Medical Device Price Declaration: Process and Information Businesses Need to Prepare

Medical device price declaration is the process by which a business submits information on the price it has determined to the competent receiving authority for products and entities subject to price declaration requirements. Businesses should not assume that all medical devices are subject to this procedure. They should first determine whether the product is included in the price declaration list, whether the company is among the entities required to submit declarations, and which authority is responsible for receiving them.

To minimize errors, businesses should maintain consistent data on device names, categories, models, configurations, units of measurement, prices, effective dates, and relevant legal information. It is also important to clearly distinguish between price declaration, price listing, and commercial quotations, as these activities serve different purposes and are subject to different management requirements.

Quick Summary

- Not all medical devices placed on the market are subject to price declaration requirements.

- Businesses should verify the applicable product categories, entities subject to price declaration, and the competent authority responsible for receiving the declaration.

- Product identification information, configurations, units of measurement, and declared prices must be consistent across the price declaration dossier, product documentation, and commercial materials.

- When a business sets a new price or adjusts an existing price, it should review whether a price declaration is required under the applicable regulations.

- Price declaration does not replace price listing, market authorization documentation, quotations, or procedures related to procurement and bidding.

What Is Medical Device Price Declaration?

Under Vietnam's Law on Prices, price declaration refers to the process by which businesses providing goods or services notify the competent state authority of the applicable price when setting or adjusting prices for goods or services subject to declaration requirements. Law on Prices No. 16/2023/QH15 took effect on July 1, 2024, and is further detailed by Decree No. 85/2024/NĐ-CP.

For medical devices, Consolidated Document No. 08/VBHN-BYT dated March 6, 2026, provides that the detailed list, applicable entities, implementation procedures, and receipt of price declarations are governed by pricing legislation. This means businesses should not rely solely on sector-specific medical device regulations but should also review the Law on Prices, its implementing regulations, and notifications issued by the receiving authority at the time of submission.

In principle, price declaration is not a procedure through which a state authority approves a price on behalf of the business. The business remains responsible for determining the price and ensuring that the declared information is accurate, truthful, reasonable, and compliant with applicable laws. The receiving authority uses declaration data for management, aggregation, analysis, and inspection where necessary.

Distinguishing Price Declaration, Price Listing, and Commercial Quotations for Medical Devices

In practice, these three concepts are often used interchangeably. However, each serves a different purpose.

Item	Price Declaration	Price Listing	Commercial Quotation
Nature	Submission of price information to the competent receiving authority	Public disclosure of prices so customers can identify them	Proposed selling price for a specific customer or purchasing requirement
Scope	Goods, services, and entities subject to declaration requirements	Manufacturers and businesses subject to price listing requirements	Depends on sales, procurement, or quotation activities
Key information	Price, effective date, and economic and technical characteristics	Name, category, configuration, unit of measurement, and listed price	Configuration, quantity, delivery terms, warranty, tax, and quotation validity
Where used	Authority receiving price declarations	Point of sale, business location, or other appropriate public disclosure channel	Hospitals, clinics, distributors, or purchasing organizations
Can they replace one another?	No	No	No

Under medical device management regulations, when prices are listed on the Ministry of Health's electronic portal, the minimum information includes the device name and category, manufacturer and country of manufacture, product owner and country, unit of measurement, configuration or technical features, and listed price.

Accordingly, submitting a quotation to a hospital or publishing a price on a company website does not automatically mean that the price declaration obligation has been fulfilled. Conversely, completing a price declaration does not replace price listing requirements or the need to provide an appropriate quotation for a particular transaction.

Not All Medical Devices Are Subject to Price Declaration

A common mistake is to assume that all medical devices manufactured or sold in Vietnam are subject to price declaration. Current regulations identify devices subject to declaration based on specific economic and technical characteristics.

Circular No. 29/2024/TT-BYT of the Ministry of Health, effective January 1, 2025, identifies nine device categories, covering a total of 60 detailed product names subject to price declaration based on their economic and technical characteristics.

The nine equipment groups are:

Each group also contains more detailed product names. For example, the ventilator category includes different types such as transport ventilators, pediatric and neonatal ventilators, and non-invasive neonatal ventilators. The X-ray category includes various systems such as digital X-ray systems, mobile X-ray units, C-arms, dental X-ray systems, and mammography systems.

Businesses should therefore not rely solely on general product names in catalogs. They should review:

If the commercial name differs from the terminology used in the regulation, businesses should assess the underlying technical characteristics and seek guidance from the competent authority if classification remains unclear.

Who Is Required to Declare Medical Device Prices?

The fact that a product belongs to a price declaration category does not necessarily mean that every company buying or selling that product must submit a declaration.

Under Circular No. 29/2024/TT-BYT, Cục Cơ sở hạ tầng và Thiết bị y tế (the Ministry of Health unit responsible for infrastructure and medical equipment) is responsible for reviewing and compiling the list of entities required to make price declarations and publishing it on the Ministry of Health's online public service system for medical device management. The Department also announces the method for receiving price declaration documents. Provincial and municipal People's Committees are responsible for organizing the receipt of declarations in accordance with pricing legislation.

Before preparing a submission, businesses should answer three questions:

Correctly identifying the responsible entity is especially important in distribution chains involving multiple parties, such as:

Businesses should not assume that responsibility automatically belongs to the importer or the market authorization holder. The published list and the actual commercial role of each legal entity should be reviewed.

A Seven-Step Medical Device Price Declaration Process

The process below is an internal framework that can help businesses prepare data and control documentation. When making an official submission, companies should follow the forms, deadlines, submission methods, and receiving authority applicable at the time.

Step 1: Determine Whether the Product Is Subject to Price Declaration

The legal or regulatory affairs team should prepare a list of all devices the company manufactures, imports, or distributes.

For each product, review:

Businesses should not rely only on keyword searches. A model may not use exactly the same name as the regulatory list but may still fall within the same category based on its technical characteristics.

Step 2: Check Whether the Company Is Included in the Declaration List

After confirming the product category, the business should check the list of entities published by the competent authority.

The company should retain:

The list may be reviewed and updated in response to management requirements. Businesses should therefore avoid checking it only once and applying that conclusion unchanged for many years.

Step 3: Standardize Product Identification Information

The product name and configuration in the price declaration should be consistent with product documentation and commercial materials.

Businesses should maintain a master data table containing:

If the same model is sold in multiple configurations, the company should determine which configuration corresponds to each price. A single price should not be used for sales packages with significant differences in accessories, modules, or functionality.

Step 4: Determine the Price and Effective Date

The declared price should be the price determined by the business through the appropriate internal authority.

Before issuing a price, the company should confirm:

Under Decree No. 85/2024/NĐ-CP, an entity subject to price declaration must submit the declaration within a maximum of five working days from the date the price is decided. The business is responsible for the accuracy, truthfulness, reasonableness, and validity of the declared documentation and data.

The internal process should therefore begin as soon as the price is approved rather than waiting until the sales team starts issuing quotations.

Step 5: Prepare the Price Declaration and Internal Supporting Documents

The declaration should be prepared using the form currently in effect. The declaration form under Decree No. 85/2024/NĐ-CP includes fields relating to the name of the goods, economic and technical characteristics, unit of measurement, previous price, current price, date of price setting or adjustment, and percentage increase or decrease.

In addition to the document submitted to the receiving authority, businesses should retain internal records such as:

Not all internal documents necessarily need to be submitted in every case. However, maintaining complete records can help the business respond to requests for clarification or inspection.

Step 6: Submit to the Correct Authority Through the Required Channel

The receiving authority may announce the submission method according to the available implementation infrastructure. Circular No. 29/2024/TT-BYT assigns the Department responsibility for announcing the method of receipt and coordinating the development of information technology systems supporting medical device price declarations.

Before submission, businesses should check:

If the system reports an error, the business should retain screenshots and contact the relevant support channel rather than continuing sales at the new price without evidence that the declaration obligation has been properly addressed.

Step 7: Track, Retain, and Update Records When Changes Occur

After submission, businesses should update the declaration status in their internal tracking system.

Tracking fields may include:

When there is a price adjustment, configuration change, or request from the authority, the business should promptly assess whether a new declaration or an amendment is required.

What Information Should Businesses Prepare?

The required information can be organized into six main groups.

Information Group	Data to Prepare	Typical Responsible Function
Legal entity	Company name, enterprise registration number, address, representative, contact details	Legal, administration
Product	Device name, category, model, product code, market authorization number	Regulatory affairs
Technical	Configuration, features, accessories, distinguishing specifications between versions	Technical, product
Commercial	Unit of measurement, price, tax, configuration conditions, and effective date	Sales, finance
Approval	Price decision, authorized approver, decision date	Management, finance
Declaration	Declaration form, previous price, increase/decrease, receiving authority	Legal, regulatory affairs

Legal Entity Information

The company name should be consistent with its enterprise registration certificate and the list of entities subject to price declaration.

Particular attention is needed when the company:

Product Information

The device name in the price declaration should be traceable to the product's market authorization documentation.

Where one market authorization covers multiple models, the business should determine:

Configuration Information

Configuration is important because it allows readers of price data to understand exactly which product package the declared price refers to.

For example, the same X-ray system may differ in:

Without a clear configuration description, price data may be misleading when compared with another system using the same product name but a different scope of supply.

Price Information

Businesses should clearly state:

Businesses should avoid placing all commercial conditions into the product name. Instead, data fields should be standardized so the price can be interpreted and compared in the correct context.

When Should a New Declaration Be Reviewed?

Businesses should initiate a review in the following situations:

Not every minor technical change necessarily triggers a new declaration. Businesses should assess whether the change affects the product, configuration, price, or the ability to identify the data previously declared.

Common Errors in Medical Device Price Declaration

Confusing Price Listing with Price Declaration

A company may publish prices on its website without checking whether it is also required to submit a price declaration.

The two processes should be managed separately:

Declaring Only the Commercial Name Without the Product Category

A commercial name may not make it clear whether the product is a ventilator, patient monitor, or X-ray system.

Businesses should record both the commercial name and the technical product category.

Failing to Separate Configurations with Different Prices

If one model is sold in several configurations but only one price line is recorded, price comparisons become difficult.

Each price should be linked to a specific configuration or a clearly defined configuration rule.

Inconsistent Prices Across Departments

The sales team may use a new price list while the legal team still retains the previous declaration. This risk often arises when price approval and declaration processes are not connected.

Businesses should establish a rule such as:

A new price list should only be released after all required legal and internal control steps have been completed.

Failing to Retain Proof of Submission

After personnel or system changes, the company may be unable to locate a receipt, email, or submission ID.

Each submission should be stored in a standardized electronic folder using consistent file names and with a clearly assigned person responsible for retention.

Continuing to Use Old Data After a Legal Entity Change

Changes to the company name, address, or distribution rights may make previously declared information no longer appropriate.

Changes to the company's legal status should therefore be communicated to teams responsible for product management, pricing, and market authorization documentation.

Checklist Before Submitting a Price Declaration

Frequently Asked Questions About Medical Device Price Declaration

Are All Medical Devices Subject to Price Declaration?

No. Businesses need to review the applicable device list, economic and technical characteristics, and the list of entities required to submit declarations as published by the competent authority.

If a Device Is Not Subject to Price Declaration, Does Its Price Still Need to Be Listed?

Price declaration and price listing are separate obligations. Businesses still need to comply with applicable price listing and disclosure requirements even when a product is not subject to price declaration.

Is a New Declaration Required When the Price Is Reduced?

When a business decides to adjust the price of goods subject to declaration requirements, it should review its obligation to submit a new declaration under pricing legislation, not only when prices increase.

Is a Quotation Sent to a Hospital Considered a Price Declaration?

No. A quotation is a commercial document sent to a customer or purchasing organization. A price declaration is the submission of price information to the competent authority as required by regulations.

How Should a Market Authorization Covering Multiple Models Be Declared?

The business should determine which models are included in the declaration list and whether the applicable prices differ. The presentation should ensure that each price can be linked to the correct model and configuration.

Does the Declared Price Become a Mandatory Selling Price?

Price declaration is not a mechanism through which the state authority approves a mandatory selling price on behalf of the business. However, the declaring entity remains responsible for the accuracy, truthfulness, and legality of the declared price and must also comply with applicable disclosure, price listing, and explanation requirements.

This article is provided for informational purposes only and does not replace legal advice or guidance from regulatory authorities. Businesses should review current regulations, the applicable list of entities subject to price declaration, and notifications from the receiving authority at the time of implementation.

From Standardizing Product Information to Expanding Market Access at PHARMEDI & HEALTHCARE VIETNAM 2026

Price declaration is only one part of the process of bringing a medical device to market. To support effective commercial operations, businesses also need to ensure that product names, models, configurations, technical characteristics, units of measurement, and commercial policies are managed consistently across legal documentation, sales materials, and partner communication channels.

Once this foundation is in place, the next challenge is to bring products to the right market, reach the right customer groups, and build an appropriate distribution network.

At PHARMEDI & HEALTHCARE VIETNAM 2026, medical device companies can connect with manufacturers, importers, distributors, buyers, and other partners across the healthcare value chain. The exhibition also offers business networking and matching programs designed to help companies connect with relevant participants and explore potential partnerships during the event.

For companies already marketing medical devices or preparing to introduce new products, participating in PHARMEDI VIETNAM 2026 can support the exploration and assessment of several important commercial considerations:

In addition to the exhibition, PHARMEDI VIETNAM 2026 includes business connection programs such as Hosted Buyer, B2B Matching, and LeadGrab, designed to help companies connect more efficiently with buyers, importers, distributors, and potential partners.

Participation in the exhibition does not replace obligations relating to price declaration, price listing, or price management. However, it can help businesses better understand the market environment, customer needs, and how products move through distribution channels. These insights can support product strategy and market development once the necessary legal requirements have been addressed.

Dates: September 22–24, 2026

Venue: Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City

Exhibitor Registration: https://pharmed.vn/exhibitor/application-form

Visitor Registration: https://ers-vn.informa-info.com/pha2026?cid=FB

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