Vietnam: Issuance of Draft Circular for Declaring the Prices of Medical Devices

The Vietnam Ministry of Health issued a draft Circular on Regulations for Declaring the Prices of Medical Devices, which will cover the following aspects:

1. The economic and technical characteristics of medical devices for price declaration; and
2. The receiving Authority and entities responsible for declaring the prices of medical devices.

The list of medical devices for which prices must be declared as specified in the Annex of this draft Circular are as follows:

1. Artificial kidney Machine
2. Ventilator
3. Anesthesia Machine
4. Patient Monitoring Machine
5. Electric syringe pump
6. Infusion Machine
7. X-ray Systems
   1. Digital General X-ray Machine
   2. Portable X-ray Machine
   3. C Arm X-ray Machine
8. CT Scanner Systems
   1. CT Scanner System with < 64 slices/rotation
   2. CT Scanner System with 64 – 128 slices/rotation
   3. CT Scanner System with ≥ 256 slices/rotation
9. MRI System with ≥ 1.5 Tesla
10. Digital Subtraction Angiography (DSA) System
11. Ultrasound
    1. Cardiovascular Ultrasound Machine
    2. General Ultrasound Machine
12. Biochemical Analyzer
13. Immunoassay Analyzer
14. Surgical Instruments
    1. Electrosurgical Unit
    2. Ultrasonic Surgical Knife / Vessel Sealer / Tissue Sealer
15. Defibrillator
16. ECMO Machine
17. Endoscopic Surgery System
18. Ceiling-Mounted Operating Light
19. Mobile Operating Light
20. Operating Table
21. Electrocardiogram Machine
22. Electroencephalogram Machine
23. Endoscopy Systems
    1. Gastrointestinal Endoscopy System (stomach, colon)
    2. Trachea and Bronchial Endoscopy System
    3. Ear, Nose, and Throat Endoscopy System
    4. Urological Endoscopy System
24. Colposcope
25. Obstetric Monitoring Machine with 2 Functions
26. Radiotherapy Equipment.

Information on the economic and technical characteristics and specifications of medical devices for price declaration includes:

1. Model;
2. Manufacturer, country of the manufacturer; Product owner, country of product owner;
3. Configuration, standard technical features;
4. Information on warranty, maintenance, servicing, training, and other service-related information is included in the purchase price of the medical device.

The Ministry of Health (Department of Infrastructure and Medical Equipment) will be the receiving Authority for declaring the prices of medical devices. The entities responsible for declaring the prices of medical devices will be the license holders or businesses authorized by the license holder of registration numbers to act as distribution agents or primary dealers in cases where the license holder does not engage in the business or sale of medical devices. The list of medical device business entities required to declare prices will be reviewed and compiled periodically before January 1^st of each year and published on the Ministry of Health’s online public service system for medical device management (imda.moh.gov.vn). The implementation roadmap for the list of medical devices requiring price declaration is as shown below: For more details on the regulation, please refer to this link: Draft of Circular on Price Declaration_2024.pdf (in Vietnamese). Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.