To encourage and support the global convergence of documentation requirements for medical devices Health Canada intends to adopt for premarket licence applications for Class III (medium- to high-risk) and IV (highest-risk) medical devices the STED - global submission document.

The STED - Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices is a harmonized global submission document developed by the Global Harmonization Task Force (GHTF). The STED’s adoption will most likely occur by way of a phased-in approach.Once fully implemented (by July 1, 2010), manufacturers would be expected to submit premarket applications for Class III and IV medical devices based on the STED guidance document.

More information under:Health Canada - Notice.
 

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