REGULATORY AUTHORITY: 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.
