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Are you looking for a new market opportunity for your medical device? Do you want to expand your business in the Middle East?

If so, you might want to consider Saudi Arabia, one of the most attractive and lucrative markets in the region. But before you can sell your device in the Kingdom, you need to get it approved by the Saudi Food and Drug Authority (SFDA), the regulatory body for medical devices in the country.

Previously, we featured a podcast episode discussing MDMA and elaborating on the similarities between TFA and MDR. It’s worth noting that we interviewed with Ahmed Hendawy, the Founder & CEO of Registitute, who shared valuable insights. I recommend revisiting it for a deeper understanding before exploring this topic further

Getting your device registered in Saudi Arabia may seem like a daunting task, but don’t worry, we are here to help.

In this blog post, we will guide you through the key steps to register your device with the SFDA, based on their official guidelines and expert insights. We will also explain why Saudi Arabia is a great market for medical device manufacturers and how you can benefit from it.

Table of Contents

Why Saudi Arabia?

Saudi Arabia is the largest and most populous country in the Gulf Cooperation Council (GCC), with a population of over 37 million and a GDP of over $1.1 Trillion. The country has a high demand for healthcare services and products, driven by factors such as (Ahmed Ali Alasiri et al., 2022):

  • A growing and aging population
  • A rising awareness of health and wellness among the public
  • A government commitment to improving the quality and accessibility of healthcare

These factors have created a booming market for medical devices in Saudi Arabia, which is expected to grow from $2.0 billion in 2022 to $3.3 billion by 2032, with a compound annual growth rate of 5.9%.

But how can you get your device approved by the SFDA and start selling it in Saudi Arabia? Let’s find out.

How to Register Your Device with the SFDA?

The SFDA is the competent authority for regulating medical devices and IVDs in Saudi Arabia. The SFDA has issued a comprehensive set of regulations and requirements for medical devices, which are largely based on the European Union’s Medical Device Regulation (MDR). This means that if you have already registered your device in the EU, you will have an easier time registering it in Saudi Arabia, as the SFDA will accept most of the documents and certificates that you have obtained from the EU.

However, there are some differences and specificities that you need to be aware of when registering your device with the SFDA. Here are the main steps that you need to follow:

Register Medical Device Saudi Arabia Flowchart Easy Medical Device

1. Appoint a Local Authorized Representative

The first step to register your device with the SFDA is to appoint a Local Authorized Representative (LAR) in Saudi Arabia. A LAR is a legal entity that has written authorization from you, the manufacturer, to act on your behalf in the country regarding the implementation of the SFDA Medical Device Law and Regulations. The LAR agreement is subject to the laws of Saudi Arabia and must be documented, approved, and registered with the SFDA. The LAR is responsible for submitting the application and documentation for the Medical Device Marketing Authorization (MDMA), as well as communicating with the SFDA and handling any post-market issues. The LAR must meet the following specific requirements (MDS – REQ 1, Requirements for Medical Devices Marketing Authorization):

  • Submit evidence of the application of a Quality Management System or an inspection report from the SFDA that confirms their compliance with the requirements of the Saudi Standard (SFDA.MD/GSO ISO 13485) or its equivalent.
  • Be present in Saudi Arabia.
  • Obtain a separate license for each establishment that they represent in Saudi Arabia.
  • Ensure that there is no other LAR appointed for the same class or general group of medical devices.
  • Document the necessary processes for performing the tasks assigned to them with the attachment of relevant documents.

2. Classify Your Medical

As mentioned earlier, SFDA’s regulations are closely aligned with the European Union’s Medical Device Regulation, including the device classification system. For more detailed information on the classification rules, you can refer to the latest version of the SFDA’s “Risk Classification Rules for Medical Devices” document (MDS-G008, Guidance on Medical Devices Classification)

Manufacture shall classify the medical device according to the “Risk Classification Rules for Medical Devices” using a set of classification rules based on the:

  • manufacturer’s intended use of the device
  • level of risk to patients, users, and other persons (the probability of occurrence of harm and the severity of that harm)
  • degree of invasiveness in the human body
  • duration of use

The SFDA medical device classification includes Class A, B, C, or D, determined by their risk class.

Register Medical Device Saudi Arabia Classification non-IVD devices

Identical devices may be classified differently if they are to be used in different parts of the body. Therefore, the manufacturer’s intended use of the device is critical to determining the appropriate classification. The intended use can be obtained from the:

  • Instructions for Use (IFU)
  • Label
  • Manufacturer’s advertising materials
  • Technical documentation
Register Medical Device Saudi Arabia Classification IVD Devices

3. Compile Technical Documentation

Technical documentation is a mandatory document that must be presented in a clear, organized, readily searchable, and unambiguous manner. Information provided by the manufacturer shall fulfill the Essential Principles of Safety and Performance requirements.

Regarding low-risk medical devices (except IVDs, sterile, having measuring function, reusable surgical instruments, and novel), the following shall be submitted in accordance by “Technical Documentation” (Annex 3)

  1. Device Description and Specification
  2. Information to be Provided by The Manufacturer
  3. Essential Principles Checklist
  4. Evidence of Compliance with the Applicable Essential Principles
  5. Risk Management File
  6. Post-Market Surveillance Plan and Report

 

We will not go into the details of the technical documentation content and quality here. However, we have previously discussed this topic in-depth in Podcast Episode 191, “How to Create Your Technical Documentation?” You may refer to that episode for more comprehensive information on creating technical documentation.

It’s important to note that SFDA has the right to request all “Technical Documentation” if necessary, even after obtaining the MDMA, and the manufacturer shall provide the requested documents within 10 days of SFDA’s request. The license for the establishment is issued after fulfilling all requirements and is valid for one year or a similar renewable period.

4. Submit the Application on GHAD

The SFDA has an online system called MDMA e-Service, where you can register your device and manufacturer, submit your MDMA application, pay the fees, and track the status of your application. You need to register your device and manufacturer on the MDMA e-Service before you can submit your application.

To apply for marketing authorization of a medical device, the applicant must submit the ‘Application Form for Medical Devices Marketing Authorization’ electronically through the ‘GHAD System – Marketing Authorization Services’ portal. All required supporting documents specified in the application form must also be provided. Here is a guide to the steps for opening your account: [https://ghad.sfda.gov.sa/assets/files/create-commercial-account-steps.pdf]

5. Pay SFDA Fees

After obtaining an establishment registration number, you need to submit a new license application through the GHAD system by uploading the required documents for the license application and proceed to the payment section if everything is in order.

Are there fees for registering low-risk medical devices and products?

Yes, 500 SAR

What are the fees for Marketing Authorization of medical devices and products, and the duration of issuing Marketing Authorization?

The SFDA charges different fees for the MDMA application, depending on the device class.

For more answers to questions like the previous one, you can refer to the (MDS – REQ 1,  Annex 12)

Register Medical Device Saudi Arabia Fees

6. Respond to SFDA Queries & Inspections

The SFDA will conduct a technical review of the application and may ask for more information or evidence to verify the safety and performance of the device. The SFDA may request:

  • Additional documents, such as clinical data, risk analysis, or post-market surveillance reports
  • Product samples for testing
  • Manufacturing site inspections scheduled for high-risk devices
  • Promptly provide full responses to queries to avoid delays

7. Obtain SFDA Approval

Once the SFDA approves the application, it will issue an MDMA certificate in both Arabic and English languages. The MDMA certificate is an official document that authorizes the marketing of the medical device or the medical devices group in Saudi Arabia. The MDMA certificate contains the following information:

  • the manufacturer information
  • sufficient information to identify the medical device or the medical devices group
  • Medical Device National Listing Numbers for the medical devices included in the MDMA
  • the period of its validity
  • certificate number

What do you know about SAUDI-DI?

The UDI system is all about keeping track of unique codes for medical devices using international standards. This system helps everyone easily find info about medical devices by checking the unique code in the system. Manufacturers and their authorized representatives are directly responsible for providing and maintaining current and accurate data on the unique device identification codes for their products in the Saudi market.

New regulations require all medical devices sold in Saudi Arabia to comply with Saudi-DI’s UDI requirements by September 2023 at the latest. These regulations apply to all non-exempted products, and compliance is a shared responsibility between manufacturers and authorized representatives.

Post-Submission

SFDA shall be informed, via the electronic system, within (10) days of the occurrence of any significant change to the relevant information or (30) non-significant changes. The MDMA certificate shall be renewed before its expiration date, and the updated documents, if necessary, shall be submitted through the electronic system, and a renewal request can be submitted 90 days before its expiry date

Conclusion

We hope that this blog post has given you a clear and comprehensive overview of how to register your medical device in Saudi Arabia. As you can see, the SFDA registration and approval process can be complex and lengthy, but it can also be a rewarding opportunity for medical device manufacturers who want to access a large and growing market in the Middle East.

By following the SFDA regulations and requirements, and by working with a qualified and experienced LAR, you can successfully place your device in Saudi Arabia and benefit from the potential of this market.

If you need help with placing your medical device in Saudi Arabia, you can contact us at Easy Medical Device. We have a team of experts who can assist you with the SFDA registration and approval process, as well as provide you with a LAR and a local importer and distributor in Saudi Arabia. We can also help you with placing your medical device in the EU, UK, and Switzerland. Contact us today and get a free quote!

Summary
How to Register Your Medical Device in Saudi Arabia?
Article Name
How to Register Your Medical Device in Saudi Arabia?
Description
Medical Device Registration in Saudi Arabia depends on the legislation in the country. We will explain to you all the requirements that you'll need to fulfill so you can get your device on this market.
Author
Publisher Name
Easy Medical Device
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Categories: Worldwide

Parvin Shakouri

With over six years of work experience in the medical device field, they have developed strong skills in medical device regulation (MDR), problem solving, and skill development. As a regulatory affairs specialist at owzan company, they contributed to the documentation and compliance of various medical devices, ensuring quality and safety standards. As a technical and purchase consultant at Soroush salamat sina, they provided expert advice and guidance on the selection, procurement, and installation of medical devices for different clients. They also have a background in biomedical engineering and a MBA degree, which enables them to understand the technical and business aspects of the medical device industry. They are passionate about improving the health and well-being of people through innovative and reliable medical devices. They are looking for a new opportunity to leverage their expertise and competencies in a collaborative and dynamic environment.

UK Representative from January 1st, 2021

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