Clinical Trials are one of the sources of clinical data gathering process to provide evidence about safety and performance of medical devices. The Saudi Food & Drug Authority requires a prior approval before conducting any clinical investigation of a medical device within the Kingdome Saudi Arabia according to The Guidance on Requirements for Clinical Investigations of Medical Device (MDS-G20). The SFDA had published the Saudi standards (SFDA.MD/ISO 14155:2017) which is used as an acceptable reference for good clinical practice in conducting clinical investigation for medical devices. 
To protect the rights and safety of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, SFDA regulate medical device clinical investigation through:
 
  • Developing regulations for conducting clinical studies.
  • Reviewing and evaluating clinical studies applications.
  • Inspection visits to clinical studies sites.
  • Collaborating with clinical Investigations stakeholders to enhance the quality of clinical research in the Kingdom.
 
You can view the registered clinical studies for medical devices through the link  ( Here ) , and for the Drug studies at the Link ( Here )