United Arab Emirates Product Registration & Certification
Important Notes
- Bilingual Labeling Requirements: Technical documents may be in Arabic or English; product labels must contain Arabic with key safety information bilingual
- Multi-layer Regulatory Approval: Medical devices require UAE Ministry of Health and Prevention (MOHAP) registration plus local emirate approval (Dubai DHA/Abu Dhabi DOH)
- ESMA Mandatory Certification: All imported products require Emirates Authority for Standardization and Metrology (ESMA) ECAS certification or Qmark for customs clearance
- Legal Trade Agent Requirement: Must appoint UAE-based authorized Trade Agent as legal entity assuming product registration and market responsibilities
- GCC Technical Regulations: Products must comply with Gulf Cooperation Council Unified Technical Regulations, especially GCC Medical Device Regulations
- VAT Compliance: All commercial transactions subject to 5% Value Added Tax requiring importer registration with UAE tax authority
- Halal Certification Advantage: While not mandatory, health products and foods with Halal certification gain significant market competitiveness
- Renewal & Change Management: Registration certificates typically valid 5 years requiring renewal application 6 months in advance; product changes require re-evaluation
United Arab Emirates Specific Requirements
- Mandatory Bilingual Labeling System: All product labels must contain Arabic with English as secondary language reflecting UAE international characteristics
- Federal-Emirate Decentralized Regulation: Federal oversight by MOHAP; emirates like Dubai (DHA), Abu Dhabi (DOH) maintain independent regulatory authority
- ESMA Certification Centrality: Emirates Authority for Standardization and Metrology ECAS/Qmark is mandatory clearance requirement for all imports
- Legal Trade Agent System: Must appoint UAE Trade Agent as local legal entity assuming full-chain responsibility
- GCC Regional Regulatory Coordination: Actively implements GCC Unified Technical Regulations playing leadership role in regional standardization
- Multi-regulatory Agency Registration: Requires registration with multiple agencies (MOHAP, DHA, DOH) based on sales regions
- Standardized Registration Validity Management: Registration certificates typically valid 5 years requiring corporate centralized license management systems
- Free Zone Special Policies: Free zones (e.g., Dubai Healthcare City) maintain special regulatory policies facilitating medical innovation
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification according to risk classes (I, IIa, IIb, III) - Adopting GCC classification system
- Complete technical documentation (Arabic or English)
- Quality Management System Certificate (ISO 13485)
- CE Marking or FDA Approval evidence
- Compliance with GCC Medical Device Regulations
- Clinical Evaluation Report (for Class IIb and III devices)
- Biocompatibility Test Reports
- Performance Verification Data
- Risk Assessment Documentation
Main Process
- Product classification determination
- Technical documentation preparation
- Quality management system review
- Local authorized representative appointment
- MOHAP/DHA registration submission
- Technical assessment review
- Registration certificate obtainment
Registration Timeline
8-18 months (depending on product class and regulatory authority)
Official Fees
AED 20,000 - 250,000 (including application fee, technical assessment fee and registration fee)
Service Fees
$18,000 - $65,000
Regulatory System Overview
MOHAP
Ministry of Health and Prevention (MOHAP)
Responsible for medical device and pharmaceutical registration approval, quality supervision and market regulation at UAE federal level. Manages national medical device registration system and coordinates regulatory requirements across emirates.
DHA
Dubai Health Authority (DHA)
Responsible for medical device, pharmaceutical and health product registration regulation in Dubai Emirate, with independent registration approval authority. All products sold in Dubai must obtain DHA approval.
ESMA
Emirates Authority for Standardization and Metrology (ESMA)
Responsible for developing UAE product standards and conducting mandatory certification, managing Emirates Conformity Assessment Scheme (ECAS) and Quality Mark Scheme (Qmark), ensuring product quality and safety comply with UAE national standards
DOH
Department of Health - Abu Dhabi (DOH)
Responsible for medical device and pharmaceutical regulation in Abu Dhabi Emirate, with independent registration approval authority. All products sold in Abu Dhabi must obtain DOH approval.
Medical Devices Registration Process
Product Classification
Determine risk classification according to UAE medical device classification rules (Class I, IIa, IIb, III), adopting GCC unified classification system
Technical Documentation
Prepare complete technical documentation (Arabic or English) including product specifications, test reports, clinical data, risk assessment
Local Authorized Representative
Appoint Trade Agent in UAE responsible for regulatory communication and product registration
Quality Management System
Provide valid ISO 13485 certificate, ensuring compliance with UAE quality system requirements
Regulatory Application
Submit medical device registration application to MOHAP (federal) or DHA (Dubai) based on target market
Technical Assessment
Regulatory authority conducts technical file evaluation, safety assessment and conformity review
ESMA Certification
Obtain ECAS certification or Qmark quality mark from Emirates Authority for Standardization and Metrology
Registration Certificate
Receive Medical Device Registration Certificate, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Registration Certificate
- Complete Cosmetic Product Safety Report (CPSR)
- Compliance with UAE Cosmetic Technical Regulations
- Arabic and English bilingual labeling
- 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
- ESMA certification obtainment
- Product registration submission
- Market access completion
Registration Timeline
5-12 months
Official Fees
AED 10,000 - 85,000 (including ESMA certification fee and registration fee)
Service Fees
$10,000 - $30,000
Regulatory System Overview
MOHAP
Ministry of Health and Prevention (MOHAP)
Responsible for medical device and pharmaceutical registration approval, quality supervision and market regulation at UAE federal level. Manages national medical device registration system and coordinates regulatory requirements across emirates.
DHA
Dubai Health Authority (DHA)
Responsible for medical device, pharmaceutical and health product registration regulation in Dubai Emirate, with independent registration approval authority. All products sold in Dubai must obtain DHA approval.
ESMA
Emirates Authority for Standardization and Metrology (ESMA)
Responsible for developing UAE product standards and conducting mandatory certification, managing Emirates Conformity Assessment Scheme (ECAS) and Quality Mark Scheme (Qmark), ensuring product quality and safety comply with UAE national standards
DOH
Department of Health - Abu Dhabi (DOH)
Responsible for medical device and pharmaceutical regulation in Abu Dhabi Emirate, with independent registration approval authority. All products sold in Abu Dhabi must obtain DOH approval.
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with UAE cosmetic regulations permitted lists and prohibited substances
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) by qualified toxicologist
ESMA Certification
Obtain ECAS certification or Qmark quality mark from Emirates Authority for Standardization and Metrology
Product Registration
Submit cosmetic product registration application to relevant regulatory authorities
Label Compliance
Ensure labels fully comply with UAE bilingual requirements (Arabic and English mandatory)
Local Responsible Party
Appoint authorized representative and importer in UAE
Health Products Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient safety and quality evidence
- Compliance with UAE Health Product Regulations
- Arabic and English bilingual labeling
- 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
- Relevant registration submission
- ESMA certification obtainment
- Market access completion
Registration Timeline
6-14 months
Official Fees
AED 12,000 - 100,000 (including registration fee and ESMA certification fee)
Service Fees
$12,000 - $35,000
Regulatory System Overview
MOHAP
Ministry of Health and Prevention (MOHAP)
Responsible for medical device and pharmaceutical registration approval, quality supervision and market regulation at UAE federal level. Manages national medical device registration system and coordinates regulatory requirements across emirates.
DHA
Dubai Health Authority (DHA)
Responsible for medical device, pharmaceutical and health product registration regulation in Dubai Emirate, with independent registration approval authority. All products sold in Dubai must obtain DHA approval.
ESMA
Emirates Authority for Standardization and Metrology (ESMA)
Responsible for developing UAE product standards and conducting mandatory certification, managing Emirates Conformity Assessment Scheme (ECAS) and Quality Mark Scheme (Qmark), ensuring product quality and safety comply with UAE national standards
DOH
Department of Health - Abu Dhabi (DOH)
Responsible for medical device and pharmaceutical regulation in Abu Dhabi Emirate, with independent registration approval authority. All products sold in Abu Dhabi must obtain DOH approval.
Health Products Registration Process
Product Classification
Determine specific product category: food, dietary supplements, health functional foods, etc.
Technical Documentation
Prepare complete technical documentation (Arabic or English) including ingredient analysis, safety evidence, efficacy claim support
Ingredient Compliance
Verify all ingredients are permitted in UAE health products and comply with relevant restrictions
Regulatory Registration
Submit health product registration application to relevant regulatory authorities
ESMA Certification
Obtain relevant product certification from Emirates Authority for Standardization and Metrology
Label Review
Ensure labels comply with UAE food labeling regulations and bilingual requirements