SFDA Registration

In Saudi Arabia, companies must register their human and veterinary consumed products and receive marketing approvals from the Saudi Food and Drug Authority (SFDA) before marketing to consumers. This regulatory process is known as SFDA registration. It must take place before shipping the goods to Saudi or locally manufacture the products. The registration process starts by submitting an application for product registration. During this process, the SFDA performs a scientific assessment and compliance verification. Product files that prove adherence to SFDA regulations will be granted a registration certificate which allows the companies to start the marketing activities and be able to clear the shipments into the Saudi market.

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:

• SFDA Drug Registration Requirements
• SFDA Medical Devices Registration Requirements
• Authorized Representatives in Saudi Arabia
• Cosmetics Registration in SFDA
• SFDA Application Fees

Background

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.

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. 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).

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.

Scope of Industries and Products

Three main industries 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, pesticides, and animal health products such as veterinary drugs and feed (fodder, forage).

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

Saudi FDA Regulations

Regarding the applications submission, the regulations allow specific legal entities to approach the Saudi FDA. The following sections will discuss the available options for local and international companies:

Who can directly submit to SFDA?

Local Saudi Companies

Local Saudi companies can submit their applications to SFDA directly. However, they must be SFDA licensed for the related activity with a proper access to SFDA electronic systems. The activities licenses include food, drug, medical devices, cosmetics, animal feeds, and pesticides.

International Companies

International companies can submit to SFDA through one of the following entities:

• Distributors
  International companies can delegate their local distributors to register on their behalf.
• Foreign investor license
  International companies can establish their official presence in Saudi Arabia as a foreign investor company then apply directly to SFDA. This is usually not the best option for new companies for many reasons such as high annual gov fees, revenue taxes, having no sales yet, and other operational expenses.
• Scientific office
  International companies can establish an SFDA licensed scientific office and perform direct submissions to the authority.
• Consulting Company
  International companies can use SFDA licensed consulting companies to submit applications on their behalf and perform all sorts of life cycle managemet and benefit from professional regulatory and pharmacovigilance support. It is a great option especially for new companies to the Saudi market and for those with small product portfolio.
• In this case, the international company will be the owner of the marketing authorisation license and will benefit from many advantages such as:
  – Non commercial and independent partner
  – Professional regulatory support
  – Privacy of data
  – Control over distributors
  – Direct SFDA communication
  – Faster access:
  Submitting your application through an SFDA approved consulting office is a significant time saving option. E.g. PharmaKnowl can apply and secure the SFDA registration certificate for the international company before they even sign with a local Saudi distributor. Meaning, rather than waiting several months until a distributor is appointed, international companies can have their products submitted to the SFDA while they evaluate, negotiate, and sign with one or more distributors.

SFDA Approval Process

The final SFDA approval is associated with the product’s compliance. 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.

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 publish and update the related guidelines, assess drug registration applications, and issue marketing approvals and licenses. The granted drug marketing authorisation MA is linked to three entities:

1. The Marketing Authorisation Holder (MAH): This entity is the owner of the marketing authorisation; 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 an MAH in Saudi except for some 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

For more details about drug file content and the registration process:

• SFDA Drug Registration Requirements
• labelling Requirements
• Clinical trials in Saudi Arabia
• Saudi Arabia QPPV

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. Here are two examples of the latest major updates:

• From 1 Jan 2022, the SFDA required 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 Harmonisation Task Force GHTF route (e.g. US FDA, EU CE, Japan).
• From September 2022, the SFDA stopped the simple registration route for low risk medical devices. Instead, they all have to secure medical device marketing approval MDMA just as any high risk device by providing the necessary technical file.

For more details, refer to our articles:

• SFDA medical device registration
• Authorized Representative in Saudi Arabia

Cosmetics

Cosmetics are also under SFDA jurisdiction. Their registration takes place in a notification procedure, which means that SFDA isn’t reviewing the content of the submitted files while listing a cosmetic product. Therefore, the compliance responsibility falls ultimately on the applicant regardless if it was listed by SFDA with a prohibited substance or claim. Submitted files must be in compliance with all applicable Saudi and GSO standards to avoid rejection of shipments at the port or withdrawals from the market. For more details, read SFDA cosmetics registration.

Food

Generally, food registration requirements are less complicated than drugs and medical devices. However, food product ingredients, label, manufacturer, and raw material sources are all must be in compliance with the SFDA regulations and GSO (GCC) standards. 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 commercialise it in Saudi.

Timelines

The product registration timelines in the SFDA depend on the type of product application. For more details, read SFDA Timelines.

Fees

SFDA fees range from free of charge for cosmetics, or as little as $267 for a product classification, reaching to as high as $49,066.6 for a drug manufacturer registration in Australia. For more details, read 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 are subject to a mandatory SFDA inspection and payment of high fees. For more details about the inspection and GMP, read SFDA GMP Manufacturer Registration.

Regulatory Consulting and Services

At PharmaKnowl Consulting, we support companies in:

• Securing marketing approvals (SFDA registration).
• Life cycle management
• Distributor search
• Local manufacturing
• Marketing authorisation transfer projects
• Full representation in Saudi Arabia
• Legal establishment of MNCs
• Provision of insights and regulatory intelligence information
• Pharmacovigilance and LQPPV services

For more information or request an online call, contact us.

Read More

• SFDA Drug Registration Requirements & Approval Process
• SFDA Medical Devices Registration
• SFDA Classification
• Pharmacovigilance & QPPV Requirements in Saudi Arabia