Vietnam: All Imported Medical Devices Now Require Registration

Vietnam has new regulations that now require registration for all medical devices imported into Vietnam. Starting in 2017, all imported medical devices are required to be registered for marketing authorization licenses.

Previously, only 24 items required registration, and the license was valid for 12 months. Now, all medical devices must be registered. The device licenses for Class A products lasts forever, and the licenses for Class B, C, and D devices last for five years.

The import licenses of companies currently selling imported Class A medical devices will only be valid until June 30, 2017. Import licenses for medical devices in all other classes will be valid only until December 31, 2017.

The Ministry of Health began receiving registration dossiers for Class A medical devices on January 1, 2017, and will start receiving registration dossiers for Class B, C, and D medical devices on July 1, 2017.