Aug 13, 2009
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.
According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing
Health Canada has announced changes to its list of recognized list of medical device
Health Canada is seeking comment from industry on a proposed risk-based inspection model for medi