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Departments Contacts
Medical Devices Authorized Representatives
Medical Device Facilities
Medical Devices Authorized Representatives
For Company regsitration as an
Authorized Representative for medical devices
, please follow the steps below:
1-Create an account on
MADAR
system
.
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
submit an application through
MADAR
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 "Madar" 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
MADAR
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), submit a variation/renewal request through the
MADAR
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
.
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