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:

• List of Registered Medical Devices Authorised Representatives.

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

• Practicing without Medical Devices licensing Corrective Action Guideline.

• The Slides Presented on 17 Aug 2022 Seminar.