Health Canada to require STED format for Class 3/4 medical device submissions
Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010. The agency says it will "most likely occur in a phased in approach" and is expected to be fully implemented by July 1, 2010. There is a new version of the STED guidance document in the works and it is expected to be released for industry comment in the fall of 2009 - just a few months away. We'll keep you posted as we learn more.