Medical Device product registration in Vietnam is overseen by the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health (MOH). Registration requirements for medical devices in Vietnam are currently in a state of transition.

New rules governing the registration of medical devices were published on November 8, 2021 with Decree No. 98/2021. This new Decree overrules previous Decree No. 36/2016/ND-CP as amended with Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. Implementation for the new rules will begin January 1, 2022 with a 1-year transition period for documentation and some Class C and D products. However, since the implementation of 98/2021, very few Class C and D Market Authorization (MA) Licenses have been issued and previously issued Import Licenses have had their validity auto-extended to December 31, 2024 via Decree 07/2023. You can read more about the latest decree here