Dr. Danstan Hipolite Shewiyo
Director, Laboratory services
Legal Status
TMDA Quality Control Laboratory is established under Section 14(1) of the Tanzania Medicines and Medical Devices Act, Cap. 219, to conduct analysis of regulated products.
The Authority operates three main laboratories located in Dodoma, Dar es Salaam, and Mwanza within TMDA’s Head office, Sub-Head Office and Zonal Office. These laboratories are further supported by 27 Medicines Quality Assurance Centers, each equipped with minilab kits. The centers are strategically stationed at ports of entry, zonal offices, and selected regional referral hospitals across the country.
Test results generated by these facilities provide robust, evidence-based data that guide TMDA in making informed regulatory decisions, ensuring the safety, quality, and efficacy of regulated products in Tanzania.
Roles and Functions of TMDA Laboratories
TMDA Quality Control Laboratory safeguards public health by ensuring that regulated products meet strict quality, safety, and efficacy standards.
Our key functions include:
- Testing medicines, medical devices, diagnostics, herbal products, raw materials, packaging materials and related products.
- Conducting research to improve testing methods, regulatory actions and decision.
- Providing training and capacity building to strengthen quality control skills and expertise.
- Accrediting public and private medical laboratories to ensure they have the competence to offer services as per quality requirements.
- Carrying out other quality-related tasks as assigned by TMDA's Director General.
TMDA top management is committed to complying with the requirements of the ISO/IEC 17025:2017 and WHO Good Practices for Pharmaceutical Quality Control Laboratories and ensures that laboratory services rendered to its customers are always offered by competent laboratory personnel in an impartial manner. Management provides resources for implementation and continually improves effectiveness of our Quality Management System by ensuring that personnel within the Laboratory are familiar with the quality documentation and implement consistently policies and procedures in their work.
Compliance
TMDA Quality Control Laboratories operate under a Quality Management System aligned with ISO/IEC 17025:2017, WHO Good Practices for Pharmaceutical Quality Control Laboratories (WHO Technical Report Series No. 1052, Annex 4), and other relevant international standards.
The Dar es Salaam medicines chemical analysis and microbiology laboratories have attained WHO Prequalification since January 2011 and 2022 respectively.
Medical Devices Testing is is accredited based on ISO/IEC 17025:2017
Likewise, the Mwanza and Dodoma laboratories are implementing QMS based on ISO/IEC 17025:2017 and are under the process of accreditation.
Quality of Results
By complying with these international standards, TMDA laboratories guarantee accurate, reliable, and internationally recognized test results. This commitment to quality strengthens confidence in the safety, efficacy, and quality of regulated products tested in our facilities.
TMDA Laboratories
TMDA operates a nationwide network dedicated to safeguarding the quality, safety, and efficacy of regulated products. This network comprises three state-of-the-art laboratories located in Dar es Salaam, Dodoma, and Mwanza — and 27 Quality Assurance Centers strategically positioned across the country.
Our laboratories are equipped with modern analytical instruments and staffed by highly qualified scientists, enabling us to deliver accurate, reliable, and internationally recognized results. Each facility operates under a robust ISO/IEC 17025:2017-accredited Quality Management System and, where applicable, WHO prequalification.
Together, this network ensures that products in Tanzania meet both national and global quality standards — protecting public health and supporting fair trade.
Our Services
Customers We Serve
TMDA Quality Control Laboratories provide services to both internal and external customers. Key customer groups include:
- Government Institutions and Ministries
- Product manufacturers
- Importers and Distributors
- Exporters
- Researchers
- Wholesalers and Retailers
- International Organizations (e.g., WHO)
Sample Analysis
We perform analysis of a wide range of regulated and non-regulated products, including:
- Medicines
- Medical devices
- In-vitro Diagnostic (IVD) Products
- Tobacco Products
- Other Non-regulated Products
All Quality Control testing is conducted in compliance with national and international standards such as Pharmacopoeias, ISO standards, and other relevant guidelines.
Turnaround Times: Testing results are issued within the timelines specified in the Client Service Charter.
Click here for more information on fees and charges for analysis of regulated and non-regulated products
Click here for sample submission procedure
Training Services
We offer a variety of training programs on laboratory operations, systems, and quality management — tailored to the needs of our customers. Training is provided on a fee basis and may include:
- Attachments
- Short Courses
- Laboratory Tours
- Internships
- Field Work
Available training areas:
- Quality Management System – ISO/IEC 17025 (Competence of Testing and Calibration Laboratories)
- Laboratory analytical techniques
- Analytical method development and validation
- Microbiological testing
- Good Laboratory Practices
- Quality Management System – ISO 15189 (Medical laboratories – Requirements for quality and competence)
The fees and charges for Training Services are outlined below as per The Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2021
| SN | TRAINING SERVICES | FEES IN USD (per person) |
| 1 | Training on Quality Management System - ISO17025 | 400 |
| 2 | Training on Quality Management System - ISO15189 | 400 |
| 3 | Training on laboratory analytical techniques | 800 |
| 4 | Training on analytical method development and validation | 1,000 |
| 5 | Training on microbiological testing | 500 |
Our laboratory provides expert consultancy in all aspects of laboratory operations and quality management systems.