: Medical devices are regulated by Supreme Board of Drugs and Medical Appliances or SBDMA. CLASSIFICATION SYSTEM:
The SBDMA classifies devices according to the EU risk-based model into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
The entire approval process, which includes registering the agent, manufacturer, and product, is complete within six months. AUTHORIZED REPRESENTATIVE:
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