SFDA Updates to Medical Device Clinical Trials Guidance

The SFDA – هيئة الغذاء والدواء issued a new version of its Requirements for Clinical Trials of Medical Devices, MDS REQ 2, V.5 (“Guidance“). The purpose of this document is to specify and clarify the requirements for conducting clinical trials of medical devices within KSA.

In general, the Guidance was updated to bring it in line with the Medical Devices Law (Royal Decree No. (M/54) dated 6/7/1442 AH) & its Implementing Regulations, update references to new regulatory pathways (including for clinical trials involving innovative medical devices), and clarify specifics of the required documents.

Specific Updates Highlighted:

The “Procedures” section adds details concerning the requirements to and process for notifying The National Center for Medical Devices Reporting regarding any serious adverse events within the specified time period indicated in the Guidance. New processes and timeframes were added for suspension of clinical trials.

The Guidance also provides additional clarity regarding the “Required Documents”, including the requirements now for version-controlled documents. There is also the addition of a Case Report Form:

“A version-controlled paper or electronic CRF to collect data from trial subjects and capture all the information required by the protocol. The CRFs shall include information on the condition of each subjects upon entering, and during the course of the clinical trial, exposure to the investigational device and any other therapies. The CRF shall specify the version number and date of the document as approved by the local EC/IRB.”

In line with other updates we have seen over recent years, SFDA is swiftly acting to incorporate new legislation, innovations, and stakeholder feedback into its regulatory processes. We expect such updates to continue to occur throughout a swath of legislation, as the Kingdom continues is transformation program.