Vietnam's Ministry of Science and Technology has published a comprehensive regulation governing the declaration of conformity to standards and technical regulations, as well as the methods for conformity assessment. The regulation establishes clear definitions for product types, classes, and groups, and sets out the roles and requirements for certification bodies and the use of conformity marks.

The regulation distinguishes between voluntary standard conformity declarations and mandatory technical regulation conformity declarations, outlining specific procedures, documentation models, and post-market surveillance obligations for each. Eight certification methods are detailed, ranging from representative sample testing to batch and management system certification, with defined surveillance and certificate validity requirements.

The new rules also address the recognition of international certificates under mutual recognition agreements, the transition of existing certificates, and the responsibilities of national and local authorities in implementation and oversight. The regulation aims to enhance transparency, traceability, and confidence in Vietnam's conformity assessment system, aligning it with international best practices.

Stakeholders such as manufacturers, importers, certification bodies, and regulatory authorities will need to adapt their processes and documentation to comply with the updated requirements. The regulation is expected to strengthen product quality and safety management across regulated sectors in Vietnam.

This regulation is classified as High Impact. It introduces mandatory and comprehensive changes to the conformity declaration and assessment system in Vietnam, affecting a wide range of products, stakeholders, and regulatory processes.

Key reasons for High Impact:

• Mandatory requirements for conformity declaration to technical regulations.
• New and updated certification methods, documentation, and surveillance obligations.
• Changes to the use of conformity marks and recognition of international certificates.
• Replacement and repeal of previous regulations, requiring adaptation by all stakeholders.

Who is affected?

Manufacturers, importers, certification bodies, testing laboratories, regulatory authorities, and distributors of regulated products and services.

Conclusion:

All regulated entities must review and update their compliance procedures, documentation, and product labeling to align with the new requirements. The regulation significantly strengthens Vietnam's conformity assessment framework and will require coordinated implementation across the supply chain.