WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices, Annex 3

Overview

Adopted by the seventy-sixth meeting of the World Health Organization Expert Committee on Biological Standardization, 24–28 October 2022. A definitive version of this document, which will differ from this version in editorial but not scientific details, will be published in the WHO Technical Report Series.

This revised GMRF recommends guiding principles and harmonized definitions, and specifies the attributes of effective and efficient regulations to be embodied within binding and enforceable national laws. Its main elements are derived from international regulatory harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF), along with regional harmonization initiatives.