TMDA has been an affiliate member of International Medical Device Regulators Forum (IMDRF) since March 2024. Through this membership, TMDA benefits from enhances capacity building in medical devices regulatory systems and staff competency. This is especially critical as the regulatory control of medical devices and diagnostics is still evolving and rapid advancement in Technology and innovations have led to increasingly complex medical devices and diagnostics that pose regulatory challenges particularly in low- and middle - income countries.

To address these challenges, more innovative regulatory approaches are required to ensure access to safe and efficient medical devices and diagnostics products.

TMDA is currently represented in IMDRF by two key officials

1. Dr. Kissa Watson Mwamwitwa - Director, Medical Devices and Diagnostics Control
2. Ms. Rehema Forgen Mariki - Manager, Medical Devices and Diagnostics Assessment

Through this membership, TMDA actively participated in various meetings focusing on regulatory oversight of medical devices and diagnostics. TMDA also contributes to the development of technical guidelines and adopts IMDRF guidelines in its assessment processes. Additionally, the membership provides capacity-building opportunities to further enhance staff expertise.

TMDA currently participates in two IMDRF Technical Working Groups:

1. Regulated Product Submission (RPS) – represented by Ms. Gudula Mpanda
2. Good Regulatory Review Practices (GRRP) – represented by Mr. Octavian Ngoda

Through this membership TMDA achieves the following

1. Harmonized frameworks enhance global collaboration, enabling efficient regulation and access to safe, effective, and quality medical devices and diagnostics.
2. Sustained oversight guarantees public health protection through evidence-based decision-making and continuous improvement.
3. Dynamic regulatory systems adapt to innovations, ensuring readiness to address emerging health technologies and challenges

For more details on IMDRF please click here.