TMDA registration
The Tanzania Medicines and Medical Devices Authority (TMDA) is a WHO Maturity Level 3 regulator. MPMED-SEZ manufacturers use a 60-day fast-track, with registration fees reduced from USD 2,000 to USD 400 per product.
| Step | Name | Responsible agency | Timeline | Documents | Fee | Link |
|---|---|---|---|---|---|---|
| 1 | Product registration (fast-track) | TMDA | 60 days | Dossier (CTD), GMP certificate, samples | USD 400 (reduced from USD 2,000) | tmda.go.tz |
| 2 | Manufacturing site licence | TMDA | 30 days after inspection | Site master file, quality manual | Per TMDA fee schedule | tmda.go.tz |
| 3 | GMP inspection & WHO-PQ support | TMDA / PIAT | Scheduled with PIAT lead | Validation batches, QA documentation | - | tmda.go.tz |