Mastering Medical Device Registration with SFDA – Saudi Arabia

About Course

Course Description: Medical Device Registration in Saudi Arabia (SFDA Guide)

Unlock the opportunity to enter one of the largest healthcare markets in the GCC — Saudi Arabia. This course provides a practical, step-by-step guide to medical device registration with the Saudi Food and Drug Authority (SFDA), helping you navigate regulatory requirements with confidence and efficiency.

Saudi Arabia represents a high-growth, high-demand market for medical devices, making regulatory knowledge a critical asset for professionals and companies aiming to expand in the Middle East. Understanding the SFDA registration process is not just beneficial — it is essential for achieving faster market access and sustainable business success.

Why You Should Enroll

This course equips you with two key advantages:

Regulatory Expertise: Learn how regulatory affairs directly impact business success and revenue generation in the GCC region.
Faster Market Access: Discover how medical device registration timelines are significantly shorter compared to pharmaceuticals, enabling quicker product launches and faster ROI.

You will gain a clear understanding of how to complete registrations within as little as 6 months, along with managing variations, renewals, and post-approval activities efficiently.

Your Learning Journey

Join me on an engaging, hands-on journey through the Saudi regulatory landscape. Together, we’ll:
Explore SFDA’s requirements and interim regulations
Prepare real submission dossiers using authentic templates.
Master bundling and grouping criteria for efficient registration.
Understand clearance, tracking, tracing, barcoding, and 2D matrix systems — all essential for market access.

Your Takeaway

By the end of this course, you will be able to:

Confidently manage medical device registration in Saudi Arabia
Handle renewals, variations, and regulatory updates
Support your organization in achieving faster access to the Saudi market
Strengthen your career in Regulatory Affairs within the GCC region

Start Your Journey

Take the next step in your regulatory career and gain the skills needed to succeed in one of the most dynamic healthcare markets in the world.

Your journey to mastering SFDA medical device registration starts here.

You will learn how to:
Understand the SFDA structure and medical device regulatory system in Saudi Arabia
Classify medical devices accurately according to SFDA classification rules and risk categories
Navigate the SFDA electronic submission system for efficient registration
Prepare and submit regulatory-compliant dossiers using official templates and guidelines
Complete the Medical Device Marketing Authorization (MDMA) submission process step by step
Apply bundling and grouping strategies to optimize multiple product registrations
Manage verification, clearance, and post-market surveillance (PV) requirements
Handle renewals, variations, and lifecycle management of registered medical devices

Course Content

Module 1: Introduction
Get introduced to the huge market of Saudi Arabia, the market that accounts for 65% of the ROI of nay company, master medical devices there, master the SFDA the GCC leader

Course Introduction

16:30

Module 2: Medical Devices Classification
In this section we will understand the first and basic step of the registration of any medical device, which is the classification the risk classes, and the 3 major health authorities

Module 3: Medical Device Electronic System
In this section we will travel to the KSA, and visit the SFDA, specially the Medical Device Electronic System" MDES", exploring its services ad how they are linked to medical devices registration

Module 4: Guidance For Medical Devices Registration
In this section we will experience the actual workflow of the medical devices registration guidance in KSA , starting from getting the RA till obtaining the final MDMA, this is the map towards MDMA

Module 5: SFDA Submission Requirement
In this section we will dive deeply to the SFDA requirement for medical devices registration ,the document list as per the medical device class and indications, to explore the documents checklist

Module 6: Notified Body
In this section we will understand the basic backbone topic in nay registration of any product in any country , which is notified body , to understand its definition, role, and types

Module 7: Classification
This is the basic starting topic towards medical devices registration with SFDA, which is the SFDA classification guide

Module 8: Registration Forms
Let us start our actual practice and see how is the registration forms look like and how to prepare them to come up with the final submission dossier

Module 9: Templates
Here are the actual templates that you will use in practice

Module 10: Bundling
This so interesting crucial section about very unique feature for SFDA , which is the bundling/grouping of medical devices in one

Module 11: Bundling Diagrams
In this section we will go step by step through the road maps towards bundling decisions using the diagrams, which decide legible for bundling or not

Module 12: MDMA Application Process
Here we will start the all actions through the SFDA interface towards MDMA, we will act as local distributors for a while and let

Module 13: Verification
In this section we will explore together the different types and certificates of verification of such a medical device, what certificate that ensure products quality and performance in each country

Module 14: MDMA Certificate
In this section we will close up our course with issuing the MDMA certificate, and then renewal or variation if any, and the action of the GHTF, samples along COA with MDMA, and the Brexit finally

Module 15: Clarence&amp,PV
Congratulations, we have completed our journey in the KSA, enjoyed all details of the SFDA, now we came to the clearance, of the medical devices from customs after we have got the MDMA. start sales

Module 16: TFA for the new dossier submissions
TFA for the new dossier submissions

Module 17: TFA for Devices and IVDS
TFA for Devices and IVDS

Module 18:TFA Sections
TFA Sections

Module 19: Surveillance and International Standards
Surveillance and International Standards

Module 20: After TFA PART 1
After TFA PART 1

Module 21: AFTRE TFA PART2
AFTRE TFA PART2

Module 22: AFTRE TFA PART 3
AFTRE TFA PART 3

Module 23: AFTRE TFA PART 4
AFTRE TFA PART 4

Module 24:Tracking /Tracing UDI
Tracking /Tracing UDI

Module 25: UDI
UDI

Module 26: ISO 13485 SFDA MDS PART 1
ISO 13485 SFDA MDS PART 1

Module 27: ISO13485 SFDA MDS PART 2
ISO13485 SFDA MDS PART 2

Module 28: ISO13485 SFDA MDS PART 3
ISO13485 SFDA MDS PART 3

Module 29: Diagnostics IVD PART 1
Diagnostics IVD PART 1

Module 30: Diagnostics IVD PART 2
Diagnostics IVD PART 2

Module 31: Diagnostics IVD PART 3
Diagnostics IVD PART 3

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About Course

Course Description: Medical Device Registration in Saudi Arabia (SFDA Guide)

Start Your Journey

What Will You Learn?

Course Content

Module 1: Introduction Get introduced to the huge market of Saudi Arabia, the market that accounts for 65% of the ROI of nay company, master medical devices there, master the SFDA the GCC leader

Course Introduction

Module 2: Medical Devices Classification In this section we will understand the first and basic step of the registration of any medical device, which is the classification the risk classes, and the 3 major health authorities

Medical Devices Classification

Module 3: Medical Device Electronic System In this section we will travel to the KSA, and visit the SFDA, specially the Medical Device Electronic System" MDES", exploring its services ad how they are linked to medical devices registration

Medical Device Electronic System

Module 4: Guidance For Medical Devices Registration In this section we will experience the actual workflow of the medical devices registration guidance in KSA , starting from getting the RA till obtaining the final MDMA, this is the map towards MDMA

Guidance For Medical Devices Registration

Module 5: SFDA Submission Requirement In this section we will dive deeply to the SFDA requirement for medical devices registration ,the document list as per the medical device class and indications, to explore the documents checklist

SFDA Submission Requirement

Module 6: Notified Body In this section we will understand the basic backbone topic in nay registration of any product in any country , which is notified body , to understand its definition, role, and types

Notified Body

Module 7: Classification This is the basic starting topic towards medical devices registration with SFDA, which is the SFDA classification guide

Classification

Module 8: Registration Forms Let us start our actual practice and see how is the registration forms look like and how to prepare them to come up with the final submission dossier

Registration Forms

Module 9: Templates Here are the actual templates that you will use in practice

Templates

Module 10: Bundling This so interesting crucial section about very unique feature for SFDA , which is the bundling/grouping of medical devices in one

Bundling

Module 11: Bundling Diagrams In this section we will go step by step through the road maps towards bundling decisions using the diagrams, which decide legible for bundling or not

Bundling Diagrams

Module 12: MDMA Application Process Here we will start the all actions through the SFDA interface towards MDMA, we will act as local distributors for a while and let

MDMA Application Process

Module 13: Verification In this section we will explore together the different types and certificates of verification of such a medical device, what certificate that ensure products quality and performance in each country

Verification

Module 14: MDMA Certificate In this section we will close up our course with issuing the MDMA certificate, and then renewal or variation if any, and the action of the GHTF, samples along COA with MDMA, and the Brexit finally

MDMA Certificate

Module 15: Clarence&amp,PV Congratulations, we have completed our journey in the KSA, enjoyed all details of the SFDA, now we came to the clearance, of the medical devices from customs after we have got the MDMA. start sales

Clarence&PV

Module 16: TFA for the new dossier submissions TFA for the new dossier submissions

TFA for the new dossier submissions

Module 17: TFA for Devices and IVDS TFA for Devices and IVDS

TFA for Devices and IVDS

Module 18:TFA Sections TFA Sections

TFA Sections

Module 19: Surveillance and International Standards Surveillance and International Standards

Surveillance and International Standards

Module 20: After TFA PART 1 After TFA PART 1

After TFA PART 1

Module 21: AFTRE TFA PART2 AFTRE TFA PART2

AFTRE TFA PART2

Module 22: AFTRE TFA PART 3 AFTRE TFA PART 3

AFTRE TFA PART 3

Module 23: AFTRE TFA PART 4 AFTRE TFA PART 4

AFTRE TFA PART 4

Module 24:Tracking /Tracing UDI Tracking /Tracing UDI

Tracking /Tracing UDI

Module 25: UDI UDI

UDI

Module 26: ISO 13485 SFDA MDS PART 1 ISO 13485 SFDA MDS PART 1

ISO 13485 SFDA MDS PART 1

Module 27: ISO13485 SFDA MDS PART 2 ISO13485 SFDA MDS PART 2

ISO13485 SFDA MDS PART 2

Module 28: ISO13485 SFDA MDS PART 3 ISO13485 SFDA MDS PART 3

ISO13485 SFDA MDS PART 3

Module 29: Diagnostics IVD PART 1 Diagnostics IVD PART 1

Diagnostics IVD PART 1

Module 30: Diagnostics IVD PART 2 Diagnostics IVD PART 2

Diagnostics IVD PART 2

Module 31: Diagnostics IVD PART 3 Diagnostics IVD PART 3

Diagnostics IVD PART 3

Quiz 1

Quiz 2

Final

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