WHO Policies on Medical Devices

Supporting the World Health Organization (WHO) in providing guidelines for medical device policies 

World Health Organization (WHO) 

Medical devices play a crucial role in preventing, diagnosing, and treating illnesses, as well as supporting patient rehabilitation. 

According to WHA60.29 and subsequent resolutions, including WHA67.20 on regulatory systems for medical products, WHA67.23 on health technology assessment, WHA76.5 on diagnostics, and WHA76.3 on oxygen, Member States have requested WHO to provide technical support for the development of policies related to medical devices or specific subsets of medical devices. 

In response to these requests, WHO published its first guidance on medical device policy development in 2011, which has since been updated. Our team was selected from numerous applicants across all continents who submitted proposals and has been granted a budget to revise and expand this document in collaboration with WHO experts, independent consultants, and NGOs. 

This forthcoming edition reflects the shift from the Millennium Development Goals (MDGs) to the Sustainable Development Goals (SDGs), emphasizing primary healthcare strengthening and the achievement of universal health coverage (UHC). 

The updated guidance, which is yet to be published, is structured into 14 chapters and introduces several new topics not covered in the previous edition, including sustainability, data management, participatory governance, and health emergencies. 

This document aims to underscore the critical role of medical device policies in strengthening health systems. It provides guidance on policy development for innovation, regulation, assessment, management, and lifecycle use at both national and local levels. The overarching goal is to ensure that medical devices are safe, effective, affordable, sustainable, and accessible, addressing population needs while optimizing resources for improved health outcomes.