Medical Devices & Supplies Control Section

Medical Devices Authorized Representatives AR

For Company regsitration as an Authorized Representative for medical devices, please follow the steps below:

1.Create an account on "Ajheza" system. For fast track conformity assessment body, - ADLIYA BUSINESS CENTER CO. W.L.L (ABC) company

2.Make sure you have all the required documents for the registration, for more information please refer to AR guideline and How to write policies guideline.

3.Once all the required documents for registration are ready, apply for None active CR (for new Authorized Representative).

4.To submit the application for NHRA review, please book an appointment on "Ajheza" system where the NTP will be issued based on NHRA fees.

5.Upon completion of the review process, the initial approval will be granted on "Ajheza" system if the application fulfills the registration requirements. The initial approval letter should then be submitted on sijilat.

6.Prepare the facility for the final approval based on inspection requirements. Once ready, send the inspection request Form to NHRA through "Ajheza" system.

7.After fulfilling the inspection requirements, the applicant should complete the payment process to obtain the registration certificate (final approval), which should then be submitted it on sijilat.

8.For adding scope/variation/renewal applications (for further modifications on the AR certificate or to renew the license), book an appointment and submit a variation/renewal request through the "Ajheza" system.

Useful links:

For more information, please watch the NHRA Medical Devices Regulation Webinars - Module 1: Authorized representative registration, 2021:     vido icon.jpg
Authorized Representative Registration steps and illustration video  vido icon.jpg

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

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