Africa
The Ethiopian Food and Drug Authority (EFDA), the country’s regulating agency responsible for medical devices, has published a guidance document dedicated to medical device bundling in the context of marketing authorization application. Regulatory Background ...
Africa
Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published guidelines dedicated to the regulatory procedures for placing low-risk medical devices on the market. The document constitutes the initial...
Africa
The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices. The appropriate...
