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WHO global model regulatory framework for medical devices including in vitro medical device diagnostics (WHO Medical device technical series)

This document was adopted by the WHO Expert Committee on 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 to ankle, to diagnosing HIV / AIDS, implanting an artificial hip or any surgical intervention - would not be possible. Medical devices are used in many different 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 treat illnesses, both acute and chronic.

Today there are an estimated 2 million different types of medical devices on the world market, categorized into 22 000 generic devices groups.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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