Objectives:

The objectives of Executive Management of Registration & Licensing are to evaluate and verify the documents submitted for medical devices marketing authorization and intended to be marketed in Saudi Arabia, by ensuring compliance with SFDA- Medical Devices rules and regulations

Responsibilities:

• Establishments licensing department:
  • The Executive Management duties and responsibilities are:
    • Establishing a nationwide registry and medical devices listing through The medical devices national registry (MDNR).
    • Classifying medical device establishments .
    • Issuing “medical device establishments” licenses for importers, distributors by MDEL system “medical devices establishment licensing”.
    • Issuing manufacturers’ authorized representatives establishments licenses.
• Medical devices licensing department:
  • The Executive Management responsibilities and duties are:
    • Classifying medical devices.
    • Issuing IVDs importing license.
    • Issuing “medical devices marketing authorization” certificates.
    • Medical Devices listing
    • Issuing “medical devices publicity and advertising” licenses.
    • Approve “medical devices” Clinical Trials.
• Non medical devices licensing department:
  • The Executive Management responsibilities and duties are:
    • Issuing importing approval to non medical IVDs, chemicals, distillation devices and radiations.
    • Classifying chemicals for medical usage based on hazard level.
    • Classifying IVDs as their intended use.