Guidance on Requirements for Import / Re-export Medical Imaging Materials - SFDA

On 27 March,2022 the Saudi Food and Drug Authority (SFDA) released this guidance detailing the Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications.

Medical Imaging Materials are anything that is used to improve contrast that can be obtained using medical imaging techniques.

Document outlines and clarifies the requirements for clearance of medical imaging materials and particle accelerators used for medical imaging and radioisotope production.

This document applies to

• Medical imaging materials

• Particle accelerators used in radioisotopes formation for medical applications

• Importers of medical imaging materials or particle accelerator formation for medical applications.

• Healthcare providers and research centers intending to import medical imaging materials or particle accelerators used in radioisotopes formation for medical applications.

Click this LINK to know more details on the requirements.