Ghana Product Registration & Certification
Important Notes
- FDA-GH Mandatory Market Authorization: All pharmaceuticals, medical devices, foods (including "Food Supplements"), cosmetics, and household chemicals require market authorization from the Ghana FDA and listing on the relevant product register.
- Explicit Definition & Claim Management for "Food Supplements": Vitamins, amino acids, herbal extracts, etc., are defined as "Food Supplements," a sub-category under foods. All health claims must undergo pre-market scientific review and receive written approval from FDA-GH.
- Local Agent or Authorized Representative System: Applications must be submitted through a locally registered Ghanaian company, which becomes the responsible party listed on the product registration certificate.
- GSA Standards & Product Conformity Assessment: Imported products must comply with relevant Ghana Standards Authority standards and may require pre-shipment conformity assessment for customs clearance.
- Stringent Advertisement Pre-approval & Public Education Duty: All advertisements for therapeutic products must be pre-approved by FDA-GH. The regulator emphasizes industry's responsibility in public health education.
- Participation in ECOWAS Harmonization: Ghana actively participates in ECOWAS regional harmonization initiatives for medicines and devices, but national authorization remains the sole legally valid marketing permit for now.
Ghana Specific Requirements
- Stable & Mature Benchmark Market in Anglophone West Africa: Relative political-economic stability and a transparent, enforceable regulatory system make it an ideal test market for West Africa.
- Rapid Growth of "Food Supplements" under Strict Claim Control: A growing middle class drives demand, but FDA-GH’s pre-market scientific review of claims presents the highest compliance hurdle, creating significant barriers for compliant products.
- Complementary Public Supply System & Vibrant Private Market: The Ghana National Medical Stores handles public procurement, while private pharmacies and "chemical seller" shops form the main channel for consumer health and OTC products.
- Regulator Focused on Capacity Building & International Collaboration: FDA-GH is a leader in regional regulatory capacity building, closely collaborating with WHO and US FDA, and its review standards are increasingly aligned with international benchmarks.
- Deep Distribution Penetration but High Logistics Costs: Products can reach widespread towns, but inland transportation, warehousing deficits, and port inefficiencies increase overall supply chain costs, a key factor in pricing strategy.
Medical Devices Registration
Regulatory Requirements
- Medical Device Marketing Authorization
- Risk-based classification (Class A, B, C, D)
- Complete English technical documentation
- Quality Management System Certificate (ISO 13485)
- English labeling and instructions for use
- Compliance with Ghana Medical Device Regulation (Public Health Act, 2012)
- Certificate of Free Sale
- CE Certificate of Conformity or FDA Approval
- Clinical Evaluation Report (if applicable)
- Performance verification data
- Test reports from accredited Ghanaian laboratories
Main Process
- Product classification determination
- Technical documentation preparation
- Quality management system review
- FDA registration application submission
- Local authorized agent appointment
- Technical documentation assessment
- Product sample testing
- Marketing authorization acquisition
Registration Timeline
7-14 months
Official Fees
GHS 25,000 - 1,000,000 (including application, evaluation, testing and registration fees)
Service Fees
$13,000 - $38,000
Regulatory System Overview
Ghana FDA
Ghana Food and Drugs Authority (FDA)
Specialized regulatory agency under Ghana Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food products. Key regulatory body in West Africa region.
Standards Authority
Ghana Standards Authority (GSA)
Responsible for developing Ghana Standards, conducting product quality certification and conformity assessment to ensure products meet Ghana technical standards requirements
Ministry of Health
Ghana Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising FDA operation and policy implementation, coordinating ECOWAS health affairs
Medical Devices Registration Process
Product Classification
Determine risk classification according to Ghana medical device regulations (Class A, B, C, D)
Technical Documentation
Prepare complete English technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or evidence of compliance with Ghana quality system requirements
Local Authorized Agent
Appoint authorized agent located in Ghana
FDA Registration
Submit complete medical device marketing authorization application to Ghana FDA
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Marketing Authorization
- Complete Product Information File
- Product Safety Assessment Report
- Compliance with Ghana Cosmetics Guidelines
- English product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
- Testing certificates from accredited Ghanaian laboratories
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic marketing authorization application
- Label compliance review
- Product sample testing
- Market access completion
Registration Timeline
5-10 months
Official Fees
GHS 15,000 - 250,000 (including application, testing and registration fees)
Service Fees
$8,000 - $20,000
Regulatory System Overview
Ghana FDA
Ghana Food and Drugs Authority (FDA)
Specialized regulatory agency under Ghana Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food products. Key regulatory body in West Africa region.
Standards Authority
Ghana Standards Authority (GSA)
Responsible for developing Ghana Standards, conducting product quality certification and conformity assessment to ensure products meet Ghana technical standards requirements
Ministry of Health
Ghana Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising FDA operation and policy implementation, coordinating ECOWAS health affairs
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Ghana permitted substances list and restrictions
Safety Assessment
Complete cosmetic safety assessment report by qualified safety assessor
Product Information File
Prepare complete product information file in English
FDA Registration
Submit cosmetic marketing authorization application to Ghana FDA
Product Testing
Complete necessary product testing in accredited Ghanaian laboratories
Pharmaceuticals Registration
Regulatory Requirements
- Medicine Marketing Authorization
- Complete registration dossier
- Comprehensive quality, safety, efficacy data
- Compliance with Ghana Medicines Regulation (Public Health Act, 2012)
- English labeling and instructions
- Good Manufacturing Practice certificate
- Stability study data
- Bioequivalence studies (if applicable)
- Product sample laboratory test reports
- ECOWAS regional requirements
Main Process
- Product classification determination
- Registration dossier preparation
- Technical documentation compilation
- Marketing authorization application submission
- Technical evaluation and assessment
- Product sample testing
- Marketing authorization acquisition
Registration Timeline
12-20 months
Official Fees
GHS 60,000 - 1,500,000 (including application, evaluation, testing and registration fees)
Service Fees
$16,000 - $48,000
Regulatory System Overview
Ghana FDA
Ghana Food and Drugs Authority (FDA)
Specialized regulatory agency under Ghana Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food products. Key regulatory body in West Africa region.
Standards Authority
Ghana Standards Authority (GSA)
Responsible for developing Ghana Standards, conducting product quality certification and conformity assessment to ensure products meet Ghana technical standards requirements
Ministry of Health
Ghana Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising FDA operation and policy implementation, coordinating ECOWAS health affairs
Pharmaceuticals Registration Process
Product Classification
Determine pharmaceutical classification and registration pathway (innovative, generic, traditional medicines)
Registration Dossier
Prepare complete registration dossier including quality, safety, efficacy data
Technical Documentation
Compile all technical documents including manufacturing process, quality control, stability data
FDA Application
Submit medicine marketing authorization application to Ghana FDA
Sample Testing & Assessment
Submit product samples for laboratory testing and pass technical evaluation