Mr. Bryceson Paul Kibassa is a Public Health Specialist and currently serves as the Manager for Premises Licensing and Compliance – Medical Devices and Diagnostics at the Tanzania Medicines and Medical Devices Authority (TMDA), a position he has held since January 2022. He holds a Bachelor of Pharmacy and a Master of Public Health, both from the Muhimbili University of Health and Allied Sciences (MUHAS).

Mr. Kibassa has over ten years of regulatory experience at TMDA, having served as ADDO Program Coordinator, Planning Manager, and Acting Director for Business Support. From 2016 to 2020, he was appointed District Executive Director (DED) in Local Government, where he oversaw sectors including health, education, infrastructure, and socio-economic development.

Earlier in his career, he worked at CCBRT (1999–2004) as a Program Pharmacist, managing supply chains for HIV/AIDS, hospital services, and outreach programs. He actively participates in national and international regulatory forums and represents Tanzania in SADC and GHWP initiatives.

Introduction

Medical Devices Premises Licensing and Compliance is a section under the Directorate of Medical Devices which is responsible for ensuring that all medical devices, diagnostics, laboratory equipment and medical gases within Tanzania Market comply with prescribed standards of quality, safety and performance. To execute this responsibility, the Section has put in place three sub-sections which are Premises Licensing and inspection, Import and Export Control and Quality Audits of domestic and overseas manufacturing facilities. As a result, this Section mainly deals with importers, wholesalers, retail and manufacturers of Medical Devices, Diagnostics, Laboratory Equipment and Medical gases.

Personnel

The Section is headed by a Manager who leads a team of full-time Officers and Senior Officers. The team comprises qualified and experienced professionals from diverse fields, including Biomedical Engineering, Biotechnology, Microbiology, Medical Laboratory Sciences and Pharmacy. All staff members possess the necessary knowledge, expertise, and experience to perform their responsibilities effectively and efficiently.

Duties and Responsibilities of the Section

Some of the key functions performed by the section in the fulfillment of the Authority’s mission of protecting and promoting public health include the following:-

1. Conduct good storage and distribution practices (GSP and GDP), inspection to ensure compliance of medical devices, diagnostics, Medical gases, and laboratory equipment.
2. Coordinate inspection of blood establishments including blood donating centers and hospitals;
3. Assessments and Issuance of permits for importation and exportation of medical devices, diagnostics, medical gases, laboratory equipment, blood and blood products;
4. Maintain and reconcile records of import and export permits issued for medical devices, diagnostics, medical gases, laboratory equipment, blood and blood products and consignments inspected;
5. Maintain and update a register of product dealers (importers, exporters, manufacturers, wholesalers and retailers) for medical devices, diagnostics, medical gases, laboratory equipment, blood and blood products
6. Coordinate quality audits of both domestic and foreign manufacturing facilities for medical devices, diagnostics and medical gases to ensure compliance to ISO Standards.
7. Coordinate Good Manufacturing Practices (GMP), inspection of manufacturers of blood, blood products and its components
8. Monitor print, electronic and social media adverts on medical devices, diagnostics, laboratory equipment, blood and blood products
9. Prepare and issue registration certificates and business permits for manufacturing, warehousing, wholesaling and retailing of medical devices, diagnostics, medical gases, laboratory equipment, blood and blood products.
10. Recall medical devices, diagnostics, medical gases, laboratory equipment, blood and blood products that are substandard or counterfeit circulating on the market. Click here to view list of Registered Premises
11. Coordinate disposal of unfit medical devices, diagnostics, blood and blood product

During the execution of its regulatory functions, the Section collaborates with all other sections within the Directorate on matters related to the registration of products from quality audited facilities, Post Marketing Surveillance, and vigilance activities. Furthermore, the Section works closely with all TMDA Zone offices to conduct regulatory inspections aimed at fulfilling TMDA’s mission of protecting and promoting public health.