Status and solutions to medical device regulations for improving the healthcare landscape in Africa.

For different reasons most African countries have a poor public healthcare system compared to developed countries. Despite an increasing number of patients they often lack skilled health workers as well as basic medical equipment. This paper focuses on the development of an affordable and sustainable system for medical device regulations to provide safe, effective and quality healthcare products for Africa. Furthermore, it is determined whether Open Source Medical Devices are an effective alternative for medical device regulations to increase innovations in Africa.