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Table 2 Regulatory legislature and health policy in EAC Member States and territories

From: Regulation of medical diagnostics and medical devices in the East African community partner states

 

Legislation for medical devices

National Health Policy

National Health Laboratory Policy

Guidelines

National Regulatory Authority

Burundi

Yes

na

na

na

Directorate of Pharmacies, Medicines and Laboratories

Kenya

Yes

Yes

Yes

Yes

Kenya Medical Laboratory Technicians and Technologist Board/Pharmacy and Poisons Board

Rwanda

Yes

Yes

na

Yes

Task force to set up FDA, but diagnostics not yet included

Tanzania Mainland

Yes

Yes

P

Yes

Tanzania Food and Drug Authority/Private Health Lab Board

Tanzania Zanzibar

Yes

Yes

na

Yes

Zanzibar Food and Drugs Board

Uganda

  

Yes

Yes

National Drug Authority/Allied Health Professionals Council of Uganda

  1. na: Not available; P: Aspects of laboratory policy incorporated in the National Health Policy.