Vigilance and Post Marketing Surveillance Forms and Checklist
TMDA is committed to ensuring the ongoing safety and performance of medical devices and diagnostics available on the market. To uphold this commitment, we rely on a robust system for post-market surveillance, which includes the vigilant reporting of any adverse events or incidents associated with their use.
The checklists and forms provided here are essential tools for healthcare facilities, professionals, manufacturers, importers, suppliers, users, consumers and the public to facilitate the accurate and timely reporting of such occurrences. It enables us to identify potential risks, monitor product performance, and take necessary actions to protect public health.
- Field Safety Corrective Action (FSCA) Form Download
- Medical Devices and In Vitro Diagnostics Adverse Event/Incident Reporting Form for Importers/Suppliers Download
- Medical Devices and Invitro Diagnostics Adverse Event/Incident Reporting Form for Manufacturers Download
- Orange Adverse Event- Incident Reporting Form for Consumer & Health Facilities Download
- Fomu ya Kutolea Taarifa za Madhara/Matukio yatokanayo na Matumizi ya Vifaa Tiba na Vitendanishi kwa Mtumiaji Binafsi na Vituo vya Afya Download