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Table 3 Control of diagnostic and medical devices in EAC Partner States

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

  1. 1Control programmes supported by donor aid e.g. TB, HIV/AIDS, Malaria.