Regulatory services KSA
The regulatory system in KSA, which has been updated in the last few years under the influence of EU MDR and IVDR, defines that medical devices and IVDs require medical device marketing authorization (MDMA) approval from the Saudi Arabia food and drug authority (SFDA)
All medical devices, including those with a low-risk class, and in vitro diagnostics (IVDs), must be MDMA registered through the technical file assessment (TFA) route before being able to market in the KSA (TFA filing is like CE marking filing, but a CE marking is not a prerequisite to get SFDA approval).
SFDA oversees the regulatory process regarding the sales and distribution of medical devices and IVDs in KSA, ensuring products’ safety, efficacy and quality. MDMA applications follow strict guidelines, and any irregularities can cause delays in the registration process. Article 1 of the Medical Devices Law gives a definition of a medical device. If your medical device or IVD falls within this definition, it requires MDMA approval. The (MDMA) is owned by the manufacturer. Marketing licenses are valid for a period of three years and can be transferred if required.
A Technical File Assessment (TFA) is needed for market authorization. A unique classification system for medical devices has been implemented by the SFDA. Products don’t have to be pre-approved in their country of origin and for MDMA registration it is not required to have approval in a reference country. But if proof of approval has been given in any other market, it needs to be submitted during the registration process.
The SFDA also submits the Medical Device Establishment License (MDEL) to importers, distributors, warehouses, and manufacturers.
In case you do not have an office or legal entity in KSA, SFDA requires foreign medical device or IVD manufacturers to appoint an authorized representative (AR). The AR, your legal representative in KSA, must have a valid license which can be renewed on an annual basis. In the process of registering your medical device or IVD, submission of all relevant documents is the responsibility of the AR. Hence the appointment of an AR early in the process.
Classification and grouping
The medical device classification system in KSA consists of four classes: A, B, C and D. These classes are quite similar to the EU classification: I, IIa, IIb, III. The class determines the registration procedure and requirements.
As far as IVD’s are concerned, SFDA aligns its classification to the European IVDR.
Primary market operators
It is possible to identify several operators when selling products in the KSA market.
- Manufacturer: In general, the manufacturer would be the legal manufacturer that holds the marketing authorization in the reference country. First step in the registration process is to appoint a local AR to start communicating with the SFDA.
- Authorized representative: a local authorized representative (AR) is mandatory in case you have no office or legal entity in Saudi Arabia. The appointed local AR will represent you towards the SFDA. This role can be executed by a distributor as well but sometimes the enquiries from the SFDA on complex regulatory matters can be challenging for a local distributor to handle correctly. The AR can be involved in handling post-market obligations and gives you better control on distributing your products in the KSA market. Gateway MedTech can act as your local AR through our local expert partner, handling different processes like:
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Medical device or IVD registration submission to the SFDA and maintain the registration status;
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Handling any queries from the SFDA and notifying the SFDA of changes to your product;
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Coordinate product recalls or so-called Field Safety Corrective Actions (FSCA);
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Providing the Unique Device Identification (UDI) information. The UDI identifies a device through its distribution and use and consists of both a device and specific product identifier.
Before you can start to market your product in Saudi Arabia, and in case you are new to the KSA market, you need to apply for the AR license through the SFDA Medical Device Establishment License (MDEL) system. The fees required vary depending on type of medical devices you plan to register and market.
- Importer: Importing medical devices requires a valid MDMA. However, it can be that the SFDA may exempt any medical device from the marketing authorization, they only require importers to issue a medical device importing license (MDIL). The SFDA announces the exempted medical devices on its website taking into consideration the public interest. The exempted medical devices can be found on the SFDA website. Examples are products used in research, semi-finished needed for local manufacturing or product used only for training or demonstrations.
- Distributor: Local distributors must have a legalized contract from the manufacturer proving the commercial relationship between them and must have proper SFDA granted business licenses.
Legal Manufacturer assigning a local AR
The registration process in KSA basically follows the following steps:
The AR applies for an AR license
The AR submits product registration application at SFDA
The SFDA reviews, asks questions and when approved, provides a Medical Device Market Authorization (MDMA)
The product can be marketed in KSA
The first step before submitting the application is to determine the device classification following the SFDA classification guideline.
It is important to assess where the current filing is not matching the SFDA requirements. This determines which studies and reports are required additionally. It also highlights post registration approval requirements such as the PMCF (Post Market Clinical Follow-up). Although a post-market surveillance requirement approving medical devices, PMCF assures that essential clinical requirements are met and is seen as such as a pre-market requirement which influences the decision to allow a product to be marketed in KSA or not.
The SFDA will check if the MDMA application is meeting the guidelines (which isn’t a content review as such). Failing to meet the requirements means a rejection of the application, a delay in the process and additional time and costs to re-apply meeting the guidelines. Gateway MedTech can support in the KSA registration process and knows what information and documents must be included in the Technical Documentation File submitted for the MDMA registration.
​When the SFDA grants MDMA approval, the legal manufacturer, owning the license, can start commercialize their products in the KSA market.
Clinical data
Based on the product classification, the SFDA may request additional information if they deem it necessary for approval. An example is the PMCF (Post Market Clinical Follow-up).
Labelling
The labeling for medical devices intended to be placed on the KSA market should be provided in Arabic and/or English. However, in the case of a medical device intended to be used only by healthcare professionals, labeling in English could be sufficient. The same rule applies to the marketing and advertising information.
Cost
Gateway MedTech can provide you with the details of the currently applicable costs for product registration, import approval and customs release per shipment of devices. There is a fast-track route to expedite the registration timeline which is more expensive.
Time-to-market
The SFDA will normally take 2-3 months as the communicated timeframe for reviewing the MDMA applications. In reality, review times can be longer dependent on additional questions asked. The validity of the MDMA is three years and application renewal can be submitted 3 months prior to the expiry of the license. During the three years updates on already approved devices can be submitted.
