The Drug Administration of Vietnam (DAV) and the Department of Medical Equipment and Health Works (DMEHW)
Under Vietnam's Ministry of Health, the Drug Administration of Vietnam (DAV) is responsible for the regulation of pharmaceuticals, and the Department of Medical Equipment and Health Works (DMEHW) is responsible for the regulation of medical devices. In addition, the Ministry of Science and Technology (MOST) performs some regulatory functions relevant for domestically made medical devices.
The DAV evaluates pharmaceutical applications for their compliance with the 2005 Pharmaceutical Law and issues licenses accordingly. Imported pharmaceuticals, however, require a separate import permit in addition to product approval. For a small fraction of pharmaceuticals, the DAV will also perform product sample analysis.
The DMEHW handles product registration and evaluation for medical devices. While the DMEHW requires product registration for all domestic devices, only some imported devices require product registration. Implantable devices, devices performing a function new to Vietnam, and the 57 types of medical devices specifically listed in Appendix 7 to the MOH's Circular No. 08/2006/TT-BYT do require registration. For all other imported medical devices, the DMEHW only requires a regular import license.
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- 2008 ASEAN Medical Device Harmonization Trends
- 2006 Vietnam's Medical Markets
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