Medical Device Registration and Approval in Bahrain

General country-specific regulatory information is provided on this page for medical device registration and approval in Bahrain.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Bahrain

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.


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For detailed device-specific compliance information for each market, including Bahrain, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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