SFDA Registration & Regulations

sfda product registration

In Saudi Arabia, companies must receive product approval from Saudi Food and Drug Authority (SFDA) before marketing to consumers. This regulatory process is known as the SFDA registration wherein companies submit an application to the authority to undergo a scientific assessment and verification of compliance. Product files that prove adherence to applicable regulations will be granted an SFDA registration certificate which entitles the companies to start marketing activities and be able to clear the shipments into Saudi Arabia.

There are three main industries that fall under the SFDA jurisdiction; food, pharmaceutical (drug), and medical devices. Under that, SFDA regulates other healthcare products such as herbals, food supplements, cosmetics, biocides, medical supplies, and pesticides. In addition, there are SFDA departments within the drug and food sectors that are dedicated to animal health products such as veterinary drugs and feed (fodder, forage).

Besides products, the SFDA inspects and licenses their related entities such as manufacturers, warehouses, consulting firms, and marketing authorization holders (MAH). The SFDA regulations also extend to include brand owners, license holders, and in some cases the ingredients suppliers.

The SFDA is considered the most stringent authority in the MENA region. It is the first adopter of international standards with its own development of laws. Hence, it is considered a reference country for the GCC and MENA region countries. 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).

In fact, the SFDA laws for some types of products are even more strict than the US which is the main reference country for Saudi. For example, food supplements in pharmaceutical forms are subject to heavy requirements in Saudi while they can be registered with few light files in their home countries. That’s why we find most the US-manufactured supplements cannot be registered in Saudi with the same US files. The same complexity applies to simple medical supplies and veterinary products.

Therefore, it is highly recommended that companies start their planning for securing the SFDA approval at the earliest stages possible.

This article will detail different types of SFDA registration applications, requirements, fees, timelines, and more. For product-specific details, you can browse our other published posts:

Why need SFDA Registration?

Regulatory authorities control product placement in the markets to protect the public from harmful (unsafe), low-quality, falsely claimed, counterfeit, and useless products. Their ultimate responsibility is to ensure the product’s safety, efficacy, and quality. Therefore, marketing in Saudi Arabia requires companies to obtain an SFDA registration to be legally permitted to market and use the approval to facilitate the importation and clearance process at the Saudi ports. The proof of SFDA registration is granted in a document called SFDA Certificate.

Saudi FDA Regulations

Regarding the submission of registration applications, the regulations allow specific legal entities to approach the Saudi FDA for approval. The below sections will discuss the local and international companies’ options.

Who can directly submit to SFDA?

1. Local Saudi Companies

Local Saudi companies can submit their product registration applications to SFDA directly. However, they must be already SFDA licensed for the related activity with proper access to SFDA electronic systems to file their application. Examples of the activities are food, drug, medical devices, cosmetics, animal feeds, and pesticides.

2. International Companies

International companies, which are new to the Saudi Arabia market, can submit to SFDA through an SFDA-licensed regulatory consultation office. For example, PharmaKnowl applies and secures SFDA registrations on behalf of international companies before they even have a local Saudi distributor. It is a great time saving option rather than waiting for distributor appointment is negotiated and signed. Instead, international companies can conduct distributor searches, commercial negotiations, and finalize their commercial contracts while their products undergo the SFDA registration process. Contact us for more details.

The other option for international companies is to establish their official presence in Saudi Arabia by establishing a foreign investor license. It is usually not the best initial option for most companies due to the applicable revenue taxes and other operating costs.

SFDA Approval Process

The final approval is associated with the product’s compliance with SFDA regulations. But approval timelines depends on the procedure type, the number of deficiencies, and the time needed to respond to inquiries.

In the below sections, we describe in detail the types of product applications with background on the compliance conditions.

How to get sfda approval?

It is by applying the required standards and complying with the SFDA requirements. Refer to the product type below and follow the instructions.

SFDA Product Registration

The SFDA is structured into three main sectors. Food, Drugs, 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. When it comes to medical products, they are classified as high-risk medical devices or low-risk medical products or supplies. Then we have the pharmaceutical products, including new innovative drugs, generic drugs, health (supplements), herbals, and cosmetics. According to the Saudi FDA regulations, every type has a different set of requirements. We will discuss every product type in more detail in the below sections.

Drug

The regulation of pharmaceuticals is the responsibility of the drug sector in the Saudi FDA. They write and update the related guidelines, assess drug registration applications, and issue marketing approvals and licenses. The granted drug marketing authorization MA is linked to three entities:

  1. The Marketing Authorization Holder (MAH): This entity is the owner of the marketing authorization; it is the same MAH reflected in the CPP for international companies. Therefore, the local Saudi company (e.g. consulting, warehouse, distributor) has no control over the license even if the MAH has no presence in the country. Note that a non-manufacturing company cannot legally be a MAH in Saudi except for exceptional cases; contact us for support on this point.
  2. The Manufacturer: Local or international finished product manufacturing site. A drug can be registered with one or more manufacturers.
  3. The agent: A local Saudi company licensed by SFDA for drug activity.

The SFDA registration applications come in several types as follows:

  • Human Drugs
    • Pharmaceuticals (Drugs)
    • Radiopharmaceuticals
    • Biologicals and Biosimilars
    • Health Products
    • Herbal Products
  • Veterinary Drugs
    • Pharmaceuticals (Drugs)
    • Biologicals, Vaccines

To learn more about the drug file, labelling, clinical trials, and pharmacovigilance requirements. You may refer to our detailed article: SFDA Drug Registration Requirements.

Medical Devices

SFDA medical device regulations are becoming more advanced every year. This is to cope with the global advancement toward more stringent medical device regulations, especially in safety. For example, starting from 1 Jan 2022, the SFDA requires companies to submit the full product Technical File (TFA), similar to the EU MDR. SFDA is no longer accepting medical device files through the Global Harmonization Task Force GHTF route (e.g. US FDA, EU CE, Japan).

For more details, refer to our articles: SFDA medical device registration. Also, it is essential to read about how to appoint a local Authorized Representative in Saudi Arabia for your legal manufacturer.

Cosmetics

Regulating cosmetics in Saudi is also under SFDA jurisdiction. Cosmetics SFDA registration takes place as a notification procedure, which means that SFDA isn’t reviewing the content of the submitted files while listing a cosmetic product. Therefore, the registration responsibility falls ultimately on the applicant, who must ensure compliance with all applicable Suadi and GSO standards to avoid rejection of shipments at the port or withdrawals from the market. To learn more, refer to our article: SFDA cosmetics registration Requirements.

Food

Generally, food registration requirements are less complicated than drugs and medical devices. However, this is only true when your food product ingredients, label, manufacturer, and source are all in compliance with the SFDA regulations and GSO (GCC) standards. Therefore, only experienced and knowledgeable professionals can provide advanced guidance and consultation.

The food sector generally accepts different types of applications such as:

  • Food
  • Food Supplements
  • Feed Products
  • Pesticides

Tobacco

In May 2015, Saudi’s tobacco law was updated by a royal decree to include a significant change to make the SFDA the official regulatory body for tobacco. It became responsible for tobacco standardization, registration, clearance approval, and entity licensing. It also monitors the components and emissions of tobacco & nicotine products. The current Tobacco Regulations are:

  • Standards: SFDA applies the Gulf (GCC) standards known as (GSO) concerning specifications and components.
  • Packaging: SFDA is enforcing plain packaging for cigarettes.
  • Electronic Cigarettes: SFDA issued specific requirements and standards for e-Cigarettes, heated cigarettes, and other related devices.
  • Licensing: local distributors have to obtain a special import license to import tobacco and commercialize it in Saudi.

Products Registration Timelines

The product registration timelines in the SFDA depend on the type of product application. It takes:

  • From 5 to 14 months for drug approval.
  • From 2 to 16 weeks for medical devices.
  • From 5 to 30 days for food products.

That’s the timelines in a nutshell, though applicants must be aware that their response time to the SFDA inquiries is not counted and would add up to the original timelines.

SFDA Registration Fees

SFDA fees range from free for cosmetics to as little as $267 for a product classification, reaching as high as $49,066.6 for a drug manufacturer registration in Australia. For more information, refer to our detailed post: SFDA Fees.

Manufacturer Registration

Manufacturer registration is required during the registration of some types of products. Manufacturers of food and medical devices need to submit their licenses and other qualifications such as ISO certifications. On the other hand, drug manufacturers must register their sites by submitting many technical documents, passing the SFDA inspection, and paying the fees. Read more in our post: SFDA GMP Manufacturer Registration.

Registration Services & Consulting

At PharmaKnowl Consulting, we support companies to secure marketing approvals and uncover the details of SFDA registration in Saudi Arabia. We help international companies to overcome any obstacles in the Saudi FDA regulations. Our x SFDA consultants are ready to listen to your needs. For more information, talk with an SFDA consultant.

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