Cambodia Product Registration & Certification
Important Notes
- DFDA Mandatory Registration & Import Permit: All pharmaceuticals, medical devices, health products, and cosmetics must be registered with the Department to obtain an import permit or registration certificate for sale.
- Dual Classification: Traditional vs. Modern Health Products: Products based on Khmer traditional medicine may be registered as Traditional Medicines. Modern supplements are managed as Health Products or Foods, requiring clear pathway distinction.
- Mandatory Local Authorized Representative/Importer: Applications must be submitted by a locally registered company at the Ministry of Commerce, which assumes product responsibility.
- Khmer/English Documentation & Legalization: Product labels must contain Khmer information. Registration dossiers are typically in English and may require authentication by Cambodian diplomatic missions.
- Price Declaration & Relatively Free Pricing: Product prices must be declared to DFDA, but the market is largely free-priced. Public procurement sets prices through tenders.
- Reliance on International Reference Approvals: DFDA references existing approvals from ASEAN countries, WHO, or SRAs during technical review.
Cambodia Specific Requirements
- Emerging Market with Rapid Growth & Developing Infrastructure: A young population and economic growth drive rising health awareness. Market potential is unfolding, though modern retail is concentrated in major cities.
- Coexistence of Traditional Medicine & Modern Health Concepts: Khmer herbal medicine remains culturally significant, while demand for international-branded supplements and cosmetics grows in urban areas.
- Dual-Track Public Procurement & Private Channels: The Ministry of Health and donor programs dominate the essential medicine market; private pharmacies, clinics, and supermarkets drive growth for consumer health products.
- Regulatory System in Capacity Building & Modernization: DFDA is strengthening its framework and capabilities. Processes are becoming more standardized, but companies should allow for adaptation time.
- ASEAN Integration Participant: Cambodia actively participates in ASEAN harmonization schemes for cosmetics and traditional medicines, making ASEAN developments relevant for long-term trends.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import License
- Technical documentation and conformity evidence
- Quality Management System certification
- Khmer language labeling and instructions for use
- Certificate of Free Sale
- Certificate of Origin
- Product performance test reports
- Biocompatibility testing (where applicable)
- Clinical evaluation data
- Risk management documentation
Main Process
- Product classification determination
- Technical documentation preparation
- FDA review submission
- Local agent appointment
- Import license acquisition
Registration Timeline
8-20 months
Official Fees
KHR 4,000,000 - 200,000,000
Service Fees
$14,000 - $45,000
Regulatory System Overview
FDA Cambodia
Food and Drug Department of Cambodia (FDDC)
Responsible for medical devices, cosmetics, traditional medicines registration approvals, import license issuance, quality supervision, and market surveillance. The primary health product regulatory authority under the Cambodian Ministry of Health.
Ministry of Health
Ministry of Health of Cambodia
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA department operations and overall health regulatory system.
Medical Devices Registration Process
Regulatory Classification
Determine product category and risk level according to Cambodian medical device regulations
Technical Documentation Preparation
Prepare technical documentation in Khmer language including conformity evidence and test reports
Local Agent Appointment
Designate authorized agent or representative within Cambodia
FDA Application Submission
Submit Medical Device Import License application to FDA Cambodia
Technical Review and Approval
Pass FDA technical review and quality system assessment
Cosmetic Products Registration
Regulatory Requirements
- Cosmetic Import License
- Ingredient safety assessment
- Khmer language labeling requirements
- Good Manufacturing Practices
- Product safety certification
- Microbiological quality specifications
- Stability study data
- Manufacturing process description
- Quality control procedures
- Restricted ingredients compliance
Main Process
- Ingredient compliance assessment
- Safety assessment completion
- Import license application
- Label review preparation
- Market access completion
Registration Timeline
6-14 months
Official Fees
KHR 2,000,000 - 80,000,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
FDA Cambodia
Food and Drug Department of Cambodia (FDDC)
Responsible for medical devices, cosmetics, traditional medicines registration approvals, import license issuance, quality supervision, and market surveillance. The primary health product regulatory authority under the Cambodian Ministry of Health.
Ministry of Health
Ministry of Health of Cambodia
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA department operations and overall health regulatory system.
Cosmetic Products Registration Process
Ingredient Compliance Assessment
Verify ingredient compliance with Cambodian cosmetic regulations and restricted substances list
Safety Assessment Report
Prepare product safety assessment report and toxicological data
Import License Application
Submit Cosmetic Import License application to FDA Cambodia
Labeling Compliance Review
Ensure labeling compliance with Khmer language requirements and local regulations
Local Agent Appointment
Designate authorized agent within Cambodia for regulatory affairs
Traditional Medicines Registration
Regulatory Requirements
- Traditional Medicine Registration
- Ingredient safety and quality evidence
- Khmer language labeling requirements
- Good Manufacturing Practices
- Traditional use evidence
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Product formulation details
Main Process
- Product classification determination
- Technical documentation preparation
- FDA registration submission
- Label review preparation
- Registration certificate acquisition
Registration Timeline
7-16 months
Official Fees
KHR 3,200,000 - 120,000,000
Service Fees
$11,000 - $30,000
Regulatory System Overview
FDA Cambodia
Food and Drug Department of Cambodia (FDDC)
Responsible for medical devices, cosmetics, traditional medicines registration approvals, import license issuance, quality supervision, and market surveillance. The primary health product regulatory authority under the Cambodian Ministry of Health.
Ministry of Health
Ministry of Health of Cambodia
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA department operations and overall health regulatory system.
Traditional Medicines Registration Process
Regulatory Classification
Determine product classification as traditional medicine under Cambodian definition
Technical Documentation Preparation
Prepare ingredient analysis, traditional use evidence, safety data in Khmer language
FDA Registration Application
Submit Traditional Medicine Registration application to FDA Cambodia
Labeling Compliance Review
Ensure labeling compliance with Cambodian traditional medicine labeling regulations
Traditional Evidence Provision
Provide historical evidence of traditional use and safety data