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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Bahrain, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on December 27, 2017.

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