Circular 36/2019/TT-BCT quality management of products and goods

CIRCULAR

Prescribing quality management of products and goods under the Ministry of Industry and Trade’s responsibility^[1]

Pursuant to the November 21, 2007 Law on Product and Goods Quality;

Pursuant to the June 29, 2006 Law on Standards and Technical Regulations;

Pursuant to the Government’s Decree No. 98/2017/ND-CP of August 18, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Industry and Trade;

Pursuant to the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing a number of articles of the Law on Standards and Technical Regulations, which was amended and supplemented under Decree No. 78/2018/ND-CP of May 16, 2018;

Pursuant to the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality, which was amended and supplemented under the Government’s Decree No. 74/2018/ND-CP of May 15, 2018;

Pursuant to the Government’s Decree No. 107/2016/ND-CP of July 1, 2016, prescribing conditions for provision of conformity assessment services;

Pursuant to the Government’s Decree No. 154/2018/ND-CP of November 9, 2018, amending, supplementing or annulling a number of regulations on investment and business conditions in fields subject to the state management by the Ministry of Science and Technology and a number of regulations on specialized inspection;

Pursuant to the Government’s Decree No. 43/2017/ND-CP of April 14, 2017, on goods labeling;

At the proposal of the Director of the Science and Technology Department;

The Minister of Industry and Trade promulgates the Circular prescribing quality management of products and goods under the Ministry of Industry and Trade’s responsibility.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular prescribes quality management of products and goods under the Ministry of Industry and Trade’s responsibility as prescribed in Article 70 of the Law on Product and Goods Quality and Clause 14, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018.

Article 2. Subjects of application

1. State management agencies in charge of quality of products and goods under the Ministry of Industry and Trade’s responsibility.

2. Organizations and individuals producing, trading in, importing or exporting products or goods managed by the Ministry of Industry and Trade.

3. Conformity assessment organizations that fully satisfy conditions for and wish to participate in assessing the conformity of quality of products and goods managed by the Ministry of Industry and Trade.

Article 3. Classification of products and goods

1. Products and goods on the list of group-2 products and goods managed by the Ministry of Industry and Trade as specified in each period.

2. Products and goods managed under national technical regulations.

3. Products and goods managed according to declared applicable standards.

Article 4. Goods labeling

1. The labeling of products and goods must comply with the Government’s Decree No. 43/2017/ND-CP of April 14, 2017, on goods labeling.

2. In case labeling contents are specified in national technical regulations and legal documents, products and goods must, apart from complying with the provisions of Clause 1 of this Article, be adequately labeled under relevant national technical regulations.

Chapter II

QUALITY MANAGEMENT OF PRODUCTS AND GOODS

Article 5. General requirement on quality management of products and goods

1. For products and goods specified in Clauses 1 and 2, Article 3 of this Circular:

a/ To apply the quality management system to ensure that product and goods quality conforms to relevant technical regulations and the products and goods are labeled under Article 4 of this Circular before they are marketed.

b/ To declare products’ and goods’ conformity with relevant technical regulations. The declaration of regulation conformity must comply with Chapter III of this Circular.

c/ To be subject to inspection by agencies in charge of product and goods quality inspection.

2. For products and goods specified in Clause 3, Article 3 of this Circular:

a/ To declare applicable standards in accordance with the law on product and goods quality.

b/ To be subject to inspection by agencies in charge of product and goods quality inspection.

Article 6. Contents of quality management of products and goods

1. Quality management of imported goods

The quality management of imported goods must comply with Section 4, Chapter III of the Law on Product and Goods Quality, and Section 2, Chapter II of the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, which was amended and supplemented under Clause 3, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018 (below referred to as Decree No. 132/2008/ND-CP.)

2. Quality management of exported goods

The quality management of exported goods must comply with Section 3, Chapter III of the Law on Product and Goods Quality, Section 3, Chapter II of Decree No. 132/2008/ND-CP, and regulations of importing countries.

3. Quality management of goods on the market

The quality management of goods on the market must comply with Section 5, Chapter III of the Law on Product and Goods Quality, Section 4, Chapter II of Decree No. 132/2008/ND-CP, the Law on Handling of Administrative Violations, relevant legal documents, and regulations of importing countries.

4. Quality management of products in manufacture

a/ For products and goods managed on the basis of applicable standards declared by manufacturers, their quality management must comply with the Minister of Industry and Trade’s Circular No. 46/2015/TT-BCT of December 11, 2015, on inspection of product and goods quality in manufacture under the Ministry of Industry and Trade’s management responsibility.

b/ For products and goods on the list of group-2 products and goods managed by the Ministry of Industry and Trade as specified in each period and products and goods managed under national technical regulations, their quality management must comply with Section 2, Chapter III of the Law on Product and Goods Quality, Article 5, Section 1, Chapter II of Decree No. 132/2008/ND-CP of December 31, 2008, and this Circular.

5. Quality management of goods in use

The quality management of goods in use must comply with Section 6, Chapter III of the Law on Product and Goods Quality, and Section 5, Chapter II of Decree No. 132/2008/ND-CP.

Article 7. State inspection agencies in charge of imported goods quality

State inspection agencies in charge of imported goods quality of the Ministry of Industry and Trade are units assigned or empowered to perform the state management of product and goods quality, including:

1. The Industrial Safety Techniques and Environment Agency.

2. The Chemical Agency.

Article 8. Product and goods conformity assessment organizations

1. Conformity assessment organizations participating in the testing, certification, inspection or assessment for declaration of standard conformity of products and goods managed according to declared applicable standards or declaration of regulation conformity of products and goods on the list of group-2 products and goods and products and goods managed according to technical regulations under the Ministry of Industry and Trade’s responsibility include:

a/ Conformity assessment organizations having registered operation of conformity assessment of products and goods under the Ministry of Industry and Trade’s management in accordance with the order and procedures specified in the Government’s Decree No. 107/2016/ND-CP of July 1, 2016, and Decree No. 154/2018/ND-CP of November 9, 2018.

b/ Conformity assessment organizations evaluated and designated by the Ministry of Industry and Trade when satisfying the conditions prescribed in Clause 8, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018, and Clauses 4 thru 7, Article 4 of the Government’s Decree No. 154/2018/ND-CP of November 9, 2018.

2. Conformity assessment organizations having registered operation fields and/or designated by the Ministry of Industry and Trade shall comply with regulations on operation of conformity assessment and submit to the Ministry of Industry and Trade’s inspection and supervision.

The list of conformity assessment organizations having registered operation fields and/or designated by the Ministry of Industry and Trade shall be posted on the Ministry of Industry and Trade’s website (www.moit.gov.vn).

Article 9. Dossiers for and forms of designation of conformity assessment organizations

1. A registration dossier for designation of a conformity assessment organization must comply with Clause 8, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018, and Clause 5, Article 4 of the Government’s Decree No. 154/2018/ND-CP of November 9, 2018.

2. Forms of dossier submission must comply with Clause 8, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018, and Clause 5, Article 4 of the Government’s Decree No. 154/2018/ND-CP of November 9, 2018.

Article 10. Order and procedures for designation of conformity assessment organizations

1. The order and procedures for designation of conformity assessment organizations must comply with Clause 8, Article 1 of the Government’s Decree No. 74/2018/ND-CP of May 15, 2018, and Clause 6, Article 4 of the Government’s Decree No. 154/2018/ND-CP of November 9, 2018.

2. The process of evaluation and designation of conformity assessment organizations is provided in Appendix 1 to this Circular.

Chapter III

DECLARATION OF REGULATION CONFORMITY

Article 11. Declaration of regulation conformity

1. Subject to declaration of regulation conformity are products and goods specified in national technical regulations promulgated by the Ministry of Industry and Trade. Declaration of regulation conformity is compulsory under Article 48 of the Law on Standards and Technical Regulations.

2. Declaration of regulation conformity shall be based on one of the following:

a/ Results of self-assessment of conformity by organizations and individuals (below referred to as self-assessment results).

b/ Certification results of certification organizations having registered their operation field or been accredited in accordance with law.

c/ Certification and inspection results of certification or inspection organizations designated by the Ministry of Industry and Trade.

Testing to serve certification or inspection shall be carried out at testing organizations that have registered operation fields or been accredited or designated in accordance
with law.

3. In case of using conformity assessment results of foreign conformity assessment institutions, such foreign institutions must have been accredited in accordance with Vietnam’s law or designated by competent state management agencies.

4. For products and goods for which national technical regulations are unavailable, their quality management shall be based on declared applicable standards and specialized legal documents until national technical regulations for such products or goods are promulgated and take effect.

Article 12. Order and dossiers for declaration of regulation conformity

1. The order and dossiers for declaration of regulation conformity and declaration notification forms must comply with the Minister of Science and Technology’s Circular No. 28/2012/TT-BKHCN of December 12, 2012, providing for declaration of standard conformity and regulation conformity and methods of assessment of conformity with standards and technical regulations, and the Minister of Science and Technology’s Circular No. 02/2017/TT-BKHCN of March 31, 2017, amending and supplementing a number of articles of Circular No. 28/2012/TT-BKHCN.

2. Upon declaration of regulation conformity, manufacturers, traders and importers shall register their regulation conformity statements with provincial-level Departments of Industry and Trade of the localities where they have registered their production, business or import operation.

Chapter IV

ORGANIZATION OF IMPLEMENTATION

Article 13. Responsibilities of the Science and Technology Department

1. To advise the Minister of Industry and Trade on performing the state management of product and goods quality nationwide.

2. To advise the Minister of Industry and Trade on designating conformity assessment organizations to test, certify, assess and inspect quality of products and goods. To examine and supervise operation of designated conformity assessment organizations.

3. To review the examination of product and goods quality and report to the leadership of the Ministry of Industry and Trade.

4. To assume the prime responsibility for, and coordinate with related agencies in, examining product and goods quality in manufacture and export.

5. To urge, guide and examine the implementation of this Circular.

Article 14. The Vietnam Directorate of Market Surveillance

To organize and direct its attached units in examining, controlling, and handling violations of regulations on quality of products and goods on the in accordance with law.

Article 15. The Industrial Safety Techniques and Environment Agency

1. To organize quality examination of group-2 imported products and goods being special industrial machinery or equipment specified in Section II of the Appendix on the list of likely unsafe products and goods under the Ministry of Industry and Trade’s management responsibility to Circular No. 33/2017/TT-BCT of December 28, 2017. Forms of notification of results of state inspection of group-2 imported goods quality are provided in Form No. 03 of the Appendix to Decree No. 74/2018/ND-CP.

2. To assume the prime responsibility for, and coordinate with related agencies in, examining the quality of products and goods in use.

Article 16. The Chemical Agency

To organize quality examination of group-2 imported products and goods being explosive precursors and industrial explosive materials specified in the Appendix on the list of likely unsafe products and goods under the Ministry of Industry and Trade’s management responsibility to the Minister of Industry and Trade’s Circular No. 33/2017/TT-BCT of December 28, 2017. Forms of notification of results of state inspection of group-2 imported goods quality are provided in Form No. 03 of the Appendix to Decree No. 74/2018/ND-CP.

Article 17. Responsibilities of provincial-level Departments of Industry and Trade

1. To issue notices of receipt of regulation conformity declaration dossiers and manage regulation conformity declaration dossiers of products and goods.

2. To examine the observance of regulations on quality management of product and goods by enterprises in their localities.

Article 18. Responsibilities of designated conformity assessment organizations

1. To exercise the rights and perform the obligations prescribed in the Law on Product and Goods Quality and relevant legal documents. Violations, depending on their nature and severity, shall be handled in accordance with law.

Designated testing organizations shall, within the validity duration of designation decisions, participate in the proficiency testing and inter-laboratory comparison program at least once with regard to testing fields and designated products and goods.

2. On December 15 every year or upon request, to send reports, made according to Form No. 11 of the Appendix to Decree No. 74/2018/ND-CP, on results of conformity assessment operation as designated, to the Ministry of Industry and Trade for summarization.

3. To notify designating agencies of any changes affecting their designated testing, assessment, inspection and certification operations within 15 days after such changes occur.

Article 19. Reporting on quality examination of products and goods

Agencies in charge of product and goods examination shall submit to the Ministry of Industry and Trade reports on results of quality examination on December 15 every year or upon request. Reporting contents must comply with Appendix II to this Circular.

Chapter V

IMPLEMENTATION PROVISIONS

Article 20. Effect

This Circular takes effect on January 15, 2020, and replaces the Minister of Industry and Trade’s Circular No. 48/2011/TT-BCT of December 30, 2011, on quality management of group-2 products and goods under the Ministry of Industry and Trade’s management.

Article 21. Implementation responsibility

1. State management agencies in charge of quality of, organizations and individuals producing, trading in, importing or exporting, and organizations assessing the conformity of, products or goods under the Ministry of Industry and Trade’s management responsibility shall implement this Circular.

2. When legal documents referred to in this Circular are amended, supplemented or replaced, the amending, supplementing or replacing documents will prevail.

3. Any problems arising in the course of implementation of this Circular should be promptly reported to the Science and Technology Department of the Ministry of Industry and Trade for reporting and proposal of revision to the Ministry.-

Minister of Industry and Trade
TRAN TUAN ANH

* The appendices to this Circular are not translated.-