, origin imported by the same importer, after three consecutive imports, with results confirming compliance with national technical regulations confirmed by the inspection agency in writing to exempt state quality inspection within two years.
b) The application for exemption from inspection includes:
- A request for exemption from inspection with the following information: name of goods, brand, type; technical characteristics; origin, manufacturer; quantity, weight of imported goods registered; unit of measurement.
- A copy of the results confirming compliance with national technical regulations of three consecutive times.
c) When the importer requests exemption or reduction of inspection, they must prepare one set of application for exemption from inspection and submit it to the inspection agency, specifically:
- In case of direct submission, copies of the documents specified in Point b of this clause that have not been certified must be accompanied by original documents for verification;
- In case of submission through postal service, the importer must submit certified copies or true copies (signed and stamped) of the documents specified in Point b of this clause.
d) Within three working days from the date of receipt of the application for exemption, if the application is incomplete or invalid according to the regulations, the inspection agency will notify in writing requiring the importer to amend and supplement the application;
Within five working days from the date of receipt of a valid application, the inspection agency will issue a written confirmation of exemption from state quality inspection including the following information: name of goods, brand, type; technical characteristics; origin, manufacturer; quantity, weight of imported goods registered; unit of measurement.
In case of refusal to confirm exemption from state quality inspection, the inspection agency must notify the reasons in writing to the importer.
đ) During the period of exemption or reduction of state quality inspection for imported goods:
- Every three months, the importer must report on the situation of imports along with the results confirming compliance with national technical regulations and published standards to the inspection agency for monitoring and post-inspection work.
- The inspection agency has the right to conduct random inspections of imported consignments when discovering or receiving complaints or reports about the quality of imported goods (if necessary).
e) During the period of exemption or reduction of inspection, if imported goods circulating in the market are found to be non-compliant with national technical regulations and published standards or when there are complaints or reports about the results of conformity assessment and such reports are verified to be true or through random inspections of imported consignments with non-compliant conformity assessment results, the inspection agency will issue a notice to stop applying the exemption from inspection.
Annually, the inspection agency will carry out inspections at the storage facilities of the importer. The Ministry of Science and Technology will stipulate the procedures and contents of product and goods quality inspections during production.
4. Amending and supplementing Point b Clause 1 Article 18a as follows:
"b) Must perform proficient testing or inter-laboratory comparison for the testing method of designated products and goods.
For tests that do not have a competent testing organization or cannot be performed through inter-laboratory comparison due to the absence of domestic laboratories capable of analysis, additional documentation of the testing method, confirmation of the usability of the testing method and reference material for controlling the quality of testing must be provided."
5. Supplementing Clause 1a Article 18b as follows:
"1a. In case of temporary designation for testing, the dossier includes:
a) Application for designation of conformity assessment according to Model No. 4 attached to this Decree;
b) Copy of the Decision on designation of the testing organization;
c) Documentation of the testing method, confirmation of the usability of the testing method and reference material for controlling the quality of testing."
6. Supplementing Clause 5 Article 18đ as follows:
"5. The sectoral management agency decides to temporarily designate a testing organization for a period of six months to meet the testing needs for new products, products without national technical regulations, and testing methods not specified in national technical regulations or to serve the administrative management requirements of the assigned sector and is responsible for the decision on temporary designation of the testing organization."
"An organization whose designation decision has been revoked may only be considered for a new designation application at least six months from the date of notification of the revocation of the designation decision and after having remedied all violations."
8. Amend paragraph 2, point b, Clause 2, Article 32 of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality, which was amended and supplemented by Clause 14, Article 1 of Decree No. 74/2018/NĐ-CP as follows:
"Fertilizers; plant protection chemicals; veterinary drugs; animal feed, aquatic feed; salt."
9. Amend and supplement Model No. 01, Model No. 04, and Model No. 08 of the Appendix issued together with Decree No. 74/2018/NĐ-CP dated May 15, 2018 of the Government amending and supplementing certain articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality by Model No. 01, Model No. 04, and Model No. 08 of Appendix III issued together with this Decree.
Article 5. Repeal Decree No. 87/2016/NĐ-CP dated July 1, 2016 of the Government on business conditions for motorcycle and bicycle helmets.
Article 6. Transitional provisions
An organization that has been granted a Registration Certificate for conformity assessment activities may continue to operate until the expiry date stated on the Registration Certificate.
In cases where an organization supplements its conformity assessment activity fields already registered, it must meet the conditions stipulated in this Decree.
Article 7. Effective Date
1. This Decree takes effect from the date of issuance.
2. Ministers, heads of ministerial-level agencies, heads of government agencies, and chairpersons of provincial people's committees directly under the central government are responsible for implementing this Decree./.
PRIME MINISTER
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