WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices (WHO Medical device technical series)
This document was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its 51st meeting, which took place in Geneva from 17 to 21 October 2016, and will be published as Annex 4 to its report: Fifty-first report of the WHO Expert Committee on specifications for pharmaceutical preparations.

INTRODUCTION
Medical devices contribute to the attainment of the highest standards of health for individuals. 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 22 000 generic devices groups.

 

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