Medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health. CLASSIFICATION SYSTEM:
All medical devices now require a marketing authorization (MA) license. They are managed according to their risk-based classification (A to D). LICENSE VALIDITY:
Licenses for Class A devices are valid indefinitely. Licenses for Class B, C and D devices are valid for five years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register medical devices in Vietnam.
Last updated on January 10, 2017.
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For more information on registration in Vietnam, check out the following articles on our blog: Country at a Glance: Vietnam