Sunday - Thursday 8AM - 5PM
Saturday and Friday - CLOSED
+966 53 530 0129
Who We Serve
For Overseas manufactures:
and submitting the AR Agreement to SFDA.
about the Medical Devices registrations with Saudi FDA.
with the manufacturers regulatory affairs team to help them with the TFA requirements preparation.
of the TF ‘’Technical File’’ documentation and providing feedback when necessary.
TFA applications to Saudi FDA to obtain the MDMA certificate approval.
renewal requests for any expired MDMA certificate for manufacturers.
any valid MDMA certificate for the manufacturers.
t follow up services for Recalls/FSCA/Adverse Events, and submission of reports to the National Centre for Medical Device Reporting ‘’NCMDR’’.
classification requests to the classification department at SFDA for them to decide whether the product falls under the SFDA
Transferring MDMA certificates from other ARs to IREM account, when requested by the manufacturer.
r Medical Devices Advertising approval.
of UDI information in the Saudi-DI database for all the products that have MDMA approval.
Head Quarter Certificate for foreign companies
For Local companies:
the ISO 13485 documentation.
Medical Device Establishment License (MDEL).
SOPs ‘’Standard Operating Procedures’’ for submission of Medical Device Establishment Licence (MDEL).
for Medical Device Importation Licence (MDIL).
for warehouse certificate with SFDA.
on behalf of local companies to help them with SFDA product registration under their account.
renewal requests for any expired MDMA certificate.
any valid MDMA certificate.
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