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Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices

The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical Devices" that specifies and clarifies the requirements for conducting clinical trials of medical devices within the Kingdom of Saudi Arabia (KSA).


These guidelines are designed to uphold the highest standards of patient safety and product efficacy while facilitating the development and approval of innovative medical devices.


The SFDA's guidance on the requirements for clinical trials of medical devices encompasses various aspects that must be addressed by sponsors, investigators, and other stakeholders involved in the clinical trial process.


This guidance applies to contract research organization (CRO) or other parties wishing to conduct clinical investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices within KSA.


A full-time Saudi national in charge of clinical trials shall be appointed, with an appropriate academic qualification not less than a bachelor's degree, and with an experience of not less than (3) years in the field of clinical trials.


The procedure involves the following steps

  1. Submitting the Application

  2. Inspection of the Study Site

  3. Deviations in a Clinical Trial

  4. Reporting and Investigating Serious Adverse Events or Device Deficiencies Related to Clinical Trial

  5. Suspension of a Clinical Trial

  6. Completion of a Clinical Trial


The clinical trial shall comply with the following:

  • Implementing Regulations of the Law of Ethics of Research on Living Creatures.

  • Declaration of Helsinki.

  • The standard of good clinical practice for clinical investigation of medical devices (ISO 14155) or any other similar standard.

  • The standard of good study practice for clinical performance studies of in vitro diagnostics medical devices (ISO 20916) or any other similar standard.


To know more about the requirements, click this LINK.


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