Comprehensive Guide to Registration with the Saudi Food and Drug Authority (SFDA)

The Saudi Food and Drug Authority (SFDA) plays a vital regulatory role in the Kingdom of Saudi Arabia, not only protecting public health but also enabling economic growth and supporting innovation in critical sectors. This report aims to provide a comprehensive and in-depth overview of the requirements and steps for registration with the SFDA, highlighting the strategic importance of this procedure for establishments and products in the Saudi market.

The Saudi Food and Drug Authority (SFDA): A Cornerstone for Public Health and Economic Growth

The SFDA plays a pivotal role in ensuring the safety and quality of products that directly impact consumers' lives. This goes beyond traditional regulatory oversight to include an active contribution to achieving the objectives of Saudi Vision 2030, which focuses on economic diversification and enhancing the business environment.

Vision, Mission, and Strategic Objectives

The SFDA's vision is to be "a globally leading authority based on scientific foundations to enhance and protect public health." Its mission revolves around "protecting society through effective legislation and a regulatory system to ensure the safety of food, drugs, medical devices, cosmetic products, pesticides, and feed." This vision and mission clearly underscore the SFDA's position as a scientifically driven regulatory body, placing consumer safety at the core of its priorities across a wide range of products.

In line with its commitment to continuous development and national aspirations, the SFDA launched its Fourth Strategic Plan for the period 2023-2027. This plan is based on three main pillars:

• Product Safety: This pillar includes developing the regulatory system, improving communication and awareness, and developing legislation and oversight for biotechnology and modern products.

• Local and International Partnerships: Through this pillar, the SFDA aims to enhance product availability, promote international leadership, encourage research and innovation, and, most importantly, empower investors.

• Operational Excellence: This pillar focuses on diversifying revenue sources, developing human capital, and increasing the use of advanced digital technologies.

The inclusion of "empowering investors" and "supporting research and innovation" among the SFDA's strategic objectives indicates that the Authority is not merely a regulatory guardian but also a catalyst for economic growth in the health and food sectors. This orientation directly aligns with the goals of Saudi Vision 2030, which aims for economic diversification and increased private sector contribution. The focus on digital transformation within the strategic plan reflects the SFDA's commitment to modern and effective governance that supports an active business environment. Consequently, companies should view compliance with SFDA requirements not just as an operational cost, but as a contribution to the Kingdom's strategic economic goals and a means to achieve long-term market stability.

Scope of Regulation: Products and Activities Supervised by the SFDA

The Saudi Food and Drug Authority exercises comprehensive oversight over a wide range of products and activities to ensure consumer safety and product quality in the Saudi market. Its regulatory scope includes the following categories:

• Food

• Drugs

• Medical Devices

• Cosmetic Products

• Pesticides

• Feed (Animal and Veterinary Products)

• Vaccines, Blood, and Biological Products

• Radiation-Emitting Products

• Tobacco Products

• Halal Products

• Laboratories

• Nutrition

The following table details the products and activities subject to SFDA regulation, providing a clear overview for any company or investor to determine if their products or services fall within the SFDA's jurisdiction.

Table 1: Products and Activities Subject to SFDA Regulation

This comprehensive list of regulated products and activities demonstrates that the SFDA adopts an integrated and holistic approach to public health and safety. By overseeing everything from food consumption to medical interventions and even lifestyle products, the SFDA aims to minimize regulatory gaps and ensure a continuous chain of safety and quality. This means that companies entering the Saudi market must recognize that compliance is not isolated; their products may interact with multiple SFDA regulatory domains, necessitating a broad understanding of the SFDA's overarching mandates.

Why is Registration with the SFDA Necessary?

Registration with the SFDA is a crucial and indispensable step for any company seeking to enter or operate in the Saudi market within the sectors supervised by the Authority. The reasons why this registration is essential are numerous, extending beyond mere legal compliance to include strategic and competitive aspects:

• Ensuring Product Safety and Quality: Registration is a fundamental step to ensure that products meet approved safety and quality standards. This protects consumers from potentially harmful or ineffective products and confirms the company's commitment to health and regulatory standards.

• Legal Market Access: The registration certificate issued by the SFDA is a government document confirming that the company or product is authorized for marketing and sale in the Kingdom. Without this certificate, products cannot be legally imported, manufactured, or distributed. For example, registration of imported feed products is explicitly required. Therefore, non-registration means an absolute inability to operate legally in the Saudi market.

• Compliance with Technical Regulations: The registration process ensures that products comply with approved technical regulations and circulars issued by the SFDA, such as those governing packaged food labels (SFDA.FD/GSO 9). This ensures that products meet all necessary technical requirements to guarantee their quality and safety.

• Facilitating Customs Clearance: A valid registration certificate contributes to facilitating the electronic customs clearance process for imported goods. This reduces delays at ports and accelerates product entry into the market, benefiting supply chains.

• Building Consumer Trust: The rigorous evaluation process conducted by the SFDA, culminating in registration, enhances public confidence in the safety and effectiveness of products available in the market. This trust is an invaluable asset for brand reputation and market acceptance, distinguishing compliant companies in a competitive environment.

In essence, while the available information clearly states that registration ensures product safety and market eligibility, the profound impact on companies is that registration represents the sole legitimate gateway to the Saudi market for regulated products. Non-registration means an absolute inability to operate legally. Beyond the purely legal aspect, the SFDA's strong scientific and regulatory framework means that a registered product carries an implicit seal of approval, significantly enhancing consumer trust and market acceptance. This trust is a critical intangible asset that distinguishes compliant companies in the competitive landscape.

General Principles of SFDA Registration: A Unified Approach

The SFDA follows a unified approach in its registration processes, based on a set of fundamental requirements and common steps that apply to most types of registration, whether for establishments or products. This approach aims to simplify the process and ensure transparency and efficiency.

Essential Prerequisites for All Registration Types

There are a set of fundamental requirements that must be met before embarking on any registration process with the SFDA, forming the legal and procedural basis for dealing with the Authority:

• Electronic Account Creation: The first and essential step for most SFDA services, including product and establishment registration, is to create an electronic account on the relevant platform, such as the "Ghad" platform. This ensures that all interactions occur through approved digital channels.

• Valid Commercial Registration: The applicant must possess a valid commercial registration that includes the activity associated with the product or establishment to be registered. This condition confirms the legal status of the company in Saudi Arabia.

• SFDA Establishment License: In many cases, especially for local manufacturers, importers, or distributors, obtaining a prior establishment license (e.g., factory, warehouse, or importer license) from the SFDA is a prerequisite for product registration. This means that the operating entity itself must be approved before its products can be registered.

• Foreign Company Considerations: International companies typically need to apply through one of the following channels: local distributors/importers, obtaining a foreign investor license from the Ministry of Investment, establishing a local entity, or through a licensed consulting office.

• Authorization Letter/Power of Attorney: For individuals or entities managing the registration process on behalf of the main company, an official authorization letter or certified power of attorney, often from the Chamber of Commerce, is required.

• Payment of Financial Fees: Registration processes generally involve the payment of specific fees, which vary depending on the product category and type.

The consistent emphasis on "electronic account creation" and possessing a "valid commercial registration" reveals that the SFDA's regulatory framework heavily relies on digital interaction and formal recognition of legal entities within the Kingdom. This means that companies must establish their fundamental legal and digital presence before they can even begin product registration. Furthermore, the requirement for an SFDA establishment license reinforces the idea that the operating entity must be compliant and approved before its products can enter the market. This structured approach streamlines the regulatory burden by ensuring basic legal and operational readiness.

Overview of Key Electronic Platforms

The SFDA relies on several specialized electronic platforms to manage its diverse regulatory functions, enhancing efficiency and facilitating access for applicants.

• Ghad Platform: This platform serves as a unified electronic system for registering products and establishments. It acts as a central hub for various categories regulated by the SFDA, including food, drugs, medical devices, and cosmetics. It is specifically used for registering local food establishments and general product registration.

• Food Registration and Clearance System (FRCS): This platform is specifically dedicated to registering traditional food products. It can be accessed via the link: https://frcs.sfda.gov.sa/Login.aspx.

• Saudi Drug Registration (SADR): This platform is the main gateway for registering human drugs.

• eCosma System: This system is used for registering cosmetic products.

• National Feed Register (AFNR): A dedicated system for registering feed products and establishments.

• Product Classification System (PCS): Used for product classification, a step often preceding full registration. It can be accessed via the link: https://pcs.sfda.gov.sa/Default.En.aspx.

The following table illustrates the SFDA's main electronic platforms and their functions, providing a clear map of the SFDA's digital environment. This table helps companies identify the correct electronic portal for their product or establishment type, simplifying their initial interactions with the SFDA and avoiding common navigation errors.

Table 2: Key SFDA Electronic Platforms and Their Functions

The extensive use of specialized electronic platforms (Ghad, FRCS, SADR, eCosma, AFNR, PCS) for various regulatory functions underscores the SFDA's commitment to digital transformation. This indicates a clear trend towards increasing efficiency, reducing processing times, and enhancing transparency across all regulatory operations. For companies, this means that the vast majority of interactions with the SFDA will be online, necessitating strong internal digital capabilities and effective data management systems. It also suggests that the SFDA is proactively investing in technology to handle the increasing volume of applications as the market expands, aiming to provide a seamless and predictable regulatory experience.

Common Steps Across Different Registration Processes

Despite variations in specific requirements for each product category, several common fundamental steps apply to most SFDA registration processes:

• 1. Electronic Account Creation: The initial step involves creating a user account on the relevant SFDA electronic platform (e.g., Ghad, FRCS, DENR).

• 2. Submission of Registration Application: The specific application form for the required registration (whether for a product or an establishment) is completed and submitted through the electronic system.

• 3. Attachment of Required Documents: All necessary supporting documents and licenses specified for the particular registration type must be uploaded.

• 4. Payment of Financial Fees: Applicable fees for the registration service are paid through designated payment channels.

• 5. SFDA Review and Evaluation: The submitted application and documents undergo thorough review and evaluation by SFDA officials to ensure compliance with all regulations and standards.

• 6. Issuance of License/Certificate: Upon successful review and approval, the relevant license or registration certificate is issued electronically.

The following table presents the general steps for SFDA registration, providing a high-level roadmap for any registration process. By highlighting commonalities, this table helps applicants understand the basic workflow, reducing initial confusion and setting realistic expectations for the entire journey, regardless of the specific product or establishment type.

Table 3: General SFDA Registration Steps

The consistent sequence of steps across different registration types (account creation, application submission, payment, review, approval) indicates a highly standardized digital workflow within the SFDA. This standardization is a strategic move to enhance predictability for applicants, allowing them to anticipate the process regardless of their specific product. Furthermore, it enables the SFDA to scale its operations more efficiently, processing a larger volume of applications with consistency. This means that companies, once familiar with this basic workflow, can more easily adapt to new or updated regulatory processes, reducing the learning curve and the likelihood of errors.

Detailed Registration Pathways: Establishments and Products

Registration with the SFDA requires a precise understanding of the specific requirements and procedures for each category of establishments and products. This section provides essential details for each pathway, enabling applicants to effectively implement the steps.

Establishment Registration with the SFDA

The process of establishment registration is a fundamental step to ensure that entities operating in the food, drug, and medical device sectors adhere to the required operational and quality standards.

1. Local Food Establishments (Factories, Warehouses, Distribution Centers)

This service aims to build a database of local food establishments (factories, warehouses, distribution centers) and enable them to register their data, attach all required documents and licenses, as well as manage and track their licensing requests electronically, and facilitate the renewal process.

Key Steps:

• Access the "Ghad" platform.

• Create an account based on user type.

• Submit an establishment registration application.

• Pay the financial fees.

• License issuance after approval and review.

Required Documents:

• Copy of the industrial license issued by the Ministry of Industry and Mineral Resources.

• For bottled water and ice factories, approval from the Ministry of Environment, Water and Agriculture for the water source is also required.

Timeline and Cost:

• Service execution time is estimated at 12 working days.

• Service cost is 5000 Saudi Riyals.

The explicit requirement to submit an "industrial license from the Ministry of Industry and Mineral Resources" and, for specific types of food factories, "approval from the Ministry of Environment, Water and Agriculture for the water source" as prerequisites for food establishment registration with the SFDA reveals a crucial aspect of the Saudi regulatory environment: inter-ministerial coordination. This means that companies cannot solely focus on SFDA requirements but must navigate a broader governmental landscape, securing foundational licenses from other ministries first. The SFDA relies on these external approvals to ensure that the fundamental aspects of the establishment (e.g., industrial safety, environmental compliance) are met before granting its specialized license, creating a sequential and integrated approval process.

2. Industrial License Requirements (as a Prerequisite)

For industrial entities, an industrial license is a vital foundational step. This license allows for the registration of target products to be manufactured, submission of applications for site allocation, obtaining industrial loans, and energy allocation.

Initial Requirements (for immediate issuance of unrestricted activities):

• Valid commercial registration with an industrial activity.

• Submission of an industrial license issuance service request on the "Sanai" platform.

Requirements for Upgrading to Operational Status:

• Valid commercial registration with an industrial activity.

• Energy allocation from the Ministry of Energy.

• Valid site license/contract from designated site authorities.

• Environmental permit for construction.

• Submission of a status upgrade request on the "Sanai" platform.

• Most importantly, licenses and activity requirements from other competent authorities, including military industries and food and drug activities.

The detailed requirements for obtaining and upgrading an industrial license, particularly the explicit reference to "licenses and activity requirements from other competent authorities, including... food and drug activities," clearly positions the industrial license as a fundamental prerequisite for any company involved in manufacturing regulated products. This means that for manufacturers, the SFDA registration process is not an isolated task but an integral part of a larger, multi-stage industrial licensing journey. Companies must understand this broader regulatory ecosystem to avoid delays and ensure comprehensive compliance from the outset of their production activities.

3. Warehouse Licensing (General)

Mandatory Requirement: All local warehouses in Saudi Arabia must obtain a warehouse license from the SFDA before commencing operations. This applies to all commercial activities involving any products subject to SFDA regulation.

Key Compliance Criteria: Licensing requires adherence to:

• Good Distribution Practices (GDP).

• A robust quality system.

• ISO certifications (e.g., ISO 13485 for medical devices).

Specific Requirements for Medical Device Warehouses:

• Copy of Quality Management System certificate (ISO 13485) or inspection report/proof of quality management system implementation.

• Copy of academic qualifications for the technical manager and quality manager (if applicable).

• Copy of property deed or lease agreement for the warehouse.

• Compliance with medical device transportation and storage requirements published on the SFDA website.

• For radiation-emitting devices, a copy of the radiation protection officer's license and qualifications of technicians/specialists are required.

• Specification of the area designated for medical device storage.

The explicit mandate for "Good Distribution Practices (GDP), a quality system, and ISO" for warehouse licensing, specifically detailed for medical device warehouses, indicates that the SFDA's regulatory oversight extends far beyond just product formulation or manufacturing. It places a high priority on the safety and integrity of the supply chain after production. This means that companies involved in the storage and distribution of regulated products must invest in robust quality management systems, appropriate infrastructure, and qualified personnel to ensure product quality and safety are maintained until they reach the consumer. This comprehensive approach reflects a deep understanding of potential risks throughout the product lifecycle.

Product Registration with the SFDA (by Category)

Product registration requirements and procedures vary significantly based on the product category, necessitating a precise understanding of the specific pathway for each product.

1. Food Products: Requirements, Steps, and Timelines

The food product registration service aims to build a database of traditional food products and provide electronic services for imported and locally produced food establishments, ensuring the safety of these products through compliance with approved technical regulations.

Key Steps for Traditional Food Products:

• Create an electronic account on the Food Registration and Clearance System (FRCS) platform via the link: https://frcs.sfda.gov.sa/Login.aspx.

• Complete the "Marketing Notification" application form.

• Receive approval or rejection through the electronic system.

General Requirements:

• The product must comply with SFDA.FD/GSO 9 (Labels of Packaged Food Materials) and the specific technical regulation for the product to be registered.

• The product label (outer packaging) must contain all necessary information, including ingredients, nutritional value, and manufacturer's name and address.

• Labels must be in Arabic. If other languages are used, all data in those languages must conform to the data written in Arabic.

• Product labels must be submitted in "ARTWORK" format.

• Each product requires a separate registration application if any mandatory data on the product label differs (e.g., net weight, country of origin, manufacturer's name).

Required Documents (Examples):

• Valid commercial registration.

• Authorization letter.

• Full image of the product label from all sides.

• Image of the final product from the main facade.

• Purchase invoice or import declaration.

• Certificate of origin.

• Health certificate issued by an official authority in the exporting country (for imported products).

• Halal certificates for Halal food products.

• Product ingredient statement or product analysis certificate.

Registration Validity: Traditional food product registration is considered open-ended unless there is a change or update to any mandatory data on the product label.

Prohibitions/Restrictions:

• The shelf life of some products must not exceed 12 months; if it exceeds this period, the registration application should not be submitted.

• It is prohibited to place the SFDA logo or barcode for promotional purposes on product labels.

• Adding food ingredients to honey is prohibited (according to SFDA.FD 147).

• The use of partially hydrogenated fats in food industries is prohibited (according to SFDA.FD 2483).

The following table illustrates the expected timelines for food product registration by category, providing crucial information for companies to plan market entry and manage supply chain logistics. Understanding the varying processing times based on product complexity aids in business forecasting and more accurate resource allocation.

Table 4: Expected Timelines for Food Product Registration by Category

Note: Timelines are calculated from the date of electronic application submission and are cumulative within the SFDA.

The significant variation in registration timelines across different food categories (e.g., 90 days for novel foods versus 5 days for traditional foods) clearly indicates that the SFDA adopts a risk-based regulatory approach. Products deemed higher risk, more complex, or novel (such as medical foods or infant formula) undergo more extensive scrutiny and take longer. This means that companies must accurately categorize their food products and prepare for longer timelines and more stringent documentation requirements for complex or innovative items, aligning with the SFDA's vision to operate on scientific foundations to protect public health.

2. Pharmaceutical Products: Requirements, Steps, and Registration Pathways

The SFDA offers several pathways for drug registration, reflecting a sophisticated regulatory environment:

• Normal Registration.

• Priority Registration.

• Bridging and Verification Registration (for drugs already approved by major international authorities like FDA or EMA).

• Conditional Registration.

• Pioneer Drug Designation.

• Orphan Drug Designation.

Key Steps for Drug Registration (via SADR platform):

• Create an account in the National Register of Pharmaceutical Establishments (DENR).

• Submit a human drug registration application through the SADR platform.

• Complete and export the form with all required data.

• Pay the application fees.

• Receive Requests for Information (RFI) from the SFDA.

• Receive SFDA decisions.

• Print the registration certificate.

• Manage changes and renewals throughout the product lifecycle.

Required Dossier Structure (Common Technical Document - CTD):

The SFDA generally requires a comprehensive dossier organized into five modules. For example:

• New Drug: All five modules are required.

• Generic Drug: Specific sections of Modules 1, 2, and 3 are required.

• Health and Herbal Products: All sections of Modules 1 and 3 are required.

• Veterinary Drugs: Parts 1 and 2 are required.

Module 1 Requirements (Examples): Cover letter, comprehensive table of contents, application form, product information (Summary of Product Characteristics - SPC), expert information (Quality), environmental risk assessment, pharmacovigilance system, and Good Manufacturing Practice (GMP) certificate.

SFDA Verification During Review: The SFDA verifies aspects such as form type and fees, compliance with Marketing Authorization Holder (MAH) and manufacturer's legal status, Active Pharmaceutical Ingredients (API), Finished Pharmaceutical Product (FPP), clinical trial data, and safety data (SPC/PIL).

Barcode and Serialization Requirements (Track & Trace System):

• Aggregation principle (barcode allowing all data within a carton or container to be known by scanning) is mandatory.

• Serial numbers for packages will be provided through electronic linkage with the Track & Trace system, and a guidance manual will be published for this.

• Exemptions from 2D Barcode Requirements: Free drug samples, unregistered drugs requested by hospitals for specific patients/quantities, unregistered drugs imported for personal use, and drugs imported for secondary packaging in Saudi Arabia.

• Global Trade Item Number (GTIN) on Outer Package: Must be 14 digits. Compliance is mandatory, even if previous government shipments used a 10-digit GTIN.

• Serial Numbers: Must be unique for each drug package, with a maximum of 20 alphanumeric characters, generated by the company itself without requiring a third party, and must not be repeated for any package of the same drug.

• Expiry Date Format: Expiry date is printed on the outer package in MM YYYY format. Encoded data within the barcode must be in YYMMDD format, allowing "00" for the day (DD) if the day is not specified. Production date is not encoded.

The following table outlines the approved customs ports for the entry of pharmaceutical products, which is critical for pharmaceutical companies and importers. This table provides precise information on specific entry points for pharmaceutical products, essential for efficient logistics, customs clearance, and supply chain planning.

Table 5: Approved Customs Ports for Entry of Pharmaceutical Products

The availability of diverse drug registration pathways (priority, bridging, orphan drug designation) indicates a highly sophisticated regulatory framework that accommodates different drug types, public health emergencies, and international recognition. This reflects global best practices (e.g., leveraging FDA or EMA approvals for "bridging"). This demonstrates the SFDA's commitment to efficiency and rigorous oversight, aiming to expedite access to essential medicines while maintaining high safety standards. Furthermore, the detailed and mandatory requirements for barcode/serialization, GTIN, and specified import ports highlight a strong focus on supply chain integrity, traceability, and anti-counterfeiting measures. This illustrates a proactive and comprehensive approach to ensuring product authenticity and safety across the entire distribution network, which is paramount for patient protection.

3. Medical Devices: Requirements, Steps, and Marketing Authorization

Companies must submit a comprehensive Technical File (TFA) to register medical devices and apply for marketing authorization.

Steps to Obtain Import and Distribution License (e.g., for Optical Devices):

• Open an account on the "Ghad" platform.

• Select the "Import and Distribution License for Optical Devices" option on the SFDA's unified electronic platform (Ghad).

• Complete the application form and attach required documents.

• Pay the financial fees for the service.

• Upon obtaining the license, the establishment is permitted to import and distribute medical devices and supplies.

General Requirements for Establishments:

• SFDA account number for the investor.

• List of types of medical devices and products intended for supply to the Kingdom, with detailed information on manufacturers' addresses.

• Notify the SFDA of any change in submitted information within ten days of the change.

• Obtain a commercial registration with optical activity (from the Ministry of Commerce and Investment), a municipal license, and a civil defense license.

• The establishment is permitted to engage in activity only after obtaining the license from the SFDA and implementing and documenting a quality management system in accordance with Saudi specifications.

Required Documents for Establishments (Examples):

• Copy from the General Organization for Social Insurance or the establishment's account in the Labor Office for the number of medical staff working within the establishment.

• Clear and accurate sketch map of the establishment's location, showing city name, district name, street names, and names of neighboring establishments, written on the sketch.

• Copy of Quality Management System certificate (ISO 13485) or inspection report/proof of quality management system implementation.

• Copy of academic qualifications for the technical manager and quality manager (if applicable).

• Copy of property deed or lease agreement.

• Copy of industrial license from the competent authority.

Definition of "Innovative Medical Device": A medical device is classified as innovative if it uses new technology not available in the Saudi market, or if its indications for use and performance specifications have not been previously tested. Additionally, its use must benefit patients by offering a significant clinical advantage over approved devices/technologies or alternative treatments, or if no approved medical device or drug alternatives exist.

Post-Market Evaluation Studies: These are studies conducted with a scientific methodology on a medical device/product to verify its safety and efficacy due to the presence of safety signals for that locally marketed device. Expected outcomes include corrective/preventive actions, requests for additional clinical studies, and dissemination of safety awareness messages.

Compliance Timelines:

• Marketing authorization fees must be paid within thirty (30) calendar days after the SFDA requests payment.

• The allowed period for submitting a corrective action plan for a safety alert is five (5) working days from the date of SFDA notification or receipt of an inquiry from the SFDA.

The detailed focus on "post-market evaluation studies" and the extremely tight "five working days" deadline for submitting a corrective action plan for safety alerts highlight the SFDA's paramount concern for patient safety in the medical device sector. This means that regulatory compliance for medical devices is not a one-time event but an ongoing, high-stakes commitment. Companies must establish highly responsive internal systems for safety and quality management, capable of immediate action and transparent communication with the SFDA. Furthermore, the mandatory ISO 13485 certification reinforces the demand for robust quality systems throughout the entire product lifecycle, from design to post-market surveillance.

4. Cosmetics, Pesticides, and Feed: Key Registration Aspects

A. Cosmetics:

• Key Requirements: Adding product ingredients to the "eCosma" system is a fundamental requirement. Required documents include a copy of the establishment's main commercial registration, a copy of the owner's national ID, the company's articles of association, an investment authority license (if a foreign or mixed company), a copy of the national ID/residency permit for the person responsible for following up on the application, and a legal power of attorney.

• Product Label: Clear images of the product from all sides are required, showing its identity clearly and legibly. This includes internal and external product labels, and any internal leaflets. Product image guidelines can be found in the Gulf Standard Specification GSO 1943.

• Categories: Cosmetic products are classified into four categories in the "eCosma" system: simple cosmetic product, single diverse cosmetic product, compound product, and product kit.

B. Pesticides:

• Requirements: Scientific data on the pesticide's toxicity level, environmental impact, and first aid (SDS) must be completed. A copy of the product's packaging label in the country of origin in either Arabic or English, and a copy of the proposed pesticide label for approval, must be attached. A copy of the last registration certificate is required if requesting re-registration of the product.

• National Pesticide Register: Accessible via the link: https://ghad.sfda.gov.sa/ar/.

C. Feed:

• Registration Steps:

  • Access the AFNR system specialized in feed product registration.

  • Click on the "Register Product" icon.

  • Fill in the feed registration data and select the type of feed to be registered.

  • Enter detailed information and data related to the feed product's characteristics.

• Requirements: Packaging label according to SFDA requirements, product ingredient statement or analysis certificate, scientific and technical file, stability study, post-market studies (impact on animals, environment, humans), product certificate of origin (for imported products), recently issued free sale certificate (for imported products), health certificate (for imported products).

• Feed Types: Feed is classified into raw feed, feed additives, feed additive mixtures, and compound feed, each with specific components and uses.

• Oversight: Monitoring is conducted for both locally produced and imported feed.

Frequently Asked Questions and Solutions

Understanding common questions related to SFDA registration is vital to avoid common pitfalls and expedite the compliance process.

1. What is the Unified Electronic Platform (Ghad) and what are the steps and conditions for registration?

• Solution: The "Ghad" platform is a unified electronic system launched by the SFDA to facilitate the registration of products and establishments in the food, drug, medical device, cosmetic, and other sectors.

  • Steps: Create a new user account on the platform, submit a registration application, the application is evaluated by the SFDA, and then the necessary license is issued.

  • General Conditions: Create an account on the electronic system, a valid commercial registration covering the activity related to the product, an SFDA establishment license (factory, warehouse, importer), invoices and certificates proving the product's origin, and accurate completion of the registration application form.

2. What are the main requirements for licensing food factories?

• Solution: The primary requirement is to obtain the final industrial license from the Ministry of Industry and Mineral Resources. If the factory produces bottled water or ice, approval for the water source from the Ministry of Environment, Water and Agriculture is also required.

3. Should imported food products be registered once or multiple times if imported from several countries?

• Solution: If any mandatory data on the product label differs (e.g., net weight, country of origin, manufacturer's name), each product requires a separate registration application.

4. What is the validity period for traditional food product registration?

• Solution: The validity of traditional food product registration is considered open-ended unless there is a change or update to any mandatory data on the product label.

5. What are the requirements for a food product label?

• Solution: The product must comply with the requirements of SFDA.FD/GSO 9 and the specific regulation for the product to be registered. The product label refers to the outer packaging that contains all product information, including the list of ingredients, nutritional value, manufacturer's name and address, and other details as per regulations. The label must be in Arabic, and if other languages are used, all data in those languages must conform to the data written in Arabic.

6. Is it allowed to add food ingredients to honey?

• Solution: No, Saudi Technical Regulation SFDA.FD 147 "Bee Honey" states that no food ingredient should be added to honey.

7. What are the approved customs ports for the entry of pharmaceutical products into the Kingdom?

• Solution: There are 13 designated ports and airports for the entry of pharmaceutical products, including King Khalid International Airport in Riyadh, King Abdulaziz International Airport in Jeddah, Jeddah Islamic Port, and King Fahd Causeway in Khobar.

8. What is the Aggregation Principle in pharmaceutical products? Is it mandatory?

• Solution: The aggregation principle is mandatory. It is a process that allows all data within a carton or container to be known by scanning its barcode, which facilitates commercial operations.

9. What is the allowed period for paying medical device marketing authorization application fees after the SFDA requests payment?

• Solution: The required fees for medical device marketing authorization must be paid within thirty (30) calendar days.

10. What is the allowed period for submitting the corrective action plan for a medical device safety alert?

• Solution: Five (5) working days, calculated from the date of SFDA notification or the date of receiving an inquiry from the SFDA regarding a corrective action for a safety alert.

11. Is it mandatory to register imported feed products?

• Solution: Yes, imported feed products must be registered.

12. How can international companies apply to the SFDA?

• Solution: International companies can apply through one of the following entities: local distributors/importers and distributors, obtaining a foreign investor license, establishing a local entity, or through a licensed consulting office from the SFDA.

Conclusion and Recommendations

The comprehensive analysis of SFDA registration requirements demonstrates that the SFDA is not merely a regulatory body but a strategic partner in promoting public health and supporting economic growth in the Kingdom of Saudi Arabia. The SFDA's focus on scientific foundations, digital transformation, and partnerships with investors reflects a commitment to a modern and effective regulatory environment.

The registration process is an indispensable gateway for legal access to the Saudi market, ensuring that products and establishments comply with the highest safety and quality standards. The SFDA's reliance on specialized electronic platforms and a unified workflow highlights its commitment to efficiency and transparency. Furthermore, the risk-based regulatory approach, evident in the varying registration timelines by product category, underscores the meticulous scrutiny of more complex or sensitive products.

For companies operating or planning to enter the Saudi market, the following recommendations are paramount:

• Digital Readiness: Companies must invest in their internal digital capabilities and data management systems to align with the SFDA's full reliance on electronic platforms.

• Comprehensive Understanding of the Regulatory Environment: It is crucial to recognize that SFDA compliance is part of a broader governmental ecosystem requiring coordination with other ministries and authorities (e.g., Ministry of Industry and Mineral Resources and Ministry of Environment, Water and Agriculture).

• Focus on Quality Across the Supply Chain: Compliance extends beyond product formulation to include good distribution practices and robust quality management systems in warehouses and post-market operations, especially for medical devices.

• Proactive and Meticulous Planning: Given the varying timelines and requirements by product category, companies must plan their registration processes well in advance, considering that more innovative or sensitive products may require longer periods and greater scrutiny.

• Leverage Consulting Services: Licensed consulting offices can provide valuable support in navigating complex regulations and ensuring compliance, especially for foreign companies or those lacking local expertise.

In conclusion, registration with the SFDA is a strategic investment in consumer safety, legal compliance, and sustainable growth in the thriving Saudi market. A deep understanding of and commitment to these requirements position companies to effectively contribute to achieving Saudi Vision 2030.