MDR (Medical Device Regulation)

Ajheza System

The national health regulatory authority would like to announce the new method of submission for medical devices authorized representatives and medical devices registration applications through AJHEZA system that will replace the current submission method done through email.

The implementation of the new method will start from the 2nd of January 2023.

Website link of the system:

Please refer to the videos and manuals below for steps on how to use the system:

Process of creating a new user in Ajheza system: vido icon.jpg

Process of submitting an Authorized Representative application through Ajheza system: vido icon.jpg Manual picture.jpg

Process of submitting Medical device registration applications through Ajheza system: vido icon.jpg Manual picture.jpg

Two Factor Authentication guide for Ajheza system: Manual picture.jpg


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