Saudi SFDA Certification
Saudi Food and Drug Authority (SFDA) - Market Access Certification for Food, Drugs and Cosmetics
Certification Overview
The Saudi Food and Drug Authority (SFDA) is the government agency responsible for regulating food, drugs, medical devices and cosmetic products in Saudi Arabia. SFDA certification is a mandatory requirement for these products to enter the Saudi market, ensuring their safety, efficacy and quality comply with Saudi standards.
Key Features
- Mandatory Certification: Regulated products must obtain certification before sale in Saudi Arabia
- Categorized Management: Implements differentiated supervision based on product risk levels
- Local Representative: Requires appointment of an authorized Saudi local representative
- Language Requirements: Key documents must be provided in Arabic
Regulatory Scope
SFDA certification covers the following product categories:
- Food and food additives
- Pharmaceuticals and active pharmaceutical ingredients
- Cosmetics and personal care products
- Health supplements
- Tobacco products
Regulatory Scope
SFDA implements mandatory certification requirements for the following products:
| Product Category | Specific Products | Certification Requirements |
|---|---|---|
| Food | Pre-packaged food, food additives, special dietary food, etc. | Mandatory SFDA registration |
| Pharmaceuticals | Prescription drugs, OTC drugs, APIs, etc. | Mandatory SFDA registration |
| Cosmetics | Skincare, makeup, perfumes, hair care products, etc. | Mandatory SFDA registration |
| Health Supplements | Vitamins, mineral supplements, etc. | Mandatory SFDA registration |
| Tobacco Products | Cigarettes, cigars, e-cigarettes, etc. | Mandatory SFDA registration |
Cosmetic Classification
Cosmetics are classified into the following categories based on application area and function:
- Skincare: Creams, lotions, serums, masks, etc.
- Makeup: Foundation, lipstick, eyeshadow, mascara, etc.
- Hair Care: Shampoo, conditioner, hair dye, styling products, etc.
- Fragrance: Perfume, cologne, body spray, etc.
- Personal Care: Body wash, body lotion, deodorant, etc.
HS Code Classification
SFDA regulated products are classified and managed according to HS codes. Below are the main HS code ranges for regulated products:
| HS Code Range | Product Category | Certification Requirements |
|---|---|---|
| Chapter 30 | Pharmaceuticals | Mandatory SFDA registration |
| Chapter 33 | Cosmetics | Mandatory SFDA registration |
| Chapter 21 | Food Additives | Mandatory SFDA registration |
| Chapter 24 | Tobacco Products | Mandatory SFDA registration |
| Chapter 34 | Soaps, Detergents | Some products require registration |
Cosmetic HS Code Examples
- 3303.00: Perfumes and toilet waters
- 3304.10: Lip makeup preparations
- 3304.20: Eye makeup preparations
- 3304.30: Manicure or pedicure preparations
- 3304.91: Powders, whether or not compressed
- 3304.99: Other beauty or makeup preparations
- 3305.10: Shampoos
- 3305.20: Preparations for permanent waving or straightening
- 3305.30: Hair fixatives
Application Process and Required Documents
Standard Application Process
1
Product Classification
Confirm product HS code and applicable standards
2
Technical Document Preparation
Prepare compliant technical documents including Arabic translations
3
Appoint Local Representative
Designate an authorized representative in Saudi Arabia (if applicable)
4
Submit Registration Application
Submit complete application materials through SFDA electronic system
5
Technical Review
SFDA conducts technical review of submitted materials
6
Obtain Registration Certificate
Receive SFDA registration certificate upon approval
Required Documents for Cosmetic SFDA Certification
| No. | Document Type | Specific Requirements | Remarks |
|---|---|---|---|
| 1 | Application Form | Complete form signed by authorized person with company seal | Mandatory |
| 2 | Test Report | Cosmetic safety test report issued by CNAS 17025 accredited laboratory | Mandatory |
| 3 | Product Photos | Showing product name, label, trademark, origin, ingredient list, usage instructions | English/Arabic |
| 4 | Ingredient Analysis | Complete ingredient list with percentage content | Mandatory |
| 5 | Manufacturing License | Cosmetic production license of manufacturer | Mandatory |
| 6 | Business License | Applicant company's business license | Mandatory |
| 7 | Label Information | Arabic version of product label and packaging | Mandatory |
| 8 | Authorization Letter | Authorization document for Saudi local representative | If applicable |
Special Requirements for Cosmetics
- Prohibited ingredient list must be strictly followed
- Restricted ingredients must be within specified concentration limits
- Colorants must comply with SFDA approved list
- Preservative use must meet regulatory requirements
- Sunscreen products must provide SPF value test reports
- All documents must be authenticated by Saudi Embassy in China
Certificate and Label Samples
SFDA Cosmetic Registration Certificate Sample
SFDA Cosmetic Registration Certificate - Typically valid for 5 years
Cosmetic Labeling Requirements
- Must include Arabic product name and description
- Display SFDA registration number
- Complete ingredient list (INCI names)
- Manufacturing date and expiry date
- Net content
- Batch number
- Usage instructions and precautions
- Importer and manufacturer information
| Title | Document | Creation Date |
|---|---|---|
| Technical Regulation for Packaging | View Document | 2025-10-27 |
| Technical regulation for Jewelery Decorations and Accessories | View Document | 2025-10-27 |
| Technical Regulation for Fireworks | View Document | 2025-10-27 |
| Technical Regulation for Degradable Plastic Products | View Document | 2025-10-27 |
| Technical Regulation for Food Safety in Tools and Appliances Used in Kitchen | View Document | 2025-10-27 |
| Technical regulation for Paints (Dyes) and Varnishes | View Document | 2025-10-27 |
| Technical Regulation for Detergents | View Document | 2025-10-27 |
| Technical Regulation for Lubricating Oils | View Document | 2025-10-27 |
| Technical Regulation for Paper and Cardboard | View Document | 2025-10-27 |
| Technical Regulation for Glue and Adhesive Materials | View Document | 2025-10-27 |
| Technical Regulations for Energy Efficiency | View Document | 2025-10-27 |
| Technical Regulation of the Requirements for Standby, off Mode Electric Power Consumption of Electrical and Electronic Equipment | View Document | 2025-10-27 |
| Technical Regulation for Electromagnetic Compatibility | View Document | 2025-10-27 |
| Technical Regulation for Electrical Appliances and Equipment Intended for Use In Explosive Atmospheres | View Document | 2025-10-27 |
| Technical Regulations for Communications and Information Technology Devices | View Document | 2025-10-27 |
| Technical Regulation for Electric Batteries | View Document | 2025-10-27 |
| Technical Regulation for Electrical Lifts Used in Buildings and Facilities | View Document | 2025-10-27 |
| Technical Regulation for Electronic Devices Used in Electronic Smoking Systems | View Document | 2025-10-27 |
| Technical Regulation for Solar Photovoltaic Systems | View Document | 2025-10-27 |
| Technical Regulation for Electric Vehicles | View Document | 2025-10-27 |
| Technical Regulation for Electric Personal Mobility Devices (Scooter) | View Document | 2025-10-27 |
| Technical Regulation for low voltage Electrical Equipments and Appliances | View Document | 2025-10-27 |
| Technical Regulation for Limiting hazardous Substances in Electrical and Electronic Equipment | View Document | 2025-10-27 |
| Technical Rregulations for special-Use Vehicle Equipment and Accessories | View Document | 2025-10-27 |
| Technical Regulation of Hydrogen Vehicles | View Document | 2025-10-27 |
| Technical Regulation for General Requirements for Machine Safety | View Document | 2025-10-27 |
| Technical Regulation for watercrafts | View Document | 2025-10-27 |
| Technical Regulation for cableway installations | View Document | 2025-10-27 |
| Technical Regulation for Machinery Safety – Part 4: Cutting and Sawing Machines | View Document | 2025-10-27 |
| Technical Regulation for Child Restraint Systems and Stroller | View Document | 2025-10-27 |
| Technical Regulation for Escalators and Moving Walkways | View Document | 2025-10-27 |
| Gulf Technical Regulation for Tiers | View Document | 2025-10-27 |
| Technical Regulation for Simple Pressure Vessels | View Document | 2025-10-27 |
| Technical Regulation for Pressure Equipment | View Document | 2025-10-27 |
| Technical Regulations Machinery Safety Part 1-Portable and Hand-oriented Machines | View Document | 2025-10-27 |
| Technical Regulation for Automated Motorcycles | View Document | 2025-10-27 |
| Technical Regulation for Tanks: Part 3: Dry Gas Transport Tanks | View Document | 2025-10-27 |
| Technical Regulation for Tanks: Part 2: LPG Tankers | View Document | 2025-10-27 |
| Technical Regulation for Tanks: Part 1: Petromleum Prodcuts Transportation Tanks | View Document | 2025-10-27 |
| Technical Regulation for Fire Control Materials and Equipment | View Document | 2025-10-27 |
| Technical Regulation for Modified Vehicles and Limited Production Models | View Document | 2025-10-27 |
| Technical Regulation for games and devices of Amusement Parks | View Document | 2025-10-27 |
| Technical Regulation for Auto Spare Parts | View Document | 2025-10-27 |
| Technical Regulation for Trailers and Semi-Trailers | View Document | 2025-10-27 |
| Technical Regulation for Gas Appliances and their Accessories | View Document | 2025-10-27 |
| Technical Regulation for Front, Rear and Side Barriers for Trucks and Trailers | View Document | 2025-10-27 |
| Technical Regulation for Machinery Safety : Part 2: Mobile Machinery and Heavy Duty Equipment | View Document | 2025-10-27 |
| Technical Regulation for Used Imported Vehicles | View Document | 2025-10-27 |
| Technical Regulation for Machinery Safety : Part 3: Lifting Equipment | View Document | 2025-10-27 |
| Technical Regulation for Water Rationalization Tools | View Document | 2025-10-27 |
| Technical Regulation for doors, windows, and accessories | View Document | 2025-10-27 |
| Technical Regulation for Building Materials Part: 5 Pipes used in Water, Electricity and Gas Networks | View Document | 2025-10-27 |
| Technical Regulation for Building Materials Part IV: Bricks, Tiles, Ceramics, Sanitary Ware and Relevant Products | View Document | 2025-10-27 |
| Technical Regulation for Building Materials – Part 3: Hydraulic Connections | View Document | 2025-10-27 |
| Technical Regulation for Building Materials - Part II: | View Document | 2025-10-27 |
| Technical Regulation for Building Materials - Part 1: Metal and Alloy Sectors for Constructions and Buildings | View Document | 2025-10-27 |
| Technical Regulation for Footwear and their Accessories | View Document | 2025-10-27 |
| Technical Regulation for Personal Protective Equipment and Clothing | View Document | 2025-10-27 |
| Technical Regulation of Textile Products | View Document | 2025-10-27 |
| GCC Technical Regulation on Children Toys. | View Document | 2025-10-27 |
| Technical Regulation for Leather Products | View Document | 2025-10-27 |
Professional SFDA Cosmetic Certification Services
Our certification expert team has extensive SFDA cosmetic certification experience and can provide one-stop services from product classification, ingredient review, testing to certificate acquisition, ensuring your cosmetics smoothly enter the Saudi market.
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