For AR Registration steps, please follow the following and you can watch the video :
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 fees. Remark: 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 requirements. Remark: 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
Remark: registration requirements should be submitted though email during the booked appointment only: Medical_devices@nhra.bh
For more information please watch the video (NHRA Medical Devices Regulation Webinars - Module 1: Authorized representative registration, 2021 :