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[Vietnam] Law No. 78/2025/QH15: risk-based quality management, import inspection and conformity declaration

Cover: Law No. 78/2025/QH15 amending the Law on Product and Goods Quality – risk-based management, import quality inspection and conformity declaration

Law No. 78/2025/QH15 amends and supplements the Law on Product and Goods Quality No. 05/2007/QH12. It was passed by the National Assembly on 18 June 2025 and takes effect on 1 January 2026, adds 10 new articles and replaces the whole of Chapter IV on quality inspection. Below are the three points that affect businesses most directly.

Quick summary

  • Products and goods are classified by three levels of risk (low, medium, high) instead of being grouped rigidly by list; medium-risk and high-risk goods are managed by list, tied to the corresponding quality management requirements.
  • Low risk: self-declaration of applicable standards. Medium risk: self-declaration, self-assessment or certification by an accredited certification body. High risk: self-declaration and certification by a certification body designated.
  • High-risk imported goods must register for quality inspection on the National Single Window and can only be cleared after the inspection agency confirms that they meet quality requirements (Clause 3, Article 34).

1. Risk-based principles for managing the quality of products and goods

Article 5 of the Law on Product and Goods Quality (as amended and supplemented in 2025) stipulates principles for classification and quality management. Products and goods are classified based on risk level, in accordance with international practices; warnings from relevant international organizations and management capabilities of state agencies in each period.

Three risk levels and the corresponding requirements

Risk level Obligations of businesses Conformity assessment Inspection by state authorities
Low risk Self-declaration of applicable standards Certification is not required No mandatory inspection on import; post-market checks according to plan or when there are signs of violation
Medium risk Self-declaration of applicable standards and declaration of conformity Self-assessment or certification by an accredited certification body Imported goods: not inspected when imported but must make a conformity declaration before circulation (Article 82 of Decree 37/2026/ND-CP)
High risk Self-declaration of applicable standards and declaration of conformity based on certification results Certification by a designated certification body Register for quality inspection of imported goods on the National Single Window; Periodic and irregular sampling

Five management principles (clause 4, Article 5)

Clause 4, Article 5 states five management principles: (a) efficiency, openness, transparency, objectivity, and appropriateness to the level of risk; do not discriminate in terms of origin of goods and related entities; Do not create unnecessary technical barriers; (b), (c) and (d) conformity assessment requirements increase with the risk level (low, medium, high) as in the table above; (e) medium-risk and high-risk goods are managed according to lists associated with corresponding quality management requirements, clearly identifying cases where other management measures are applied according to relevant laws.

Risk assessment criteria and State policy

Risk assessment criteria include the level of impact on health, the environment, the ability to control the supply chain and warnings from international organisations (Clause 3, Article 5). State policy (Article 6) encourages the application of advanced standards, develops national quality infrastructure, supports small and medium-sized enterprises, promotes traceability, digital technology and mutual recognition of conformity assessment results. Under Article 6a, the Ministry of Science and Technology is the lead agency; Ministries, ministerial-level agencies and People’s Committees at all levels implement according to scope and area.

Product list documents open on a desk with a magnifier and a pen, a packed carton softly blurred behind

2. Registering quality inspection of high-risk imported goods on the National Single Window

Clause 3, Article 34 of the Law on Product and Goods Quality (amended and supplemented in 2025) stipulates: “Register high-risk imported goods for quality inspection on the National Single Window.” This is a mandatory obligation for goods in the high-risk category; Decree 37/2026/ND-CP provides detailed regulations in Article 82 and Article 83.

Obligations by risk level (Article 82, Decree 37/2026/ND-CP)

  • Medium risk: Before releasing goods into circulation on the market, importing organizations and individuals do not have to carry out quality inspection when importing but must carry out declaration of conformity (clause 1) – there is no inspection registration step.
  • High risk: must register for quality inspection under Article 83 (clause 2).
  • Goods that have been licensed for circulation or have had corresponding quality management measures under specialised law are not re-inspected under Article 82 (clause 3).

Where, when and with which dossier to register

  • Implementation channel: Procedures for registering for state inspection of imported goods quality are carried out on the National Single Window or National Public Service Portal; If the system fails, handling follows Article 17 of Decree 85/2019/ND-CP (Clause 4, Article 83).
  • When: register before customs clearance — High-risk goods are only allowed to clear customs and circulate on the market after the inspection agency issues a Notice of state inspection results on quality that meets quality requirements (Clause 5, Article 83).
  • Dossier: Register for inspection according to Form No. 1, Appendix VII, Decree 37/2026/ND-CP with photos or a description of goods characteristics; The inspection agency confirms the registration using Form No. 2, Appendix VII. If the dossier is incomplete, the enterprise has 07 working days to complete it (Clause 1, Article 83).
  • No Certificate of Conformity: Enterprises carry out procedures with customs authorities to bring goods to storage locations and contact a designated certification body to assess conformity with the national technical regulations; Subsequent inspection steps will only be performed when the dossier is complete (Clause 2, Article 83).

Import dossier, a stamp and a barcode scanner on a desk, with cartons on a pallet behind

Inspection results and post-clearance obligations

  • Results: When the dossier is complete and valid, the inspection agency will issue a Notice of state inspection results on the quality of imported goods that meet quality requirements (Form No. 3, Appendix VII) to carry out customs clearance procedures. If the goods label or regulation conformity mark does not meet the requirements, the enterprise must remedy it and provide evidence together with the shipment’s certificate of conformity (Article 85).
  • Testing: Quality testing of high-risk imported goods is carried out at a designated testing organization; Test results are the basis for assessing compliance with corresponding national technical regulations (Clause 6, Article 83).
  • After customs clearance: High-risk goods are still subject to quality inspection on the market according to Article 88 of Decree 37/2026/ND-CP (Clause 5, Article 83).
  • Exemption or reduction of inspection (Article 86): Inspection is waived on import for luggage, movable assets, gifts within the duty-free allowance, diplomatic goods, research and test samples, raw materials for processing and producing export goods, duty-free goods and emergency goods; Inspection is reduced for goods of the same name, type, production facility and origin from the same enterprise after 03 consecutive qualifying imports; Enterprises determine and keep their own records.
  • Enhanced inspection: Imported goods originating from countries or territories with high-risk warnings or from organizations or individuals with a history of repeated violations must apply enhanced inspection measures, without giving rise to new administrative procedures (Clause 4, Article 34 of the Law; Article 84 of Decree 37/2026/ND-CP).

3. Conformity declaration

Declaring applicable standards, standards conformity and regulation conformity (Article 23)

Organisations and individuals producing or importing goods declare the applicable standards according to the law on standards and technical regulations, expressed in one of four forms: on goods; on goods packaging; on product labels or in documents accompanying products and goods. Standards conformity announcements and conformity declarations follow Decree 22/2026/ND-CP and Circular 14/2026/TT-BKHCN (08 conformity assessment methods, effective 25 May 2026).

Conformity declaration in production, import and circulation

  • In production (Article 28): medium-risk and high-risk goods must be declared compliant under the law on standards and technical regulations; the enterprise must also keep quality records, conformity assessment results, conformity declaration records and standards conformity records for traceability and post-market inspection.
  • Imported goods (Article 34): Before circulation, the applicable standards must be declared and the goods labelled — physical labels, electronic labels or digital passports of the products — showing codes, barcodes, and traceability. Medium-risk goods must declare conformity on the basis of a self-assessment or a certification of conformity with the national technical regulation issued by a recognised certification body.
  • No re-declaration required: Medium-risk goods that have been declared conformable to regulations do not have to be re-declared with shipments of the same type, unless there are changes in national technical regulations, changes in product characteristics of the producing organization or individual, or there is a risk warning from a competent Vietnamese agency.
  • Goods in circulation (Article 34a): must comply with technical regulations or internal control measures to maintain quality during transport, storage and distribution; physical labels, electronic labels or digital passports showing codes, barcodes, traceability and quality information; and update electronic data for traceability. Organizations and individuals selling goods are subject to quality inspection according to Article 45.
  • Goods sold on digital platforms (Article 34b): must comply with the conditions in Article 34a and publish quality information (name of goods, origin, name of responsible organization or individual, standard conformity mark, regulation conformity mark, instructions for use, safety warnings). Platform operators must require sellers to provide information, check and handle non-compliant goods, and set up a channel for consumer complaints.

Designated conformity assessment bodies and costs (Articles 23a and 23b)

Conditions for a designated conformity assessment body include: the management system is recognized as conforming to national standards and corresponding international standards; have satisfactory proficiency testing or interlaboratory comparison results (for testing bodies); Register designated activities with competent state agencies. The designation is based on records, technical capacity and need to serve state management; The list of designated bodies is published in the National Database on standards, measurement and quality; designated bodies are subject to periodic or unscheduled supervision and decisions may be revoked upon violation. Regarding costs (Article 23a), manufacturing enterprises pay the costs of testing and certification of standard and regulation conformity according to the agreement with the testing organization and certification organization; Those bodies must publish their costs.

Test report and a certificate sheet with a seal on a desk next to a document file

4. Transitional rules for conformity declarations and certifications made before 1 January 2026

According to Article 3 of Law No. 78/2025/QH15, products and goods that have been declared standard conformity, declared conformity, and have been issued a certificate of standard conformity or certificate of conformity before the effective date of the Law will continue to comply with the deadline stated in the content of the declaration or issued certificate. Dossiers for standards conformity announcement, conformity declaration or import quality inspection registration already submitted but not yet completed by 1 January 2026 continue to be processed under Law No. 05/2007/QH12 (amended and supplemented according to Law No. 35/2018/QH14).

5. Implementing documents

Conformity assessment, regulation conformity announcement and quality inspection activities are currently implemented according to Decree 22/2026/ND-CP (January 16, 2026), Decree 37/2026/ND-CP (January 23, 2026), Circular 14/2026/TT-BKHCN (April 9, 2026, effective May 25, 2026) and Circular 36/2026/TT-BKHCN on the list of medium-risk and high-risk products and goods under the management responsibility of the Ministry of Science and Technology.

Conclusion

The overarching direction of the 2025 amendment is risk-based management, stronger post-market control and data-driven oversight. Businesses should review: (1) risk level of products and goods according to the list issued by the sectoral ministry; (2) respective type of conformity assessment — self-assessment, certification by a recognized organization or by a designated organization; (3) procedures for declaring conformity according to Decree 22/2026/ND-CP and Circular 14/2026/TT-BKHCN; (4) For high-risk imported goods, register for quality inspection before customs clearance according to Decree 37/2026/ND-CP.

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    Disclaimer

    This article is our own interpretation; not legal advice. Source: Law No. 78/2025/QH15, Decree 22/2026/ND-CP and 37/2026/ND-CP, Circular 14/2026/TT-BKHCN and 36/2026/TT-BKHCN. Businesses should check the original texts and consult a designated conformity assessment body. Copyright Policy & Disclaimer.