Medical Devices

Price declaration of medical devices

Medical devices are a special type of goods that can directly or indirectly affect the health of users during use. Therefore, current laws have applied many regulations, standards, and conditions that require manufacturers and owners to comply with before circulating them on the Vietnamese market. One of those conditions is to declare the selling price on the Ministry of Health’s Electronic Information Portal.

1. List of medical equipment requiring price declaration

The Draft Circular on Promulgating the List and Instructions for Medical devices Information with Price Declaration in 2023 of the Ministry of Health is a document listing detailedly the medical devices required price declaration. Accordingly, the types of medical devices include:

  • Artificial lens (IOL, toric IOL).
  • Drug – eluting coronary stent.
  • Balloon.
  • Dual-chamber pacemaker.
  • Total and partial hip joint.
  • Knee joint.
  • Artificial vertebrae.
  • Spinal fusion and disc replacement used in spinal surgery.
  • Blades, cutting blades, cartilage cutters, cautery blades used in surgery.
  • Magnetic resonance imaging systems of 1.5T or higher.
  • Computerized tomography scanners with 128 or more slices.
  • PET, PET/CT, SPECT, SPECT/CT machines.
  • Biochemical test analyzers with speeds of 400 tests per hour or higher.
  • Immunoassay analyzers with speeds of 100 tests per hour or higher.
  • Invasive ventilators.

Ví dụ trang thiết bị y tế cần kê khai giá

Example of medical devices required price declaration

2. Medical devices price declaration contents

The agency receiving medical devices price declarations is the Department of Infrastructure and Medical Equipment under the Ministry of Health. According to the provisions of Clause 1, Article 45 of Decree 98/2021/ND-CP, the information to be declared includes:

a) Name, type of medical devices.

b) Manufacturing country or country of product owner.

c) Unit.

d) Production cost (for domestically produced medical devices) or import cost (for imported medical devices).

e) Expected profit.

f) Maximum price corresponding to each configuration and technical features of medical devices according to unit of calculation.

g) Other information, if any:

  • Price of components and accessories.
  • Warranty, maintenance and repair costs.
  • Cost of training.
  • …

3. Public information of price declaration

The owner of medical devices is responsible for publicly posting the price of medical devices on the Ministry of Health’s electronic information portal. The required infomation includes:

a) Name, type of medical devices.

b) Manufacturing country or country of product owner.

c) Unit.

d) Maximum price corresponding to each configuration and technical features of medical equipment according to unit of calculation.

e) Other information, if any:

  • Price of components and accessories.
  • Warranty, maintenance and repair costs.
  • Cost of training.
  • …

When there is a change in price, the owner of the medical devices needs to quickly update detailed information according to the above requirements

To learn more about MEDGATE medical equipment registration services , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for free consultation on documentation services and procedures, quote registration for publication and advertising of medical devices.