Official Investment Gateway

Tanzania Pharmaceutical & Medical Devices Investment Forum

MPMED-SEZ is the Ministry of Health’s official portal for local and international investors seeking opportunities in pharmaceutical manufacturing, medical device assembly, and strategic health infrastructure at Mloganzila, Dar es Salaam.
Explore Opportunities Join the London Forum Investor Hub
15+
Priority investment sectors
$2B+
Estimated pipeline potential
600ha
Dedicated dual-sector zone

Investor Hub

Everything you need to invest with confidence.

Opportunities

Open for investment right now.

Events & Engagement

Browse upcoming forums and briefings.

Invest Now

Submit inquiry and receive follow-up details.
Pharmaceuticals — Primary Mandate
·
Medical Devices — Second Mandate
·
PIAT — Pharmaceutical Investment Acceleration Taskforce
·
TMDA WHO Maturity Level 3 · First in Africa
·
ISO 13485 Medical Device Assembly
·
MSD $491M Centralised Procurement · 15% Local Preference
·
600 Hectares · Mloganzila, Dar es Salaam
·
Green-Lane Approval · Rolling EOI
·
TISEZA One Stop Facilitation Centre
·
Ministry of Health · United Republic of Tanzania
Pharmaceuticals — Primary Mandate
·
Medical Devices — Second Mandate
·
PIAT — Pharmaceutical Investment Acceleration Taskforce
·
TMDA WHO Maturity Level 3 · First in Africa
·
ISO 13485 Medical Device Assembly
·
MSD $491M Centralised Procurement · 15% Local Preference
·
600 Hectares · Mloganzila, Dar es Salaam
·
Green-Lane Approval · Rolling EOI
·
TISEZA One Stop Facilitation Centre
·
Ministry of Health · United Republic of Tanzania
Key Investment Sectors

Two mandates.
One zone. Full supply chain.

MPMED-SEZ is East Africa's only Special Economic Zone encoding both pharmaceutical manufacturing and medical device assembly within a single governed industrial site — addressing a $491M annual domestic market (MSD) with 80%+ import dependency, and access to 331M+ (EAC) and 450M+ (SADC) regional consumers.

Primary Mandate

Pharmaceuticals

Tanzania imports over 80% of its medicines — with only 19 domestic pharmaceutical manufacturing facilities vs 726 authorized foreign manufacturers. MPMED-SEZ is the designated site for expanding domestic production of generic medicines, biologics, APIs, vaccines, and traditional medicines at WHO-GMP certified industrial scale.

Generic medicines: solid dosage, injectables, topicals, oral liquids
Biologics and vaccines: WHO-prequalified bioproduction suites, cold chain
Active Pharmaceutical Ingredient (API) synthesis
Traditional and herbal medicines: GMP certification and standardisation
Oncology and specialty medicines: antiretrovirals, antimalarials
Pharmaceutical-grade packaging and labelling
View pharmaceutical opportunities
Second Mandate

Medical Devices

Over 90% of Tanzania's medical devices and 99% of diagnostics are imported — 157,444 import permits issued between 2022–2025 alone. MPMED-SEZ creates East Africa's first dedicated medical device assembly zone — precision surgical devices, clinical consumables, IVD diagnostics, and digital health hardware.

Precision medical devices: surgical instruments, orthopaedic implants, ophthalmic
Clinical consumables: gloves, syringes, IV sets, wound care, PPE
In-vitro diagnostics (IVDs): reagents, test kits, lab diagnostic equipment
Digital health hardware: monitoring devices, point-of-care diagnostics
Medical imaging system components and hospital diagnostic equipment
Sterilisation services and sterile barrier packaging
View medical device opportunities
TMDA Market Intelligence

The data behind
the opportunity

Authoritative regulatory data from TMDA — WHO Maturity Level 3 (first in Africa), ISO 9001:2015 certified, with WHO-prequalified laboratories — showing the scale of Tanzania's healthcare manufacturing gap.

8,465
Registered Medicines (since 2003)
19
Domestic Pharma Facilities
726
Foreign Manufacturers Authorised
141
Device Manufacturers (local)
157K
Import Permits 2022–2025
Critical Manufacturing Gaps (TMDA)
✕ Zero human biologics or vaccine manufacturing plants
✕ No API or excipients manufacturing facilities
✕ No small volume parenterals plants (ampoules & vials)
✕ No manufacturers of anti-TB, anti-cancer, cardiovascular, or anti-diabetic medicines
✕ Few packaging materials manufacturers (erratic supply)
✕ Only 2 sterile human I.V infusion facilities for 61.7M population
Highly Imported Products (TMDA Data)
Medicines
Antibiotics (22.4%)
Cardiovascular agents
Oncology products
GI medicines
Antiretrovirals
Vaccines
Analgesics
Antidiabetics
Antimalarials
Devices & Diagnostics
Condoms & sutures
Syringes & IV cannulas
Surgical & exam gloves
Analyser reagents
IV giving sets
Lab equipment
Orthopaedic implants
Blood bags & catheters
X-ray films
Regional Market Access: Products manufactured in MPMED-SEZ benefit from EAC Common Technical Document harmonisation (342 applications, 158 products approved via joint review) and SADC Mutual Recognition framework — accelerating access to 400M+ regional consumers. African Medicines Agency (AMA) treaty ratified.
Structured Market Assurance

Guaranteed market access through
centralised procurement

Medical Stores Department (MSD) — Tanzania's national public health supply chain agency — provides structured market assurance for local manufacturers through centralised procurement, serving 8,800+ health facilities across 10 zones.

$491M
Total Commodities Procured (FY 24/25)
3,000+
Health Products Supplied
8,800+
Health Facilities Served
15%
Price Preference for Local Products
103%
Revenue Growth in 4 Years
MSD Partnership Models for Investors
JV
Joint Venture with MSD Medipharm
Direct access to local market. MSD Medipharm offers up to 40,000 sqm land at Kibaha Cluster 2 (56km from DSM, 8km from SGR depot). Facilitated approvals and incentives.
PPM
EAC & SADC Pooled Procurement
Access regional markets through established pooled procurement mechanisms — EAC-PPM and SADC-SPPS platforms. 331M+ (EAC) and 450M+ (SADC) population reach.
DST
Distribution & Priority Local Manufacturer
Utilise MSD's 10-zone distribution network. 15% government price preference for locally produced products. Zero importation for products made locally in sufficient quantity. Dedicated tenders for local manufacturers.
Addressable Market Scope
61M
Tanzania
$491M/yr
331M
EAC Region
EAC-PPM Access
450M
SADC Region
SADC-SPPS
Donor funding contributes ~$280M/yr to Tanzania's pharmaceutical market (MSD)
MSD Product Lines & Supply Categories
Pharmaceuticals Medical Supplies Medical Equipment Vaccines ARVs TB Medicines Antimalarials Dialysis Dental Strategic Projects
MSD operates long-term Framework Agreements (FWAs) with strategic procurement. ISO 9001:2015 certified for 11 years. MSD Medipharm Manufacturing subsidiary handles local production.
Pharmaceutical Investment Acceleration Taskforce

Accelerating local
pharmaceutical manufacturing
in Tanzania

PIAT is a government-established, high-level coordination mechanism to facilitate, de-risk, and fast-track pharmaceutical manufacturing investment in Tanzania — composed of senior decision-makers from across the health, investment, and industrial sectors. Investors are assessed through a transparent, standardised due diligence framework across 11 weighted areas.

🏛️

High-Level Political Commitment

Pharmaceutical manufacturing is a top government priority under President H.E. Dr. Samia Suluhu Hassan, with strong leadership backing.

🤝

Whole-of-Government Coordination

Multiple government agencies working together to streamline processes and provide unified investor support.

📋

Policy Alignment

Integrated with national health, investment, and industrial development agendas for coherent support.

⚡

Implementation Mandate

Clear directive to PIAT to move from policy discussion to actionable projects and tangible results.

PIAT Composition
Ministry of Health
Tanzania Medicines & Medical Devices Authority (TMDA)
Medical Stores Department (MSD)
Tanzania Investment & SEZ Authority (TISEZA)
Private Sector Representatives
Other Key Government Institutions
Decision-Making Authority

PIAT is composed of senior decision-makers ensuring approvals are taken at the highest level — fast-tracking approvals, avoiding administrative delays, and bringing together diverse stakeholders to drive Tanzania's pharmaceutical industry forward.

Fast-tracking investment approvals
Addressing historical investment bottlenecks
Coordinating investment, regulation, procurement, and financing
Facilitating collaborative multi-stakeholder approaches
PIAT Approach

How PIAT accelerates
your investment

PIAT works across three pillars to create the most enabling environment for pharmaceutical manufacturers entering Tanzania — de-risking entry, streamlining approvals, and aligning incentives with infrastructure.

De-risking Investment Entry

PIAT mitigates risks and barriers through the Green-Lane Approval System — priority regulatory approvals, accelerated decision-making, coordinated government support, and connecting investors with local partners including MSD Medipharm.

Streamlining Approvals

Green-Lane Approval System — coordinating across government agencies to simplify and expedite approvals. Rolling, accelerated review of EOIs with approval granted promptly to investors demonstrating technical capacity, financial strength, and strategic alignment.

Aligning Incentives & Infrastructure

Aligning tax benefits and fiscal incentives with development of industrial parks, reliable utilities, and supporting infrastructure for pharmaceutical operations.

Demand Forecasting & Structured Market Assurance

PIAT develops medium-to-long-term demand projections based on population, coverage, disease burden, and utilisation trends. MSD provides structured market assurance through centralised procurement — $491M/year, serving 8,800+ health facilities, with 15% price preference and dedicated tenders for local manufacturers.

Forecasts are for planning purposes — MSD procurement access is through standard tender processes with local manufacturer preference
EOI Eligibility Criteria
Technical expertise in pharmaceutical manufacturing
Proven regulatory compliance track record (WHO-GMP)
Financial capacity for proposed investment
Experience in large-scale industrial projects
Commitment to quality assurance and technology transfer
PIAT Is
A facilitative and coordinating mechanism for pharmaceutical investment
A problem-solving platform with access to senior government decision-makers
A vehicle for fast-tracking manufacturers committed to local production in Tanzania
PIAT Is Not
A substitute for regulatory compliance — all standards must be met
A waiver-granting body for quality or safety standards
A vehicle for facilitating importers — PIAT supports manufacturers only
Priority
PIAT Focus Area 1

Essential Medicines

Manufacturing and supplying essential pharmaceuticals — antibiotics (22.4% of 8,465 registered medicines), cardiovascular agents (12.4%), analgesics (13.1%), GI medicines (16.6%). MSD provides 15% price preference and dedicated tenders. $491M annual procurement market.

High Impact

Vaccines & Biologics

Zero human biologics or vaccine manufacturing plants in Tanzania (TMDA) — only 3 veterinary vaccine facilities exist. A critical gap for investing in vaccine and biologic therapy production to strengthen public health infrastructure. EAC/SADC regional market reach.

Import Substitution

Medical Consumables

Expanding local manufacturing of critical medical supplies — 157,444 import permits issued 2022–2025 for devices and diagnostics. Top imports: condoms, sutures, syringes, gloves, IV sets, reagents, blood bags. Reduce 90%+ import dependence.

Long-Term Strategy

APIs & Critical Inputs

Neither API nor excipients manufacturing facilities exist in Tanzania or the entire EAC region — 100% of APIs are imported (MSD/TMDA). Developing medium-to-long-term capability to produce Active Pharmaceutical Ingredients and other critical inputs. Addresses the deepest supply chain vulnerability.

Investor Journey

Your path with PIAT —
from interest to manufacturing

From initial expression of interest to full-scale manufacturing establishment — PIAT guides you through every step with coordinated government support.

Step 1

Expression of Interest

Investors express their interest in partnering with PIAT and investing in Tanzania's pharmaceutical manufacturing sector through the MPMED-SEZ portal or direct engagement with the facilitation desk.

Step 2

Technical & Strategic Due Diligence

PIAT conducts a preliminary due diligence assessment across 11 weighted areas using a standardised scoring tool (1–5 scale). Investors scoring 85–100 are Highly Recommended; 70–84 Recommended; 55–69 Conditional. Assessment based on business plan, feasibility study, interviews, and site visits.

Step 3

Joint Structuring & Localisation Roadmap

PIAT collaborates with the investor to develop a customised localisation roadmap — outlining milestones for technology transfer, skills development, and local value addition within the SEZ framework.

Step 4

Regulatory & Operational Fast-Tracking

PIAT provides streamlined support facilitating the regulatory approval process and addressing operational requirements — TMDA, TISEZA, BRELA coordination for smooth establishment within MPMED-SEZ.

Step 5

Manufacturing Establishment & Scale-Up

Set up the manufacturing facility in Tanzania, leveraging PIAT's support and MPMED-SEZ infrastructure, and gradually scale up production to meet local and regional demand across EAC/SADC markets.

Strategic Value to Investors

PIAT provides a stable, government-backed framework operating under the Green-Lane Approval System — offering reduced policy and execution risk, priority approvals, and predictable timelines for long-term pharmaceutical manufacturing investments in Tanzania.

Reduced policy & execution risk
Predictable investment timelines
Government-backed support framework
Regional export capability enablement
Express Interest Now
Investment Philosophy
01 Commit to physical manufacturing presence in Tanzania
02 Demonstrate technology transfer and skills localisation
03 Meet international quality standards (WHO-GMP)
04 Pursue long-term regional manufacturing strategies
PIAT Due Diligence

Transparent assessment.
Clear criteria.

PIAT uses a standardised Preliminary Due Diligence Assessment Tool across 11 weighted areas. Score 1–5 on each criterion, with an overall weighted score determining your recommendation level. No hidden criteria — here's exactly what we evaluate.

85–100 Highly Recommended
70–84 Recommended
55–69 Conditional
Below 55 Not Recommended
15%
Capital Investment
Financial capacity, equity contribution, funding reliability, projections, break-even and ROI analysis
15%
Manufacturing Capacity
Facility layout, production lines, equipment quality, scalability, technical expertise, expansion plans
10%
Products & Patents
Portfolio breadth, essential medicines list fit, dosage forms, IP portfolio, freedom to operate, R&D pipeline
10%
Regulatory & Compliance
WHO-GMP certification, inspection history, QMS maturity, pharmacovigilance, anti-corruption, compliance record
10%
Feasibility & Business Plan
Technical/financial/market feasibility, financial model, P&L projections, risk analysis, sensitivity and contingency
10%
Quality Management
QMS implementation, documentation, SOPs, QC laboratory, testing capability, CAPA system, change control
7%
Market & Promotions
Market research, competitive analysis, pricing, distribution strategy, MSD public sector access, export strategy
6%
Human Resources
Leadership quality, industry experience, pharmacists/chemists, engineers, QA/QC staff, training and retention
5%
Supply Chain & Procurement
API sourcing strategy, supplier qualification, import/export capability, logistics, risk management, quality assurance
5%
Legal & Governance
Corporate structure, governance framework, ownership clarity, compliance record, contracts, dispute history
4%
Risk Management
Risk framework, risk register, monitoring, insurance, financial/operational/market/regulatory risk management
3%
Environmental & Social
Environmental impact assessment, waste management, emissions, community engagement, local content, health & safety
Submit Your EOI — Begin Due Diligence Process
Investor Hub

Everything you need to
invest with confidence

Sector-specific resources for pharmaceutical and medical device investors — zone data, investment profiles, regulatory guides, PIAT demand forecasts, and feasibility tools published by the Ministry of Health.

MPMED-SEZ 600ha Zone Overview

Boundary maps, pharmaceutical cluster, medical device cluster, logistics zone, R&D park, infrastructure status, and the complete 600ha master development plan.

Updated March 2026Dual-Sector Zone

Pharmaceutical Investment Profiles

Detailed profiles for generic medicines, biologics, API synthesis, vaccines, and traditional medicines — market demand (8,465 registered products, 900–1,000 new applications/year), IRR benchmarks, GMP requirements, and TMDA 60-day pathway.

6 Sub-SectorsPharma

Medical Device Investment Profiles

Profiles for precision devices, clinical consumables, IVDs, and digital health hardware — 1,906 registered products, 1,000–1,500 new applications/year, ISO 13485 requirements, and TMDA device registration guide.

6 Sub-SectorsDevices

Investment Policy and Incentive Framework

Tanzania's SEZ investment regulations under TISEZA (Act No. 6 of 2025), reduced corporate tax, zero import duty, 100% foreign ownership rules, profit repatriation guarantees, and preferential procurement policy.

TISEZA 2025–2030Official

Feasibility Study Templates

MoH-approved financial models for pharmaceutical manufacturing plants, medical device assembly facilities, GMP warehousing, cold-chain logistics, and IVD production units.

8 TemplatesFree Download

Investor Forum and Site Visit Pipeline

Ministry-convened forums for pharmaceutical and medical device investors — PIAT sector briefings, TISEZA site visits, TMDA pre-licensing consultations, and business matching with MoH facilitation.

Next: Q3 2026Register Interest
Investment Opportunities

Open for investment
right now

Priority pharmaceutical and medical device investment opportunities within MPMED-SEZ — identified by the Ministry of Health, PIAT, and the Tanzania Investment Centre. Essential medicines and vaccines are PIAT strategic focus areas.

Pharmaceuticals

Generic Medicines Manufacturing Plant

WHO-GMP facility for Tanzania's essential medicines list — solid dosage, injectables, oral liquids, topicals. Only 19 domestic manufacturers vs 726 foreign; antibiotics 22.4% of registered medicines. TMDA 60-day fast-track. MSD 15% price preference and dedicated local tenders.

Min. Investment$8M USD
Land5.2 ha
SupportTax Holiday
Medical Devices

Clinical Consumables Manufacturing Facility

High-volume production of gloves, syringes, IV sets, wound care, PPE, and surgical disposables. 157,444 import permits issued 2022–2025 — Tanzania's largest import substitution opportunity by unit volume. Direct MoH public procurement contracts available.

Min. Investment$5M USD
Land4.0 ha
MarketEast Africa
Pharmaceuticals

API Synthesis and Raw Materials Facility

Active Pharmaceutical Ingredient production — no API or excipients manufacturing facilities exist in Tanzania or the entire EAC region; 100% of APIs are imported (TMDA/MSD). Chemical engineering infrastructure, dedicated API cluster. Zero domestic or regional competition.

Min. Investment$12M USD
Land6.5 ha
IRR Target20–25%
Medical Devices

In-Vitro Diagnostics (IVD) Production Unit

Reagent manufacturing, rapid test kit assembly, and laboratory diagnostic equipment for malaria, HIV, TB, and NCD panels. 99% of diagnostics are imported (TMDA). WHO Emergency Use Listing pathway supported within the zone.

Min. Investment$3.5M USD
Land2.2 ha
Payback5–7 yrs
Logistics

Cold-Chain Pharmaceutical Logistics Hub

Purpose-built GMP-compliant cold-chain storage and distribution for vaccines, biologics, and temperature-sensitive medicines — serving MPMED-SEZ manufacturers and the wider East African supply chain.

Min. Investment$2.2M USD
Capacity2,400 m²
MarketEast Africa
R&D

Biomedical R&D and Innovation Centre

Clinical research, biomedical innovation, and health technology development — linked to Muhimbili National Hospital and Tanzanian universities. Academic and private sector partnership-ready facility within the zone.

Min. Investment$2.8M USD
PartnershipsMNH / UDSM
Demand GapHigh
Investment Incentives

Compelling economics for
manufacturing investors

Tanzania's TISEZA investment framework (Act No. 6 of 2025) delivers one of East Africa's most competitive incentive environments for pharmaceutical and medical device manufacturers.

0%
Import Duty on Capital Goods & Raw Materials
Zero import duty on manufacturing equipment, capital goods, and raw materials used in pharmaceutical or medical device production within MPMED-SEZ. (TISEZA General Scheme)
20%
Reduced Corporate Tax (5 years)
Reduced corporate tax rate of 20% for the first 5 consecutive years for pharmaceutical and medical device manufacturing investments under TISEZA.
100%
Foreign Ownership Permitted
Qualifying pharmaceutical and medical device manufacturing investments may be 100% foreign-owned with unconditional free repatriation of net profits, loan repayments, royalties, and fees.
Free
Land — On Agreed Terms
Free land allocation within the MPMED-SEZ boundary on agreed terms for qualifying pharmaceutical and medical device manufacturing investments through TISEZA.
Immigration Quota
Automatic immigration quota — initially 10 expatriates during project implementation, additional permits based on project size and requirements. Work and resident permits via TISEZA One Stop Centre.
MSD Preferential Procurement
15% government price preference for locally manufactured products. MSD runs dedicated tenders for local manufacturers. Zero importation policy for products made locally in sufficient quantity. $491M annual procurement (FY24/25).
TMDA Facilitative Approach
TMDA dedicated desk at TISEZA. Reduced registration fees (USD 400 domestic). No import fees on raw materials and machinery. Fast-track mechanism for WHO-prequalified products. GMP and ISO 13485 advisory and construction supervision.
TISEZA One Stop Centre
Single facilitation window — TISEZA coordinates all investment services: certificates, licences, permits, immigration, tax, and TMDA liaison through One Stop Facilitation Centre.
MPMED-SEZ Zone Map
MPMED-SEZ 600ha Zone Map Pharma Cluster · Device Cluster · Logistics · R&D
MPMED-SEZ — Ministry of Health Zone Visualisation March 2026
Zone Configuration

The 600ha dual-sector industrial site

Mloganzila Plateau, 25km west of Dar es Salaam — the zone is physically designed around two industrial clusters with shared logistics, utilities, and regulatory infrastructure.

Pharmaceutical Manufacturing Cluster

Dedicated pharmaceutical zone — GMP-compliant factory shells, pharmaceutical-grade water, controlled environments, API production area.

Medical Device Assembly Cluster

ISO 13485 clean-room zone — device assembly units, sterilisation services, sterile packaging, TMDA device registration support office.

Cold-Chain Logistics Hub

GMP-compliant temperature-controlled warehousing and distribution connecting both manufacturing clusters to domestic and East African markets.

Biomedical R&D and Innovation Park

Clinical research, biomedical engineering, and health technology development — linked to Muhimbili National Hospital campus.

Request Zone Briefing Pack
Knowledge Repository

Sector documents for
pharmaceutical and device investors

Official policy documents, pharmaceutical manufacturing guides, medical device regulatory frameworks, feasibility templates, and market intelligence — published by the Ministry of Health.

Pharmaceutical Manufacturing Licensing Guide — TMDA
Regulatory · TMDA
2.1 MB
Medical Device Registration and ISO 13485 Guide — TMDA
Regulatory · TMDA
1.8 MB
MPMED-SEZ 600ha Zone Master Development Plan
Planning · Ministry of Health / TISEZA
18.6 MB
Tax Incentives and Investment Certificate Guide — TISEZA
Incentives · TISEZA / TRA
1.4 MB
Tanzania Pharmaceuticals Market Analysis — Import Substitution 2025
Research · Ministry of Health
6.8 MB
Medical Devices and Consumables Market Profile — Tanzania 2025
Research · Ministry of Health
5.2 MB
Call for Expression of Interest — Pharmaceutical Manufacturing (Green-Lane)
EOI · Ministry of Health · Green-Lane Approval System
ACTIVE
PIAT Preliminary Due Diligence Assessment Tool — Pharma V1.0 (XLSX)
Assessment · PIAT · 11 Weighted Sections · Scoring 1–5
NEW
National Health Investment Policy 2024–2030
Policy · Ministry of Health
4.2 MB
Pharmaceutical and Medical Device Facility Feasibility Templates (XLSX)
Template · Ministry of Health
1.2 MB
Pharmaceutical Sector Profile — East Africa (WHO AFRO)
Sector · WHO AFRO
7.9 MB
Regulatory Pathways

Two sector pathways.
One coordinated gateway.

MPMED-SEZ's regulatory framework includes separate licensing tracks for pharmaceutical manufacturers and medical device companies — both coordinated through PIAT and TISEZA's One Stop Facilitation Centre.

Pharmaceutical Manufacturers

TMDA Pharmaceutical Licensing Pathway

Step-by-step from pre-application consultation to manufacturing authorisation — accelerated 60-day timeline for domestic products. Reduced registration fees (USD 400 vs USD 2,000 for imports).

1Pre-application consultation — facility classification, GMP readiness assessment via TMDA desk at TISEZA
2Industrial drawings/layout approval — TMDA supervises construction at all stages
3WHO-GMP site inspection and compliance evaluation by TMDA
4Product dossier submission — formulation, stability, quality data (60 days domestic / 180 days import)
5Manufacturing Authorisation Certificate — fast-track for WHO-prequalified and EAC/SADC-harmonised products
6Post-market surveillance registration and annual GMP renewal
Medical Device Manufacturers

TMDA Medical Device Registration Pathway

Specific to medical device and IVD assembly within MPMED-SEZ — ISO 13485 certification aligned with TMDA device registration requirements.

1Device classification (Class I–IV) and pre-submission meeting with TMDA
2ISO 13485 Quality Management System certification for the manufacturing facility
3Technical file submission — design, safety, clinical evidence (45–120 days review)
4TMDA Medical Device Registration Certificate issued
5Post-market surveillance and annual renewal — TMDA and TISEZA zone compliance
TMDA WHO Maturity Level 3 · First in Africa

Tanzania Medicines & Medical Devices Authority

WHO ML-3 ISO 9001:2015 Lab ISO 17025 CoRE Drug Registration CoRE Vaccines
  • Pharmaceutical GMP manufacturing authorisation — 60-day accelerated pathway for domestic products
  • Medical device registration — ISO 13485 / TMDA device pathway (1,906 products registered)
  • Dedicated desk at TISEZA for investor facilitation
  • Reduced registration fees: USD 2,000 → USD 400 for domestic products
  • Fast-track mechanism and abridged assessment for WHO-prequalified products
  • EAC & SADC harmonised regulatory approval procedures
  • No importation fees for raw materials, packaging materials, and machinery
Open TMDA Portal — tmda.go.tz
TISEZA Replaces TIC & EPZA · Act No. 6 of 2025

Tanzania Investment & Special Economic Zones Authority

  • Investment certificate and SEZ/EPZ zone licence — single authority
  • One Stop Facilitation Centre — all permits, licences, certificates, immigration
  • 100% foreign ownership confirmation and profit repatriation guarantee
  • SEZ Developer's, SEZ User, EPZ Operator's, and SEZ Permits licensing
  • Coordination with TMDA and BRELA for pharmaceutical and device investors
  • Ongoing investor aftercare, compliance monitoring, and zone facilitation
Investment Categories (TISEZA)
$500KForeign Normal
$50MForeign Strategic
$300MSpecial Strategic
Open TISEZA Portal — tiseza.go.tz
BRELA

Business Registrations & Licensing Agency

  • Company registration for local and foreign pharmaceutical and device companies
  • Business name search and reservation — online, 24 hours
  • Tax Identification Number (TIN) via TRA integration
  • Sector-specific manufacturing business licence
  • Annual renewal and compliance certificate
Open BRELA Portal
Expression of Interest

Submit your
investment
expression of interest

The Government of Tanzania invites qualified investors to submit Expressions of Interest under the Green-Lane Approval System — implemented through the Pharmaceutical Investment Acceleration Programme (PIAP). Selected investors benefit from priority regulatory approvals, accelerated decision-making, and coordinated government support.

Green-Lane Approval System
Priority regulatory approvals
Accelerated decision-making across institutions
Coordinated government support — PIAT, TISEZA, TMDA, MSD
Rolling, accelerated review of submissions
Permanent Secretary, Ministry of Health, P.O. Box 743, 40478 Dodoma, Tanzania
PS@afya.go.tz — Official EOI submission email
+255 26 2323267 · Ministry of Health, Dodoma
Submissions reviewed on rolling, accelerated basis

✓ Expression of interest received — the Ministry of Health investment team will respond under the Green-Lane accelerated process.