Medical Devices, News

Enterprises without circulation registration numbers will not be able to import class C, D medical devices from 2025.

According to the provisions of Decree 07/2023/ND-CP, Section 18 of the amendment and supplement to Article 76 of Decree 98/2021/ND-CP on the management of medical devices as follows:

  1. Import licenses for medical devices other than in vitro diagnostic biological products, issued from January 1, 2018, to December 31, 2021, will continue to be used until December 31, 2024.
  2. Import licenses for medical devices that are in vitro diagnostic biological products, issued from January 1, 2018, to December 31, 2021, will continue to be used until December 31, 2024, and there is no limit on the number of imports

Accordingly, the import license will expire on December 31, 2024 (currently there is no official dispatch for renewal import license), so businesses that do not have a circulation registration number will not be able to import medical devices from January 1, 2025

The solution to ensure uninterrupted import of medical devices when the import license expires:

  1. Enterprises can request authorization of the circulation registration number of another enterprise.
  2. Enterprises proceed to submit applications for the circulation number of the medical device

For consultation on MEDGATE’s registration and import-export services, please contact us via Hotline: (+84) 98.546.1894, email:  medgatevn@gmail.com, or send a message via our fan page.