Egypt Product Registration & Certification
Important Notes
- EDA Centralized Approval: Pharmaceuticals, medical devices, herbal products, cosmetics, and food supplements are regulated by the Egyptian Drug Authority, requiring marketing authorization and central registration.
- Clear Demarcation: "Food Supplements" vs. "Herbal Medicines": Vitamins, protein powders, etc., are "Food Supplements" requiring notification; herbal products with therapeutic claims are "Herbal Medicines" with stricter registration. Product positioning and claims must be unequivocally clear on this divide.
- Mandatory Local Agent (MAH): A foreign company must appoint a locally registered Egyptian pharmaceutical company as its exclusive agent and Marketing Authorization Holder, assuming all legal and commercial liabilities.
- Arabic Documentation & Special Legalization: All submitted documents must be in Arabic. The notarization/legalization process requires authentication by Egyptian diplomatic missions, which is time-consuming.
- Government Pricing & Inclusion in Essential Lists: All drug prices are strictly controlled. Inclusion in the Ministry of Health Drug List is a prerequisite for public procurement and reimbursement, involving lengthy negotiations.
- Reference to GCC Standards: Although not a GCC member, Egypt actively references and sometimes adopts GCC standards for certain products to facilitate regional trade.
Egypt Specific Requirements
- Dual "Gateway" to the Arab World & Africa: Its geography, population, and cultural influence make Egypt a traditional strategic hub for accessing the MENA region and Francophone Africa.
- Large & Stratified Hybrid Healthcare System: The market comprises a dominant public sector, a growing private hospital/pharmacy network, and a military healthcare system, with vastly different demands and purchasing power.
- Strong Local Pharma Industry Shapes Ecosystem: A robust local manufacturing base is not only a competitor in generics but also a key partner for international companies seeking localization and contract manufacturing.
- Regulatory Reform Paired with Digital Transition: EDA is modernizing its electronic submission and database systems while reforming pricing policies, gradually improving transparency and predictability amid fluctuations.
- High Consumer & Prescriber Brand/Channel Loyalty: The market has high brand concentration. Gaining trust as a new entrant is costly, making alliances with established local partners critical for success.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Risk-based classification (Class I, II, III, IV)
- Complete Arabic technical documentation
- Quality Management System Certificate (ISO 13485)
- Arabic labeling and instructions for use
- Certificate of Free Sale
- CE Certificate of Conformity or FDA Approval
- Clinical Evaluation Report (if applicable)
- Performance verification data
- Test reports from accredited Egyptian laboratories
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- EDA registration application submission
- Local authorized agent appointment
- Technical documentation assessment
- Product sample testing
- Registration certificate acquisition
Registration Timeline
9-18 months
Official Fees
EGP 80,000 - 1,500,000 (including application, evaluation, testing and registration fees)
Service Fees
$16,000 - $48,000
Regulatory System Overview
Egyptian Drug Authority
Egyptian Drug Authority (EDA)
Specialized regulatory agency under Egyptian Ministry of Health and Population, fully responsible for registration approval, quality supervision and market surveillance of medical devices, cosmetics, food supplements and pharmaceuticals
Ministry of Health
Egyptian Ministry of Health and Population
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of Egyptian Drug Authority
Standardization Organization
Egyptian Organization for Standardization and Quality (EOS)
Responsible for developing Egyptian Standards, conducting product quality certification and conformity assessment to ensure products meet Egyptian technical standards requirements
Medical Devices Registration Process
Product Classification
Determine risk classification according to Egyptian medical device regulations (Class I, II, III, IV)
Technical Documentation
Prepare complete Arabic technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or evidence of compliance with Egyptian quality system requirements
Local Authorized Agent
Appoint authorized agent located in Egypt
EDA Registration
Submit complete registration application and documents to Egyptian Drug Authority
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Registration
- Complete product information file
- Cosmetic Product Safety Report (CPSR)
- Compliance with Egyptian Cosmetic Regulation
- Arabic product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
- Testing certificates from accredited Egyptian laboratories
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic registration application
- Label compliance review
- Product sample testing
- Market access completion
Registration Timeline
7-14 months
Official Fees
EGP 30,000 - 400,000 (including application, testing and registration fees)
Service Fees
$10,000 - $26,000
Regulatory System Overview
Egyptian Drug Authority
Egyptian Drug Authority (EDA)
Specialized regulatory agency under Egyptian Ministry of Health and Population, fully responsible for registration approval, quality supervision and market surveillance of medical devices, cosmetics, food supplements and pharmaceuticals
Ministry of Health
Egyptian Ministry of Health and Population
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of Egyptian Drug Authority
Standardization Organization
Egyptian Organization for Standardization and Quality (EOS)
Responsible for developing Egyptian Standards, conducting product quality certification and conformity assessment to ensure products meet Egyptian technical standards requirements
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Egyptian permitted substances list and restrictions
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) by qualified safety assessor
Product Information File
Prepare complete product information file in Arabic
EDA Registration
Submit cosmetic registration application to Egyptian Drug Authority
Product Testing
Complete necessary product testing in accredited Egyptian laboratories
Food Supplements Registration
Regulatory Requirements
- Food Supplement Registration
- Ingredient safety and quality evidence
- Compliance with Egyptian Food Supplement Regulation
- Arabic labeling and instructions
- Good Manufacturing Practice certificate
- Ingredient analysis reports
- Scientific justification for nutrition claims
- Stability study data
- Analysis reports from accredited Egyptian laboratories
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- Registration application submission
- Label compliance review
- Product sample analysis
- Registration certificate acquisition
Registration Timeline
8-16 months
Official Fees
EGP 40,000 - 500,000 (including application, analysis and registration fees)
Service Fees
$12,000 - $32,000
Regulatory System Overview
Egyptian Drug Authority
Egyptian Drug Authority (EDA)
Specialized regulatory agency under Egyptian Ministry of Health and Population, fully responsible for registration approval, quality supervision and market surveillance of medical devices, cosmetics, food supplements and pharmaceuticals
Ministry of Health
Egyptian Ministry of Health and Population
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of Egyptian Drug Authority
Standardization Organization
Egyptian Organization for Standardization and Quality (EOS)
Responsible for developing Egyptian Standards, conducting product quality certification and conformity assessment to ensure products meet Egyptian technical standards requirements
Food Supplements Registration Process
Product Classification
Determine product falls under food supplement category per Egyptian food regulations
Technical Documentation
Prepare ingredient analysis, safety evidence, nutrition claims in Arabic
EDA Registration
Submit food supplement registration application to Egyptian Drug Authority
Label Review
Ensure compliance with Egyptian food labeling regulations and nutrition claim requirements
Product Analysis
Complete ingredient analysis and safety assessment in accredited Egyptian laboratories