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 themedical 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 therenewal and variations as well.

These updates started in 2020, passed by transition stage within 2021 to be inforced in Jnuary 2022

So let us master the updates of the leader of the region

As those upadates 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

See on board