Establishments trading in medical equipment of categories B, C, D in Vietnam must meet the conditions under Decree 98/2021/ND-CP on medical equipment management. As follows:
Article table of contents
Conditions for establishments trading in class B, C, and D medical equipment (Illustration photo)
(1) Having at least 01 technical staff with a college degree in engineering, medicine, pharmacy, chemistry, biology or a college degree in medical equipment engineering or higher or a college degree or higher with specialized training suitable to the type of medical equipment that the establishment buys and sells.
(2) Having a storage warehouse and means of transport that satisfy the following minimum conditions:
* For storage warehouse in Vietnam:
- Having an area suitable to the type and quantity of preserved medical equipment,
- Ensure ventilation, dry, clean, not near sources of pollution,
- Meet other storage requirements of medical equipment according to the instructions for use.
* Regarding the means of transporting medical equipment from the trading establishment to the place of delivery, suitable to the type of medical equipment that the establishment buys and sells.
In case there is no warehouse or means of preserving medical equipment, a contract must be signed with a competent facility to preserve and transport medical equipment.
(3) For establishments trading in medical equipment containing narcotics and precursors:
- The person in charge of the specialty must have a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry or biology.
- Having a warehouse to ensure that narcotics and precursors are preserved in a separate area in the warehouse or in a separate warehouse, which must ensure safety.
- Having a system to monitor and manage the process of export, import and inventory of medical equipment containing narcotics and precursors.
Dossier and procedures for announcing eligibility to buy and sell medical equipment in Vietnam
* An application for declaration of eligibility to purchase and sell medical equipment is made in 1 set, including the following papers:
- Written announcement of eligibility to purchase and sell medical equipment;
- Personnel declaration;
- Documents proving that the storage warehouse and means of transport of medical equipment meet the requirements. These papers must be certified by the establishment declaring the eligibility for trading;
- Papers prove that the storage warehouse, the system to monitor and manage the export, import and inventory of medical equipment containing narcotics and precursors meet the requirements according to regulations. These documents must be certified by an establishment that declares eligibility to trade in medical equipment containing narcotics and precursors.
* Procedures for the announcement of eligibility for trading in Vietnam
Step 1: Before carrying out the purchase and sale of medical equipment, the medical equipment trading establishment is responsible for submitting the announcement dossier to the Department of Health of Vietnam where the place of purchase and sale is located.
Step 2: Upon receipt of the application (including documents certifying payment of fees as prescribed by the Ministry of Finance of Vietnam), the Department of Health in the area where the medical equipment trading establishment is located shall publicly post it on the website. The electronic portal on the management of medical equipment contains information and documents announcing the eligibility to purchase and sell medical equipment.
In the course of operation, the trading establishment is responsible for making a written notice of the change enclosed with the documents related to the change and updating such documents into the publicized dossier on the electronic portal on the management of medical equipment within 3 working days from the date of change of information in the public dossier.
The purchase and sale of medical equipment of types B, C, D on the list of medical equipment promulgated by the Minister of Health of Vietnam may be purchased and sold as ordinary goods without having to satisfy the conditions under the provisions of this Law of Vietnam and at the same time are not required to declare eligibility for trading according to the above-said regulations. However, the conditions on preservation, storage, and transportation must still be met as prescribed by the owner of the medical equipment.
Officially putting medical equipment in the goods subject to price declaration in Vietnam
This Decree of Vietnam has added the following measures to control the price of medical equipment:
- Declare the price of medical equipment before circulating in Vietnam and update when changing the declared medical equipment price according to regulations.
- Posting the wholesale and retail prices of medical equipment in Vietnam dong at the place of transaction or the place of sale of medical equipment of the medical equipment trading establishment; publicly announced on the board, on paper or in other forms.
- Publicize the winning bid for medical equipment of public medical facilities.
- Not to buy and sell medical equipment without the declared price and not to buy or sell higher than the price declared on the website of the Ministry of Health of Vietnam at the time of purchase and sale.
Meanwhile, specifying the content of the declaration of prices including the cost of imports or the cost of production, management costs, training and retraining costs, warranty costs, expected profits and final selling prices.
In addition, only the owner of the circulation number or the distributor authorized by the owner can publish the price and the remaining distributors must not sell more than the price that the owner of the circulation number has announced and must, at the same time, list and publicize the price that the distributor sells.
Bao Ngoc
