Key Development
Vietnam’s government is proposing amendments to Article 113 of the Law on Medical Examination and Treatment that would manage medical devices across their product lifecycle and supply chain, while expanding price disclosure, distributor transparency and product traceability.
A particularly important proposal is to connect data across healthcare, customs, tax, procurement and health insurance systems. In principle, this could allow regulators to compare import values, selling prices, listed prices and hospital tender prices for the same device rather than viewing each transaction in isolation.
For pharmaceuticals, the proposed amendments would strengthen rules around publication of the expected wholesale price and data sharing. This builds on existing pharmaceutical legislation under which the expected wholesale price is effectively the maximum wholesale price determined by the manufacturer or importer before first commercial sale.
Why It Matters
- Medical-device distributors may increasingly need to prove the value created at each layer of the channel.
- Data integration could become more important than formal price ceilings, enabling authorities to identify unusual price spreads.
- Hospital procurement could gain better benchmarks, provided models, configurations and bundled services are correctly matched.
- Pharmaceutical pricing will become more closely connected to transaction-level market data, rather than operating as a stand-alone declaration process.
Healthcare Insight Analysis
Healthcare Insight believes the structural shift is from price disclosure to price traceability.
Vietnam already has price-listing and declaration requirements for selected medical devices. Circular 29/2024/TT-BYT, effective January 2025, defines devices subject to price declaration, while the Ministry of Health instructed provinces in August 2026 to strengthen monitoring and identify unusual price movements.
The remaining weakness is that a declared price does not explain how the price was formed.
A device may move through:
manufacturer → importer → national distributor → regional distributor → hospital tender → installation → maintenance.
When those transactions live in separate databases, regulators can see numbers but not necessarily the economic logic connecting them.
An integrated system could change the central question from:
“Is this price high?”
to:
“Which part of this price increase is justified, and what value was added?”
That distinction matters.
A medical device sold to a hospital often includes installation, commissioning, clinical training, warranty, maintenance, software, spare parts and financing terms. A hospital purchase price materially above the customs value is therefore not automatically evidence of excessive margin.
Poorly designed transparency could create another problem: false comparability.
Two systems carrying the same product name may differ substantially in detectors, software modules, warranty duration, maintenance coverage or accessories. If procurement databases compare them as identical, transparency could unintentionally incentivize under-specification rather than efficiency.
The more mature objective is therefore not simply a lowest-price database.
It is a comparable total-cost-of-ownership architecture.
The pharmaceutical side has a parallel challenge.
Vietnam’s expected wholesale-price framework can establish a transparent ceiling and identify unusual spreads relative to tender prices. Existing legislation already provides mechanisms for scrutiny when the difference between expected wholesale prices and hospital tender prices exceeds specified parameters.
But pharmaceutical access ultimately depends on more than price.
A product that appears inexpensive on paper provides little system value if procurement fails, reimbursement is delayed or supply repeatedly disappears.
Price governance therefore works best when connected with availability, purchasing and reimbursement data.
Market Implications
Medical-device distributors: low-value multi-layer distribution structures could face increasing pressure.
Manufacturers: companies with transparent pricing, strong direct-market capabilities and clearly defined service economics may benefit.
Hospitals: purchasing teams will need to compare configuration, service and lifecycle cost — not merely acquisition prices.
Pharma: pricing, tender and market-access functions will become increasingly interconnected as government datasets converge.
ANALYTICAL MATRIX
| Dimension | Current Model | Emerging Model | Key Risk |
| Device pricing | Declaration/listing | End-to-end traceability | False comparisons |
| Distribution | Multiple layers possible | Distributor visibility | Removing legitimate services |
| Data | Fragmented | Customs–tax–tender–insurance linkage | Poor data quality |
| Medicines | Expected wholesale price | Connected pricing data | Overly rigid price control |
| Procurement | Price benchmarking | Lifecycle value | “Cheapest wins” incentives |
If implemented effectively, the reform should not ultimately be judged by how many percentage points medical-device prices fall.
A better test is whether price spreads become explainable, unnecessary distribution layers shrink, and hospitals obtain equivalent or better clinical value at lower total lifecycle cost.
That would represent a more significant evolution: from administrative price supervision toward data-driven market governance.