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Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from worldwide national medical device regulatory authorities and the regulated industry.

Primary Purpose
To encourage convergence in regulatory practices through publication and explanatory guidelines of harmonized guidance documents on basic regulatory practices.

Availability
The documents http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm, which are developed by five different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The recommendations in these documents are widely used, however it is important to notice that requirements in the Directives might not be implemented in the GHTF documents. 
 

 

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