• 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.

• 2021-08-26 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).

• 2021-06-25 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.

• 2020-02-21 07:28:40

VN MOH released the Decree 03/2020, to amend Decree 36 & 169, which is effective from Jan 1, 2020. Below are remarks relating to the imported Medical Device as below: Qualtech marks up the different place comparing to Decree 36 & 169.

• 2020-02-12 09:09:07

On December 31, 2018, the Vietnam Ministry of Health (MOH) issued Decree No. 169/2018/ND-CP amending and supplementing some articles of Decree No.36 on Medical Device Management and took effect from the date of signing.

• 2020-02-12 14:58:58

In order to unify the management of medical device import license, MoH informed and stopped receiving the contents of request for adjustment of import license which has a validity period until Dec 31st, 2017 granted in accordance to Circular No. 30/2015/TT-BYT.