Rehema Forgen Mariki is a Pharmacist and the Manager for Medical Devices and Diagnostics Assessment Section at the TMDA. With over 20 years of experience in the regulation of medicines and medical devices, she brings significant expertise in evaluating and overseeing health technologies. Her current role focuses on the market authorization of medical devices and diagnostics, supporting TMDA’s mission and vision.

Before her managerial role, Rehema was a principal officer at the former Tanzania Food and Drugs Authority (TFDA). Her duties involved assessing medical device including diagnostic dossiers, conducting quality audit and GMP inspections of medical devices and pharmaceutical facilities, participating in development of regulations and several guidelines that contributed to the development of regulatory systems. She involved in developing medical devices regulatory tools used under African Medical Devices Forum (AMDF) supported by AUDA-NEPAD and she serves as a member of Technical Committee representative to Global Harmonization Working Party (GHWP)

Introduction

Medical Devices and Diagnostic Assessment (MDA) Section is a under the Directorate of Medical Devices and Diagnostics Control (DMD). The Section's mandate derived from Section 51 of the TMDA Act, Cap 219, is to protect public health by ensuring the availability of safe, effective and quality medical devices and diagnostics on the Tanzanian market. The key regulatory functions of the MDA include medical device and diagnostics registration, notifications, control of medical device and diagnostics promotion materials and advertisements. The MDA achieves its mandate through medical devices and diagnostics assessment of applications and maintain the register for medical devices and diagnostics.

Personnel

Personnel The Section is headed by the Manager who leads a team of full time Officers, including Senior and Principal Officers. The team comprises of qualified and experienced professionals from diverse fields such as pharmacy, medicines, biomedical engineering, microbiology and medical laboratory sciences. They are well equipped with adequate knowledge, expertise and experience to ensure that registered medical devices and diagnostics circulating in Tanzania market are of quality, safety and are well performing the requirements

Functions

The MDA Section archives its mandate through the following functions: -

• Processing and approval of new, renewal and variation applications
• Dossier aassessments of summary technical iinformation of devices applied for marketing approval following Essential Principals of Safety and Performance;
• Maintain a medical device and diagnostics register;
• Notification of Class A medical devices, diagnostics, laboratory consumables and medical gases;
• Issuance of registration certificates;
• Revocation of registration certificates;
• Coordination of the Technical Committee for recommendation of medical devices and diagnostics registration;
• Coordination of performance evaluation of In Vitro Diagnostics; and
• Developing and reviewing of Regulations, Guidelines for medical devices and diagnostics registration
• Control of Promotional materials and advertisement of medical devices and diagnostics
• Correspondences with applicants.