Since SFDA product registration is required before marketing food, drug, medical devices, and other healthcare products in Saudi Arabia. Manufacturers and marketing companies ought to plan for securing SFDA approvals at the early stages to have their products marketed without delay. In this article, we will list with details all available SFDA product applications for registration, their requirements, fees, timelines, and more.
Table of contents
- Why SFDA Registration is Required?
- Who Can Apply for SFDA Product Registration?
- SFDA Products Registration
- Products Registration Timelines
- Registration Fees
- SFDA Manufacturer Registration
Why SFDA Registration is Required?
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 safety, efficacy, and quality of the products. Therefore, marketing in Saudi Arabia requires companies to obtain an SFDA registration approval to be legally permitted to market and use the approval to facilitate the importation and clearance process at the Saudi ports.
Who Can Apply for SFDA Product Registration?
Local Saudi Companies
Local Saudi distributors who are SFDA licensed can submit their applications to SFDA. They need to have access to SFDA electronic systems to file their application.
– Without a local Saudi distributor
If an international company is new to Saudi Arabia and without a local distributor, it still can perform many SFDA procedures through an SFDA licensed regulatory consultation office.
At PharmKnowl, we provide a group of direct services for new international companies. It is a legal solution to cut the time needed for the distributor search, commercial negotiations, and the agreement legalization. Instead, international companies will be able to go directly to the submission process. Our office will officially submit your application to the SFDA and work in parallel on the distributor search and agreement. Contact us now for more details.
– With a local Distributor
International companies can submit requests for SFDA product registration through their local distributors. They need to have a commercial agreement in place with an agency certificate issued by the Saudi Ministry of Commerce.
– Licensed as a Foreign Investment Company
Foreign companies who are licensed through the Ministry of Investment are holders of a Saudi commercial record which entitles them to act in the market just as local companies. They still need to secure a valid SFDA license for the needed activity (pharmaceuticals, cosmetics, etc).
– With a Scientific Office
The Scientific Office is a legal entity that is only available for pharmaceutical companies. This office is allowed to perform scientific activities related to regulatory and drug safety without trading. This type of entity is allowed to submit applications for product registration to the SFDA.
SFDA Products Registration
SFDA is structured into three main sectors. Food, drugs, and medical devices. Each sector has many procedures and routes of registration that depend on product type and nature. For example, food comes into two types; the regular food registration and the food supplement registration. Medical devices are subject to different types of applications according to their class. With regard to drug product registration, they also vary in types such as new innovative drugs, generic drugs, health, and herbal products. Every type of registration is with a different set of requirements and registration timelines.
In drug product registration, every drug is linked to three entities:
- The Marketing Authorization Holder (MAH): The owner of the marketing rights, could be a local or international pharmaceutical company. A non-manufacturing company cannot legally be an MAH in Saudi except with special conditions, contact us for support on this point.
- The Manufacturer: Local or international site. Every product could be with multiple registered manufacturers.
- The local distributor: A local Saudi pharmaceutical company.
The drug sector in the SFDA is responsible for the regulation of drugs in Saudi. The related guidelines for drug registration are published by this sector. Under it, the evaluation administration performs the assessment of the applications and publishes the guidelines. They are responsible for different types of applications in (SDR) and (eSDR) system, as follows:
- Human Drugs
- Pharmaceuticals (Drugs)
- Biologicals and Biosimilars
- Health Products
- Herbal Products
- Veterinary Drugs
- Pharmaceuticals (Drugs)
- Biologicals, Vaccines
To learn more, refer to SFDA Drug Registration Requirements
In drug marketing, the local MAH terminology is not officially used by SFDA nor that it is popular in Saudi. The term “agent” is the official name for the local company that has the marketing right from the international company. Worth mentioning that SFDA allows assigning more than one local agent or distributor for international companies. This was not allowed until 2011 when SFDA announced this change in favor of drug availability.
SFDA medical devices requirements are becoming more advanced every year. This is to cope with the global progress toward more strict regulations for medical devices, especially in the safety part. Starting from 1 Jan 2020, the SFDA is only accepting the Technical File assessment application which is similar to the EU MDR. Approval in reference agencies such as the FDA or CE certifications will no longer be sufficient without submission of full technical files.
SFDA medical devices applications are not so different than the EU, they are in four types in Ghad system:
- Low-Risk Medical Devices (Medical Supplies)
- Class I
- Class II
- Class III
Regulating cosmetics in Saudi is also under SFDA jurisdiction. Cosmetics products need to be registered in eCosma registration/notification system before marketing. To learn more, refer to SFDA cosmetics registration Requirments.
Generally, food registration requirements are less complicated than drugs and medical devices. However, this is only true when your food product ingredients, label, manufacturer, source, are all in compliance with the SFDA regulations and GSO (GCC) standards. Therefore, only experienced and knowledgable professionals are able to support with advanced guidance and consultation.
Food registration system is (FRCS). The food sector generally accept different types of applications such as:
- Food Supplements
- Feed Products
In May 2015, tobacco law in Saudi was updated by a royal decree to include a significant change which is to make the SFDA the official regulator body for tobacco in Saudi. It became responsible for tobacco standardization, registration, and entity licensing. It also monitors the components of marketed tobacco products, their emissions, issues scientific reports, and periodically updates its regulations accordingly.
Current Tobacco Regulations:
- Standards: SFDA is applying the Gulf (GCC) standards known as (GSO) with regard to specifications and components.
- Packaging: SFDA is enforcing plain packaging for cigarettes.
- Electronic Cigarettes: SFDA had 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 be allowed to import tobacco and commercialize it in Saudi.
Products Registration Timelines
The product registration timelines in the SFDA depends on the type of product application. It takes:
- From 4 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 fees range from $266.66 for a product classification request to $49,066.6 for a drug manufacturer registration in Australia!
SFDA Manufacturer Registration
The manufacturer registration is required during the registration of some types of products. Manufacturers of food and medical devices just need to submit their licenses such as ISO certifications. On the other hand, drug manufacturers are required to register their sites by paying fees, receive SFDA inspection, and provide many technical documents. Then they need to maintain the validity of their SFDA GMP license in addition to the product license.