WHO Draft: Global Model Regulatory Framework for Medical Devices including IVDs, 7/16

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In mid-2016, the World Health Organization (WHO) published the 2^nd draft of Global Model Regulatory Framework for Medical Devices including IVDs. This document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices to ensure the quality and safety of medical devices.

Since many modern medical devices contain software, developers of device software and applications will want to become familiar with the global framework being proposed by WHO.

WHO has specified that the draft framework not be published on any non-WHO websites, so to obtain a copy, please use this link:  http://www.gmp-compliance.org/download/ModelregulatoryFramework_MedDev_QAS16-664Rev1_27072016.pdf