Science & Technology: Electronic Regulatory Submissions for Medical Devices in the US and the EU

Regulatory agencies in the US and European Union are moving toward requiring submissions for medical devices in electronic format. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to achieve greater uniformity and standardized format across national medical device regulatory systems. The aim of GHTF is twofold: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.