New Rules for Vietnam’s Medical Devices Businesses

Published 11 February 2019 by Dezan Shira & Associates

Vietnam recently announced new rules governing the management of medical devices.

From January 1, 2019 – all medical devices sold in Vietnam will require approval by local authorities. Previously, the assessment of the risks and classification of medical devices by international qualified bodies were recognized by the government of Vietnam.

Government approved entities will also use the highest risk threshold when arriving at the final classification result – irrespective of the uses of the medical device and how it may be used alongside other devices.

This is an exerpt from an article appearing on Vietnam Briefing. For the latest economic, regulatory and business news on Vietnam, visit