HomeSFDA Certification: Ensuring Your Products Meet Saudi Standards

Scope of SFDA Regulation

The Saudi Food & Drug Authority (SFDA) oversees a wide range of industries to ensure public safety and product quality. The primary sectors regulated by the SFDA include: 

• Food: Ensuring safety and quality of all food products, whether processed or unprocessed. 
• Pharmaceuticals: Regulating drugs, including both human and veterinary medicines. 
• Medical Devices: Overseeing the safety and efficacy of medical devices used in the market. 

Additionally, the SFDA also regulates: 

• Healthcare Products: Such as herbals, supplements, cosmetics, biocides, medical supplies, and pesticides. 
• Animal Health Products: Including veterinary drugs and animal feeds. 

The SFDA not only monitors these products but also inspects and licenses associated entities like manufacturers, warehouses, consulting firms, and marketing authorization holders (MAH). Brand owners, license holders, and raw material suppliers might also fall under SFDA regulations. 

Food Product Certification (PCA Program) 

To enhance consumer trust and ensure fair trade, the SFDA mandates the registration of food products entering the Saudi market. Since 2020, our certification body has been approved by the SFDA to conduct product certifications for food products. Our global network of experts facilitates the entire registration process, ensuring swift and secure market access. 

Regular Food Registration 

This applies to any substance intended for human consumption or used in food manufacturing, preparation, or treatment. 

Special-Use Food Registration 

Special-use food products require additional scrutiny under the SFDA program, including: 

• Food supplements (proteins, amino acids, carbohydrates, etc.) 

• Vitamin and mineral supplements 

• Lozenges 

• Collagen products 

• Food products containing moringa leaves 

• Novel foods 

• Prebiotics and probiotics 

SFDA Application for Local and International Companies 

For Local Saudi Companies 

Local companies can submit their applications directly to the SFDA. These companies must be licensed for their specific activities and have access to the relevant electronic systems. Activities that require SFDA approval include food, drugs, herbals, medical devices, cosmetics, veterinary drugs, animal feeds, and pesticides. 

For International Companies 

International companies have multiple pathways to submit their applications to the SFDA: 

• Distributors: Companies can appoint local distributors to register products on their behalf. 
• Foreign Investor License: International companies can establish a presence in Saudi Arabia as foreign investment companies, complying with local investment and operational regulations. 
• Pharmaceutical companies can hire pharmacists, and get the office licensed by the SFDA for direct submissions. 
• Consulting Company: Engaging an SFDA-licensed consulting firm like PharmaKnowl Consulting to represent the foreign company. This option offers: 
• Non-commercial and independent partnership 
• Professional regulatory support 
• Data privacy 
• Enhanced SFDA communication 
• The foreign company retains the product license (MAH) 
• Greater control over commercial partners 
• Accelerated market access 

The SFDA certification process

The process includes several key steps to ensure product compliance: 

• Technical Evaluation: Detailed assessment of product documents. 
• Physical Inspection: Sampling and inspection of products. 
• Testing and Analysis: Conducted in accredited laboratories. 
• Regulation Compliance Check: Ensuring conformity with SFDA standards. 
• Label Review: Ensuring product labels meet SFDA requirements. 
• Container Supervision: Monitoring container loading and sealing. 
• Certificate Issuance: Providing a certificate of conformity for market access. 

Key Aspects of Product Testing in Saudi Arabia 

Product testing is mandatory to ensure consumer safety and product integrity. Here’s what you need to know: 

• Products Tested: Food, pharmaceuticals, and industrial goods. 
• Testing Facilities: Accredited laboratories. 
• Documentation: Detailed reports and certificates issued after testing. 
• Duration: Varies by product but is essential for market access. 
• Barcode : Barcodes facilitate product tracking and identification in the market. Each product variant may require separate registrations depending on the category and regulatory requirements. 

FASEH Platform for Cosmetic Products 

To streamline the certification process, the SFDA provides the FASEH platform. This platform allows importers to request a Certificate of Conformity (CoC) through approved bodies like SGS, ensuring compliance with SFDA standards for cosmetics and other products. 

SFDA Regulated Industries

The SFDA regulates a wide range of products, including: 

• Food: Regular and special-use food products. 
• Pharmaceuticals: Drugs, generics, biologics, and radiopharmaceuticals. 
• Medical Devices: High-risk and low-risk medical products. 
• Cosmetics: Notification-based registration system. 
• Herbals and Supplements: Products containing high levels of vitamins and minerals or making medical claims. 
• Veterinary Products: Drugs and health products for animal use. 
• Biocides: Sanitisers and disinfectants. 
• Tobacco: Including e-cigarettes and heated tobacco products. 

Regular Food Registration 

For food products, compliance involves ensuring that ingredients, labels, manufacturers, and raw material sources meet SFDA regulations and GSO (GCC) standards. 

Special-Use Food Registration 

Special-use food products include: 

• Supplements: Proteins, amino acids, vitamins, and minerals. 
• Novel Foods: New and innovative food products. 
• Functional Foods: Products with added health benefits like prebiotics and probiotics. 

Registration Pathways for Pharmaceuticals and Medical Devices 

The SFDA offers several registration pathways depending on the product type: 

• Drug Registration: For new chemical entities, generics, biologics, and radiopharmaceuticals. 
• Medical Device Registration: Includes submission of full product technical files and marketing approval processes.