SFDA Bolsters Global Standing by Regulating Innovative Medical Device Clinical Studies

The Saudi Food and Drug Authority (SFDA) continues to regulate clinical studies for medical devices and supplies. This is a fundamental requirement to evaluate their safety and actual performance during use, aligning with the SFDA's regulatory role and its aim to reinforce its position among leading global regulatory bodies.
 The SFDA has evaluated 295 clinical studies in this field, approving 157 of them after all regulatory requirements were met. Currently, 84 clinical studies are being conducted across various regions of the Kingdom.
 These studies include 33 aimed at assessing the safety and efficacy of devices before market release, alongside nine studies for innovative medical devices and supplies that utilize modern technologies. This significantly contributes to supporting innovation and stimulating research and development in this vital sector.
 The SFDA emphasizes that obtaining its approval is a mandatory prerequisite before commencing any clinical study on medical devices and supplies. This is based on Articles (7) and (8) of the Law of Medical Devices and Supplies, ensuring the safety and effectiveness of the devices when used on participants.
 For those interested in clinical studies on medical devices and supplies, you can directly contact the Clinical Trials administration via email at mdci@sfda.gov.sa.
 All regulatory requirements are available at https://www.sfda.gov.sa/en/regulations.
 A list of registered clinical studies can be viewed at https://www.sfda.gov.sa/en/drug_clinical_trials_list