Quote from VigiServe Admin on July 20, 2024, 6:44 AM

Medical Devices

To register medical devices, please follow the steps below:

1. Medical devices registration is going to be mandated by the 1st of February 2026.
2. In order to register medical devices, applicants must be registered as medical devices authorized representatives.
3. Before submitting medical devices registration applications, applicants should list all devices by submitting the listing form to medical_devices@nhra.bh.
4. Medical devices registration process is done through Ajheza system by booking an appointment and submitting all required documents at the booked date and time on the system.
5. NHRA have recognized ABC company as a conformity assessment body for fast-track application submissions.
6. Fees will be applied and notice to pay will be sent to applicants Ajheza system.
7. Approvals will be sent to applicants through Ajheza system and devices will be published on the List of registered medical devices.
8. List of Emergency Use approved medical devices
   
9. Medical Device Registration Service Level Agreement
10. MDD to MDR transition guideline

Other resources:

NHRA Medical Devices registration process

Slides of latest Medical device registration presentation (17 Aug 2022)

QAC verification process guideline

Medical Device Labelling guidelineMedical Devices Violations guideline

For more information on Ajheza system, please visit Ajheza system page

 

Post Market

Decision (48) 2020, Article (16) intended to guide and encourage all healthcare facilities, importers, patients and professionals to the importance of reporting problems associated with medical devices, including:

Permit To Use

Field Safety Notice and Recalls

Adverse Events and complains

Medical Devices Destruction