New regulations in Vietnam: Regis

A 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 expired on June 30, 2017 for Class A and on December 31, 2017 for other classes medical devices. Companies should start to submit their application for the 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.