04 Measures for management of medical device prices under the law in Vietnam

04 Measures for management of medical device prices under the law in Vietnam (Internet image) 

Regarding this issue, LawNet would like to answer as follows: 

1. Rules for state management of medical device prices in Vietnam

According to Article 43 of Decree 98/2021/ND-CP, the rules for state management of medical device prices include:

- Manage prices of medical devices according to the market mechanism; respect the right to pricing and price competition of entities trading in medical devices in accordance with regulations of law.

- Ensure transparency of prices of medical devices placed on the market.

- Protect lawful rights and interests of medical device traders and users, and of the State.

- Take measures for ensuring management of medical device prices appropriate for socio-economic development in each period.

2. Measures for management of medical device prices in Vietnam

The measures for management of medical device prices specified in Article 44 of Decree 98/2021/ND-CP include::

- Prices of medical devices must be declared in accordance with regulations of this Decree before they are placed on the market in Vietnam, and declared again whenever they are changed.

- Wholesale and retail prices in VND of medical devices shall be posted at transaction or selling locations of medical device trading establishments; such prices shall be publicly posted on a board, paper or otherwise posted.

- Successful bids for medical devices of public health facilities must be made publicly available.

- Trading establishments shall not be allowed to trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading.

3. Contents and responsibility for declaration of medical device prices in Vietnam

3.1. Contents of declaration of medical device prices

Specifically, in Clause 1, Article 45 of Decree 98/2021/ND-CP, the contents of declaration of medical device prices: include:

- Name and category of the medical device;

- Manufacturing country;

- Unit;

- Import cost price of the imported medical device or manufacturing cost of the domestically manufactured medical device;

- Expected profits;

- The highest price of the medical device determined according to its design configurations, technical functions and unit;

- Prices of accessories and parts (if any);

- Warranty or maintenance costs (if any);

- Training costs (if any);

- Other costs (if any);

3.2. Contents about medical device prices to be publicly posted

Contents about medical device prices to be publicly posted include:

- Name and category of the medical device;

- Manufacturer and manufacturing country; product owner and country of product owner;

- Unit;

- The highest price of the medical device determined according to its design configurations, technical functions and unit;

- Prices of accessories and parts (if any);

- Warranty or maintenance costs (if any);

- Training costs (if any);

- Other costs (if any);

(Clause 2, Article 45 of Decree 98/2021/ND-CP)

4. What is medical device?

According to Clause 1, Article 2 of Decree 98/2021/ND-CP, medical device means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

(i) It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:

+ Diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;

+ Investigation, replacement, modification or support of the anatomy or of a physiological process;

+ Supporting or sustaining life;

+ Control of conception,

+ Disinfection of medical devices;

+ Providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

(ii) The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned in (i).

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