Tanzania Product Registration & Certification
Important Notes
- TMDA Mandatory Registration: All pharmaceuticals, medical devices, cosmetics, and "Herbal/Traditional Medicines" must be registered with the Tanzania Medicines and Medical Devices Authority to obtain a Product Registration Certificate before import or local sale.
- "Traditional Medicines" as an Independent Statutory Category: Herbal products with traditional use in Tanzania/East Africa are classified and regulated separately as "Traditional Medicines." Efficacy claims must be based on traditional use evidence, differing from modern medicine pathways.
- Local Authorized Agent (Local Company) Requirement: Foreign manufacturers must appoint a locally registered Tanzanian company (holding a valid wholesale license) as the legal agent, fully responsible for registration, customs, market surveillance, and all official TMDA communication.
- Document Legalization & Kiswahili Language Mandate: All registration documents require notarization and Tanzanian embassy legalization. Product labels must contain information in Kiswahili; instructions may include English.
- Stringent Price Control & Public Procurement Dominance: Prices for all registered drugs and some devices must be submitted to TMDA for approval. The vast majority of market share relies on centralized procurement by public health systems and donor-funded programs.
- Reliance on WHO Prequalification & Reference Approvals: TMDA technical reviews heavily rely on WHO Prequalification (PQ) and approvals from Stringent Regulatory Authorities. Possession of such certifications is key to expedited review.
Tanzania Specific Requirements
- Fragmented "Public-Private-Donor" Tripartite Market: The market consists of three independent segments: public procurement, private pharmacies, and international aid projects, each requiring distinct market access strategies. Public procurement ensures volume, the private sector offers profitability.
- Integration of Traditional Medicine with Modern Regulation: The "Traditional Medicines" category respects indigenous knowledge systems while evolving towards modern standards, with increasing demands for quality control, standardized production, and adverse event monitoring.
- Regulatory Capacity Building with High External Reliance: With limited resources, TMDA's review decisions depend heavily on external references (WHO PQ, UN agency procurement lists). Providing comprehensive international certification evidence is a core strategy for efficient access.
- Potential Gateway within Regional Integration: As an EAC member, TMDA registration offers theoretical regional mutual recognition, but practically, meeting specific additional requirements of each member state is still necessary.
- Logistics & Distribution Infrastructure Challenges: Post-registration, complex distribution logistics and "last-mile" delivery pose major barriers to market penetration, making partnerships with experienced, well-networked local distributors critical.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification according to risk classes (Class I, II, III, IV)
- 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 III and IV devices)
- Risk Assessment Documentation
- English/Swahili Bilingual Labeling
- Compliance with EAC Medical Device Regulations
Main Process
- Product classification determination
- Technical documentation preparation
- Local agent appointment
- TFDA registration application submission
- Technical assessment review
- Registration certificate obtainment
Registration Timeline
8-18 months (depending on product class and complexity)
Official Fees
TZS 8,000,000 - 120,000,000 (including application fee, assessment fee and registration fee)
Service Fees
$15,000 - $45,000
Regulatory System Overview
TFDA
Tanzania Food and Drugs Authority (TFDA)
Statutory regulatory body under Tanzania Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices, cosmetics and food according to Food, Drugs and Cosmetics Act. Important member of EAC Medicine Registration Harmonization initiative.
TBS
Tanzania Bureau of Standards (TBS)
Tanzania national standards body, responsible for developing and maintaining Tanzania Standards (TZS), implementing product certification schemes, ensuring product quality, safety and performance comply with national standards and EAC standards requirements.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising TFDA and other health regulatory agencies, coordinating EAC health affairs cooperation, ensuring public health safety and medical product quality.
Medical Devices Registration Process
Product Classification
Determine risk classification according to Tanzania medical device classification rules (Class I, II, III, IV), based on EAC classification system
Technical Documentation
Prepare complete English technical documentation including product specifications, test reports, clinical data, risk assessment, labeling
Local Agent Appointment
Appoint authorized agent in Tanzania responsible for TFDA communication and product registration
TFDA Registration
Submit medical device registration application and technical files to TFDA through authorized agent
Technical Assessment
TFDA conducts technical file evaluation, safety assessment and quality system review
Label Compliance
Ensure labels comply with Tanzania bilingual labeling requirements (English and Swahili)
Registration Certificate
Receive Medical Device Registration Certificate from TFDA, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate
- Complete Cosmetic Product Safety Report (CPSR)
- Compliance with Tanzania Cosmetic Regulations
- English/Swahili Bilingual Labeling
- Good Manufacturing Practice (GMP) Certificate
- Product Stability Test Reports
- Microbiological Testing Reports
- Non-animal Testing Declaration (if applicable)
- Product Information File
- Compliance with EAC Cosmetic Standards
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Technical documentation preparation
- TFDA registration application submission
- Label compliance review
- Market access completion
Registration Timeline
6-12 months
Official Fees
TZS 3,500,000 - 35,000,000 (including application fee, assessment fee and registration fee)
Service Fees
$9,000 - $25,000
Regulatory System Overview
TFDA
Tanzania Food and Drugs Authority (TFDA)
Statutory regulatory body under Tanzania Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices, cosmetics and food according to Food, Drugs and Cosmetics Act. Important member of EAC Medicine Registration Harmonization initiative.
TBS
Tanzania Bureau of Standards (TBS)
Tanzania national standards body, responsible for developing and maintaining Tanzania Standards (TZS), implementing product certification schemes, ensuring product quality, safety and performance comply with national standards and EAC standards requirements.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising TFDA and other health regulatory agencies, coordinating EAC health affairs cooperation, ensuring public health safety and medical product quality.
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Tanzania 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
Local Agent Appointment
Appoint authorized agent in Tanzania responsible for registration application
TFDA Registration
Submit cosmetic registration application and technical files to TFDA
Label Compliance
Ensure labels fully comply with Tanzania bilingual labeling regulations (English and Swahili)
Pharmaceuticals Registration
Regulatory Requirements
- Medicine Registration Certificate
- Complete Safety and Efficacy Evidence
- Compliance with Tanzania Medicine Regulations
- English/Swahili Bilingual Labeling
- Good Manufacturing Practice (GMP) Certificate
- Stability Study Data
- Ingredient Analysis Reports
- Bioequivalence Studies (for generic medicines)
- Clinical Trial Data (for new drugs)
- Compliance with EAC Medicine Registration Requirements
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- TFDA registration application submission
- Scientific review approval
- Registration certificate obtainment
Registration Timeline
12-24 months (depending on medicine category and complexity)
Official Fees
TZS 15,000,000 - 250,000,000 (including application fee, assessment fee and registration fee)
Service Fees
$20,000 - $65,000
Regulatory System Overview
TFDA
Tanzania Food and Drugs Authority (TFDA)
Statutory regulatory body under Tanzania Ministry of Health, comprehensively responsible for registration approval, quality supervision, market regulation and compliance enforcement of pharmaceuticals, medical devices, cosmetics and food according to Food, Drugs and Cosmetics Act. Important member of EAC Medicine Registration Harmonization initiative.
TBS
Tanzania Bureau of Standards (TBS)
Tanzania national standards body, responsible for developing and maintaining Tanzania Standards (TZS), implementing product certification schemes, ensuring product quality, safety and performance comply with national standards and EAC standards requirements.
MOH
Ministry of Health (MOH)
Responsible for developing national health policies, regulatory frameworks and strategic directions, supervising TFDA and other health regulatory agencies, coordinating EAC health affairs cooperation, ensuring public health safety and medical product quality.
Pharmaceuticals Registration Process
Product Classification
Determine product category: prescription medicine, over-the-counter medicine, traditional medicine or herbal product
Technical Documentation
Prepare complete registration dossier complying with EAC medicine registration technical requirements
GMP Compliance
Provide valid GMP certificate or undergo TFDA site inspection
Local Agent Appointment
Appoint authorized agent in Tanzania responsible for medicine registration
TFDA Registration
Submit medicine registration application and complete technical dossier to TFDA
Scientific Review
TFDA conducts comprehensive assessment of quality, safety and efficacy
Label Review
Ensure labels comply with Tanzania medicine labeling regulations and bilingual requirements
Registration Approval
Receive Medicine Registration Certificate from TFDA, typically valid for 5 years