Starting in 2017, all medical devices imported into Vietnam will be required to register for marketing authorization (MA) licenses. Previously, imported medical devices did not require MA licenses; certain types were subject to import licenses, while others could be imported freely.
The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and will begin receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D. Class A medical devices are considered “lowest-risk,” and include products such as bandages, surgical gloves, and IV tubes, while Class B, C, and D medical devices are generally higher-risk and/or more invasive products, such as contact lenses, pregnancy test kits, and artificial hearts.
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.
These changes are the result of new legislation issued in 2016 (Decree No. 36/2016/ND-CP on the management of medical devices and Circular No. 39/2016/TT-BYT on the classification of medical devices). Under this legislation, 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.