Bahrain
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY
: Medical device regulation in Bahrain is supervised and directed by the National Health Regulatory Authority (NHRA). 

CLASSIFICATION SYSTEM: The NHRA accepts both the FDA and CE classification models.

TIMEFRAME: The importation permit takes up to 21 working days. When full registration will come into force, the registration is expected to take two months.

LICENSE VALIDITY: The importation permit is valid for 60 days and should be obtained prior to any importation. Licenses issued in Bahrain expire after two years. 

AUTHORIZED REPRESENTATIVE: Authorized representative licensed to act as an importer is required.

Last updated on December 27, 2017.



Interested in obtaining fast marketing approval for your medical device or IVD in Bahrain? REQUEST A FREE QUOTE>

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