Between 2019 and 2022, the Saudi Food and Drug Authority (SFDA) extensively updated the medical device regulations in Saudi Arabia. In particular, the requirements for medical device marketing authorization (MDMA). It evolved to cope with EU Medical Device Regulations (MDR) updates. The continuous development and reengineering of the registration procedures has increased the complexity of the SFDA registration process. To market in Saudi, all medical devices, including low-risk classes and in vitro diagnostics(IVDs), must be MDMA registered through the technical file application (TFA) route.
In this article, we will clarify the SFDA medical device registration requirements and the details of the abovementioned updates. We will also define the differences in the medical device classification with the EU regulations.
Table of contents
- Medical Device Regulation
- Medical Device Classification
- Medical Devices Registration (MDMA)
- Registration Support
Medical Device Regulation
In the below sections, we’ll summarize the medical device regulations in Saudi Arabia for products and companies. We’ll brief you about product registration procedures, required files, classification, and the required license for the medical device companies in Saudi.
The SFDA is responsible for regulating medical device products in Saudi Arabia. They ensure their safety, efficacy, and quality. All medical device legal manufacturers must acquire SFDA approval (MDMA) before marketing the product. In addition, all application updates or variations must also be submitted to the authority and receive approval before selling the new product version. This includes minor and major changes.
Here is a summary of the registration routes that SFDA offers or used to offer for medical device registration:
Since January 2022, all medical devices, equipment, supplies, software/apps, and IVD products must be registered through one available MDMA route called TFA (or MDMA2). This route has resulted from the SFDA’s continuous updates of regulations influenced by the EU MDR and IVDR.
Therefore, the registration requirements became more stringent, with many conditions to meet and studies to provide, such as clinical evaluation reports (CER), biocompatibility test reports, and the need to conduct a post-market clinical follow-up (PMCF) study in Saudi Arabia.
Although the TFA file is similar to the CE mark file, it is not mandatory to have a CE certificate to receive SFDA approval. However, the product will mostly go through a more rigorous assessment journey that requires an experienced regulatory professional.
- The SFDA used to consider approvals from the GHTF members’ countries such as the European Union EU, United States, Canada, Australia, and Japan. This was an easy referencing route without deep technical inquiries. However, SFDA cancelled this GHTF route by the end of 2021.
In September 2022, the SFDA officially cancelled the registration procedure for low-risk medical devices, known as the Medical Device National Registry (MDNR). This simple application isn’t available anymore. All devices now must have a full technical file and appoint an authorized representative (AR) in Saudi.
The SFDA also regulates medical device companies in the Saudi market and enforces special requirements on international companies. Below are the requirements from both types:
Local Saudi Company
They license local distributors, warehouses, and medical device manufacturers. This license is called the Medical Device Establishment License (MDEL). The main requirement here to pay attention to is the implementation of a quality management system (QMS) according to the ISO 13485 standards. Note that the ISO certificate is mandatory for distributors Class A & B and all local manufacturers. SFDA performs inspections on all local manufacturers to obtain and maintain their licenses.
International legal manufacturers must appoint an authorized representative (AR) company in Saudi. The AR will be responsible for product compliance and post-marketing surveillance. The AR is issued by SFDA in the form of a certificate that must be maintained valid during commercial activities in Saudi. Read more: Authorized representative in Saudi Arabia.
Medical Device Classification
The applicant is responsible for classifying the product according to SFDA rules and creating the related files in the technical file. Generally, the SFDA medical device classification will follow the same class in the reference country. For example, the SFDA will match the classification in the CE certificate. However, we have seen cases where SFDA did not adopt the same. For example, a product is considered a low-risk medical device in its home country but a non-medical device in Saudi, and vice-versa.
Medical Devices (Except IVDs)
SFDA medical device classification is either Class A, B, C, or D. This is according to their risk class. The class is necessary to determine the registration procedure and its requirements, as discussed in the table below:
|SFDA Classification||Risk Class||MDR Classification Rule|
|Class A – Sterile||Low-medium||Is|
|Class A – Measuring function||Low-medium||Im|
|Class A – Reusable surgical instruments||Low-medium||Ir|
The applicant is responsible for the classification of their device in Saudi. This is by using special classification rules based on the following:
- Intended use.
- Risk level (harm probability and severity to the patients, users, and others).
- Invasiveness to the human body.
- Use duration.
Identical devices could be classified differently according to the targeted part of the body. Therefore, the intended use is a crucial factor in determining the correct classification. The intended use is clarified in the following:
- Instructions for Use (IFU)
- Promotional materials
- Technical File
Concerning in vitro diagnostics, the SFDA is also adopting the European medical device regulation IVDR:
|SFDA IVD Classification||Risk Class||Classification Rule|
|Class A||Low individual risk and low public health risk||A|
|Class B||Moderate individual risk and/or low public health risk||B|
|Class C||High individual risk and/or moderate public health risk||C|
|Class D||High individual risk and high public health risk||D|
The applicant is responsible for determining the class of the IVD by:
- Applying the classification rules for IVD medical devices
- Intended use
- Level of risk
Medical Devices Registration (MDMA)
After appointing an authorized representative by execution of the AR agreement and issuing an SFDA AR license, the product application can be submitted by the AR.
- Table of content
- Detailed device description/intended purpose/device history/Classification.
- Device labels and instructions for use
- Design and manufacturing information
- Essential Principles of Safety & Performance (formerly known as Essential Required checklist
- Benefit-risk analysis
- Risk Management File (Plan & Report)
- Product verification & validation, including
- Pre-clinical testing & testing reports, including Biocompatibility testing reports.
- Clinical investigation plan & report
- Clinical Evaluation Report CER
- Post Market Clinical Follow Up (PMCF)
- Post Market Surveillance (PMS), Plan & Report
- Periodic Safety Update Report (PSUR)– for class B, C, and D Devices
Besides the above-cited documents, SFDA officials may ask for further information during the application process.
Time needed: 90 days
We can summarize the medical device registration and approval process in the following few steps:
- Appoint a Saudi authorized representative (AR)
Manufacturers should appoint an independent AR to represent their company in Saudi. Even if there was an appointed AR before, manufacturers can transfer the AR and the current MDMA approvals. Contact us for more details.
- Prepare the technical file for MDMA submission.
To be ready for MDMA submission, companies need to establish a thorough gap analysis on the file against the SFDA requirements. Identifying the gaps is essential to determine the must-have studies, reports, or post-approval commitments such as PMCF in Saudi. Rejection of an application costs time and high SFDA fees.
- MDMA Submission
Firstly, the SFDA assessor will scan the submitted file to examine the rightfulness of the submission. They will mostly reject a file that is not professionally submitted, even from a reputable company. In this case, the SFDA feedback will not clarify the gaps; they will ask the applicant to resubmit according to the applicable guidelines. The applicants will have few permitted chances to rectify.
- Payment of fees.
If the file passes the initial examination by SFDA, they will issue an invoice for the applicable SFDA fees. This must be paid before the start of the assessment, and it is not refundable.
- Respond to Inquiries
SFDA will send their inquiries in multiple waves as the file goes through multiple layers of assessment. In many cases, the assessor does not guide and detail the deficiency but will point out the concerning section or study.
- MDMA Approval
Once granted by SFDA, the owner of the license (the legal manufacturer) can ship the goods to one or more distributors with the help of the independent AR.
The assessment timelines taken by SFDA vary according to many factors such as the risk factor, complexity of the product, number of bundled accessories and variants, and most importantly, the completeness of the file. Non-identified gaps before the submission will risk delaying the approval if not rejected. The entire registration project timeline will include the time to prepare for the submission. This part depends on the amount of gaps and how professional the due diligence process is.
The official review timelines are changing; please refer to our article SFDA timelines for the most updated duration.
The MDMA application fees vary according to the medical device Class and the number of products in the application. For the updated fees please refer to our SFDA Fees post.
Grouping multiple devices in the same application is permissible; the applicant may bundle up to 50 items in one MDMA application. However, products must meet several conditions, such as being with the same risk class and intended use.
MDMA license validity
Medical device companies can initiate application renewal two months (60 days) before the expiry of the current MDMA certificate.
There are minor and major update types; both differ in fees and timelines. They can be submitted at any time during the license validity. However, they can be grouped with a renewal request.
Whether you’re a new company in the Saudi market or already active, PharmaKnowl can support you to have your products marketed in the shortest time. We ensure compliance and efficient regulatory services for our clients.
- PharmaKnowl is an SFDA-licensed authorized representative in Saudi Arabia for international companies across the globe. We perform:
- Files due diligence and gap analysis.
- Preparations of Saudi-specific files and compilation of total technical files
- Submission & interpretation of SFDA inquiries
- Follow up until approvals are secured.
- Post-marketing support (Safety and compliance cases)