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Extending deadline for receiving requests for Marketing Authorization Applications via GHTF route.

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  • December 29, 2020

SFDA has recently announced extending the deadline for receiving requests for Medical Device Marketing Authorization applications; Click here to read the official document.

Published on: 28th December, 2020

 

 

 

 

 

 

 

 

 

Highlights from this Document

This announcement is intended for Medical Devices Marketing Authorizations Applications

This announcement applies to local and Overseas Medical Devices Manufacturers and Authorized Representatives.

In reference to the requirements for Medical Devices listing and Marketing Authorization published on 22nd June 2020, Stating that the last day for accepting applications via the GHTF route is 01st January 2021. SFDA would like to inform you the following:

  • Receiving new marketing authorization requests via the GHTF route will be extended until (01/07/2021), and optionally via the Saudi Route (TFA), SFDA reserve the right to request the technical file or part of it whenever needed.
  • Receiving renewal and updating marketing authorization requests via the GHTF route will be until 01/01/2022

 

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

 

SFDA’s Guidance on Import and Clearance Requirements for Particle Accelerators
SFDA’s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only.