Skip to contentOverseas manufactures:
- Reviewing and submitting the AR Agreement to SFDA.
- Consultation about the Medical Devices registrations with Saudi FDA.
- Communicating with the manufacturers regulatory affairs team to help them with the TFA requirements preparation.
- Revision of the TF ‘’Technical File’’ documentation and providing feedback when necessary.
- Submitting TFA applications to Saudi FDA to obtain the MDMA certificate approval.
- Submitting renewal requests for any expired MDMA certificate for manufacturers.
- Updating any valid MDMA certificate for the manufacturers.
- Post Market follow up services for Recalls/FSCA/Adverse Events, and submission of reports to the National Centre for Medical Device Reporting ‘’NCMDR’’.
- Submitting classification requests to the classification department at SFDA for them to decide whether the product falls under the SFDA
- supervision or not.
Transferring MDMA certificates from other ARs to IREM account, when requested by the manufacturer. - Applying for Medical Devices Advertising approval.
- Submission of UDI information in the Saudi-DI database for all the products that have MDMA approval.
- Contractor Classification Certificate.
- Local Content Certificate.
- Regional Head Quarter Certificate for foreign companies
