Key Development
Deputy Minister of Health Do Xuan Tuyen has formally signed and issued an urgent regulatory directive to the People’s Committees of all central-level provinces and cities regarding heightened state oversight, price declaration, and comprehensive audits of medical devices across Vietnam.
The regulatory directive mandates local authorities to proactively monitor, detect, and penalize cases involving arbitrary price spikes, significant price discrepancies among distributors, and sales exceeding declared/listed public prices across public and private healthcare sectors.
Core Directives & Compliance Mandates Issued by the Ministry of Health:
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Auditing & Updating Declared MedTech Commercial Registries:
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Provincial authorities must direct Health Departments to update and publish the official registry of medical device commercial enterprises subject to mandatory price declaration under Article 24 of Decree No. 148/2025/ND-CP.
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Scope determination strictly adheres to Item 15, Appendix V of Decree No. 85/2024/ND-CP and technical-economic classifications defined under Circular No. 29/2024/TT-BYT.
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Registries and declaration portals must be publicly published on Department of Health portals and synchronized with the National Price Database managed by the Ministry of Finance.
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Mandatory 5-Day Declaration Filing Window: Commercial distributors must submit formal price declarations within a strict timeline of maximum 05 business days from the internal pricing decision date, bearing full legal liability for cost-structure transparency and data integrity.
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Enforcing Public Price Listing Compliance (Article 29, Law on Price):
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Listed prices must represent the final gross selling price (inclusive of applicable taxes and fees), explicitly tagged with product model, brand, manufacturer, origin, and core technical specifications.
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Selling above listed prices is strictly prohibited. For bundled commercial packages (including shipping, installation, maintenance, clinical training, or consumables), vendors must itemize hardware prices separately from service fees.
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Deploying Multi-Agency Joint Enforcement Tasks: Health Departments will lead inter-agency audits with Finance Departments, Market Surveillance agencies, and Tax authorities. Any detected signs of anti-competitive collusion, tax evasion, transfer pricing, or public tender manipulation must be immediately transferred to the Ministry of Public Security for criminal investigation.
Why It Matters
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Preventing Artificial Procurement Markups & Protecting Public Funds: High-value capital medical equipment (e.g., MRI, CT, PET/CT, linear accelerators, IVD systems) involves specialized supply chains susceptible to transfer-pricing schemes through offshore intermediary networks. Strict declaration and listing enforcement safeguard state procurement budgets and national health insurance reserves.
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Standardizing Capital Investment Estimates for Non-Construction Projects: The directive aligns with the Ministry of Health’s forthcoming Circular standardizing cost-estimation methodologies for stand-alone medical equipment procurement projects, establishing objective valuation baselines for hospital tenders.
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Eliminating Bundled “Turnkey” Pricing Ambiguities: Mandating separate itemization for capital hardware versus post-warranty service contracts prevents vendors from concealing inflated hardware costs within opaque maintenance packages.
Healthcare Insight Analysis
From the perspective of Healthcare Insight, Deputy Minister Do Xuan Tuyen’s August 15, 2026 directive illustrates National MedTech Price Transparency & Inter-Agency Governance.
Historically, fragmented local oversight allowed MedTech distributors to exploit information asymmetry, submitting divergent price declarations across different provincial jurisdictions without systematic cross-verification.
The 2026 regulatory framework introduces three systemic oversight controls:
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Centralized Data Integration via National Repositories: Integrating provincial price declarations into the National Price Database enables automated algorithmic screening to flag pricing anomalies for identical equipment models across different regions.
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Mandatory Cost-Breakdown Justification: Regulatory agencies possess explicit statutory authority to demand formal cost-structure audits (including declared CIF customs values, logistics overhead, and operating margins) when suspicious price variations are detected.
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Inter-Agency Enforcement Coalitions (Health – Finance – Tax – Market Surveillance – Police): Formalized data-sharing protocols bridge the regulatory gap between technical healthcare licensing and tax/customs fraud enforcement.
Market Implications
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Comprehensive National Audits on MedTech Distributors: Capital equipment importers and distributors in Hanoi, Ho Chi Minh City, and Da Nang will face inter-agency pricing audits throughout H2 2026.
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Accelerated Adoption of Digital Declaration Portals: Transitioning 100% of price declaration workflows to standardized digital administrative portals, eliminating bureaucratic delays.
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Tender Valuation Stabilization in Public Hospitals: Public hospital procurement boards will access verified reference price benchmarks, reducing legal and procedural compliance risks during bidding cycles.
Regulatory Matrix: Medical Device Price Management Framework (2026)
| Governance Vector | Statutory Mandate & Legal Baseline | Enforcement Mechanism & Compliance Action |
| Entity Identification | Item 15, App. V (Decree 85/2024) & Circular 29/2024/TT-BYT | Publicly published on Department of Health portals. |
| Filing Timeline | Maximum 05 business days post-pricing decision | Synchronized to the National Price Database. |
| Listing Standards | Gross price inclusive of taxes; explicit Model/Origin | Zero tolerance for selling above listed prices. |
| Bundled Packages | Mandatory itemization of hardware vs. service fees | Eliminates opaque maintenance contract markups. |
| Anomaly Triage | Irregular price divergence across regions/periods | Mandatory justification; referral to Police. |