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: Medical devices are regulated by Supreme Board of Drugs and Medical Appliances or SBDMA.
The SBDMA classifies devices according to the EU risk-based model into Classes I, IIa, IIb, III, and IV.
The entire approval process, which includes registering the agent, manufacturer, and product, is complete within six months.
An authorized representative is required to register medical devices in Yemen.
Last updated on March 30 2015.
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For more information on registration in Yemen, check out the following articles on our blog:
Country at a Glance: Yemen