The first edition of the Development of Medical Devices Policies was published in 2011. This second edition has been updated to reflect the global shift from the Millennium Development Goals to the Sustainable Development Goals, ensuring alignment with today’s health priorities.
New sections have been introduced to address emerging public health challenges, including sustainability, digital health, participatory governance, and responses to public health emergencies. The document also incorporates updated regulatory frameworks, as well as expanded guidance on Health Technology Assessment (HTA) and Health Technology Management (HTM). A new section on medical device nomenclature has been added to support consistency and clarity in classification.
This edition places strong emphasis on prioritizing health needs, responding to recent World Health Assembly resolutions, and referencing the latest WHO medical device technical series. It further provides practical guidance on implementing effective strategies and offers tools for measuring progress through defined indicators and evaluation mechanisms.
The second edition can be accessed using the following link
