Vietnam Price Declaration: Ceiling Prices Before Circulation

Q: Must medical device prices be declared in Vietnam?

A: Yes, and it must be done before the device circulates. Decree 98/2021/NĐ-CP lists medical devices and biological products among the categories whose prices must be declared and provides that:

• device prices must be declared before the device circulates on the Vietnamese market and updated on the MOH portal;
• the wholesale and retail prices must be displayed in Vietnamese dong at the trading or sales premises (on a notice board, in print or in another form);
• the winning bid prices of devices supplied to public healthcare institutions must be published;
• devices without a declared price may not be traded, and no device may be traded at a price above the price published on the MOH website.

Q: Who may publish the ceiling price?

A: Only the circulation number holder (MAH), or a distributor it has authorised, may publish the ceiling price; other distributors may not sell above that published price. This provision concentrates pricing authority in the holder and is the core mechanism of Vietnamese price control.

Q: What must the declaration disclose?

A: Decree 98 requires fairly detailed price information: import cost or production cost, management costs, training and retraining costs, warranty costs and expected profit, together with the final selling price. Where necessary, the competent state authority, not only the MOH, may require the holder and distributors to supply further price information.

Q: What other price rules apply?

A: The governing statute is the Law on Prices No. 16/2023/QH15, and its implementing Decree 85/2024/NĐ-CP sets out detailed rules on price declaration and publication. The device pricing provisions of Decree 98 apply in parallel with that framework, and the declaration is still made on the MOH medical device management portal.

Q: What happens if prices are not declared or the ceiling is exceeded?

A: These are sanctionable violations. Price declaration is an obligation expressly set by Decree 98, and both circulating without a declaration and selling above the published price can trigger administrative action. In the public hospital channel, price declaration and publication of winning bid prices also directly affect tender eligibility.

Practical note: treat price declaration as the last gate before launch. Many companies ship as soon as the certificate is issued and skip this step. The portal carries a clear timestamp, so once checked it is an established fact of “selling without a declared price”. Write into the MAH service agreement that “price declaration must be completed after the circulation number is issued and before the first shipment“, and make the declaration receipt one of the release conditions for shipping.

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, price management provisions (declaration before circulation, portal update, price display at trading premises, publication of winning bid prices, prohibition on sales above the published price, only the holder or an authorised distributor may publish the ceiling price); (2) Law on Prices No. 16/2023/QH15; (3) Decree No. 85/2024/NĐ-CP (implementing the Law on Prices); (4) the price declaration section of the MOH medical device management portal.