Vietnam: What conditions must medical equipment establishments comply with? Is it necessary to carry out the procedure for declaring eligibility for sale or not?
- What conditions must the business of buying and selling medical equipment comply with in Vietnam?
- Is it necessary to carry out procedures for declaring eligibility for purchase and sale of medical equipment in Vietnam?
- What are records and procedures for announcing establishments eligible for purchase and sale of medical equipment in Vietnam?
What conditions must the business of buying and selling medical equipment comply with in Vietnam?
Currently, there are only regulations on conditions for medical equipment of categories B, C and D. According to Clauses 2, 3, Clause 4 Article 4 of Decree 98/2021/ND-CP stipulating these types of equipment as follows:
- Class B medical equipment is medical equipment with a low average risk level.
- Class C medical equipment is medical equipment with a high average level of risk.
- Medical equipment of class D is medical equipment with a high level of risk.
And Article 40 of Decree 98/2021/ND-CP stipulates that establishments carrying out the purchase and sale of this equipment must meet the following conditions:
Article 40. Requirements for trading in Class-B, C, D medical devices
To be permitted to trade in Class-B, C, D medical devices, an establishment must:
1. Have at least 01 employee who has an associate degree, or higher, in technology, medicine, pharmacy, chemistry, biology or medical devices, or an associate degree, or higher, suitable for the medical devices sold by the establishment.
2. Have warehouse and vehicles that satisfy the following requirements:
a) The warehouse must:
- have an area suitable for the categories and quantities of medical devices stored therein;
- be well ventilated, dry and clean, and separated from sources of pollution;
- satisfy storage requirements for the medical devices laid down in their user manuals.
b) The vehicle used for transporting medical devices to buyers must be suitable for categories of such medical devices;
A trading establishment that does not have a warehouse or vehicle may sign a contract with a qualified storage or transport service provider.
3. Requirements for trading in medical devices that contain narcotic substances or precursors:
a) The chief technician has a bachelor’s degree in medical devices, medicine, pharmacy, pharmaceutical chemistry or biology.
b) The trading establishment must have a warehouse that satisfies the requirements laid down in Article 7 of the Government’s Decree No. 80/2001/ND-CP dated November 05, 2001.
c) There is an inventory monitoring system for medical devices containing narcotic substances and precursors.
Accordingly, it will have to comply with the conditions of personnel and facilities, in addition, for establishments buying and selling medical equipment containing narcotics and precursors will be subject to separate regulations.
Vietnam: What conditions must medical equipment establishments comply with? Is it necessary to carry out the procedure for declaring eligibility for sale or not?
Is it necessary to carry out procedures for declaring eligibility for purchase and sale of medical equipment in Vietnam?
Article 42 of Decree 98/2021/ND-CP stipulates that cases where conditions are not required to be met and procedures for publication are carried out as follows:
Article 42. Trading in medical devices without satisfying eligibility requirements and following procedures for declaration of eligibility for medical device trading
1. Class-B, C, D medical devices included in the list of medical devices promulgated by the Minister of Health shall be traded as normal goods.
2. Establishments trading in the medical devices prescribed in Clause 1 of this Article shall not be required to satisfy eligibility requirements laid down in Article 40 of this Decree and follow procedures for declaration of eligibility for medical device trading as prescribed in Article 41 of this Article but must still meet the storage and transport requirements as prescribed by product owners.
Thus, in addition to the case under this regulation, conditions on purchase and sale of medical equipment must be ensured and disclosure procedures must be carried out.
What are records and procedures for announcing establishments eligible for purchase and sale of medical equipment in Vietnam?
As prescribed in Article 41 of Decree 98/2021/ND-CP stipulates:
- For the record:
+ Written declaration of eligibility for purchase and sale of medical equipment;
+ Personnel declaration;
+ Documents proving that warehouses and means of transporting medical equipment meet the requirements specified in Clause 2, Article 40 of this Decree. These documents must be confirmed by the establishment announcing eligibility for sale and purchase;
+ Documents proving that the storage warehouse, the monitoring system for managing the process of export, import and inventory of medical equipment containing narcotic substances and precursors meet the requirements specified in Clause 3, Article 40 of this Decree.
These documents must be confirmed by the facility declaring eligibility for the sale of medical equipment containing narcotics and precursors.
- About the procedure consists of 2 steps:
Step 1: Apply
Before buying and selling medical equipment, a medical equipment purchase and sale establishment shall submit a dossier of publication to the Department of Health where the place of purchase and sale is located.
Step 2: Upon receiving the dossier, the Department of Health in the area where the medical equipment purchase and sale establishment is located shall publicly post on the portal on medical equipment management the information and dossiers declaring eligibility for purchase and sale of medical equipment.
Note: During the operation of the purchase and sale establishment, it is responsible for making a written notice of change accompanied by documents related to the change and updating such documents into the published dossier published on the portal on medical equipment management.
Within 03 working days from the date of change of information in the disclosure dossier.
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