Vietnam Assigns MOH Oversight for Chemicals in Medical Products

On 17 January 2026, Vietnam issued “Decree No. 26/2026/ND-CP,” providing detailed implementation guidance for the Law on Chemicals. For foreign manufacturers and importers, the most significant development is the clear designation of the Ministry of Health (MoH) as the responsible authority for chemicals used in MoH-regulated health products.

This clarification directly addresses long-standing uncertainty for international companies supplying medical devices, in vitro diagnostics, and medicinal products into Vietnam, particularly where regulated chemicals intersect with health product compliance pathways.

Resolving Regulatory Ambiguity Under Vietnam’s Chemicals Law

Vietnam’s Chemicals Law establishes broad controls over chemical production, trading, and importation, with primary administration assigned to the Ministry of Industry and Trade. In practice, however, challenges have emerged when a substance is both a regulated chemical and an integral component of a health product overseen by the MoH.

For overseas companies operating through multi-tier supply chains, this overlap has generated recurring questions around regulatory authority, documentation requirements, and enforcement responsibility. In some cases, uncertainty over which ministry held primary oversight affected regulatory strategy, import planning, and responses to inspection findings.

Against this backdrop, “Decree No. 26/2026/ND-CP” functions as an institutional clarification intended to reduce jurisdictional overlap and improve regulatory predictability for MoH-regulated product portfolios.

MOH Confirmed as the Responsible Authority for Health-Product Chemicals

The Decree does not introduce new chemical control lists or reclassify substances. Instead, its purpose is to clarify regulatory authority based on the regulatory status of the end product. Where a chemical is used in a product that falls within the Ministry of Health’s (MoH) regulatory remit, the MoH is confirmed as the responsible authority, even if that substance would otherwise be subject to the general chemical management framework administered by the Ministry of Industry and Trade.

Under this allocation of responsibilities, the scope includes chemicals used in:

Pharmaceutical products for human use
Medical devices (including In Vitro Diagnostic products)
Disinfectants and insecticides for household and medical use
Food additives, processing aids, and related substances
Other products regulated by the MoH

Chemicals used outside MoH-regulated product contexts remain within the general chemical management framework led by the Ministry of Industry and Trade.

What This Means for Foreign Manufacturers

This clarification is operationally significant for foreign manufacturers and importers because it reduces the risk of parallel or conflicting oversight for the same chemical when used within an MOH-regulated product. Historically, overlapping jurisdiction created potential exposure to:

Exposure to duplicative or conflicting compliance and reporting obligations
Ambiguity around inspection, enforcement, and corrective action authority
Potential delays in registration, variation approvals, and import clearance driven by jurisdictional overlap

While “Decree No. 26/2026/ND-CP” improves accountability and engagement clarity, it does not relax underlying chemical safety, import, or documentation obligations. Companies should therefore continue to treat chemical controls as fully applicable across the supply chain, including upstream suppliers and local importers.

Practical Actions for Overseas Manufacturers and Importers

In light of the clarified responsibility structure, foreign manufacturers and Vietnam-based importers supporting MOH-regulated products should reflect this allocation within their internal compliance frameworks.

Practical steps include:

Updating Vietnam regulatory responsibility matrices so chemical-related issues for MoH-regulated products are routed through MoH-aligned regulatory owners and advisors
Reviewing product dossiers and technical documentation to ensure chemical-related evidence supports both product compliance and chemical-related import processes
Aligning importer standard operating procedures and escalation pathways to ensure chemical compliance questions for MoH products are handled consistently
Monitoring early implementation signals, particularly coordination between authorities during import declarations and post-market enforcement

Taken together, these adjustments can help reduce friction during regulatory interactions while maintaining full compliance with Vietnam’s chemical and health product requirements.

Final Thoughts

“Decree No. 26/2026/ND-CP” marks an important step toward greater regulatory coherence under Vietnam’s Chemicals Law. While it does not change the scope of chemical controls, it resolves a jurisdictional gap by clearly aligning regulatory responsibility with the authority governing the end product. For foreign manufacturers, this clarity supports more consistent compliance planning, smoother regulatory engagement, and reduced risk of conflicting oversight across pharmaceuticals, medical devices, and other Ministry of Health–regulated products.

For companies seeking structured support for navigating Vietnam’s chemical and health product regualtions, get in touch with Cisema today for further guidance.