Medical devices

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

WHO Medical device technical series

Publication details

Number of pages: 76
Publication date: 2017
Languages: English
ISBN: 978-92-4-151235-0

Summary

The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).