Before any clinical investigation of a medical device or clinical performance study of an In-Vitro Diagnostic (IVD) can begin in Saudi Arabia, the study must be approved by the Saudi Food and Drug Authority (SFDA). The requirements are set out in the SFDA's Requirements for Clinical Trials of Medical Devices (MDS-REQ 2), issued under the Medical Devices Law (Royal Decree No. M/54) and its Implementing Regulation.
An application may be submitted by a local sponsor, a licensed Contract Research Organization (CRO), or, where the sponsor is located outside Saudi Arabia, an SFDA-licensed Authorized Representative (AR) acting on the sponsor's behalf. Bio-Standards acts in this AR capacity: we prepare, submit, and follow up the clinical trial application and represent the sponsor in all dealings with the SFDA.
Where investigational devices need to be imported for the trial, we can arrange the required SFDA import permission through our importation licensing services.
The application is submitted to the SFDA's Medical Device Clinical Investigation department together with the documents specified in MDS-REQ 2, including:
These study documents are developed by the sponsor and its clinical team or appointed CRO. Our role is to review the package for completeness and conformity with the SFDA's submission requirements before filing.
Once the documentation is complete, the SFDA evaluates the application and issues either an Approval Letter or a Rejection Letter with justifications. The applicant may lodge an objection within 30 days of a rejection.
SFDA approval is the beginning of a set of ongoing regulatory obligations, which we manage on the sponsor's behalf:
Step 1: Document Review. We assess the sponsor's clinical trial documentation package against MDS-REQ 2 and identify any gaps before submission.
Step 2: Application Preparation. We complete the SFDA application form and compile the submission package in the required format.
Step 3: SFDA Submission. We submit the application to the SFDA as the sponsor's Authorized Representative.
Step 4: SFDA Communication & Lifecycle Management. We act as the sponsor's local point of contact with the SFDA, responding to queries and handling amendments, notifications, safety reporting submissions, and completion documents throughout the study.
Bio-Standards supports clinical trials strictly within the scope of an SFDA-licensed Authorized Representative. We do not conduct clinical trials, design studies, develop Clinical Investigation Plans or protocols, or provide CRO services such as site management, monitoring, or data management. These activities remain the responsibility of the sponsor and, where appointed, a licensed CRO. Our role is regulatory: preparing, submitting, and representing the clinical trial application before the SFDA in accordance with the applicable SFDA requirements.
Clinical trial submission is part of our end-to-end medical device registration services in Saudi Arabia. Planning a clinical investigation or IVD performance study in Saudi Arabia? Contact Bio-Standards to discuss your submission.
The SFDA notifies the applicant of any missing documents within 5 days of submission.
The application is considered void if the required documents are not completed within 60 days from the date of submission.
The SFDA evaluates the completed application and issues its decision within approximately 60 days.
SFDA approval applies to the specific study and study site approved. A separate application is required for each study site in Saudi Arabia.
Investigational devices imported for the trial also require SFDA import permission under MDS-REQ 5.
Substantial amendments to SFDA-approved documents must be notified to the SFDA within 10 days.
Changes of Principal Investigator must be notified with the required supporting documents. Major deviations from the approved CIP must be reported within 5 days.
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