MEDICAL DEVICE REGISTRATION AND APPROVAL IN Bahrain

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 update: January 2024

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 implemented the EU classification system, which is I, IIa, IIb, III for medical devices and A, B, C, D for IVD.

TIMEFRAME: The registration process takes approximately 2 months. Expedited routes can be utilized to minimize this timeframe.

LICENSE VALIDITY: The license is valid for three years.

AUTHORIZED REPRESENTATIVE: An authorized representative licensed to act as a distributor is required.

Other Middle East & North Africa Countries: Algeria,Egypt,Israel,Jordan,Kuwait,Lebanon,Morocco,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen

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