Medical Device Registration and Approval in Yemen
General country-specific regulatory information is provided on this page for medical device registration and approval in Yemen.
Last updated on November 24th, 2021.
Medical Device Regulations and Classification in Yemen
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.
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* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.