MEDICAL DEVICE REGISTRATION AND APPROVAL IN Yemen

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 update: December 2022

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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