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SFDA changed the regulatory pathway of medical devices from GHTF to Technical file submission
Updated on Sep, 2026
Business, Industry, Medical Device Development
Duration - 1.5 hours
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In this course, we will explore together the latest updates of SFDA, the health authority of the KSA the leader of the GCC countries, and the whole META region.
The SFDA has changed the regulatory pathway of medical devices registration from the GHTF, "Global Harmonization Task Force", which is the global organization responsible for handling the registration of medical devices with global standards
and requirements for the dossier submission.
SFDA adopted the Technical File submission regulatory pathway of medical devices, which is closer to pharmaceutical products, the checklist went longer with a high emphasis on the quality, and safety of the medical devices, as per the general trend of most of the health care authorities in the META region, that the pharmacovigilance activities which is handling the safety of the products are highly involved, not only during the first time submission of the dossier but also during the renewal and variations as well.
These updates started in 2020, passed through transition stage in 2021, to were enforced in January 2022.
So let us master the updates of the leader of the region
As those updates are expected to be enforced by other GCC countries in a matter of months
Let's face the challenge of the regulatory affairs profession, which is keeping up with the updates
So let's start our interesting journey with SFDA
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