Ms. Catherine Mgela Luanda
Manager, Medical Devices and IVDs Testing Section
Ms. Catherine Mgela Luanda is an enthusiastic Healthcare Science professional with an MSc. in Health and Biomedical sciences and 17 years’ experience as a laboratory analyst in clinical research, microbiology quality control and laboratory management. She is adept in laboratory quality management system establishment, implementation and monitoring.
Her adaptability is instrumental in responding to diverse quality testing requirements, expansion of testing scope to include numerous test parameters and devices such as medical textiles, surgical supplies and intravenous administration equipment thus contributing to strengthening of Laboratory services and Authority regulatory capacity.
The Medical Devices and Diagnostics Testing Laboratory is accredited to ISO/IEC 17025:2017 since 2024, demonstrating its technical competence and commitment to delivering reliable, internationally recognised testing services. We ensure that medical devices and in-vitro diagnostics (IVDs) are safe, reliable, and perform as intended before they reach users.
Medical Devices Testing
We assess a wide range of medical devices — from condoms and gloves to syringes, surgical blades, bandages, absorbent cotton, diapers, and other healthcare products. Our testing focuses on essential safety, quality, and performance characteristics such as durability, strength, integrity, and functionality in line with national and international standards.
Using advanced technology, including automated measurement systems, leak detection equipment, and tensile testing machines, we are able to simulate real-world use and ensure that products meet strict regulatory requirements.
In-Vitro Diagnostics (IVDs) Testing
We verify the performance of diagnostic products, including rapid tests for Malaria and HIV, to confirm they provide accurate and dependable results.
The laboratory includes:
- Molecular Biology Laboratory – equipped with advanced systems such as the QuantStudio™ 5 Real-Time PCR System for high-precision molecular testing.
- IVDs Performance Testing Area – dedicated to performance verification under controlled laboratory conditions.
Our Commitment
Through rigorous testing, ISO/IEC 17025:2017 accreditation, and state-of-the-art equipment, we ensure that medical devices and diagnostics meet the highest safety and quality standards, helping to protect public health and build trust in healthcare products.
For details on specific tests and associated fees, please refer to the Fees and Charges Regulations.