Kuwait Product Registration & Certification
Important Notes
- Mandatory Arabic Language Requirements: All technical documents, labels, and instructions must be in proper Arabic requiring translation by Kuwaiti-approved agencies
- Ministry of Health Registration: Medical devices require approval from Kuwait Ministry of Health Drug and Medical Equipment Department; cosmetics need respective department approval
- KUCAS Mandatory Certification: All imported products require Kuwaiti Conformity Assurance Scheme (KUCAS) certification for customs clearance
- Legal Agent System: Must appoint Kuwaiti-based authorized agent responsible for product registration, customs clearance, and market responsibilities
- GCC Technical Regulation Compliance: Products must comply with Gulf Cooperation Council technical regulations and Gulf Standardization Organization (GSO) standards
- Registration Validity Management: Registration certificates require renewal application 6 months before expiration with updated technical documentation
- Change Control Requirements: Significant product changes (design, composition, manufacturing) require re-registration approval
- Halal Certification Consideration: Food and health products recommended to obtain Halal certification for enhanced market acceptance
Kuwait Specific Requirements
- Strict Arabic Labeling System: All product information must be in Arabic reflecting Kuwaiti language policy and consumer protection
- KUCAS Certification Centrality: Kuwaiti Conformity Assurance Scheme is mandatory clearance document for all imported products
- Mandatory Legal Agent Requirement: Must appoint Kuwaiti local agent as legal entity assuming product registration and market supervision responsibilities
- GSO Standard Dominance: Must comply with Gulf Standardization Organization technical standards with specific GSO requirements for medical devices and electronics
- Categorical Registration Management: Different product categories follow distinct registration processes for medical devices, pharmaceuticals, and cosmetics
- Clear Registration Validity Management: Registration certificates have defined validity periods (typically 3-5 years) requiring corporate renewal tracking systems
- Gulf Region Coordination Characteristics: Actively participates in GCC regulatory harmonization while maintaining Kuwait-specific supplementary requirements
- High-standard Medical Market: As high-income Gulf country, maintains high requirements for medical product quality and technical standards
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification according to risk classes (I, II, III, IV)
- Technical documentation and conformity evidence
- Quality Management System Certificate (if applicable)
- Arabic labeling and instructions for use
- Compliance with GCC Technical Regulations
- Clinical Evaluation Report (for high-risk devices)
Main Process
- Product classification determination
- Technical documentation preparation
- MOH review submission
- Local agent appointment
- Registration certificate obtainment
- KUCAS certification
Registration Timeline
8-18 months
Official Fees
KWD 1,200 - 15,000 (depending on product class)
Service Fees
$18,000 - $55,000
Regulatory System Overview
Kuwait MOH
Kuwait Ministry of Health (MOH)
Primarily responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, and health products. Includes specialized departments like Drug and Medical Equipment Administration, Public Health Department, Food and Nutrition Administration
Public Authority for Industry
Public Authority for Industry (PAI)
Responsible for managing Kuwait Conformity Assessment Scheme (KUCAS), ensuring imported products comply with Kuwait technical regulations and mandatory standards, issuing product conformity certificates
Standards Organization
Kuwait Organization for Standards and Metrology (KOWSMD)
Responsible for developing and maintaining Kuwait National Standards (KSS), participating in Gulf Standardization Organization (GSO) standard development, ensuring product quality meets Kuwait and international standards
Medical Devices Registration Process
Product Classification
Determine risk classification according to Kuwait medical device classification rules (Class I-IV)
Technical Documentation
Prepare complete Arabic technical documentation including technical file, declaration of conformity
Local Agent Appointment
Appoint authorized agent in Kuwait responsible for MOH communication
MOH Application Submission
Submit registration application to MOH Drug and Medical Equipment Administration
Technical Review
MOH conducts technical documentation review and conformity assessment
KUCAS Certification
Obtain Kuwait Conformity Assessment Scheme certification
Registration Certificate
Receive Kuwait Medical Device Registration Certificate, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration License
- Ingredient safety assessment report
- Arabic labeling requirements
- Good Manufacturing Practice certificate
- Compliance with Gulf Standardization Organization (GSO) standards
- Product stability test report
- Non-animal testing declaration (if applicable)
Main Process
- Ingredient compliance assessment
- Safety assessment completion
- Product registration submission
- Label review preparation
- KUCAS certification obtainment
- Market access completion
Registration Timeline
5-10 months
Official Fees
KWD 600 - 5,000 (depending on product type)
Service Fees
$9,000 - $25,000
Regulatory System Overview
Kuwait MOH
Kuwait Ministry of Health (MOH)
Primarily responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, and health products. Includes specialized departments like Drug and Medical Equipment Administration, Public Health Department, Food and Nutrition Administration
Public Authority for Industry
Public Authority for Industry (PAI)
Responsible for managing Kuwait Conformity Assessment Scheme (KUCAS), ensuring imported products comply with Kuwait technical regulations and mandatory standards, issuing product conformity certificates
Standards Organization
Kuwait Organization for Standards and Metrology (KOWSMD)
Responsible for developing and maintaining Kuwait National Standards (KSS), participating in Gulf Standardization Organization (GSO) standard development, ensuring product quality meets Kuwait and international standards
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Kuwait cosmetic regulations prohibited substances list
Safety Assessment
Prepare complete product safety assessment report (Arabic version required)
Registration Application
Submit cosmetic registration application to MOH Public Health Department
Label Compliance Review
Ensure labels fully comply with Kuwait Arabic labeling regulations
KUCAS Certification
Obtain conformity assessment scheme certification from Public Authority for Industry
Registration Approval
Receive cosmetic registration license, typically valid for 3 years
Health Products Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient safety and efficacy evidence
- Arabic labeling requirements
- Good Manufacturing Practice certificate
- Compliance with Kuwait food and health product regulations
- Nutritional composition analysis report
- Shelf-life stability studies
Main Process
- Product classification determination
- Technical documentation preparation
- Registration application submission
- Scientific review approval
- Label review preparation
- Market access completion
Registration Timeline
6-12 months
Official Fees
KWD 900 - 7,000 (depending on product complexity)
Service Fees
$12,000 - $35,000
Regulatory System Overview
Kuwait MOH
Kuwait Ministry of Health (MOH)
Primarily responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, and health products. Includes specialized departments like Drug and Medical Equipment Administration, Public Health Department, Food and Nutrition Administration
Public Authority for Industry
Public Authority for Industry (PAI)
Responsible for managing Kuwait Conformity Assessment Scheme (KUCAS), ensuring imported products comply with Kuwait technical regulations and mandatory standards, issuing product conformity certificates
Standards Organization
Kuwait Organization for Standards and Metrology (KOWSMD)
Responsible for developing and maintaining Kuwait National Standards (KSS), participating in Gulf Standardization Organization (GSO) standard development, ensuring product quality meets Kuwait and international standards
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 documents
Registration Application
Submit health product registration application to MOH Food and Nutrition Administration
Scientific Review
MOH conducts safety, efficacy and quality assessment
Label Review
Ensure labels comply with Kuwait food labeling regulations and Arabic requirements
KUCAS Certification
Obtain Kuwait Conformity Assessment Scheme certification
Registration Approval
Receive health product registration certificate, typically valid for 3 years