Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Vietnam
In Vietnam, drugs are regulated by the Drug Administration of Vietnam (DAV), and must be registered prior to marketing. Medical devices that are on a restricted list must be registered with the Department of Medical Equipment and Health Works (DMEHW . In addition, the Ministry of Science and Technology (MOST) performs some regulatory functions relevant for domestically made medical devices.
Depending on your regulatory strategy, the Vietnamese government may or may not require local clinical trials on your medical products. These clinical trials are usually done at government hospitals and conducted by the government itself. Government price controls are also a risk to be considered.
IVDs are regulated as drugs in Vietnam only if they contain biological substances. Otherwise, they are regulated as medical devices.
For more information on regulatory issues in Vietnam, please see the following PBM publications and/or contact us to discuss your specific needs.
- 2011 Updates on Vietnam's Medical Device Market
- 2008 Managing Asian Cultural/Business Diversity
- 2008 ASEAN Medical Device Harmonization Trends
- 2006 Vietnam's Medical Markets
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