Medical Device Registration and Approval in Vietnam

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

Medical device regulations and classification in 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 8, 2018.

For more information on Medical Device Registration in Vietnam, check out the following articles on our blog!

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand

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