In Saudi Arabia, companies must apply for SFDA registration to receive marketing approval for their products. A successful review of the registration application results in obtaining an SFDA certificate that reflects the SFDA approval status for your drug product, food, or medical device.
In this post, we will clarify:
The Saudi Food and Drug Authority (SFDA) regulates human and animal-consumed products to protect the public from harmful, low-quality, falsely claimed, counterfeit, and useless products. Their ultimate responsibility is to ensure the product’s safety, efficacy, and quality.
The SFDA is the most stringent authority in the MENA region. This is the result of the continuous development of Saudi Pharmaceutical laws and regulations and investment in the growth of local scientists since 2004.
Their continuous development of regulations culminated in 2021 when SFDA became a full regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Hence, the GCC and MENA countries regard Saudi Arabia as a reference country.
The Saudi FDA regulations cover three primary industries: food, pharmaceuticals (drugs), and medical devices. It also regulates other healthcare products such as herbals, food supplements, cosmetics, biocides, medical supplies, pesticides, and animal health products such as veterinary drugs and feed additives.
The authority comprises three main sectors: food, drug, and medical devices. Each has many procedures and routes of registration that depend on the product type and nature. The food comes into two types: regular food and food supplement registration. Medical products are high-risk medical devices or low-risk medical supplies. Then, we have pharmaceutical products, including new innovative drugs, generic drugs, health (supplements), herbals, and cosmetics. According to the Saudi FDA regulations, every type has different requirements.
In addition to products, the authority inspects and licenses related entities, such as manufacturers, warehouses, consulting firms, and marketing authorisation holders (MAH). In some cases, the SFDA regulations might also apply to brand owners, license holders, and raw materials suppliers.
We will start with who can submit before what to submit. The regulations allow specific legal entities to approach the Saudi FDA for application submission.
The following sections will discuss the available options for local and international companies.
Local Saudi companies can directly submit their applications to the SFDA. However, they must be licensed for the related activity and have proper access to related electronic systems. Commercial activities include food, drugs, herbals, medical devices, cosmetics, veterinary drugs, animal feeds, and pesticides.
International companies can submit to SFDA through one of the following entities:
The SFDA approval process starts by assessing the submitted product file by different departments inside SFDA. The approval is associated with the product’s full compliance with applicable laws, standards, and requirements. The approval timelines depend on the procedure type, the number of deficiencies, and the time needed to respond to inquiries.
In the sections below, we describe the different types of product registration applications.
The SFDA registration and approval process is a scientific and technical review of the product files to ensure the safety, efficacy, and good quality of the drug products and medical devices. The authority also ensures the safety of food, cosmetics, and other types of products that we will cover in this post.
The approval process starts when the company submits the SFDA product registration requirements in the application. The authority then performs a scientific assessment to verify compliance, and the product that proves adherence to the regulations and applicable standards will be granted marketing approval.
Read below a brief on how to register different product types in SFDA with a link to a detailed reference post.
The Saudi FDA’s drug sector publishes and updates the related guidelines, assesses drug registration applications, and issues marketing approvals and licenses.
They detail the drug registration requirements for chemical entities, biologicals, biosimilars, radiopharmaceuticals, health products, herbal products, generics, and veterinary drugs.
The SFDA links the drug marketing authorisation MA to three entities:
The SFDA registration applications come in several types, as follows:
This application includes new chemical entities, known active substances, biologicals (vaccines), biosimilars, radiopharmaceuticals, generics, and health products. The application can go through one or more of the following procedures and designations:
Read more about labelling requirements, Pharmacovigilance (QPPV), and Clinical Trials in Saudi Arabia.
Herbal and health products for human medical use must be registered under the drug sector. The SFDA requires a complete CTD or eCTD file for registration.
This application includes new drugs, biologicals, generics, herbal products, and health animal products. The application can go through one or more of the following procedures:
Medical device regulations in Saudi Arabia are becoming more advanced every year. This is to cope with the global advancement toward more stringent medical device regulations. Here are two examples of the latest significant updates:
Read more in Medical Device Registration | Authorised Representative.
Cosmetic regulation is under SFDA jurisdiction, which requires cosmetics registration through a notification procedure. This means the SFDA doesn’t review the content of the submitted cosmetics; it instead leaves the compliance responsibility to the applicant. The SFDA will list the product in its database whether it is fully complied with or not.
Therefore, submitted files must comply with all applicable Saudi and GSO standards to avoid rejection of shipments at the port or withdrawals from the market.
Read more about cosmetics registration.
Generally, food registration requirements are less complicated than those for other types of products. However, food product ingredients, labels, manufacturers, and raw material sources must all comply with the SFDA regulations and GSO (GCC) standards. The food sector also does not thoroughly review food labels. It leaves the compliance review to the applicant and only checks compliance at the port of entry.
The registration of food supplements might fall under the food sector in the advanced food application. Alternatively, it might fall under the drug sector in the health and herbal application if it contains high levels of vitamins and minerals or medical claims.
Biocides such as sanitisers and disinfectants are also regulated by SFDA and require registration. If they are for human use, they are health products; if they are used on medical instruments, they are classified as medical devices. In most cases, an expert must review such products to determine their pathway and provide advice on how to alter the applicable procedure if possible.
Biocides not for human use are under the regulations and registration requirements of the Saudi Standards, Metrology, and Quality Organization (SASO) or the Ministry of Agriculture.
Animal feed additives (also called fodder or forage) are products for which SFDA requires registration. The process is simple and only gets complicated with complex ingredients. The evaluation itself should not take more than 1-2 weeks, but in other cases, the request for more information could take the process to months of review and scientific committee involvement.
In May 2015, a royal decree made the SFDA the official regulatory body for tobacco. It became responsible for tobacco standardisation, registration, clearance approval, and entity licensing. It also monitors the components and emissions of tobacco & nicotine products. The current Tobacco Regulations are:
Pharmaceutical manufacturer registration is required for sites producing drugs, health products, and herbal products. These sites are subject to mandatory inspection and fee payment. For more, read SFDA GMP Manufacturer Registration.
Only poultry, dairy, and fish product manufacturers are subject to registration and inspection. This also includes their related slaughterhouses and suppliers. Inspection might be waived for some cases.
SFDA inspection and registration is applicable to local medical device manufacturers and selectively to international ones. Currently, global manufacturers are required to appoint an authorised representative in Saudi Arabia.
Other types of product manufacturers are not required to be inspected. They must submit a manufacturer license (ML) and other qualifications, such as ISO certifications and related audit reports.
The product registration timelines depend on the product application type. For more details, read SFDA Timelines.
The government fees range from free of charge for cosmetics to as little as $267 for a product classification, reaching as high as $49,066.6 for a drug manufacturer registration.
For more details about all types of governmental charges, read SFDA Fees.
A governmental certificate issued by the SFDA indicates a product’s approval for marketing in Saudi Arabia. This certificate is issued after completing the registration process of a product or a manufacturer. It gives the green light to local manufacturers to start manufacturing and allows clearance of imported product shipments at the Saudi ports.
The images below are examples of an SFDA license and SFDA registration certificate.
It is by applying the required standards and complying with the SFDA requirements. To learn more about the process, refer to the related product type in this article.
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