Are you thinking about marketing your innovative device in Japan? If so, you should know that the Pharmaceuticals and Medical Devices Agency (PMDA) has specific...
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.