Iraq Product Registration & Certification
Important Notes
- Mandatory Arabic Language Requirements: All technical documents, labels, and instructions must be in Arabic requiring translation by Iraqi-approved agencies
- Legal Agent System: Imported products must appoint Iraqi-based authorized agent or distributor for registration applications and market responsibilities
- Ministry of Health Import Licenses: Medical devices and health products require Iraqi Ministry of Health import licenses for customs clearance and sales
- Multi-level Document Authentication: All documents require notarization in origin country, foreign ministry legalization, and Iraqi consular authentication
- Country of Origin Certification: Must provide authenticated free sale certificates and GMP compliance certificates proving legal marketing in origin country
- Halal Certification Requirements: Health products and cosmetics typically require Islamic Halal certification, especially products with animal-derived ingredients
- Product Registration Procedures: All therapeutic products require registration with Iraqi Ministry of Health Drug Control Directorate for registration certificates
- Possible Local Testing: High-risk medical devices may require sample testing or quality verification in designated Iraqi laboratories
Iraq Specific Requirements
- Strict Import License Management: Implements strict import license system requiring Ministry of Health approval for all therapeutic products
- Arabic Single-language System: All technical documentation and labeling must be in Arabic reflecting Iraqi language and cultural policy
- Multi-tier Document Authentication: Strict and complex document authentication requiring notarization, legalization, and consular authentication triple process
- Legal Agent Responsibility System: Must appoint Iraqi authorized agent responsible for product registration, customs clearance, and market supervision
- Widespread Halal Certification: Halal certification mandatory for most health products and cosmetics, especially foods and pharmaceuticals
- Centralized Ministry of Health Oversight: Iraqi Ministry of Health Drug Control Directorate centrally manages registration and market supervision
- Post-conflict Regulatory Characteristics: Regulatory system in reconstruction phase with possible requirement changes requiring close policy monitoring
- Regional Implementation Variations: Autonomous regions like Kurdistan may have special regulatory provisions requiring attention
Medical Devices Registration
Regulatory Requirements
- Medical Device Import License
- Technical documentation and test reports
- Quality Management System certificate (ISO 13485)
- Arabic labeling and instructions
- Free Sale Certificate
- Certificate of Origin and Halal certificate (if applicable)
Main Process
- Product classification determination
- Technical documentation preparation
- Local agent designation
- MOH application submission
- Import license acquisition
Registration Timeline
8-24 months
Official Fees
IQD 500,000 - 15,000,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
MOH
Ministry of Health
Responsible for medical devices, pharmaceuticals, and health products registration, import licensing, and quality supervision, the main health product regulatory authority in Iraq
COSQC
Central Organization for Standardization and Quality Control
Responsible for product standards development, quality control, and compliance assessment, ensuring imported products meet Iraqi standards
MOT
Ministry of Trade
Responsible for import-export trade management, commercial registration, and trade policy development, coordinating product import administrative procedures
Medical Devices Registration Process
Product Classification
Determine product risk classification and registration pathway according to Iraq medical device regulations
Technical Documentation
Prepare Arabic technical documentation including specifications, test reports, instructions for use
Local Agent Designation
Designate authorized agent in Iraq (mandatory requirement)
MOH Registration
Submit medical device import license application and complete technical file to Ministry of Health
Document Authentication
Complete document review, authentication, notarization, and obtain final approval
Cosmetics Registration
Regulatory Requirements
- Cosmetic Import License
- Ingredient safety assessment report
- Arabic product labeling
- Good Manufacturing Practice certificate
- Free Sale Certificate
- Halal certification (if applicable)
Main Process
- Ingredient compliance assessment
- Safety assessment completion
- Import license application
- Labeling compliance confirmation
- Market access approval
Registration Timeline
6-15 months
Official Fees
IQD 200,000 - 5,000,000
Service Fees
$10,000 - $25,000
Regulatory System Overview
MOH
Ministry of Health
Responsible for medical devices, pharmaceuticals, and health products registration, import licensing, and quality supervision, the main health product regulatory authority in Iraq
COSQC
Central Organization for Standardization and Quality Control
Responsible for product standards development, quality control, and compliance assessment, ensuring imported products meet Iraqi standards
MOT
Ministry of Trade
Responsible for import-export trade management, commercial registration, and trade policy development, coordinating product import administrative procedures
Cosmetics Registration Process
Ingredient Compliance
Confirm all ingredients comply with Iraq cosmetic regulations and Halal requirements
Safety Assessment
Prepare complete product safety assessment report and quality control documentation
Import License Application
Submit cosmetic import license application to Iraq Ministry of Health
Arabic Labeling
Ensure product labeling fully complies with Arabic labeling regulations
Local Agent
Designate authorized agent in Iraq responsible for product registration and market surveillance
Health Products Registration
Regulatory Requirements
- Health Product Import License
- Ingredient safety and quality evidence
- Arabic labeling requirements
- Good Manufacturing Practice certificate
- Free Sale Certificate
- Halal certification
Main Process
- Product classification determination
- Technical documentation preparation
- Import license application
- Labeling review confirmation
- Regulatory approval acquisition
Registration Timeline
7-18 months
Official Fees
IQD 300,000 - 8,000,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
MOH
Ministry of Health
Responsible for medical devices, pharmaceuticals, and health products registration, import licensing, and quality supervision, the main health product regulatory authority in Iraq
COSQC
Central Organization for Standardization and Quality Control
Responsible for product standards development, quality control, and compliance assessment, ensuring imported products meet Iraqi standards
MOT
Ministry of Trade
Responsible for import-export trade management, commercial registration, and trade policy development, coordinating product import administrative procedures
Health Products Registration Process
Product Classification
Determine product category: food supplement, traditional medicine, or health product
Technical Documentation
Prepare Arabic technical documentation including ingredient analysis, safety evidence, efficacy claims
Import License Application
Submit health product import license application to Iraq Ministry of Health
Labeling Compliance
Ensure Arabic labeling complies with Iraq food and health product labeling regulations
Document Authentication
Complete all document authentication, notarization, and consular legalization procedures