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SFDA’s Guidance on Import and Clearance Requirements for Particle Accelerators

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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
  • November 25, 2020

SFDA has recently published a Guidance on the requirements of Import and Clearance for Particle Accelerators Used in Radioisotope Formation for Medical Applications; Click here to read the official document.

Published on: 15th November, 2020

 
 
 
 
 
 
 
 

 

Highlights from this Document

This guidance is intended to clarify SFDA requirements of importation and clearance of particle accelerators used in radioisotope formation for medical applications.

This guideline applies to healthcare providers and importers of particle accelerators used in radioisotope formation for medical applications.

 

Particle accelerators used in radioisotope formation for medical
applications may only be imported after obtaining an import permit
from the authority.

Importers of particle accelerators used in radioisotope formation for
medical applications should have:

  • Create an account in the SFDA Unified Electronic System
    (GHAD): https://ghad.sfda.gov.sa/en/
  • MDEL license to practice the activity of importing medical
    devices (issued by the SFDA).
  • Classified medical device / product that offered for marketing and/or
    use within the Kingdom must obtain a medical device & product
    marketing authorization (MDMA).

 

Page 5 to 9 in the guidance states all the required documents needed to obtain approval, import and clear Particle accelerators used in radioisotope formation for medical applications

Application form for permission to import particle accelerators
used in radioisotope formation for medical applications.

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 Requirements of Shipments Clearance at Ports of Entry
Extending deadline for receiving requests for Marketing Authorization Applications via GHTF route.