MDR (Medical Device Regulation)

Medical Devices Authorized Representatives AR

For AR Registration steps, please follow the following and you can watch the video vido icon.jpg :

1.Fill out New authorized representative Application Form. For fast track conformity assessment body, - ADLIYA BUSINESS CENTER CO. W.L.L (ABC) company

2.Make sure you have all 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 Microsoft bookings where NTP will be issued based on NHRA feesRemark: capture from the booked appointment should be attached on the email

5.Once the application is reviewed and the initial approval is granted, submit the initial approval on sijilat.

6.Prepare the facility for the final approval based on inspection requirements, once ready book an appointment to submit the requirementsRemark: capture from the booked appointment should be attached on the email

7.Once final approval is obtained after fulfilling inspection requirements, applicant should complete the payment process to obtain the registration certificate & once obtaind submit it on sijilat.

8.Adding scope/ variation/ renewal form. (For further modification on AR certificate or renew the license book an appointment and submit variation/ renewal form through email).

9. List of Registered Medical Devices ِAuthorised Representatives.

10. MDR_Circular_1_2022_Cases that will not be included in the medical device's regulation.

11. Practicing without Medical Devices licensing Corrective Action Guideline.

12. The Slides Presented on 17 Aug 2022 Seminar. 

Remark: registration requirements should be submitted though email during the booked appointment only:

For more information please watch the video (NHRA Medical Devices Regulation Webinars - Module 1: Authorized representative registration, 2021 :     vido icon.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