Module 19 2021

01/06/2021

The global picture

Number of countries with a legal framework for medical devices by WHO region!

Global Atlas of medical devices WHO medical devices technical series ISBN: 978-92-4-151231-2

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The GLOBAL HARMONIZATION TASK FORCE (GHTF) • 1993 – 2011 • Voluntary group of representatives from national medical device regulatory authorities and the regulated industry. • Founding members ● Australia, Canada, Europe, Japan, US • Purpose: Encourage convergence in regulatory practices ● ensuring the safety, effectiveness/performance and quality of medical devices, ● promoting technological innovation, and ● facilitating international trade • Methodology ● publication and dissemination of harmonized guidance documents on basic best regulatory practices.

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