Qatar Product Registration & Certification
Important Notes
- Mandatory Arabic Language Requirements: All technical documents, labels, and instructions must be in Arabic requiring translation by Qatari-approved agencies
- Ministry of Public Health Registration: Medical devices must register with Qatar Ministry of Public Health and obtain registration certificates for import and sale
- Dual Legal Representative Requirements: Must appoint both Qatari Authorized Representative (technical) and importer (commercial)
- GCC Technical Regulation Adoption: Accepts CE certification as technical basis but requires supplementary compliance with GCC Unified Technical Regulations
- Post-market Surveillance Obligations: Must establish complete PMS system and adverse event reporting system reporting serious incidents to Ministry of Public Health
- Import License Management: All imported products require corresponding import licenses from Qatar Customs and Ministry of Public Health
- Product Category Registration: Medical devices, cosmetics, and health products follow distinct registration processes and technical requirements
- Renewal & Change Management: Registration certificates require periodic renewal; significant product changes require re-submission
Qatar Specific Requirements
- Strict Arabic Single-language System: All product information must be in Arabic reflecting Qatari language and cultural policy
- Dual Legal Representative System: Requires both Qatari Authorized Representative and importer assuming technical and commercial responsibilities respectively
- GCC Unified Regulatory Framework: Medical device registration follows GCC Unified Technical Regulations coordinating with Saudi Arabia, UAE, etc.
- Qatari Standards Dominance: All products must comply with mandatory standards from Qatar General Organization for Standards (QGOS)
- High-standard Quality Review: Emphasizes product quality and safety with strict technical review processes and scientific evidence requirements
- Post-registration Compliance Maintenance: Requires periodic updates, annual reports, and ongoing compliance maintenance with strict regulatory oversight
- Gulf Region Medical Hub: As important Gulf medical hub, maintains regionally leading technical requirements for medical products
- Halal Certification Market Advantage: While not mandatory, health products with Halal certification gain competitive advantage in Qatari market
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- GCC risk-based classification (Class I, IIa, IIb, III)
- Complete Arabic technical documentation
- Quality Management System Certificate (ISO 13485)
- Compliance with GCC Medical Device Regulation
- CE Marking or FDA Approval evidence
- Clinical Evaluation Report (if applicable)
- Performance verification data
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- Ministry of Public Health review and submission
- Local authorized representative appointment
- Registration certificate acquisition
- Post-market surveillance establishment
Registration Timeline
8-18 months
Official Fees
QAR 15,000 - 200,000 (including application, evaluation, and registration fees)
Service Fees
$16,000 - $48,000
Regulatory System Overview
Ministry of Public Health
Qatar Ministry of Public Health (MoPH)
Responsible for registration approval, quality supervision, and market surveillance of medical devices, pharmaceuticals, cosmetics, food and health products. Primary regulatory authority for health products in Qatar.
Qatar Standardization
Qatar General Organization for Standards and Metrology (QS)
Responsible for developing Qatari product standards and conducting mandatory certification to ensure product quality and safety comply with Qatari Standards
GCC Standardization
GCC Standardization Organization (GSO)
Responsible for coordinating technical regulations and standards among GCC member states, developing unified technical regulations for medical devices, cosmetics, and promoting regional market integration
Medical Devices Registration Process
Product Classification
Determine risk classification according to GCC medical device classification rules (Class I, IIa, IIb, III)
Technical Documentation
Prepare complete Arabic technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or undergo MoPH audit
Local Representative
Appoint authorized representative located in Qatar
Registration Application
Submit medical device registration application to Qatar Ministry of Public Health
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Registration
- Complete ingredient safety assessment report (CPSR)
- Compliance with GCC Cosmetic Regulation
- Arabic product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Technical documentation preparation
- Product registration application
- Label compliance review
- Market access completion
Registration Timeline
5-9 months
Official Fees
QAR 8,000 - 50,000 (including application and registration fees)
Service Fees
$9,000 - $22,000
Regulatory System Overview
Ministry of Public Health
Qatar Ministry of Public Health (MoPH)
Responsible for registration approval, quality supervision, and market surveillance of medical devices, pharmaceuticals, cosmetics, food and health products. Primary regulatory authority for health products in Qatar.
Qatar Standardization
Qatar General Organization for Standards and Metrology (QS)
Responsible for developing Qatari product standards and conducting mandatory certification to ensure product quality and safety comply with Qatari Standards
GCC Standardization
GCC Standardization Organization (GSO)
Responsible for coordinating technical regulations and standards among GCC member states, developing unified technical regulations for medical devices, cosmetics, and promoting regional market integration
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with GCC permitted substances list
Safety Assessment
Complete Product Safety Report (CPSR) by qualified toxicologist
Product Registration
Submit cosmetic product registration application to relevant Qatari authorities
Label Compliance
Ensure labels meet Arabic language requirements and GCC labeling regulations
QS Certification
Obtain relevant certification from Qatar Standardization Organization
Health Products Registration
Regulatory Requirements
- Health Product Registration
- Ingredient safety and quality evidence
- Compliance with Qatari food and health product regulations
- Arabic labeling and instructions
- Good Manufacturing Practice certificate
- Ingredient analysis reports
- Stability study data
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- Registration application submission
- Label compliance review
- Market access completion
Registration Timeline
6-12 months
Official Fees
QAR 10,000 - 80,000 (including application, evaluation and registration fees)
Service Fees
$11,000 - $30,000
Regulatory System Overview
Ministry of Public Health
Qatar Ministry of Public Health (MoPH)
Responsible for registration approval, quality supervision, and market surveillance of medical devices, pharmaceuticals, cosmetics, food and health products. Primary regulatory authority for health products in Qatar.
Qatar Standardization
Qatar General Organization for Standards and Metrology (QS)
Responsible for developing Qatari product standards and conducting mandatory certification to ensure product quality and safety comply with Qatari Standards
GCC Standardization
GCC Standardization Organization (GSO)
Responsible for coordinating technical regulations and standards among GCC member states, developing unified technical regulations for medical devices, cosmetics, and promoting regional market integration
Health Products Registration Process
Product Classification
Determine if product falls under food, health supplement or drug category
Technical Documentation
Prepare ingredient analysis, safety evidence, efficacy claims in Arabic
Registration Application
Submit health product registration application to Qatar Ministry of Public Health
Label Review
Ensure compliance with Qatari food and health product labeling requirements
QS Certification
Obtain relevant certification from Qatar Standardization Organization