• 2022-02-18 09:44:59

On 9 December 2021, the Vietnamese government issued Decree No. 111/2021/ND-CP amending and supplementing a number of articles of Decree No. 43/2017/ND-CP on Goods Labels, including medical devices ("Decree 111"), which will take effect as of 15 February 2022.

• 2021-11-24 03:09:42

MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.

• 2021-10-27 07:25:14

Recently, MOH has introduced regulations for a total of seventeen COVID-19-related medical device categories, along with their submission dossiers and routes. Specifically, there are seven selective cases that can applied for fast approval. This circular also includes regulation on Import of medical device in view of COVID-19 prevention for purposes of aid.

• 2021-10-27 07:19:29

More than 100 administrative procedures under management of the Ministry of Health have been reduced and simplified with a recently introduced regulation. One of these is to convert Import Permit number to Registration number and to amend requirement on application for fast approval from 2 CFS to 1 CFS.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-06-25 13:01:35

Department of Medical Equipment and Constructions issued a draft Decree on medical devices management with a letter to collect comments on the draft Decree on March 31st, 2021.

• 2021-06-25 12:57:00

The event is taking place in the 20th year reaching its largest scale so far with more than 400 exhibitors from 35 countries and territories displacing their state-of-the-art products and services.

• 2021-06-25 12:51:04

The guidance, released as Decision No. 2426/QĐ-BYT, was constructed according to AMDD and with reference to the guidance of Singapore and Malaysia, and applicable to medical devices Class B, C, D including in-vitro diagnostic IVD MD.

• 2021-03-22 06:57:43

Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.