WHO Global Benchmarking Tool + Medical Devices (GBT + medical devices) for evaluation of national regulatory systems of medical devices including in-vitro diagnostics

The Global Benchmarking Tool Plus Medical Devices (GBT+MD) is an extension of the World Health Organization’s GBT framework, designed to support the evaluation and strengthening of regulatory systems for medical devices. While sharing common regulatory principles with other medical products such as medicines, vaccines, and blood products, regulating medical devices presents unique challenges and opportunities that the GBT+MD addresses explicitly. 

 The WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD) Revision VI+MD version 2, published in December 2024, is the latest release of the GBT for benchmarking medical devices' national regulatory systems. This release comprises six (6) regulatory functions under the overarching framework of the national regulatory system (RS). Additionally, the GBT+MD includes a detailed glossary and fact sheet to provide clarity on key terms and definitions.

Currently, the GBT+MD is available in English. Work is underway to translate the GBT+MD into other official languages of the United Nations (UN).

All queries related to the GBT+MD including requests for the computerized platform (cGBT) should be sent to the WHO Regulatory Systems Strengthening Team at  nra_admin@who.int