SFDA’s Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications

  • Home
  • DRAFT Guidance
  • SFDA’s Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications
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 - mdma registration - compliance timeframe for medical devices - Guidance on artificial intelligence - Medical ultraviolet radiation

SFDA has recently published the Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications; Click here to read the official document.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 radioactive materials used in medical applications.

This guidance is applicable to importers, exporters and transporters of radioactive material used in medical applications.

 

 

Page 4 and 5 in the DRAFT guidance states all the requirements needed to obtain approval for importation and re-exportation of radioactive material used in medical applications.

Page 6 to 8 in this DRAFT guidance states all the required documents that is needed to obtain approval for importation and re-exportation of radioactive material used in medical applications.

Application form of Importation/Re-Exportation for Radioactive Material.

Form of Radioactive Materials Transportation Agreement.

Form of List of Radioactive Materials.

Disclosure Form of Narcotic Substance or Chemicals Subject to Public Security Control.

Attestation Form

 

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