Vietnam
REGULATORY AUTHORITY: 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.



ARE YOU INTERESTED IN REGISTRATION IN VIETNAM? REQUEST A FREE QUOTE>​

For​ more information on registration in Vietnam, check out the following articles on our blog:
Country at a Glance: Vietnam
 
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