1. Develop rules and procedures for the medical devices establishment registration and medical devices listed.
  2. Develop rules and procedures for the medical devices establishment licensing.
  3. Develop rules and procedures for marketing authorization of medical devices intended to be marketed in SA.
  4. Develop rules and procedures for surveillance of medical devices in SA.
  5. Ensure safety, quality and the effectiveness of:
    • Medical devices and In Vitro Diagnostics (IVD) and Their performance according to its intended purpose.
    • Prescription eye glasses, contact lenses and their solutions.
    • Radiation emitting electronic devices, and make sure they do not affect human health.
  6. Assure the accuracy of calibration of medical and diagnostic devices and their safety.
  7. Set a database for the medical devices manufacturers and importers.
  8. Establish the necessary laboratories and physical locations for medical devices testing.
  9. On market monitoring of medical devices, IVDs, prescription eye glasses, contact lenses and their solutions to ensure establishment compliance with MDS-SFDA storage and handled requirements.
  10. Trace medical devices and IVDs after marketing and during use to ensure the safety of their performance.
  11. Assure the compliance of medical devices importers and distributors with MDS-SFDA rule and regulation.