Vietnam
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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 8, 2018.



Interested in obtaining fast market approval for your medical device or IVD 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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