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.