1-MDS-REQ1 – General Requirements for Medical Device Marketing Authorization (MDMA)
MDS-REQ1
Outlines the essential requirements for obtaining marketing authorization of medical devices in Saudi Arabia, including technical documentation, quality system certifications, and bundling criteria.
2-MDS-G008 – Guidance on Classifications of Medical Devices
MDS–G008
Provides criteria for classification medical devices And helps the manufacturers to classify their products.
3-MDS-REQ7 – Requirements for Unique Device Identification (UDI)
MDS_REQ_7_Requirments For UDI
Specifies the mandatory UDI system requirements for all medical devices marketed in Saudi Arabia.