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) had evolved to cope with EU Medical Device Regulations (MDR) updates. The continuous development and reengineering of the registration procedures 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 classification of medical devices according to EU regulations.
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. Post-approval, they are responsible for product safety and other life cycle management, such as MDMA updates, renewals, and providing the Unique Device Identification (UDI) information.
Here is a summary of the registration routes for medical devices:
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, having a CE certificate to receive SFDA approval is not mandatory. However, the product will mainly undergo a more rigorous assessment requiring 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 must have a whole technical file, and an authorized representative (AR) must be appointed in Saudi Arabia.
The SFDA also regulates medical device companies in the Saudi market and enforces special requirements on international companies. Below are the requirements for both types:
SFDA licenses local medical device companies such as importers, distributors, warehouses, and manufacturers. This license is called the Medical Device Establishment License (MDEL). The main requirement to pay attention to is implementing a quality management system (QMS) and having an ISO 13485 certificate. A valid ISO must be maintained to keep the license, which is frequently checked during SFDA inspections.
International legal manufacturers must appoint an authorized representative (AR) company in Saudi Arabia; it is the first step to enable communication with the SFDA. The AR’s primary responsibility is product compliance in pre and post-marketing activities. The AR will maintain registration status, facilitate shipments, monitor safety, report cases, and represent the company in the Saudi market for regulatory or governmental matters. The SFDA issues the AR certificate for a minimum of 1 year and must be maintained valid during commercial activities in Saudi.
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 instance, a product is considered a low-risk medical device in its home country but a non-medical device in Saudi Arabia, and vice versa.
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:
|MDR Classification Rule
|Class A – Sterile
|Class A – Measuring function
|Class A – Reusable surgical instruments
The applicant is responsible for the classification of their device in Saudi. This is by using special classification rules based on the following:
Identical devices could be classified differently according to the targeted part of the body. Therefore, the intended use is crucial in determining the correct classification. The intended use is clarified in the following:
Concerning in vitro diagnostics, the SFDA is also adopting the European medical device regulation IVDR:
|SFDA IVD Classification
|Low individual risk and low public health risk
|Moderate individual risk and/or low public health risk
|High individual risk and/or moderate public health risk
|High individual risk and high public health risk
The applicant is responsible for determining the class of the IVD by:
Time needed: 90 days
We can summarize the medical device registration and approval process in the following few steps:
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.
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.
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.
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.
SFDA will send their inquiries in multiple waves as the application goes through various layers of assessment. In many cases, the assessor does not guide and detail the deficiency but will point out the concerning section or study.
Once granted by SFDA, the license owner (the legal manufacturer) can ship the goods to one or more distributors with the help of the independent AR.
The first step is to appoint an authorized representative for every unique legal manufacturer by submitting a signed AR agreement to receive an AR license from the SFDA. Afterwards, the applicant can submit the product registration application.
The following are the requirements summary, but not all. They vary according to the product type and class. In general, SFDA will require many custom changes for Saudi applications that must be made before submission.
Besides the above-cited documents, SFDA officials may ask for further information during the application process.
The assessment timelines vary according to many factors, such as risk factors, complexity of the product, number of bundled SKUs (accessories and variants), and 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.
For the official review timelines, refer to our article: SFDA timelines.
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.
MDMA is valid for three years. Companies can submit the renewal application three months (90 days) before the license expires.
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 in some cases.
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.
Whether your company is new or already active in the Saudi market, PharmaKnowl will help you comply with SFDA in the shortest time. We are an SFDA-licensed consulting company that provides regulatory and authorized representative services in Saudi Arabia for international companies across the globe. We perform: