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Sunday - Thursday 8AM - 5PMSaturday and Friday - CLOSED+966 53 530 0129info@i-regulations.comIshbiliyahRiyadh 13226

For Overseas manufactures:

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

For Local companies:

  1. Prepared the ISO 13485 documentation.
  2. Obtaining Medical Device Establishment License (MDEL).
  3. Preparing SOPs ‘’Standard Operating Procedures’’ for submission of Medical Device Establishment Licence (MDEL).
  4. Applying for Medical Device Importation Licence (MDIL).
  5. Applying for warehouse certificate with SFDA.
  6. Working on behalf of local companies to help them with SFDA product registration under their account.
  7. Submitting renewal requests for any expired MDMA certificate.
  8. Updating any valid MDMA certificate.

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