Receiving SFDA approval is required before marketing of medical and health products in Saudi Arabia. The regulations stats that SFDA registration of drugs, food, medical devices, food supplements, cosmetics, and other products needs to be achieved before marketing the products in the country. Otherwise, heavy penalties and shipments rejections should be expected.
Since the Saudi FDA regulations are under frequent updates, manufacturers and marketing authorization holders should plan for SFDA approvals at early stages to prepare their products for compliance to pass the SFDA registration requirements.
The Saudi Food and Drug Authority (SFDA) regulates three primary industries in Saudi Arabia; food, drug, and medical devices. Under those three sectors, the SFDA also regulates other healthcare products such as herbals, supplements, cosmetics, biocides, and pesticides. In addition, it regulates animal health products such as veterinary drugs and feed (fodder, forage). SFDA also regulate and issue licenses for related companies such as manufacturers, warehouses, and consulting firms.
The SFDA is considered one of the most stringent authorities in the MENA region. It is one of the first adopters of international standards in the region. In 2021, SFDA became a full regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
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
Why do companies need SFDA Registration?
Regulatory authorities control the 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 products’ 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 such as distributors or manufacturers can submit their product registration applications to SFDA. They must be 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 new to the Saudi Arabia market can submit their files in different SFDA procedures through an SFDA licensed regulatory consultation office. For example, PharmKnowl applies and secures SFDA registrations on behalf of international companies before they even contract with a local Saudi distributor. It is a great option to reduce the long time usually needed for a new market entry. This is since a company can conduct the distributor search, commercial negotiations, and make agreements 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 seeking a foreign investor license. It is the establishment of their branch entity in the country. It is usually not the best initial option for most companies due to the applicable revenue tax and other operating costs.
SFDA Approval Process
The SFDA approval is ultimately associated with the product’s compliance with SFDA regulations. While the approval time is usually affected by the regulatory professionals’ performance and the company’s experience in the market.
In the below sections, we describe in detail the types of product applications with background on the compliance conditions.
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, 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 registration 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), herbal, 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.
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:
- 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.
- The Manufacturer: Local or international finished product manufacturing site. A drug can be registered with one or more manufacturers.
- 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)
- Biologicals and Biosimilars
- Health Products
- Herbal Products
- Veterinary Drugs
- Pharmaceuticals (Drugs)
- Biologicals, Vaccines
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 the medical defies 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.
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.
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 Supplements
- Feed Products
In May 2015, Saudi’s tobacco law was updated by a royal decree to include a significant change to make the SFDA the official regulator 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.
The 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.