Development of medical device policies, 2nd ed.

Overview

A first edition of the Development of Medical Devices Policies was published in 2011. This second edition was prepared to reflect the transition from the Millennium Development Goals to the Sustainable Development Goals, ensuring its relevance to current global health priorities. Moreover, new sections have been added to address recent pressing public health issues such as sustainability, digital health, participatory governance, and public health emergencies. The document now encompasses updated regulatory frameworks, Health Technology Assessment and Health Technology Management, and includes a new section on the nomenclature of medical devices. It focuses on prioritizing needs, addressing relevant new World Health Assembly resolutions, and referencing recent WHO medical devices technical series publications. Additionally, it includes guidance on implementing effective strategies and measuring progress through defined indicators and evaluation systems.