In recent years, the import of medical devices for medical examination and treatment at facilities has increased significantly. The import of medical devices into Vietnam is managed by competent authorities according to regulations to ensure safe and effective use. In this article, let’s learn about the latest procedures for importing class A medical devices with Medgate.

Classification of medical devices class A

According to Article 5 of Decree 98/2021/ND-CP, the classification of medical devices must be based on the classification rules on risk levels. Accordingly, medical devices class A includes medical devices with low risk levels.

Type A medical devices must be granted a circulation number, which is the registration number for announcing applicable standards, before being circulated on the market.

In addition, the classification of medical devices must be performed by the classification facility that is the facility that publishes the applicable standards.

To learn more about medical devices class A, see: https://medgate.vn/en/what-are-a-class-medical-devices-and-what-are-they-included

Importing medical devices class A

According to Article 46 of Decree 98/2021 ND-CP, organizations and individuals exporting and importing medical devices must meet the conditions prescribed by law on export and import and must be responsible for ensuring the quality, quantity, type and purpose of use of such medical devices.

Medical devices with circulation numbers in Vietnam can be exported and imported according to demand, without quantity restrictions and without having to be approved by the Ministry of Health.

Therefore, enterprises wishing to import class A medical devices must classify medical devices and declare the applicable standards with competent authorities in Vietnam before importing.

Some cases of importing medical devices must have an import license as prescribed in Article 48 of Decree 98/2021 ND-CP.

To learn more about the process and service fees for applying for a medical device import license according to the latest regulations, visit: https://medgate.vn/en/service-fee-for-applying-for-medical-equipment-import-license/

Some medical devices on the market

Requirements for organizations and individuals importing medical devices

For medical devices with a circulation number, organizations and individuals importing must meet the following conditions:

a) Be the owner of the circulation number or have a power of attorney from the owner of the circulation number. When authorizing an import facility to import medical devices, the owner of the circulation number must simultaneously send that power of attorney to the agency issuing the circulation number and the customs agency;

b) Have warehouses and means of transport that meet the requirements as prescribed or have a contract with a facility with sufficient capacity to store and transport medical devices;

c) Have a warehouse and a system to monitor and manage the export, import, and inventory of medical devices containing narcotics and precursors that meet the requirements as prescribed.

 

To learn more about medical device registration services and the process to issue a medical device circulation number at MEDGATE , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for advice on profile services, procedures, price quotes for registration, circulation announcement, and advertising of medical devices.