Vietnam MoH Introduces Risk-Based Regulation Across Medical Devices, Pharmaceuticals, & Food Products

Vietnam’ Ministry of Health (MOH) has been implementing a new risk-based quality management framework since Decree No. 37/2026/ND-CP took effect on January 23, 2026. On July 1, 2026, four MOH circulars operationalizing the decree for medical devices, pharmaceuticals, traditional medicine, and food-contact materials came into force.  Together, this transition replaces a legacy, "one-size-fits-all" regulatory approach with a tiered system where oversight is proportional to a product's actual impact on public health and safety. 

This fundamental shift impacts all manufacturers, importers, and overseas applicants operating in the medical device, pharmaceutical, traditional medicine, and food-contact material sectors. 

Implementing the Framework: Four Key Circulars

To operationalize this decree, the MOH has released four circulars defining the risk criteria for specific sectors.

What Manufacturers and Importers Should Do Now

Because state scrutiny will dynamically scale with risk, misclassifying a product can lead to immediate compliance friction.

Market participants should proactively execute three strategic steps:

• Audit Product Portfolios: Identify the risk classification for each product in your lineup.
• Evaluate Compliance Impacts: Determine how these classifications alter requirements for registration, conformity assessments, labeling, and technical documentation.
• Upgrade Quality Management Systems: Align internal compliance and auditing protocols with risk-proportional enforcement standards.

Preparing for Vietnam's Evolving Regulatory Landscape

Vietnam’s transition toward a risk-proportional model signals a broader alignment with international best practices. By allocating resources based on actual product risk, regulators can strengthen supervision of high-stakes products while reducing administrative burdens for lower-risk items.

While this framework promises greater regulatory predictability, it also places increased responsibility on companies to accurately classify their products and understand their specific obligations. Proactive alignment with these new standards is essential for minimizing regulatory risk and maintaining efficient market access in Vietnam.

With an established local presence in Vietnam, Cisema helps manufacturers navigate these evolving requirements through product classification, regulatory strategy, market entry support, and ongoing Regulatory Affairs services. By combining local regulatory expertise with regional experience, we help companies achieve and maintain market access.

To discuss how the new requirements may affect your products, contact Cisema today.

Further Information

• Explore Cisema’s services for medical devices in Vietnam.
• Explore Cisema’s Pharmaceutical consulting services.

About the Author: Rosie Nguyen

Rosie Nguyen is a Regulatory Affairs Manager at Cisema with over 8 years of experience in cosmetics and medical device regulations in Vietnam. Based in Ho Chi Minh City, she has supported numerous brands in successfully entering the Vietnamese market by ensuring full compliance with product registration and regulatory compliance.

References

• Decree 37/2026/ND-CP
• Circular No. 24/2026/TT-BYT
• Circular No. 26/2026/TT-BYT
• Circular No. 27/2026/TT-BYT
• Circular No. 28/2026/TT-BYT