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, 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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