Objectives

Objectives:

• Develop rules and procedures for the medical devices establishment registration and medical devices listed.
• Develop rules and procedures for the medical devices establishment licensing.
• Develop rules and procedures for marketing authorization of medical devices intended to be marketed in SA.
• Develop rules and procedures for surveillance of medical devices in SA.
• 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.
• Assure the accuracy of calibration of medical and diagnostic devices and their safety.
• Set a database for the medical devices manufacturers and importers.
• Establish the necessary laboratories and physical locations for medical devices testing.
• 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.
• Trace medical devices and IVDs after marketing and during use to ensure the safety of their performance.
• Assure the compliance of medical devices importers and distributors with MDS-SFDA rule and regulation.