MANAGEMENT OF QUALITY OF PRODUCTS AND GOODS UNDER THE MANAGEMENT OF THE MINISTRY OF INDUSTRY AND TRADE

This Circular provides for management of quality of products and goods under the management of the Ministry of Industry and Trade Pursuant as prescribed in Article 70 of the Law on Quality of Products and Goods and Clause 14 Article 1 of the Government's Decree No. 74/2018/ND-CP dated May 15, 2018.

Food products under the management of the Ministry of Industry and Trade which are specified in legislative documents on food safety are not governed by this Circular.

1. Regulatory authorities that conduct state management of quality of products and goods under the management of the Ministry of Industry and Trade.

2. Organizations and individuals that produce, sell, import and export products and goods under the management of the Ministry of Industry and Trade.

3. Conformity assessment bodies that are qualified and wish to participate in assessment of conformity of products and goods under the management of the Ministry of Industry and Trade.

1. Products and goods on the List of group 2 commodities under the management of the Ministry of Industry And Trade, which is promulgated in each period.

2. Products and goods which are managed according to national technical regulations.

3. Products and goods which are managed according to applicable standards.

1. Products and goods shall be labeled in accordance with to the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017 on good labels.

2. If labeling regulations are specified in national technical regulations and legislative documents, in addition to complying with regulations specified in Clause 1 of this Article, products and goods shall comply with the former.

1. Regarding products and goods mentioned in Clauses 1 and 2 Article 3 hereof.

a) Apply the quality management system to ensure product quality in accordance with corresponding technical regulations and label products as prescribed in Article 4 hereof before their marketing.

b) Submit declarations of conformity of products and goods with corresponding technical regulations. Declarations of conformity shall be submitted as prescribed in Chapter III hereof.

c) Be subject to inspections by authorities inspecting quality of products and goods.

2. Regarding products and goods mentioned in Clause 3 Article 3 hereof.

a) Declare applicable standards in accordance with regulations of the Law on Quality of Products and Goods.

b) Be subject to inspections by authorities inspecting quality of products and goods.

1. Management of quality of imported goods.

Quality of imported goods shall be managed as prescribed in Section 4 Chapter III of the Law on Quality of Products and Goods and Section 2 Chapter II of the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 which is amended by Clause 3 Article 1 of the Government's Decree No. 74/2018/ND-CP dated May 15, 2018.

2. Management of quality of exported goods.

Quality of exported goods shall be managed as prescribed in Section 3 Chapter III of the Law on Quality of Products and Goods and Section 3 Chapter II of the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 and regulations of importing countries.

3. Management of quality of goods sold on the market

Quality of goods sold on the market shall be managed as prescribed in Section 5 Chapter III of the Law on Quality of Products and Goods and Section 4 Chapter II of the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008, regulations of the Law on Penalties for Administrative Violations and relevant legislative documents and regulations of importing countries.

4. Management of product quality during manufacturing process.

a) Regarding products and goods managed according to the manufacturer’s applicable standards, their quality shall be managed as prescribed in the Circular No. 46/2015/TT-BCT dated December 11, 2015.

b) Regarding products and goods on the List of group 2 commodities under the management of the Ministry of Industry And Trade, which is promulgated in each period and products and goods managed according to the national technical regulations, their quality shall be managed as prescribed in Section 2 Chapter III of Law on Quality of Products and Goods, Article 5 Section 1 Chapter II of the Government's Decree No. 132/2008/ND-CP dated December 31, 2008.

5. Management of quality of goods during their use.

The management of quality of goods during their use shall comply with Section 6 Chapter III of the Law on Quality of Products and Goods and Section 5 Chapter II of the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008.

Authorities conducting state inspection of quality of imported goods of the Ministry of Industry and Trade are those assigned by the Minister of Industry and Trade to perform state management of quality of products and goods, including:

1. Industrial Safety Techniques and Environment Agency.

2. Vietnam Chemicals Agency.

1. Conformity assessment bodies participating in testing, certification, assessment and inspection to serve submission of declarations of standard conformity of products and goods managed according to applicable standards or serve submission of technical-regulation conformity of products and goods on the List of group 2 commodities, and products and goods managed according to technical regulations within the jurisdiction of the Ministry of Industry and Trade include:

a) Conformity assessment bodies that have registered their assessment of conformity of products and goods under the management of the Ministry of Industry and Trade in accordance with the procedures specified in the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 and Decree No. 154/2018/ND-CP dated November 09, 2018.

b) Conformity assessment bodies that are assessed and designated by the Ministry of Industry and Trade when satisfying the eligibility requirements specified in Clause 8 Article 1 of the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 and Clauses 4, 5, 6 and 7 Article 4 of the Decree No. 154/2018/ND-CP dated November 09, 2018.

2. Conformity assessment bodies that have their registered their services and/or designated by the Ministry of Industry and Trade shall comply with regulations on conformity assessment and be subject to inspection and supervision by the Ministry of Industry and Trade.

The List of conformity assessment bodies that have their registered their services and/or designated by the Ministry of Industry and Trade shall be posted on the website of the Ministry of Industry and Trade (www.moit.gov.vn).

1. Applications for designation as conformity assessment bodies shall be prepared as prescribed Clause 8 Article 1 of the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 and Clause 5 Article 4 of the Decree No. 154/2018/ND-CP dated November 09, 2018.

2. Methods for submission of applications are set forth in Clause 8 Article 1 of the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 and Clause 5 Article 4 of the Decree No. 154/2018/ND-CP dated November 09, 2018.

Article 10. Procedures for designation of conformity assessment bodies

1. Procedures for designation of conformity assessment bodies are specified in Clause 8 Article 1 of the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 and Clauses 5 Article 4 of the Decree No. 154/2018/ND-CP dated November 09, 2018.

2. The procedure for inspecting and designating a conformity assessment body is provided in the Appendix 1 hereof.

1. Declarations of conformity are used for products and goods that are specified in national technical regulations promulgated by the Ministry of Industry and Trade. Submission of declarations of conformity is mandatory as prescribed in Article 48 of the Law on Technical Standards and Regulations.

2. A declaration of conformity shall be submitted using:

a) Result of conformity self-assessment by the organization or individual (hereinafter referred to as “the self-assessment result”).

b) Certification result given by a certification body that has registered its services or has been accredited as prescribed by law.

c) Certification/inspection result given by the certification/inspection body designated by the Ministry of Industry and Trade.

The testing in service of certification and inspection shall be carried out at an inspection body that has registered its services or accredited or designated as prescribed by law.

3. If the conformity assessment result given by a foreign conformity assessment body is used, such foreign conformity assessment shall be accredited as prescribed by Vietnam’s law or designated by a competent authority.

4. If national technical regulations are not available, quality shall be managed according to applicable standards and specialized legislative documents until such national technical regulations are promulgated and take effect.

1. Procedures for submission of declarations of conformity, documents for registration of declarations of conformity and sample notifications of receipt of documents for registration of declarations of conformity are specified in the Circular No. 28/2012/TT-BKHCN dated December 12, 2012 and Circular No. 02/2017/TT-BKHCN dated March 31, 2017 of the Ministry of Science and Technology.

2. Upon submission of declarations of conformity, organizations and individuals that produce, sell and import products and goods shall register their declarations of conformity at the Department of Industry and Trade of the province where such organizations and individuals register their production, sale and import.

1. Assist the Minister of Industry and Trade in performing the main functions of conducting state management of quality of products and goods.

2. Assist the Minister of Industry and Trade in designating appropriate conformity assessment bodies to carry out testing, certification, assessment and inspection of quality of products and goods. Inspect and supervise activities performed by designated conformity assessment bodies.

3. Consolidate results of inspection of quality of products and goods and report them to heads of the Ministry of Industry and Trade.

4. Take charge and cooperate with relevant authorities in inspecting quality of goods and products during their manufacturing and export.

5. Expedite, provide guidance on and inspect the implementation of this Circular.

Article 14. The Vietnam Directorate of Market Surveillance shall organize and direct its affiliates to carry out inspection and supervision and take actions against violations of regulations on quality of products and goods sold on the market as prescribed by law.

1. Organize the inspection of quality of industrial machinery and equipment specified in Section II of the List of potentially unsafe commodities under the management of the Ministry of Industry and Trade promulgated together with the Circular No. 33/2017/TT-BCT dated December 28, 2017. The form of notification of result of state inspection of quality of imported group 2 commodities is provided in the Form No. 03 in the Appendix enclosed with the Circular No. 74/2018/ND-CP.

2. Take charge and cooperate with relevant authorities in inspecting quality of goods during their use.

Article 16. The Vietnam Chemicals Agency shall organize the inspection of quality of explosive precursors and industrial explosive materials on the List of potentially unsafe commodities under the management of the Ministry of Industry and Trade promulgated together with the Circular No. 33/2017/TT-BCT dated December 28, 2019 of the Minister of Industry and Trade. The form of notification of result of state inspection of quality of imported group 2 commodities is provided in the Form No. 03 in the Appendix enclosed with the Circular No. 74/2018/ND-CP.

1. Issue notifications of receipt of documents for registration of declarations of conformity and manage documents for registration of declarations of conformity of products and goods.

2. Inspect the compliance with regulations on quality of products and goods by enterprises within their provinces.

1. Exercise their rights and obligations in accordance with the Law on Quality of Products and Goods and relevant legal documents. In case any violation is committed, consider imposing penalties as prescribed by law depending on its nature and severity.

During the effective period of the designation decision, every designated testing service provider shall participate in proficiency testing or inter-laboratory comparison applied to the testing field or the products and goods specified in the designation decision at least once.

2. On December 15 or upon request, submit a report on their operation according to the Form No. 11 in the Appendix enclosed with the Decree No. 74/2018/ND-CP of the Ministry of Industry and Trade.

3. Notify the designating body of any change that may affect the capacity for carrying out testing, assessment, inspection or certification activities within 15 days from the date of change.

Authorities inspecting products and goods shall submit a consolidated report on inspection of products and goods on December 15 or upon request to the Ministry of Industry and Trade. Contents of the report are provided in the Appendix II hereof.

This Circular comes into force from January 15, 2020 and supersedes the Circular No. 48/2011/TT-BCT dated December 30, 2011 of the Minister of Industry and Trade.

1. Authorities performing state management of quality, organizations and individuals that produce, sell and import products and goods and bodies responsible for assessment of conformity of products and goods under the management of the Ministry of Industry and Trade are responsible for the implementation of this Circular.

2. In the cases where any of the legislative documents referred to in this Circular is amended or replaced, the newest one shall apply.

3. Difficulties that arise during the implementation of this Circular should be promptly reported to the Science and Technology Department affiliated to the Ministry of Industry and Trade./.

 

 

PROCEDURE FOR INSPECTING AND DESIGNATING A CONFORMITY ASSESSMENT BODY
(Promulgated together with the Circular No. 36/2019/TT-BCT dated November 29, 2019 of the Minister of Industry and Trade)

Procedure for designating a body to assess conformity of products and goods under the management of the Ministry of Industry and Trade:

1. In the case of the first designation, change or addition of the scope and field covered by the designation decision applied for:

a) Within 03 working days from the receipt of the application for designation, if the application is not satisfactory as per law, the Ministry of Industry and Trade shall request the conformity assessment body in writing to complete the application according to the Form No. 01 in the Appendix.

b) Within 20 days from the receipt of the satisfactory application, the Ministry of Industry and Trade shall establish an inspectorate to carry out a site inspection at the conformity assessment body. Composition of the inspectorate shall be decided by the Minister of Industry and Trade. Inspection contents are specified in Point c of this Clause.

In the case of amendment to the designation decision, if the application is satisfactory, the Ministry of Industry and Trade shall carry out verification according to the application and does not have to establish an inspectorate to carry out site inspection.

If the application is sufficient but its contents are inappropriate or a site inspection is requested by a competent authority or there is information about violations related to the application, the Ministry of Industry and Trade shall carry out a site inspection at the conformity assessment body.

Depending on the contents of the site inspection, the inspectorate shall be composed of at least 05 members: 01 chief (who is a senior representative of a Department), 01 deputy chief (who is a senior representative of a Division), 01 secretary (who is an official) and 02 experts (who are representatives of affiliates of the Ministry of Industry and Trade or independent external experts). If the chief is absent, the deputy chief shall direct the site inspection. Independent external experts shall be trained in the quality management system corresponding to each type of the conformity assessment body applying for designation.

The conformity assessment body site shall be notified in writing of the site inspection. After the site inspection is done, the inspectorate shall make an inspection record according to the Form in the Appendix III hereof.

If the conformity assessment body has to rectify the deficiencies mentioned in the inspection report, within 30 days, it shall send a rectification report to the Ministry of Industry and Trade. If it is required to extend the time limit for rectifying deficiencies, the conformity assessment body shall send a notification specifying official time limit for completing the deficiency rectification to the Ministry of Industry and Trade.

Within 05 working days from the receipt of the rectification report, if the conformity assessment body satisfies all requirements, the Ministry of Industry and Trade shall issue a designation decision to the conformity assessment body according to the Form No. 08 in the Government's Decree No. 74/2018/ND-CP dated May 15, 2018. Depending on capacity of the conformity assessment body, the Ministry of Industry and Trade shall decide on effective period of the designation decision which is not meant to exceed 05 years from the date on which it is signed.

In case of rejection of the application, the Ministry of Industry and Trade shall provide a written explanation to the conformity assessment body. The notification of invalidity of the application for designation as a conformity assessment body shall be made using the Forms No. 01 and No. 02 in this Appendix.

c) Contents of a site inspection:

- Compliance with regulations of law by the conformity assessment body in the field covered by the designation decision applied for;

- Authenticity of the application;

- Other activities related to the field covered by the designation decision applied for.

The costs incurred in connection with activities by experts or inspectorate shall be covered by the conformity assessment body.

2. In the case of re-issuance of the designation decision:

During the effective period of the designation decision, the conformity assessment body that wishes to apply for re-issuance of the designation decision shall prepare an application as prescribed in Article 18b of the Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 and submit it to the Ministry of Industry and Trade.

Within 05 working days from the receipt of the satisfactory application, the Ministry of Industry and Trade shall consider re-issuing the designation decision. In case of rejection of the application, the conformity assessment body shall respond and provide a written explanation. The notification of invalidity of the application for designation as a conformity assessment body shall be made using the Forms No. 01 and No. 02 in this Appendix.

  (This translation is for reference only)