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 the Manager leads the team of seven (7) full time Officers and Senior Officers. The team is made of qualified and experienced experts from the fields of Biomedical Engineering, Pharmacy and Medical Laboratory Sciences. All Staff members have adequate knowledge, expertise and experience to perform effectively and efficiently their responsibilities.

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
11. Coordinate disposal of unfit medical devices, diagnostics, blood and blood product

During execution of these responsibility regulatory functions, the Section collaborates with the Medical Devices and Diagnostics Assessment Section, in matters related to registration of products from Quality Audit complied facilities. Furthermore, the section works hand in hand with all TMDA Zone offices to perform regulatory inspection activities targeting to achieve the TMDA mission of protecting and promoting public health.