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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Yemen, free of charge, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on March 30 2015.

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