Medical Devices & Supplies Control Section

Permit To Use

  1. Medical devices permit to use process is done through Ajheza system by booking an appointment and submitting all required documents at the booked date and time on the system.
  1. NHRA have recognized ABC company as a conformity assessment body for fast-track application submissions.

NHRA Medical Devices Regulation Webinars - Module 5: Medical device Permit To Use, 2021


1- Medical Device Permit to Use Guideline

2- Medical Devices Violation Guideline 


Pre Market

First, before importing or registering medical devices, you must be registered as an authorized representative in NHRA by applying and obtaining a license to import and register medical devices.

Secondly, classify medical devices by making sure that they are listed under medical devices or other category by applying for classification.

Third, submitting an application to register medical devices to facilitate the importation process into the Kingdom of Bahrain by applying for registration of medical devices.

On Market

Controlling medical device importation at the ports of entry where importers must submit an application through Ofoq website and submitting the required documents to obtain NHRA approval before importing medical devices.

Regulating advertisements for medical devices based on Decision (48) 2020, Article (10) “It is forbidden for any person to market or advertise the medical device and product unless obtaining a license from the Authority.

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

Healthcare Facilities Inspection