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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.
Last updated on November 17th, 2021.
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.
For detailed device-specific compliance information for each market, including Bahrain, to expedite the preparation of your medical device or IVD registration application.
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