DMEC had a meeting with Vietnam MOH where the 1 year extension of new decree implementation has been approved. The medical device in the controlled list of the circular Decree 30/2015/TT-BYT shall be extended until 31 Dec 2018. Hence, the new decree will be effective from Jan 1, 2019.
The main reason for 1 year extension of new decree implementation was due to a lack of resources at DMEC to review and approve thousands of applications. Even though 1 year extension is granted, DMEC shall still focus on review and approval of submission under new decree as well as ensuring the proper guidance documentation are published for industry to make comprehensive submission. Also, DMEC will focus on getting submission requirements finalized and online system stabilized.