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.



ARE YOU INTERESTED IN REGISTRATION IN YEMEN? REQUEST A FREE QUOTE>​

For​ more information on registration in Yemen, check out the following articles on our blog:
Country at a Glance: Yemen
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