October 6, 2017

         Starting in 2017, all medical devices imported into Vietnam will be required to register for Marketing Authorization (MA) licenses. The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and began receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D.

             Companies currently selling imported medical devices in Vietnam should note that any import licenses they are holding will only remain valid through June 30, 2017, for Class A medical devices and through December 31, 2017, for medical devices in the other classes. With the possibility of a backlog for approving the new MA licenses, companies should proceed to submit their applications early. Under the new Decree 36, a foreign medical device company can allow its Vietnam representative office or subsidiary, or another third-party local entity, to be the MA holder. The MA holder does not have to be the importer/distributor of the medical devices.  



Decree No. 36/2016/ND-CP dated May 15th, 2016, on medical device management