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.
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.