Regulation of Medical Devices: A Step-by-step Guide (2016)



The purpose of Regulation of medical devices: a step-by-step guide is to improve access by countries to quality and safe medical devices by offering guidance on strengthening their regulatory controls. It provides decision-makers with a roadmap for implementing regulatory systems in their national settings and a step-by-step approach towards the development of national programmes for the regulation of medical devices. It can be applied by any country seeking to develop its regulatory capacity.