Vietnam’s Ministry of Health has implemented a new regulation on the registration of Medical Devices. The Decree (169/2018/ND-CP) was issued on December 31, 2018 and describes the changes made to the supplement Decree 36/2016/ND-CP on the management of Medical Devices.

New registration rules to extend validity of import licenses until December 31, 2019

The general import guidelines stipulate, among other things, that import licences of Class A devices are valid until June 30, 2017, while all Classes B, C and D licenses granted in 2018 (valid as of December 31, 2018) and in 2019 are valid until December 31, 2019.

For Class B, C, and D devices that do not require a license, the importation can continue normally until December 31, 2019 without the requirement of the Ministry of Health (MoH) Confirmation Letter.