The Summary Technical Document (STED) is a harmonized submission format developed by the Global Harmonization Task Force (GHTF). The GHTF is a cooperation between representatives from the United States of America and four other member states: European Union, Canada, Australia, and Japan. The GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines. The STED harmonized submission format is already accepted by multiple regulatory authorities worldwide.
The STED format and content is described in the document titled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices”, and can be found on the website of the GHTF (http://www.ghtf.org/).