Vietnam and United States Sign Agreement Regulating Medical Devices and Drugs

On June 24, 2008, Vietnam and the United States signed a memorandum of understanding (MOU) to enhance the safety of medical devices, drugs, food, and feed traded between the two nations.

This MOU is a result of discussions between senior Vietnamese officials in Hanoi and the US Department of Health and Human Services. Previously, unsafe goods were intercepted at the border. This new plan focuses on actively working together to ensure quality during each step of the product’s lifespan.

The first part of the MOU focuses on information sharing. Both countries will exchange information on their respective regulatory systems such as laws and regulations, guidance documents, and training programs.

The second part focuses on regulatory cooperation. The two nations will conduct joint workshops and training sessions concerning medical products. Training sessions will include workshops on Good Clinical Practice and the regulatory inspection of medical product clinical trials. Other training course topics include risk analysis, technical evaluation of medical products, and ensuring safety of medical products.

This MOU is already in effect and has an initial life of three years. Revisions and renewals are possible upon the approval of both nations.