From: Regulation of medical diagnostics and medical devices in the East African community partner states
Country | Burundi | Kenya | Rwanda | Tanzania Mainland | Tanzania Zanzibar | Uganda |
---|---|---|---|---|---|---|
Are medical devices regulated by a National Authority | Some | Some | Programme only (MOH) | Yes | Joint with Mainland (TFDA) | Yes |
Regulation of in-vitro diagnostics | Not yet | In development | Programme only (MOH) | Yes | Joint with TFDA | Guidelines (Allied Health Professionals Council of Uganda) |
Regulation of IVDs in the private sector | Not yet | In development | N/A | Yes | Joint with TFDA | Guidelines (Allied Health Professionals Council of Uganda) |
Regulation lab reagents and stains for diagnostics use | Import controls | In development | N/A | Yes | Joint with TFDA | Guidelines (Allied Health Professionals Council of Uganda) |
Regulation of diagnostic tests for veterinary use | None | In development | None | Yes | Joint with TFDA | Yes |
Pre-market control on IVDs | None | None | Programme only1 | Yes | Joint with TFDA | None |
Post market control on IVDs | None | None | Programme only1 | Yes | Joint with TFDA | None |