Nigeria Product Registration & Certification
Important Notes
- NAFDAC Mandatory Registration & "Product Notification": All drugs (including herbal), cosmetics, foods (including "Food Supplements"), medical devices, and chemicals must be registered with NAFDAC. A "NAFDAC Registration Number" is required for import, advertisement, and sale.
- Clear Distinction between "Herbal Medicines" & "Food Supplements": Herbal products with therapeutic claims must be registered as "Herbal Medicines." Vitamins, minerals, etc., for nutritional support only are regulated as "Food" or "Food Supplements." Claims are the legal determinant of regulatory category.
- Local Agent or Company Authorization Requirement: Applications must be submitted by a locally registered Nigerian company (with a valid permit), which becomes the legal importer and product responsible party.
- SONCAP Certification (Pre-shipment Conformity Assessment): In addition to NAFDAC registration, all regulated products require a SONCAP Certificate from the Standards Organisation of Nigeria prior to shipment, mandatory for customs clearance.
- Stringent Advertisement Pre-approval System: All product advertisements directed at the public must be pre-approved by NAFDAC before airing. Scrutiny of claims is extremely rigorous, especially for medicines and health products.
- Reliance on WHO PQ & Reference Countries: NAFDAC regards WHO Prequalification and US FDA approval as critical references, possession of which can streamline the review process and enhance registration credibility.
Nigeria Specific Requirements
- Large, Price-Sensitive Hybrid Market Driven by Population: As Africa's most populous nation, the market is vast but with limited purchasing power. Extreme cost-competitiveness and high value-for-money are key to winning the mass market. Private pharmacies and PPMV networks are primary retail channels.
- Increasingly Strict Enforcement with Persistent Vigilance Required: NAFDAC is one of Africa's most active enforcement agencies, with frequent market raids and anti-counterfeiting operations. While adhering to the highest compliance, companies must cultivate transparent local partnerships to mitigate operational risks.
- Highly Fragmented & Multi-tiered Distribution Channels: Products pass through multiple layers of distributors and sub-distributors, making channel management, price maintenance, and anti-counterfeiting traceability major operational challenges.
- Strong Cultural & Market Foundation for "Herbal Medicines": There is a vast market for traditional herbs in modern dosage forms, but it is increasingly subject to modern regulation, with rising demands for standardization, safety, and quality control.
- Potential Gateway within the ECOWAS Region: NAFDAC registration carries some regional recognition, but actual regional expansion still requires navigating diverse registration requirements and trade barriers in each country.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Risk-based classification (Class A, B, C, D)
- Complete English technical documentation
- Quality Management System Certificate (ISO 13485)
- English labeling and instructions for use
- SONCAP Mandatory Certification (Standards Organization of Nigeria Conformity Assessment Program)
- Certificate of Free Sale
- CE Certificate of Conformity or FDA Approval
- Clinical Evaluation Report (if applicable)
- Performance verification data
- Test reports from accredited Nigerian laboratories
Main Process
- Product classification determination
- Technical documentation preparation
- Quality management system review
- SONCAP certification acquisition
- NAFDAC registration application submission
- Technical documentation assessment
- Product sample testing
- Registration certificate acquisition
Registration Timeline
9-20 months
Official Fees
NGN 800,000 - 15,000,000 (including application, evaluation, testing and registration fees)
Service Fees
$18,000 - $55,000
Regulatory System Overview
NAFDAC
National Agency for Food and Drug Administration and Control (NAFDAC)
Specialized regulatory agency under Nigerian Federal Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food supplements. One of the most important regulatory bodies in West Africa.
Standards Organization
Standards Organization of Nigeria (SON)
Responsible for developing Nigerian Industrial Standards, conducting mandatory SONCAP certification to ensure imported products meet Nigerian technical standards requirements
Federal Ministry of Health
Federal Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising NAFDAC operation and policy implementation
Medical Devices Registration Process
Product Classification
Determine risk classification according to Nigerian medical device regulations (Class A, B, C, D)
Technical Documentation
Prepare complete English technical documentation including specifications, test reports, clinical data
SONCAP Certification
Obtain mandatory SON conformity assessment program certification
Quality System
Provide ISO 13485 certificate or evidence of compliance with Nigerian quality system requirements
NAFDAC Registration
Submit complete medical device registration application to NAFDAC
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Registration
- Complete Product Information File
- Product Safety Assessment Report
- Compliance with Nigerian Cosmetic Regulations
- English product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
- SONCAP Certification
- Testing certificates from accredited Nigerian laboratories
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- SONCAP certification acquisition
- Cosmetic registration application
- Label compliance review
- Product sample testing
- Market access completion
Registration Timeline
7-15 months
Official Fees
NGN 300,000 - 4,000,000 (including application, testing and registration fees)
Service Fees
$12,000 - $30,000
Regulatory System Overview
NAFDAC
National Agency for Food and Drug Administration and Control (NAFDAC)
Specialized regulatory agency under Nigerian Federal Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food supplements. One of the most important regulatory bodies in West Africa.
Standards Organization
Standards Organization of Nigeria (SON)
Responsible for developing Nigerian Industrial Standards, conducting mandatory SONCAP certification to ensure imported products meet Nigerian technical standards requirements
Federal Ministry of Health
Federal Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising NAFDAC operation and policy implementation
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Nigerian permitted substances list and restrictions
Safety Assessment
Complete cosmetic safety assessment report by qualified safety assessor
SONCAP Certification
Obtain relevant SON certification
NAFDAC Registration
Submit cosmetic registration application to NAFDAC
Product Testing
Complete necessary product testing in accredited Nigerian laboratories
Food Supplements Registration
Regulatory Requirements
- Food Supplement Registration
- Ingredient safety and quality evidence
- Compliance with Nigerian Food Supplement Regulations
- English labeling and instructions
- Good Manufacturing Practice certificate
- Ingredient analysis reports
- Scientific justification for nutrition claims
- Stability study data
- SONCAP Mandatory Certification
- Analysis reports from accredited Nigerian laboratories
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- SONCAP certification acquisition
- NAFDAC registration application submission
- Label compliance review
- Product sample analysis
- Registration certificate acquisition
Registration Timeline
8-18 months
Official Fees
NGN 500,000 - 6,000,000 (including application, analysis and registration fees)
Service Fees
$14,000 - $35,000
Regulatory System Overview
NAFDAC
National Agency for Food and Drug Administration and Control (NAFDAC)
Specialized regulatory agency under Nigerian Federal Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and food supplements. One of the most important regulatory bodies in West Africa.
Standards Organization
Standards Organization of Nigeria (SON)
Responsible for developing Nigerian Industrial Standards, conducting mandatory SONCAP certification to ensure imported products meet Nigerian technical standards requirements
Federal Ministry of Health
Federal Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising NAFDAC operation and policy implementation
Food Supplements Registration Process
Product Classification
Determine product falls under food supplement category per Nigerian food regulations
Technical Documentation
Prepare ingredient analysis, safety evidence, nutrition claims in English
SONCAP Certification
Obtain mandatory SON conformity assessment program certification
NAFDAC Registration
Submit food supplement registration application to NAFDAC
Product Analysis
Complete ingredient analysis and safety assessment in accredited Nigerian laboratories