Medical Device Registration

Medical Device Registration with the NHRA allows all suppliers to import medical devices into Kingdom of Bahrain in accordance with international regulations. Medical Device Registration is Mandatory Requirement to import Medical Devices in to the Kingdom of Bahrain.

Easy and Fastest way of Medical Device Registration in Kingdom of Bahrain.
FAST TRACK Medical Devices Registration is an optional process (out-sourced by NHRA) available to applicants who have clearly defined projects. ABC Launch next-generation web-based software for medical device and IVD registration in the Kingdom of Bahrain in association with NHRA. Our platform provides fast track regulatory intelligence process, application preparation, submission and approvals management in Bahrain. Our clients also have access to our Bio-Medical engineers, compliance experts to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days through ABC’s expert adviser

General Requirement
1. It is required to appoint an Authorized Representative and register it with the NHRA. The authorized representatives are the only party entitled to submit an application for registration.
2. Any and all medical devices should be assigned with a proper class in accordance with the risk-based classification before submitting an application.
3. After the registration, the information about the registered device, and also about the appropriate authorized representative, would be accessible via the NHRA website.
4. Healthcare institutions are allowed to purchase only the devices properly registered to be placed on the Bahrain market.
5. Importation and NHRA registration are separate procedures and should be carried out independently.
6. NHRA Fee structure is published and available at NHRA website https://www.nhra.bh/Departments/MDR/ .
7. The license holder must submit a renewal request in advance (six months before the license expiration date).
8. Any and all medical devices to be placed on the Bahrain market should have a quality assurance certificate issued by a notified body.

Documents Requirement
1. Declaration on recall status or the letter indicating the history of recalls.
2. Description of the device containing the name, model of the device and brand.
3. An agreement concluded by and between the authorized representative and the manufacturer of the device.
4. Healthcare institutions are allowed to purchase only the devices properly registered to be placed on the Bahrain market,or an authorization letter provided by the manufacturer to the authorized representative (Distributor).
5. Instruction for use.
6. Verified Quality Assurance Certificate & Quality Management System.
7. List of the national markets on which the device is already present (should be provided by the manufacturer).
8. Sample of labeling that should be in Arabic or English.
9. Request for the registration in the form of an acknowledgment available on our website.
10. Documents containing technical information, such as service/user manual.
11. Free Sale Certificate issued by the appropriate regulating authority of the country of origin.
12. Declaration of Conformity (Doc) indicating the class of the device in accordance with the risk-based classification (should be also provided by the manufacturer).

• For Requirements, please Click here.

• For Guidelines, please Click here.

• To Register Click here.