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.

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categories Regulatory Affairs | Chris Schorre, Emergo Group August 13, 2009 | comments Comments (0)

MHRA publishes updated guidance document for clinicals conducted in UK

In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation. In addition the guidance talks about how to complete an application, outlines how it will be processed and what documentation will be required. You can download the document here.

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categories Regulatory Affairs | Chris Schorre, Emergo Group August 12, 2009 | comments Comments (0)