Medical Device



To register medical devices, please follow the steps below:

  1. In order to register medical devices, applicants must be registered as medical devices authorized representatives.
  2. Before submitting medical devices registration applications, applicants should list all devices by submitting the listing form to medical_devices@nhra.bh.
  3. Medical devices registration process is done through Madar system by submitting all required documents on the system.
  4. Fees will be applied and notice to pay will be sent to applicants through the system.
  5. Approvals will be sent to applicants through Madar system and registered devices will be published on the List of registered medical devices.
  6. List of Emergency Use approved medical devices
  7. Medical Device Registration Service Level Agreement
  8. MDD to MDR transition guideline

Other resources:

QAC verification process guideline

Medical Device Labelling guideline

Medical Devices Violations guideline