Saudi food and drug authority, Authorized representative-SFDA, MDMA

Medical Devices / IVD

Medical Devices / IVD


DRC is a licensed Authorized Representative. According to the Saudi FDA regulations, overseas medical manufacturers must aappoint a local Authorized Representative. The Authorized Representative will act as a communication channel between the manufacturer and the Saudi FDA.

In addition, DRC provides regulatory consultation to overseas medical manufacturers to grant the Saudi FDA approvals for their products.

DRC services in Medical & Non-Medical Devices/IVDs include but not limited to:

  • Medical Device National Registry “MDNR”.
  • Medical Device Establishment License “MDEL”.
  • Medical Device Marketing Authorization “MDMA”.
  • Medical Device Importing License “MDIL”.
  • National Center For Medical Devices Reporting “NCMDR”.
  • Product Classification System “PCS”.
medical device / IVD