Medical Device Registration

Medical Device Registration with NHRA in Bahrain: Import Medical Devices Easily and Efficiently.

When it comes to importing medical devices into the Kingdom of Bahrain, Medical Device Registration with the National Health Regulatory Authority (NHRA) is a mandatory requirement. NHRA ensures that all suppliers comply with international regulations, making the process streamlined and hassle-free.

Fast and Efficient MDR Registration Process

For applicants with clearly defined projects, NHRA offers a Fast Track Medical Devices Registration process. This optional service, outsourced by NHRA, is designed to expedite the registration process. ABC, in collaboration with NHRA, provides a next-generation web-based software for medical device and IVD registration. Our platform offers fast track regulatory intelligence, application preparation, submission, and approvals management in Bahrain. With the support of our Bio-Medical engineers and compliance experts, critical questions can be verified quickly and efficiently. What used to take 6 months can now be accomplished within 6 days through our expert guidance.

General Requirement
1. Appointment of Authorized Representative: It is mandatory to appoint an Authorized Representative and register them with NHRA. The authorized representatives is the only party allowed to submit the registration application.
2. Risk-Based Classification: All medical devices must be assigned a proper class based on risk classification before submitting the application.
3. Accessible Information: After the registration, the information about the registered medical device, and the authorized representative, would be accessible on the NHRA website.
4. Purchase of Registered Medical Devices: Healthcare institutions can only purchase devices that are properly registered and approved for the Bahrain market.
5. Separation of Importation and Registration: Importation and NHRA registration are separate procedures and should be carried out independently.
6. NHRA Fee Structure: The NHRA fee structure is published and available on the NHRA website (https://www.nhra.bh/Departments/MDR/) .
7. Renewal Process: The license holder must submit a renewal request at least six months before the license expiration date.
8. Quality Assurance Certificate: All medical devices intended for the Bahrain market must have a quality assurance certificate issued by a notified body.

Documents Requirement
1. Declaration on Recall Status: A declaration or letter indicating the history of recalls.
2. Device Description: Detailed description of the device, including its name, model, and brand.
3. Authorized Representative Agreement: An agreement between the authorized representative and the device manufacturer.
4. Authorization Letter: For healthcare institutions, an authorization letter from the manufacturer to the authorized representative (distributor) allowing the purchase of registered devices.
5. Instruction for Use: Comprehensive instructions for using the medical device.
6. Quality Assurance Certificate: A verified quality assurance certificate and quality management system.
7. National Market List: A list of the national markets where the device is already present, provided by the manufacturer.
8. Labeling Sample: A sample of the device labeling in Arabic or English.
9. Registration Request: A completed registration request form, available on the NHRA website.
10. Technical Documents: Documents containing technical information such as service/user manuals.
11. Free Sale Certificate: A certificate issued by the appropriate regulating authority of the device's country of origin.
12. Declaration of Conformity: A declaration indicating the device's class based on the risk-based classification, provided by the manufacturer.

By adhering to these requirements and providing the necessary documents, you can ensure a smooth and successful medical device registration process with NHRA in Bahrain.

• For Requirements.

• For Guidelines.

• To Register.