Welcome to Medical Regulations Gate
Medical Regulation GateMedical Regulation GateMedical Regulation Gate
(Sat - Thursday)
Kingdom of Saudi Arabia
Medical Regulation GateMedical Regulation GateMedical Regulation Gate

SFDA’s Project Draft Guidance of Import / Re-export Requirments for Medical Imaging Materials.

  • Home
  • DRAFT Guidance
  • SFDA’s Project Draft Guidance of Import / Re-export Requirments for Medical Imaging Materials.
Medical Regulations Gate - Importation Requirements of Medical Devices - Radioactive Materials - Particle Accelerators - Marketing Authorization Applications - Medical Masks and Particulate Respirators - Quality Management System - Products Classification Guidance
  • January 4, 2021

SFDA has recently published the Draft Guidance of Import / Re-export Requirements for Medical Imaging Materials; Click here to read the official document.

To post your comments on this DRAFT, please use the message box below

 
 
 
 
 
 
 
 

 

Highlights from this Document

This guidance is intended to clarify SFDA Requirements of importation and re-exportation of medical imaging materials.

This guidance is applicable to:

  • Imaging materials used in medical applications (diagnostic/therapeutic).
  • Importers and exporters of these materials and health service providers.

 

 

Page 4 in the DRAFT guidance states all the requirements needed to obtain approval for import or re-export of imaging materials used in medical applications.

Page 6 and 7 in this DRAFT guidance states all the required documents that is needed to obtain approval for import or re-export if imaging materials used in medical applications.

Application form for permission to import and re-export electronic medical imaging materials in the unified system.

Disclosure form of Radioactive Materials, Narcotic Substance or Chemicals subject to public security control.

 

For any questions, please drop us a message and we will contact you shortly

 

SFDA’s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only.
SFDA’s Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications