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Master Medical Device Registration In Saudi Arabia

Dr. Zahra Hassan

Master medical devices registration in the most important and biggest market ever in the GCC region, the market of Sudi Arabia, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

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Master medical devices registration in the most important and biggest market ever in the GCC region, the market of Sudi Arabia, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

This course will equip you with two powerful tools to invade the pharma industry, as a regulatory affairs professional you are responsible for bringing up to 80% if not 90% of the company revenue from only one market in the GCC region in one hand while in your other hand you are dealing with the second powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, it is almost half the time frame of the pharmaceuticals.

To register a medical device you will need only 6 months, 3 months for variation, and 2 to 1 month only for renewal.

So from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of the KSA.

Daer pharma industry future professionals, let us start our interesting journey towards medical device registration in KSA, we will travel together in Saudia Arabia, meet the health authority there "SFDA", and explore its requirements for registration, renewal, and variations, let us get our MDMA and place our products there.

In this course, we will cover all topics related to medical devices in the KSA, starting from the requirements, interim regulations, classification, verification, and special conditions.

Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, budling /grouping criteria of the medical devices in only one MDMA application, and interact with the actual SFDA gateway for MDMA submission. 

and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for KSA market importation.

And finally, congratulations to you for mastering medical device registration in the KSA market and see you soon in the pharma industry my dear colleagues.

Enroll now

What's inside

Learning objectives

  • By the end of this course you will master medical devices registration in saudi arabia, the biggest gcc market ever
  • Medical devices registration in saudi arabia
  • Medical devices registration in ksa
  • Medical devices registration in the biggest market in the gcc
  • Medical devices registration in the highest roi market in the gcc

Syllabus

Introduction

In this interesting introduction, you will be exposed to the topics that we will cover in this course of medical devices registration in KSA, the huge important market of the GCC region from which most of the revenue of such a company comes, KSA market could not be missed for any company,

we will start with the definition of the medical devices, they will go through different types of medical devices, such as MD, AMD, AIMD, IVD as per the general directive of medical devices classification

Read more

Intro Quiz

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

In this section, we will start our journey towards medical device registration in the KSA market with the basic and initial step, which is the classification, we will explore together the universal riks classes of the medical devices, either normal medical devices or invasive medical devices, in addition to comparison among the three major health authorities and their classification rules.

So let us travel together to the KSA and start our journey from there     

Medical Devices Classification

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

In this section, we will travel deeper into the Medical Device Electronic System, exploring its services and how they are linked to the classification and registration of the medical device, then we will understand step by step the KSA registration process, considering the reference core documents for this, which is the SFDA decree of medical devices registration, issuing dates along with its amendments.

Let us dive deeper into the MDES

Medical Device Electronic System

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

In this section we will experience the actual workflow of the medical devices registration guidance in KSA, starting from getting the RA to obtaining the final MDMA, this is the map towards MDMA, we will s start with the LOA, and retrieve the notarization and legalization data.

Let us read our map towards medical devices in KSA 

Guidance For Medical Devices Registration

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

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

so let us master SFDA requirements

SFDA Submission Requirement

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

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, types, and what if you as a company decided to change this notified body? let us go together to the world of the notified body

Notified Body

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

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

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

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

Let us see the actual templates how it looks like, let us see actual forms from practice

Here are the actual templates that you will use in practice

Templates

This so interesting crucial section about very unique feature for SFDA , which is the bundling/grouping of medical devices in one MDMA application, only one fee , saving time and money

This so an interesting crucial section about a very unique feature for SFDA , which is the bundling/grouping of medical devices in one MDMA application, only one fee, saving time and money, based on what we bundle these medical devices? let us see together.

Bundling

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

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

let us play the puzzle

Here we will start the all actions through the SFDA interface towards MDMA, we will act as local distributors for a while and let's access the interface and upload the documents checklist step by step

Here we will start the all actions through the SFDA interface towards MDMA, we will act as local distributors for a while and let's access the interface and upload the documents checklist step by step

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

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

so let us go in a quick trip to the main countries that most probably the medical devices come from   

Verification

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

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

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

Congratulations, we have completed our journey in the KSA, enjoyed all details of the SFDA, and now we came to the clearance, of the medical devices from customs after we have got the MDMA.

Let us start placing our medical devices in the market, launch the products and sales, earning our great revenue out of the potentially huge market of the KSA.

Congratulations again my dear pharma industry colleague

Good to know

Know what's good
, what to watch for
, and possible dealbreakers
Focuses on the Saudi Food and Drug Authority (SFDA) requirements, which is essential for professionals seeking to navigate the regulatory landscape in Saudi Arabia
Covers the entire process, from initial registration to custom clearance, offering a comprehensive understanding of medical device market access in Saudi Arabia
Explores the Medical Device Electronic System (MDES), which is critical for efficient navigation of the SFDA's online portal
Examines bundling and grouping strategies for medical devices, which can lead to significant cost and time savings during the registration process
Requires learners to engage with the SFDA interface, which may necessitate access to specific credentials or permissions typically held by local distributors
Deals with regulatory information specific to Saudi Arabia, which may not be applicable in other regions without additional research and adaptation

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Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Master Medical Device Registration In Saudi Arabia with these activities:
Review Medical Device Classification Principles
Reinforce your understanding of medical device classification, a fundamental aspect of KSA registration.
Show steps
  • Review the general principles of medical device classification based on risk.
  • Compare classification rules across different health authorities.
  • Practice classifying various medical devices based on provided descriptions.
Read 'Medical Device Regulations: A Comprehensive Guide'
Enhance your knowledge of medical device regulations with a comprehensive guide covering key aspects of the regulatory process.
View Counseling Ethics: Philosophical and... on Amazon
Show steps
  • Obtain a copy of 'Medical Device Regulations: A Comprehensive Guide'.
  • Read the sections relevant to pre-market approval, post-market surveillance, and regulatory compliance.
  • Compare the regulatory principles discussed in the book with the SFDA requirements.
Read 'Global Medical Device Regulations'
Gain a broader perspective on medical device regulations worldwide to better understand the KSA-specific requirements.
View Alter Ego: A Novel on Amazon
Show steps
  • Obtain a copy of 'Global Medical Device Regulations'.
  • Read the chapters relevant to regulatory frameworks and classification.
  • Compare and contrast the KSA regulations with those discussed in the book.
Four other activities
Expand to see all activities and additional details
Show all seven activities
Compile a List of SFDA Resources
Create a centralized repository of SFDA guidelines, forms, and templates for easy access and reference.
Show steps
  • Visit the SFDA website and identify key documents related to medical device registration.
  • Download and organize the documents into a structured folder system.
  • Create a document listing with brief descriptions of each resource.
Practice Filling Out MDMA Forms
Familiarize yourself with the MDMA application process by repeatedly filling out sample forms.
Show steps
  • Obtain blank MDMA application forms from the SFDA website.
  • Create hypothetical medical device scenarios with varying classifications.
  • Fill out the MDMA forms for each scenario, paying attention to detail.
  • Compare your completed forms with examples to identify areas for improvement.
Create a Presentation on Bundling Rules
Deepen your understanding of SFDA's bundling/grouping rules by creating a presentation explaining the criteria and process.
Show steps
  • Review the SFDA guidelines on bundling/grouping medical devices.
  • Create a presentation outlining the eligibility criteria and decision-making process.
  • Include diagrams and examples to illustrate the bundling rules.
  • Present your findings to peers or colleagues for feedback.
Follow SFDA Gateway Submission Tutorials
Gain hands-on experience with the SFDA gateway by following online tutorials on MDMA submission.
Show steps
  • Search for official SFDA tutorials or guides on MDMA submission.
  • Follow the tutorials step-by-step, creating a test submission if possible.
  • Document any challenges or questions encountered during the process.

Career center

Learners who complete Master Medical Device Registration In Saudi Arabia will develop knowledge and skills that may be useful to these careers:
Regulatory Affairs Specialist
A Regulatory Affairs Specialist ensures that a company's medical devices comply with regulations and standards. The role involves preparing and submitting regulatory documents to health authorities. Taking a course such as the "Master Medical Device Registration In Saudi Arabia" may help you navigate the specific regulatory landscape of the Saudi Food and Drug Authority (SFDA). This course covers the requirements for registration, renewal, and variations, providing practical knowledge directly applicable to the work of a Regulatory Affairs Specialist. The course's deep dive into the Medical Device Electronic System (MDES) and the preparation of submission dossiers may be particularly beneficial for those aiming to excel as a Regulatory Affairs Specialist in the Saudi Arabian market.
See salaries and explore the career path for Regulatory Affairs Specialist
Regulatory Affairs Manager
A Regulatory Affairs Manager leads a team responsible for ensuring a company's medical devices comply with regulations. The "Master Medical Device Registration In Saudi Arabia" course helps build expertise in the SFDA's regulatory requirements, a crucial element for success. By covering registration processes, the Medical Device Electronic System (MDES), and submission dossier preparation, the course provides practical knowledge that can be applied to manage regulatory affairs effectively. Mastering the nuances of the Saudi market will position you as a valuable asset to any organization.
See salaries and explore the career path for Regulatory Affairs Manager
Medical Device Documentation Specialist
A Medical Device Documentation Specialist creates and maintains the documentation required for regulatory submissions. This role requires strong attention to detail and a thorough understanding of regulatory requirements. The "Master Medical Device Registration In Saudi Arabia" course helps one understand the specific documentation requirements of the SFDA. This course provides hands-on experience with preparing submission dossiers and navigating the Medical Device Electronic System (MDES). This level of practical knowledge can significantly enhance a Documentation Specialist's effectiveness in ensuring compliance.
See salaries and explore the career path for Medical Device Documentation Specialist
International Regulatory Consultant
An International Regulatory Consultant advises companies on navigating regulatory requirements in various countries. The "Master Medical Device Registration in Saudi Arabia" course may help a consultant specialize in the Saudi Arabian market. This course's focus on the SFDA requirements for medical devices, including registration, renewal, and variations, provides valuable expertise. This course's insights into the Medical Device Electronic System (MDES) and practical aspects of preparing submission dossiers may be particularly attractive to those wishing to succeed as consultants.
See salaries and explore the career path for International Regulatory Consultant
Medical Device Product Manager
A Medical Device Product Manager oversees the lifecycle and market strategy of medical devices. This includes understanding regulatory requirements to ensure product compliance. The "Master Medical Device Registration In Saudi Arabia" course helps one understand the regulatory approval processes, giving a product manager insight into launch timelines and market access strategies. By understanding the nuances of SFDA regulations, a Medical Device Product Manager can better plan product development and marketing activities. The course content on bundling criteria and interacting with the SFDA gateway is particularly relevant, helping one to streamline the registration process and optimize product portfolios.
See salaries and explore the career path for Medical Device Product Manager
Market Access Manager
A Market Access Manager is responsible for gaining and maintaining market access for medical devices, which includes navigating regulatory hurdles and reimbursement pathways. The "Master Medical Device Registration In Saudi Arabia" course helps build a strong understanding of the regulatory landscape in Saudi Arabia, a crucial aspect of market access. By mastering the registration process, renewal procedures, and variations, a Market Access Manager can develop effective strategies for launching and sustaining medical device products in the Saudi market. Training on the SFDA requirements will be particularly valuable.
See salaries and explore the career path for Market Access Manager
Import/Export Specialist
An Import Export Specialist manages the import and export of medical devices, ensuring compliance with customs regulations and trade laws. The "Master Medical Device Registration In Saudi Arabia" course may help an import export specialist to understand the specific requirements for importing medical devices into Saudi Arabia. The course's coverage of custom clearance, barcoding, and 2D Matrix systems for shipments provides practical knowledge directly applicable to this role. Understanding the SFDA's regulations and procedures can streamline the import/export process and ensure compliance.
See salaries and explore the career path for Import/Export Specialist
Compliance Officer
A Compliance Officer develops and implements compliance programs to ensure a company adheres to regulations. In the medical device industry, this requires detailed knowledge of regulatory requirements. The "Master Medical Device Registration In Saudi Arabia" course helps to understand the SFDA's regulatory framework for medical devices. The course's coverage of registration, renewal, variations, and custom clearance provides a comprehensive overview of the compliance landscape in Saudi Arabia. The practical insights into preparing submission dossiers and interacting with the SFDA gateway are particularly useful for a Compliance Officer.
See salaries and explore the career path for Compliance Officer
Labeling and Packaging Specialist
A Labeling and Packaging Specialist ensures that medical device labeling and packaging meet regulatory requirements and provide accurate information to users. Understanding the specific requirements of the SFDA, as covered in the "Master Medical Device Registration In Saudi Arabia" course, may help one ensure compliance with Saudi regulations. The course's coverage of barcoding and 2D Matrix systems for shipments is particularly relevant, helping ensure that labeling and packaging meet the necessary standards for market access in the Kingdom.
See salaries and explore the career path for Labeling and Packaging Specialist
Quality Assurance Manager
A Quality Assurance Manager ensures that medical devices meet quality standards and regulatory requirements throughout their lifecycle. This often involves close collaboration with regulatory affairs teams. The "Master Medical Device Registration In Saudi Arabia" course may help a Quality Assurance Manager understand specific regulatory requirements in Saudi Arabia. The section on verification and certificates helps one ensure product quality and performance align with SFDA expectations. A Quality Assurance Manager who understands regulatory submission requirements may be more effective in ensuring compliance and minimizing potential delays.
See salaries and explore the career path for Quality Assurance Manager
Medical Device Auditor
A Medical Device Auditor conducts audits of medical device manufacturers to ensure compliance with quality management systems and regulatory requirements. The "Master Medical Device Registration In Saudi Arabia" course helps one develop a deeper understanding of the SFDA's regulatory framework for medical devices. This course's insights into registration processes, bundling criteria, and verification procedures may be helpful for an auditor. This knowledge can enhance an auditor's ability to assess compliance and identify potential risks.
See salaries and explore the career path for Medical Device Auditor
Medical Device Sales Representative
A Medical Device Sales Representative requires a solid understanding of the products they sell, including their regulatory status. The "Master Medical Device Registration In Saudi Arabia" course helps one understand the regulatory requirements for medical devices in Saudi Arabia. This knowledge helps a sales representative communicate effectively with healthcare professionals. Understanding the SFDA requirements, bundling criteria, and custom clearance processes can provide a competitive edge, making the sales process more streamlined and successful.
See salaries and explore the career path for Medical Device Sales Representative
Pharmacovigilance Specialist
A Pharmacovigilance Specialist monitors the safety of medical devices and drugs, collecting and assessing adverse event reports. While this course focuses on registration rather than post-market surveillance, understanding the regulatory landscape in Saudi Arabia, as taught in the "Master Medical Device Registration in Saudi Arabia" course, may provide a Pharmacovigilance Specialist with valuable context. Awareness of SFDA regulations can inform the development of effective safety monitoring programs and ensure compliance with reporting requirements.
See salaries and explore the career path for Pharmacovigilance Specialist
Clinical Research Associate
A Clinical Research Associate (CRA) manages clinical trials for medical devices, ensuring compliance with regulatory requirements and ethical standards. While this course doesn't directly cover clinical trials, understanding the regulatory landscape in Saudi Arabia, as provided by the "Master Medical Device Registration in Saudi Arabia" course, may help a CRA navigate the specific requirements for clinical studies in that market. Awareness of SFDA regulations and submission processes can contribute to the successful conduct of clinical trials and the subsequent registration of medical devices.
See salaries and explore the career path for Clinical Research Associate
Medical Device Engineer
A Medical Device Engineer designs, develops, and tests medical devices. While this role is primarily technical, understanding regulatory requirements is important for ensuring products meet safety and compliance standards. The "Master Medical Device Registration In Saudi Arabia" course may provide a Medical Device Engineer with valuable insights into the SFDA's regulatory framework. Knowledge of SFDA requirements can inform the design process and help ensure that devices meet the necessary criteria for registration and market access in Saudi Arabia.
See salaries and explore the career path for Medical Device Engineer

Reading list

We've selected two books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in Master Medical Device Registration In Saudi Arabia.
Cover image
Counseling Ethics
Save
Provides a broad overview of medical device regulations worldwide, including information on regulatory pathways, quality systems, and post-market surveillance. It offers a comparative perspective that can enhance understanding of the SFDA's requirements. This book useful reference tool.
Counseling Ethics: Philosophical and Professional...
Paperback
$$$
Cover image
Alter Ego
Save
Provides a comprehensive overview of medical device regulations worldwide. It offers valuable insights into the regulatory landscape beyond KSA, helping you understand the global context of medical device registration. While not specific to KSA, it provides a strong foundation for understanding regulatory principles and variations across different markets. This book is useful as additional reading.
Alter Ego: A Novel
Paperback
$$

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Effort
3 total hours
Via
Udemy
Instructor
Dr. Zahra Hassan
Language
English
Good to know
Focuses on the Saudi Food and Drug Authority (SFDA) requirements, which is essential for professionals seeking to navigate the regulatory landscape in Saudi Arabia
Covers the entire process, from initial registration to custom clearance, offering a comprehensive understanding of medical device market access in Saudi Arabia
Explores the Medical Device Electronic System (MDES), which is critical for efficient navigation of the SFDA's online portal
Examines bundling and grouping strategies for medical devices, which can lead to significant cost and time savings during the registration process
Requires learners to engage with the SFDA interface, which may necessitate access to specific credentials or permissions typically held by local distributors
Deals with regulatory information specific to Saudi Arabia, which may not be applicable in other regions without additional research and adaptation
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