New regulations in Vietnam: Regis

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) has been approved.

From this year, all medical devices imported into Vietnam will be required to register for marketing authorization (MA) licenses.

All the companies that are selling in Vietnam should remark that their licenses will expire on June 30, 2017, for Class A on December 31, 2017, and other classes’ medical devices. Companies should start to submit their application for new MA licenses as soon as possible. The Ministry of Health began to receive registration dossiers on January 1, 2017, for Class A products and from July 1, 2017, will begin with other class products.


Do not hesitate to contact us for any questions, prices or timelines in the registration process.