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Canada issues much-awaited draft STED guide

This article was originally published in Clinica

Executive Summary

Health Canada has set an implementation deadline of July 2011 to adopt the global submission document, STED, as the only format for processing licensing applications for medium- and high-risk devices (Class III and IV). To that end, it has issued for public consultation a much-awaited guidance document that outlines both Canada-specific requirements and STED-based filing requirements for device licensing applications.

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