Medical devices

                                  Overview

                                  Access to good quality, affordable, and appropriate health products is indispensable to advance universal health coverage, address health emergencies, and promote healthier populations.

                                  Without medical devices, common medical procedures – from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention – would not be possible. Medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians and dentists and by health-care professionals in advanced medical facilities, for prevention and screening and in palliative care. Such health technologies are used to diagnose illness, to monitor treatments, to assist disabled people and to intervene and treat illnesses, both acute and chronic.

                                  Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups.

                                  A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

                                  WHO Response

                                  Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. Within the context of a robust health system they ensure access to safe, effective, and high-quality medical devices that prevent, diagnose, and treat disease and injury, and assist patients in their rehabilitation.

                                  WHO’s “Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices” supports Member States to develop and implement regulatory controls and regional guidelines for good manufacturing to ensure the quality, safety and efficacy of medical devices available in their countries. The Organization also works with Member States and collaborating centres to develop guidelines and tools, including norms and standards on medical devices.

                                  Additionally, WHO supports Member States in establishing mechanisms to assess national needs for health technologies in particular medical devices and to assure their availability and use, particularly in low-resource settings. A web-based health technologies database serves as a clearing house and provides countries guidance on appropriate medical devices according to levels of care, setting, environment, and intended health intervention, tailored to the specific needs of country or region.

                                  34%

                                  of 145 countries

                                  have a health technology national policy that is part of the national health programme

                                  Learn more

                                  41 out of 135

                                  countries

                                  do not have at least one computer tomography device per million inhabitants.

                                  Find out more

                                  Publications

                                  All →
                                  Generating Evidence for Artificial Intelligence Based Medical Devices: A Framework for Training Validation and Evaluation

                                  This first-of-its-kind publication from the WHO is a framework targeted at developers and researchers of AI-based software as a medical device, as well...

                                  WHO neonatal resuscitation manikin technical specifications

                                  The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One...

                                  WHO compendium of innovative health technologies for low-resource settings 2021. COVID-19 and other health priorities

                                  Health technologies, specially medical devices are essential for a functioning health system. The  response  to  the  global ...

                                  Portable digital radiography system: technical specifications

                                  This WHO-IAEA joint publication takes its origin from a substantial and increased need from Member States, donor agencies and NGOs to use “portable”...

                                  WHO Global Fora on Medical Devices

                                  Member States recognized in World Health Assembly (WHA) resolutions WHA60.29 (2007) and WHA 67.20 (2014) that medical devices are indispensable for health-care delivery but that their selection, regulation and use present enormous challenges, especially for low- and middle-income countries (LMIC).

                                  In order to increase access to appropriate, safe, affordable, effective medical devices of quality for all; the WHO Medical Devices has enable the WHO Global Fora on Medical Devices. 

                                  The WHO Global Fora on Medical Devices serve as opportunities to share WHO initiatives to support country needs towards Universal Health Coverage (UHC) and the achievement of the Sustainable Development Goals (SDGs). The Fora also serve as occasions to listen to regional and country activities on medical devices issues. The Fora present the WHO resources available to Member States in a range of topics concerning medical devices:

                                  • policy of medical devices
                                  • regulation of medical devices
                                  • nomenclature of medical devices
                                  • medical devices innovation 
                                  • selection and prioritization of medical devices
                                  • human resources for medical devices
                                  • management of medical devices
                                  • among others

                                  The programmes of the WHO Global Fora have include presentations on the a huge range of topics on medical devices and also help present WHO projects, initiatives, tools, resources and work in progress.

                                  WHO Medical Devices Technical Series

                                   

                                   

                                  What is the Medical Devices Technical Series?

                                  The "Medical Devices Technical Series (MDTS)" is a series of publications intended to increase access to medical devices. WHO developed this series that cover the following areas:

                                  • Development of medical devices policies
                                  • Human resources for medical devices
                                  • Regulation of medical devices
                                  • Health technology assessment of medical devices
                                  • Health technology management
                                  • Priority and essential medical devices

                                  Who could use the MDTS?

                                  • Policy-makers, biomedical engineers working in health care settings and government institutions
                                  • Hospital and clinical managers
                                  • Donors of medical devices and NGOs working in health technology
                                  • Academic institutions studying health technology
                                  • District, national, regional and global health managers

                                  Global collaborations on Medical Devices

                                  WHO directs and coordinates international health work through collaboration. WHO partners with countries, the United Nations system, international organizations, civil society, foundations, academia, and research institutions. Official collaborations with WHO are conducted in the following forms: 

                                   

                                   

                                  Contact