Saudi Arabia Product Registration & Certification
Important Notes
- Mandatory Arabic Language Requirements: All technical documents, labels, and instructions must be in proper Arabic requiring translation by Saudi-approved agencies
- GCTS Electronic Registration System: Medical devices must register through Saudi Food and Drug Authority (SFDA) GCC Electronic Submission System (GCTS)
- SASO Conformity Certification: All imported products require Saudi Standards, Metrology and Quality Organization (SASO) Certificate of Conformity (CoC) for customs clearance
- Legal Authorized Representative System: Must appoint Saudi-based Mandated Representative assuming product registration and market responsibilities
- SFDA Registration Approval: Health products and cosmetics require Saudi Food and Drug Authority registration approval managed by risk classification
- GCC Technical Regulation Compliance: Products must comply with Gulf Cooperation Council Unified Technical Regulations, especially GCC Medical Device Regulations
- VAT Compliance Management: All commercial transactions subject to 15% Value Added Tax requiring importer tax registration and declarations
- Halal Certification Requirements: Food and health products must comply with Sharia law; Halal certification expected though not always mandatory
Saudi Arabia Specific Requirements
- Strict Arabic Labeling System: All product information must be in Arabic reflecting Saudi language policy and cultural traditions
- Mandatory GCTS Electronic System: Medical devices require registration through GCC Electronic Submission System (GCTS) enabling Gulf region unified management
- SASO Certification Centrality: Saudi Standards, Metrology and Quality Organization Certificate of Conformity is essential clearance document for all imports
- Mandatory Authorized Representative: Must appoint Saudi Authorized Representative as legal entity assuming full product lifecycle responsibility
- GCC Region Technical Leadership: Actively promotes GCC Unified Technical Regulations playing leading role in regional regulatory coordination
- High Standard Islamic Compliance: Products must comply with Sharia law requirements with Halal certification crucial for market acceptance
- Clear Registration Validity Management: Registration certificates have defined validity periods (typically 3-5 years) requiring corporate renewal tracking
- Advanced Digital Regulation: Saudi Food and Drug Authority actively advances digital regulation with electronic systems covering entire registration process
Medical Devices Registration
Regulatory Requirements
- Medical Device Marketing Authorization Certificate
- Classification according to risk classes (I, IIa, IIb, III, IV)
- Complete Arabic technical documentation
- Quality Management System Certificate (ISO 13485)
- CE Marking or FDA Approval evidence
- Compliance with GCC Medical Device Regulations
- Clinical Evaluation Report (for Class IIb, III, IV devices)
- Biocompatibility Test Reports
- Performance Verification Data
- Risk Assessment Documentation
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- Local authorized representative appointment
- GCTS system registration submission
- SFDA technical assessment
- Marketing authorization obtainment
Registration Timeline
10-24 months (depending on product class and complexity)
Official Fees
SAR 15,000 - 300,000 (including application fee, technical assessment fee and registration fee)
Service Fees
$20,000 - $75,000
Regulatory System Overview
SFDA
Saudi Food and Drug Authority (SFDA)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and health products. Manages GCTS system and technical assessment processes.
SASO
Saudi Standards, Metrology and Quality Organization (SASO)
Responsible for developing Saudi product standards and conducting mandatory certification, managing Product Conformity Certification Program (CoC), ensuring imported products meet Saudi national standards and technical regulations
GCC
Gulf Cooperation Council (GCC)
Responsible for coordinating technical regulations and standards harmonization among Gulf countries, developing GCC medical device technical regulations, promoting regional market integration and trade facilitation
Medical Devices Registration Process
Product Classification
Determine risk classification according to Saudi medical device classification rules (Class I, IIa, IIb, III, IV), referencing GCC unified classification system
Technical Documentation
Prepare complete Arabic technical documentation including product specifications, test reports, clinical data, risk assessment
Local Authorized Representative
Appoint Mandated Representative in Saudi Arabia responsible for SFDA communication and product registration
GCTS System Registration
Submit registration application through SFDA GCC Electronic Submission System (GCTS)
SFDA Technical Assessment
SFDA conducts technical file evaluation, safety assessment and conformity review
Quality Management System
Provide valid ISO 13485 certificate or undergo SFDA quality system audit
Marketing Authorization
Receive Medical Device Marketing Authorization Certificate, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Registration Certificate
- Complete Cosmetic Product Safety Report (CPSR)
- Compliance with Saudi Cosmetic Technical Regulations
- Arabic product labeling and instructions
- Good Manufacturing Practice (GMP) Certificate
- Product Stability Test Reports
- Microbiological Testing Reports
- Non-animal Testing Declaration
- Product Information File
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Technical documentation preparation
- SASO certification obtainment
- SFDA registration submission
- Market access completion
Registration Timeline
7-15 months
Official Fees
SAR 8,000 - 80,000 (including SASO certification fee and SFDA registration fee)
Service Fees
$12,000 - $35,000
Regulatory System Overview
SFDA
Saudi Food and Drug Authority (SFDA)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and health products. Manages GCTS system and technical assessment processes.
SASO
Saudi Standards, Metrology and Quality Organization (SASO)
Responsible for developing Saudi product standards and conducting mandatory certification, managing Product Conformity Certification Program (CoC), ensuring imported products meet Saudi national standards and technical regulations
GCC
Gulf Cooperation Council (GCC)
Responsible for coordinating technical regulations and standards harmonization among Gulf countries, developing GCC medical device technical regulations, promoting regional market integration and trade facilitation
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Saudi cosmetic regulations permitted lists and prohibited substances
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) Arabic version by qualified toxicologist
SASO Certification
Obtain Product Conformity Certificate (CoC) from Saudi Standards, Metrology and Quality Organization
SFDA Registration
Submit cosmetic product registration application to Saudi Food and Drug Authority
Label Compliance
Ensure labels fully comply with Arabic requirements and Saudi cosmetic labeling regulations
Local Responsible Party
Appoint authorized representative and importer in Saudi Arabia
Health Products Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient safety and quality evidence
- Compliance with Saudi Health Product Regulations
- Arabic labeling and instructions
- Good Manufacturing Practice (GMP) Certificate
- Ingredient Analysis Reports
- Stability Study Data
- Active Ingredient Quantitative Analysis
- Heavy Metals and Contaminants Testing
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- SFDA registration submission
- SASO certification obtainment
- Market access completion
Registration Timeline
8-18 months
Official Fees
SAR 12,000 - 120,000 (including SFDA registration fee and SASO certification fee)
Service Fees
$15,000 - $45,000
Regulatory System Overview
SFDA
Saudi Food and Drug Authority (SFDA)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and health products. Manages GCTS system and technical assessment processes.
SASO
Saudi Standards, Metrology and Quality Organization (SASO)
Responsible for developing Saudi product standards and conducting mandatory certification, managing Product Conformity Certification Program (CoC), ensuring imported products meet Saudi national standards and technical regulations
GCC
Gulf Cooperation Council (GCC)
Responsible for coordinating technical regulations and standards harmonization among Gulf countries, developing GCC medical device technical regulations, promoting regional market integration and trade facilitation
Health Products Registration Process
Product Classification
Determine specific product category: food, dietary supplements, health functional foods, etc.
Technical Documentation
Prepare complete Arabic technical documentation including ingredient analysis, safety evidence, efficacy claim support
Ingredient Compliance
Verify all ingredients are permitted in Saudi health products and comply with relevant restrictions
SFDA Registration
Submit health product registration application to Saudi Food and Drug Authority
SASO Certification
Obtain product conformity certification from Saudi Standards Organization
Label Review
Ensure labels comply with Saudi food labeling regulations and Arabic requirements