Kenya Product Registration & Certification
Important Notes
- PPB Mandatory Product Registration: All pharmaceuticals, medical devices, cosmetics, and "Herbal/Complementary Medicines" must be registered with the Pharmacy and Poisons Board to obtain a Product Registration Certificate for sale in Kenya.
- Parallel Regulation of Herbal & Complementary Medicines: Traditional herbal products and modern supplements fall under "Herbal & Complementary Medicines." Registration requires safety evidence and efficacy substantiation based on traditional use or modern studies.
- Local Authorized Agent (Licensed Entity) Requirement: A foreign manufacturer must appoint a locally registered entity (typically a licensed pharmacist or pharmaceutical wholesale company) as its legal agent with PPB, responsible for all registration and regulatory matters.
- Impact of EAC Common Market Protocol: As a key EAC member, Kenya participates in regional harmonization efforts for medicines and devices, but national registration remains the legal prerequisite for marketing.
- KEBS Standards & PVoC Conformity Certification: All imported products require a Pre-Export Verification of Conformity Certificate from the Kenya Bureau of Standards prior to customs clearance.
- High Reliance on International Certifications: PPB extensively recognizes WHO Prequalification, FDA, and EMA approvals as critical references for safety, efficacy, and quality during technical review.
Kenya Specific Requirements
- Economic & Regulatory Leader in East Africa: Boasts the region’s most dynamic private healthcare market, mature logistics hub, and internationalized business environment, making it the preferred location for regional headquarters.
- Testing Ground for Innovative Payment & Digital Health Models: High penetration of private health insurance and mobile money fuels telemedicine, e-pharmacy, and high receptivity to digital health products.
- Formalization of the Herbal & Complementary Medicines Market: PPB is steering this category from traditional empiricism towards evidence-based and quality-managed modernization, creating advantages for compliant products with standardized production and data.
- Public Procurement & International Programs Drive Volume: Bulk procurement by the Ministry of Health, KEMSA, and donors like the Global Fund constitutes the primary market for essential drugs and devices, but is highly competitive with thin margins.
- Diverse Channels Coupled with Supply Chain Challenges: The market ranges from modern pharmacy chains to ubiquitous informal drug outlets. Cold chain logistics, anti-counterfeiting, and distribution management pose significant operational hurdles.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification according to risk classes (A, B, C, D)
- Complete English technical documentation
- Quality Management System Certificate (ISO 13485)
- CE Marking or FDA Approval (as technical assessment basis)
- Performance Test Reports and Verification Data
- Biocompatibility Test Reports (if applicable)
- Clinical Evaluation Report (for Class C and D devices)
- Risk Assessment Documentation
- Kenya Authorized Representative Agreement
Main Process
- Product classification determination
- Technical documentation preparation
- KEBS certification obtainment
- PPB registration application submission
- Technical assessment review
- Registration certificate obtainment
Registration Timeline
9-18 months (depending on product class and complexity)
Official Fees
KES 150,000 - 3,500,000 (including application fee, assessment fee and registration fee)
Service Fees
$16,000 - $55,000
Regulatory System Overview
PPB
Pharmacy and Poisons Board (PPB)
Statutory body under Kenya Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices and cosmetics. Exercises regulatory authority according to Kenya Pharmacy and Poisons Act.
KEBS
Kenya Bureau of Standards (KEBS)
Kenya national standards body, responsible for developing and maintaining Kenya Standards (KS), implementing mandatory product certification schemes, ensuring product quality, safety and performance comply with national standards.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising PPB and other health regulatory agencies, ensuring public health safety and medical product quality.
Medical Devices Registration Process
Product Classification
Determine risk classification according to Kenya medical device classification rules (Class A, B, C, D), Class A being lowest risk, Class D highest risk
Technical Documentation
Prepare complete English technical documentation including product specifications, test reports, clinical data, risk assessment, labeling
KEBS Certification
Obtain product conformity certification from Kenya Bureau of Standards ensuring compliance with Kenyan standards
Local Representative
Appoint authorized representative in Kenya responsible for PPB communication and product registration
PPB Registration
Submit medical device registration application and technical files to PPB through authorized representative
Technical Assessment
PPB conducts technical file evaluation, safety assessment and quality system review
Registration Certificate
Receive Medical Device Registration Certificate from PPB, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate
- Complete Cosmetic Product Safety Report (CPSR)
- Compliance with Kenya Cosmetic Regulations
- English product labeling and instructions
- Good Manufacturing Practice (GMP) Certificate
- Product Stability Test Reports
- Microbiological Testing Reports
- Non-animal Testing Declaration (if applicable)
- Product Information File
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Technical documentation preparation
- PPB registration application submission
- Label compliance review
- Market access completion
Registration Timeline
6-12 months
Official Fees
KES 75,000 - 1,200,000 (including application fee, assessment fee and registration fee)
Service Fees
$9,000 - $28,000
Regulatory System Overview
PPB
Pharmacy and Poisons Board (PPB)
Statutory body under Kenya Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices and cosmetics. Exercises regulatory authority according to Kenya Pharmacy and Poisons Act.
KEBS
Kenya Bureau of Standards (KEBS)
Kenya national standards body, responsible for developing and maintaining Kenya Standards (KS), implementing mandatory product certification schemes, ensuring product quality, safety and performance comply with national standards.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising PPB and other health regulatory agencies, ensuring public health safety and medical product quality.
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Kenya cosmetic regulations permitted lists and prohibited substances
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) by qualified safety assessor
Technical Documentation
Prepare complete technical file including product formulation, manufacturing method, safety evidence, labeling
PPB Registration
Submit cosmetic registration application and technical files to PPB
Label Compliance
Ensure labels fully comply with Kenya cosmetic labeling regulations and English requirements
KEBS Certification
Obtain cosmetic conformity certification from Kenya Bureau of Standards
Pharmaceuticals Registration
Regulatory Requirements
- Medicine Registration Certificate
- Complete Safety and Efficacy Evidence
- Compliance with Kenya Medicine Regulations
- English Product Labeling and Instructions
- Good Manufacturing Practice (GMP) Certificate
- Stability Study Data
- Ingredient Analysis Reports
- Bioequivalence Studies (if applicable)
- Clinical Trial Data (for new drugs)
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- PPB registration application submission
- Scientific review approval
- Registration certificate obtainment
Registration Timeline
12-24 months (depending on medicine category)
Official Fees
KES 200,000 - 5,000,000 (including application fee, assessment fee and registration fee)
Service Fees
$25,000 - $85,000
Regulatory System Overview
PPB
Pharmacy and Poisons Board (PPB)
Statutory body under Kenya Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices and cosmetics. Exercises regulatory authority according to Kenya Pharmacy and Poisons Act.
KEBS
Kenya Bureau of Standards (KEBS)
Kenya national standards body, responsible for developing and maintaining Kenya Standards (KS), implementing mandatory product certification schemes, ensuring product quality, safety and performance comply with national standards.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising PPB and other health regulatory agencies, ensuring public health safety and medical product quality.
Pharmaceuticals Registration Process
Product Classification
Determine product category: prescription medicine, over-the-counter medicine, or traditional medicine
Technical Documentation
Prepare complete registration dossier including quality, safety and efficacy data
GMP Compliance
Provide valid GMP certificate or undergo PPB site inspection
PPB Registration
Submit medicine registration application and complete technical dossier to PPB
Scientific Review
PPB conducts comprehensive assessment of quality, safety and efficacy
Label Review
Ensure labels comply with Kenya medicine labeling regulations and English requirements
Registration Approval
Receive Medicine Registration Certificate from PPB, typically valid for 5 years