Master the updates of medical devices registration with KSA

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 by transition stage within 2021 to be enforced in Jnuary 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

See on board

Rating Distribution

• 1 stars: 0 votes
• 2 stars: 0 votes
• 3 stars: 1 votes
• 4 stars: 1 votes
• 5 stars: 2 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!