A Summary TEchnical Document (STED) is a harmonized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF); known now as the International Medical Device Regulators Forum (IMDRF). The long term goal of STED is to globally standardize regulatory submissions.
The five original GHTF members are actively using or evaluating STED as a pilot program: Australia, the European Union, Japan, Canada and the United States. There are other countries which also utilize the STED format for regulatory submissions. Canada now strongly recommends the use of STED format for Class III and IV medical device license submissions. In Japan, the Japanese submissions are essentially required to be in STED with more detail.
The information required for the preparation of a Summary Technical Document (STED) is most similar to the documentation required for a European Technical File. Other countries around the world have begun to accept the STED or ASEAN CSDT.
Emergo has expertise in preparing submissions in the STED format and we can fully assist in preparing or reviewing submissions for your medical devices for any of the markets mentioned above.