HOW TO DECLARE THE ELIGIBILITY TO TRADE CLASS B, C, D MEDICAL DEVICES IN VIETNAM?

The epidemic rate has decreased, increasing the demand for medical equipment sales.  "Medical devices” include devices, tools, materials for implanting activities, reagents and in vitro calibration solutions, software that are used separately or in association with each other according to the instruction of the product owner for human use for one or more purposes. However, not all organizations and individuals are fully aware of the legal requirements for declaring class B, C, and D medical equipment. As a result, Doanh Tri Law Firm would like to send the article "How to Declare Eligibility to Trade Class B, C, D Medical Devices In Vietnam" below to Customers!

I. Legal basis

- Law on Investment dated November 26, 2014;

- Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on the management of medical equipment.

II. Conditions for trading Class B, C or D medical devices in Vietnam

-    Have at least 01 employee who has at least a college degree in technology, health, pharmacy or medical devices or at least a college degree suitable for the medical devices sold by the establishment;
-    Have at least a warehouse and a vehicle that satisfy the following requirements: (i) having an area suitable for the categories and quantities of medical devices stored therein, (ii) Being airy, dry, clean, separated from sources of pollution, (iii) Satisfying storage conditions of the medical devices according to their instructions manuals.
-    The vehicle for delivery of medical devices is suitable for the devices carried therein;
-    An establishment without a warehouse or vehicle may sign a contract with a qualified storage or transport service provider.

III. Procedures for declaration of eligibility to trade medical devices in Vietnam

1. Dossier

The declaration dossier includes:

- A declaration form of eligibility to trade medical devices;

- List of medical devices;

- A personnel list;

- Papers proving that the storage facilities and vehicles are conformable to requirements: Warehouse diagram; Warehouse lease contract; Vehicles rental contract;

- Personnel documents: Diploma; Practicing certificate.

2. Procedures for announcing eligibility to buy and sell medical equipment of grades B, C, and D

Step 1: Prepare a dossier and send it to the Department of Health where the trading establishment is located by submitting an online application at the online public service portal on equipment management.

Step 2: Upon receipt of a complete and valid application, the Department of Health shall issue a notice of receipt of the application for a declaration of eligibility to trade according to the form prescribed in Decree No. 26/2016/ND-CP.
Step 3: Within 03 working days from the date of receipt of the application for the announcement of eligibility to trade, the Department of Health is responsible for publishing on the portal the following information: Name, address of medical equipment trading establishments;

Step 4: After completing the procedures for declaring eligibility to trade, the establishment may purchase and sell medical equipment of types B, C, and D.

The above information is about the ‘How to declare the eligibility to trade class B, C, D medical devices in Vietnam?' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:
Hotline: (+84) 911.233.955 - (024) 6293 8326
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