Regulatory System The Ministry of Health in Vietnam (MOH) oversees medical device regulations. Wi

Regulatory System

The Ministry of Health in Vietnam (MOH) oversees medical device regulations. Within the MOH, the Department ofMedical Equipment and Health Works (DMEHW) regulates medical devices specifically. In addition, the Ministry of Science and Technology performs some regulatory functions relevant for domestically made medical devices. In terms of labeling requirements, text must be in English and Vietnamese or French and Vietnamese.

Previously, only local players wereallowed to distribute medical devices in Vietnam. Foreign companies were required to sell their products to a local wholesaler that would then distribute the goods themselves or through a network of smallerdistributors. Since 2009, wholly foreign-owned companies have been allowed toestablish a market presence in Vietnam.