SFDA’s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only.

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SFDA has recently published a Guidance on the requirements of Medical Devices Intended for Demonstration or Training Purpose only; Click here to read the official document.

Published on: 27th December, 2020

 
 
 
 
 
 
 
 

 

Highlights from this Document

This guidance is intended to specify the requirements for obtaining an importation license for medical devices intended for demonstration or training purpose only.

This document is applicable to:

  • Medical devices establishments wishing to import medical devices intended for demonstration or training purpose only.
  • Establishments organizing exhibitions and other establishments wishing to import medical devices intended for demonstration and training purpose at exhibitions.

 

 

Page 5 in the guidance states all the required documents needed to obtain approval for demonstration or training purpose only.

Application form for Medical Devices intended for Demonstration or Training Purpose Only.

Attestation for Importers of Medical Devices Intended for Demonstration or Training Purpose only.

 

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