Master the updates of medical devices registration with KSA
Master the updates of medical devices registration with KSA, available at $19.99, has an average rating of 4.38, with 6 lectures, based on 4 reviews, and has 11 subscribers.
You will learn about Master the latest updates of medical devices registration with SFDA SFDA changed the regulatory pathway of medical devices from GHTF to Technical file submission Keep up to date with latest regulations of medical devices in KSA Place your medical devices in KSA market through the new system of technical file submission This course is ideal for individuals who are All levels of Pharma student , fresh graduates, and Pharma industry professionals It is particularly useful for All levels of Pharma student , fresh graduates, and Pharma industry professionals.
Enroll now: Master the updates of medical devices registration with KSA
Summary
Title: Master the updates of medical devices registration with KSA
Price: $19.99
Average Rating: 4.38
Number of Lectures: 6
Number of Published Lectures: 6
Number of Curriculum Items: 6
Number of Published Curriculum Objects: 6
Original Price: $49.99
Quality Status: approved
Status: Live
What You Will Learn
- Master the latest updates of medical devices registration with SFDA
- SFDA changed the regulatory pathway of medical devices from GHTF to Technical file submission
- Keep up to date with latest regulations of medical devices in KSA
- Place your medical devices in KSA market through the new system of technical file submission
Who Should Attend
- All levels of Pharma student , fresh graduates, and Pharma industry professionals
Target Audiences
- All levels of Pharma student , fresh graduates, and Pharma industry professionals
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
Course Curriculum
Chapter 1: Introduction
Lecture 1: Introduction
Chapter 2: Technical File Assessment Overview
Lecture 1: Technical File Assessment Overview
Chapter 3: Technical File Assessment checklist
Lecture 1: In this section we will go through the checklist point by point in detail
Chapter 4: Technical File Submission
Lecture 1: Technical File Submission
Chapter 5: The Annexes
Lecture 1: The Annexes
Chapter 6: Closing Technical File Submission
Lecture 1: Closing Technical File Submission
Instructors
-
Dr. Zahra Hassan
Pharma industry expert
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
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